The Hamner Institutes for Health Sciences has signed an agreement with China Medical City to create the Hamner-China Medical City Institute for International Drug Development. Building on strengths of the two organizations in translational research, business development, and education, the Institute will help to produce new biomedical technologies that benefit the U.S. and People's Republic of China as well as the rest of the world.

During the first phase of this agreement, the Institute for International Drug Development will be established at The Hamner's campus in Research Triangle Park (RTP), NC, and will focus on preclinical drug development and compliance with FDA regulatory standards. After the partners validate research capabilities and new technologies at The Hamner campus, they will transfer them to China Medical City, a new life science park located in the Yangtze River Delta north of Shanghai.

In 2008, The Hamner launched a Bioscience Accelerator on its 56-acre campus in the heart of RTP. There are two initial start-ups: BioMedomics, a diagnostics company started by Chinese-American scientists, and b3bio, a spinout from Duke University.

Newsummit Biopharma, one of China Medical City's premier partners, is establishing its North American business center in The Hamner's Bioscience Accelerator. Newsummit Biopharma is a contract research and technology development company whose service platform includes support for commercialization, intellectual property, funding, and staffing in science and technology parks throughout China.

The partnership with China Medical City and Newsummit Biopharma creates a vital bridge of opportunity between NC and China. Acknowledged worldwide as a major hub of biotechnology, NC is an ideal location for companies from China that seek to enter the U.S. market. After establishing an initial presence in RTP, which already has a strong Chinese community of scientists and business professionals, companies from China can expand around the state as their businesses prosper and grow.

As part of its strategic agreement with China Medical City, The Hamner has worked with the NC Dept. of Commerce and NC Biotechnology Center, a world leader in bioscience development, to create a "North Carolina-China partner network" that supports Chinese business and educational initiatives. Other members of this innovative network include the NC China Center, the NC China Business Association, Council for Entrepreneurial Development, and NC Research Parks Network as well as economic development organizations in counties such as Wake and Durham.

China Medical City and Newsummit Biopharma are actively using their network to assist NC's R&D companies, contract organizations (research, manufacturing, and commercial), and academic institutions that want to establish strategic alliances, research sites, and branch offices in China. The new Hamner Bioscience Center in China Medical City and the NC Dept. of Commerce office in Shanghai are serving as gateways for NC organizations, such as Cirrus, Specialty Operations Solutions, Inc., and SyneCor, that are developing new markets in China.

Stem Cell RNL Biostar's $6 Million Expansion in Maryland

The state's stem cell segment will be enhanced as South Korea-based stem cell RNL Biostar expands its US presence with its upcoming opening next month of a $6 million stem cell R&D and manufacturing facility within Montgomery County. RNL will move from the Maryland Technology Development Center incubator in Rockville, Md., to the Montgomery County-run Germantown (Md.) Innovation Center. The company will grow its workforce from the current four employees to 50 over five years, and its space from its current 800-square-foot laboratory to 10,000 square feet of labs immediately and to 20,000 square feet of labs in the new facility over five years, said company executive Donna Lee.

RNL is in second phase tests for its stem-cell-based treatments, designed to fight Buerger’s Disease and osteoarthritis. Most of the jobs will be cell manufacturing technician positions that pay an average annual salary of $50,000.

Lee said that after searching several East Coast and West Coast locations, RNL opted to expand in Montgomery County because of its sizeable biotech presence: More than 350 companies, plus 19 federal research and regulatory agencies, all employing about 60,000 public and private sector life sciences professionals. The county boasts that it has the nation's highest concentration of PhDs.

Yet even Montgomery County, she added, had relatively few sites for stem cell companies, which require different equipment and cell-expansion or "culturing" facilities than can be found in traditional wet labs. "Surprisingly, the incubator space was the most state of the art," she said. "We need GMP standards. We've got to have cleanroom standards because we're going to be using these cells in patients."

A former DBED employee, Lee said RNL has been showered with support by the state and Montgomery County, whose County Executive Isiah (Ike) Leggett met with RNL representatives during a trade trip to South Korea last year. "I really feel like we have an entire cheerleading squad helping us with everything, from hiring people, to finding the best location, anything and all that we need to really help us grow."

The biotech tax credit will remain budgeted at $6 million annually in FY 2010 despite an effort by Maryland's House of Delegates to chop funding for the program to $4 million.

The report outlines four priorities for Maryland's life sciences effort:

Ensure the sustained growth and competitiveness of the state's bio industry.
Support the creation and growth of innovative bioscience companies by ensuring access to capital.
Position Maryland for global leadership in cutting-edge areas of bioscience research and emerging and growth markets.
Advance efforts to generate bioscience talent and develop a life sciences workforce.

The report's BioMaryland name — shared with the Maryland pavilion at this year's BIO convention — will become the brand name for the state's life-sci effort going forward, under the report's third recommendation. The report envisions "an experienced professional marketing/public relations firm" creating a campaign for BioMaryland, which would include a network of on-call volunteers called "BioMaryland Partners," and a "Leader to Leader" program to boost ties between CEOs of existing biobusinesses in the state and heads of companies considering Maryland.

Unlike O'Malley's initial package of life-sci proposals, termed BIO 2020 and announced at the BIO 2008 convention in San Diego, the BioMaryland recommendations do not prescribe year-by-year incremental increases in the program between now and 2020. The state's budget squeeze forced O'Malley to bypass the doubling of funding for the program in FY 2010 to $12 million as called for under BIO 2020, and forced the state to skip specified spending hikes in other existing programs singled out for expansion by that initiative.

However, according to O'Malley, BioMaryland will require the same $1.3 billion through 2020 that was envisioned under a revised version of BIO 2020; the initial cost estimate was $1.1 billion. Both figures purposely were set to exceed the $1 billion over 10 years now being implemented by Massachusetts through its Life Sciences Act of 2008, signed into law by Gov. Deval Patrick.

Jaytina Begins Construction of New Food Manufacturing Facility In Wisconsin

Jaytina LLC recently started construction on a new food manufacturing facility in Plover, Wisconsin. Jaytina is making a $9 million investment for the construction of a 100,000-square-foot building and the installation of processing equipment to manufacture a line of healthy appetizer products. According to Industrial Info's North American Industrial Database, Wisconsin is home to more than 300 major food and beverage manufacturing plants and distribution centers

Burnham Institute Official Discusses Goals for New Florida Digs

Florida's more than $1 billion in state and local subsidies has drawn to the Sunshine State a half dozen research institutes that are expected in return to create new jobs and economic activity beyond the tourism, hospitality, and agricultural industries that rise and fall with the economy.

The latest research center to settle into new Florida digs is the Burnham Institute for Medical Research. Over the coming week Burnham, which operates a research center in La Jolla, Calif., expects to finish moving personnel and equipment from three smaller Orlando sites to a new $85 million, 175,000-square-foot building within the 600-acre 'Medical City' science and technology park.

The Medical City is part of the 7,000-acre Lake Nona mixed-use, master-planned community in Orlando, developed by the Tavistock Group of Windermere, Fla.

Burnham is bringing to the new facility the 75 staffers currently employed at its Florida locations, and the institute says it is on track to grow its headcount this year and next. Indeed, as part of its relocation agreement, Burnham agreed in 2006 to employ at least 303 people at Lake Nona within 10 years, in return for its $310 million package of state and local government incentives.

The package consists of $155 million from Florida's $250 million Innovative Incentive Fund, eliminated last year in a budget-cutting move and an equivalent sum from several local sources: $31 million toward building costs from the city of Orlando; $30 million in tissue donations from Orlando Regional HealthCare System and its Florida Hospital; $25 million from the University of Central Florida; and $20 million from Tavistock Group toward site and construction costs.

Within the new building, Burnham investigators plan to study diabetes, obesity, and heart disease. The institute hopes to generate additional news later this month, at the BIO 2009 International Convention, when it anticipates making what Burnham Institute for Molecular Research at Lake Nona spokeswoman Deborah Robison called "an important announcement regarding a very exciting hire."

Burnham is the first institution to open its permanent facility within Medical City. Set to join Burnham in the sci-tech campus will be:

The University of Florida, which has announced plans for a $62 million, 100,000-square-foot research and academic/conference facility adjacent to the institute;

UCF, which has almost completed its $99 million, 198,000-square-foot Burnett School of Biomedical Sciences and still constructing its $68 million classroom building and medical library for the new College of Medicine, set to be completed in 2010 though the college will welcome its first med students in 86 days, according to a countdown clock on its web site. Both facilities are within UCF's Health Sciences Campus; http://www.med.ucf.edu/

MD Anderson Cancer Center, which will relocate its Cancer Research Institute into 30,000 square feet of fifth-floor space it has agreed to lease at the five-story Burnett building from UCF, while it completes planning for a permanent facility;

Nemours Foundation, which on Feb. 25 broke ground on a $400 million, 620,000-square-foot children's hospital with 95 beds, set to open in 2012; and

The US Department of Veterans Affairs, which broke ground in October 2008 on a $656 million VA Medical Center to consist of a 134-bed hospital, a 118-bed nursing home, a 60-bed residential rehabilitation center, eight operating rooms, two cardiac catheterization laboratories, an outpatient clinic, and a veterans' benefits mini service center. The med center is also to open in 2012.

BioRegion News spoke on Thursday with Cyril Doucet, vice president of operations and administration for Burnham Florida, about the institute's move into its Lake Nona facility, and its research focus in Florida. Following is an edited transcript of that interview.

How far along is Burnham's move to its permanent facility?

Pretty far along. We've moved everybody in to the new facility here, and we're just settling in and unpacking, and we're testing and calibrating some equipment, and some of the systems in the building. We should be okay next week, which is about mid-May. [Researchers] are already in some cases starting experiments, and starting to feel at home.

What's your target day for finishing up?

It's one of these things where it's hard to pick a specific date. It's not like a manufacturing facility, where we're going to flip a switch, and everything's going to start running. We basically are by mid-May, I would say that by the 15th [or] 16th of May, everything will be up and running.

Has equipment been mostly or entirely been moved, at this point?

Yes, that's correct. It hasn't all been tested, and calibrated, and hooked up. But it has all been moved in.

The cost of the move has been reported to be $100,000.

Yes, that's correct. That's the cost of the move [as charged by] the various vendors and moving companies that we used. We had a situation where we had about 15 specialty vendors. In our case, we were moving some very specialized equipment that had been manufactured by Nikon and Olympus, particularly microscopes. So there were a number of vendors that were involved in coming in, and packing up their equipment, and then taking it over here. Plus we have the regular move agent that we used to pick up all of our belongings, and a lot of the supplies, and administrative files, and a wide variety of computers, and that sort of thing.

Our equipment included different robots, a half-million-dollar confocal microscope, microfluidic machines. We had biological material — the scientists were doing experiments, and then they had to plan for this move. So in preparation, one of our scientists froze 10 million cells as a backup to what was going to be moved, had that down as minus 346 [degrees Farenheit] in liquid nitrogen, and then even as a double backup, he took two million of those cells and FedEx'd them to his collaborative partner at a university.

How many people made the move?

There were 75 of us who moved from a couple of locations in Orlando. Most of us were at the fourth floor of the Florida Blood Center, but there was a number of administrative staff who were located next door to the blood center, in a building called the Liner Building, and we had a few people in downtown Orlando. Now, what's really good about this is that we're all in the same place, and able to make our connections, and get up and running.

What will happen to the blood center space? Will Burnham hold onto that or give it up?

We'll give it up. As far as Burnham is concerned, two years ago we moved into the fourth floor, and we were two guys sitting in a box, trying to figure out how to pick up the phones. And over the intervening two-year period, the fourth floor was renovated to make it lab-ready. Then we recruited and on-boarded a number of scientists.

We're leaving it in a condition that Florida Blood Center can use it for wet lab space. I believe that they have been discussing with the Orlando Economic Development Commission a possibility of using the space as incubator space for small companies, for those that are interested in starting up in Orlando. We renovated 10,000 square feet into wet lab space on the fourth floor, at a cost of about $2 million in 2007. We used it for two years, and now it's available for others to use.

How closely did the move hew to your schedule?

Well, it was on budget and on schedule. We had always anticipated completing construction around the end of March, or beginning of April, and then being in the building in the spring. Some of the state benchmarks said that they had hoped we would get in, or wanted us to get in by 2010. We're actually in by 2009. In that sense, we finished ahead of schedule. But in terms of the contract that we signed with Lake Nona Corporation and B&K Construction, we signed a contract that was brought in on budget and on schedule.

What brought Burnham to Lake Nona and its 'Medical City' in the first place?

There was a variety of criteria that came into play. There was an incentive program from the state of Florida that was very attractive. I think the location at the Medical City was in and of itself a great incentive, and a great attraction, to have the opportunity to be in a location enabling us to collaborate so closely with universities — the two universities being Central Florida and the University of Florida, with the VA, with Nemours, MD Anderson.

[We liked] the location of the Medical City, the incentive program, the kind of community support we found, and the sort of can-do entrepreneurial spirit that certainly the leadership of Burnham saw when they first came here. And also, I think Orlando, being in central Florida, presents a very attractive place for an organization to locate. It's accessible to one of the best and largest airports in the United States. There's a terrific lifestyle, and accessibility to affordable housing here in central Florida, which helps us in terms of recruiting the best and the brightest for our organization. Those are the elements that were in play when Burnham was going national and trying to asses where it was going to locate. I just think it was a great decision, and one that's going to work out well both for Burnham and central Florida.

You mentioned recruiting the best and the brightest. To what extent will you be recruiting people to fill Burnham's remaining positions, and to what extent will the institute be able to develop talent locally through education?

In terms of our investigators, the plan is to hire 30 faculty level investigators who basically lead research programs. And these investigators potentially are the ones that will draw in the grant support that will allow us to become completely self-sustaining. Those investigators we recruit nationally, both in terms of trying to attract established researchers, as well as young up-and-coming scientists.

Those labs then, in turn, hire postdoctoral fellows, research technicians, and associates. And we also have a variety of research support staff and administrative staff. At that level, we would tend to recruit locally, if possible. It provides us with the opportunity — again, one of the reasons why central Florida was interesting and attractive was because it provides us highly qualified people from a variety of sources.

We expected at this point in time to have about a half dozen investigators on staff, and we're now already at double that, at 12. So we anticipate being over 100 people by the fall, and close to 130 people by the summer of 2010, and within the next seven years, we expect to reach our target of 300 staff in the building, and we even expect to even do better than that.

How many of those staffers will be investigators hired this year and in 2010?

Our target in 2009 into 2010 is to hire another four investigators, and we already have 12 on staff.

How far along is the local recruitment effort?

We recruit. We post our positions on our web site. We have reached out to the universities and colleges to establish contact, so that they're aware of when we put up our positions. We've been very fortunate that, partly because of the interest in Burnham, a little bit hopefully because of our name, we have had excellent response in our recruitment locally.

What effect has the state of the economy in the last few months had on finding people?

I think it's clear that we've been getting larger than anticipated response. We've had a very good response, but I think we're getting an even stronger response because of the local economic conditions on our local positions.

On the scientific level, in our recruiting for scientists and faculty, I don't think it has had that much of an impact, because we're basically making our search countrywide.

Burnham has said diabetes, obesity, and heart disease will be its areas of research focus of its East Coast campus in Orlando. Is the East Coast more suited to this work than San Diego because of a particular partner, or population?

No, I don’t think that has really anything to do with that. The selection of that theme had more to do with just the general issue that really has arisen over the past five to 10 years as the next big thing. It's also an area that's very complementary to the programs that Burnham has already set up in cancer, and neuroscience, and allergic diseases in San Diego. I think it has more to do with the population as a whole, and a view of what the next epidemic is that we need to address, as opposed to anything specific about Florida.

The East Coast move was driven by wanting to have access to collaboration opportunities with the East Coast universities and organizations, and also to be able to draw on the scientific talent on the East Coast. And I think the motivation [for opening the facility] in Florida was what Florida offers, and offered Burnham as a location on the East Coast. It flowed that way more so than a disease-related issue. The theme was picked because of its importance nationally.

As the Lake Nona facility grows, what effect will that have on Burnham's San Diego labs?

San Diego has basically been growing itself. As [Burnham President and CEO] Dr. [John] Reed has often said, a rising tide lifts all boats. There is a strategic plan that's been approved by the board of trustees for Burnham that sees growth in San Diego in the areas of cancer, neuroscience, and infectious diseases programs, as well as childhood diseases. There has now been a new center that has been opened in San Diego to address that. These are complementary efforts, but certainly Lake Nona is going to be an opportunity to grow on its own, while still collaborating effectively with the mother ship in San Diego.

Our Diabetes and Obesity Research Center is complementary to the four centers of study in La Jolla. But in addition, there are these collaborative efforts [between researchers at both Burnham campuses] that take place. Since this summer, we have the Conrad Prebys Center for Chemical Genomics; it has a base currently in La Jolla, and we're in the process of establishing the screening center here at Lake Nona. And that will be occurring this summer, where we bring in probably the most advanced high throughput screening resources that are available — it's virtually unprecedented for an independent not-for-profit research institute to have this type of equipment. There will be a three-pod, highly flexible robotic screening system for small molecule screening — basically $12 million worth of robots and support services — in our new institute at Burnham Lake Nona here.

When we look at what is coming up ahead, the robot pieces start to get delivered in just a few weeks, and we'll be working on that, and having that center up and running by the end of the summer. There's an example of where there will be collaborative research in the chemical genomics area between Lake Nona and La Jolla, because the center has bases at both campuses.

This is a collaboration between Burnham's East and West Coast campuses. Are there partners from other institutions involved?

We will be doing screening for assays and investigations that are led by Burnham PIs as well as externally. This will be done through one of the biggest NIH grants ever awarded, $98 million. Investigators would apply to NIH for screening funding, and then NIH assigns them to go to one of the four approved comprehensive centers in the US, of which Burnham is one. We will be doing that screening for external PIs.

Another opportunity for collaboration is right here in Orlando, the institute has established a partnership with Florida Hospital regarding a clinical research institute for studying diabetes and cardiovascular disease. Burnham looks at disease at a molecular-cellular level. We really need to have a process by which we take our information, and our discovery, and translate it through into clinical activity. And here's a great opportunity to collaborate with a health provider like Florida Hospital, which is establishing its own clinical research institute. There will be a connection from pretty much the bench to the bedside.

That's the kind of example of what we're trying to establish in Orlando. And it does have connections to Burnham in San Diego, because there are researchers there that are looking at diabetes, and have projects that are relevant to the theme that is here. We also have a connection here between a scientist working here at Burnham and the Harbor branch Oceanographic Institute. We're trying to create synthetic anti-cancer compounds by understanding some of the natural compounds that come from the sea.

New Orleans Prepares for a Southern Bio-Boom

A delegation from New Orleans was in Atlanta as part of an effort to lay the groundwork for the expected future boom in the biotechnology industry in southern cities. The scientists, researchers and economic development leaders are attending the 2009 Bio International Convention.

New Orleans has been represented at the convention the last four years. "But this is the first time that we've ever created a strictly New Orleans delegation to promote what's happening in New Orleans," says Bio Boom event marketer Thea Pagel.

Pagel says they want biotech companies and entrepreneurs to see that New Orleans is emerging as a new hub of the biotech industry, with the future Veterans Affairs hospital, the proposed LSU teaching hospital and the construction of the Cancer Research Center and Bio Innovation Center.

"We're creating this hub," says Pagel. "The VA Hospital is going to be at the core of it." About $2 billion will be spent in the city over the next few years those projects.

Pagel says this area has always had great researchers because of LSU, Tulane and Xavier's #1 pharmaceutical school. And now, with the new teaching hospital and everything surrounding it, "there's sort of a rebirth of our whole infrastructure."

She says New Orleans is poised to become the Bio-Capital of the South, with thousands of new jobs created in the medical district.

James McNamara, President of the Greater New Orleans BioSciences Economic Development District says the city is transitioning out of its Katrina recovery phase and now has the perfect storm for economic development. "New Orleans has very specific and unique opportunities that make us a great place for investors," said McNamara.

"It is a rare opportunity in this country to find both a New Market as well as Historic Restoration and Angel Tax Credits on this scale. Additionally, due to our recovery status there are aggressive state and federal incentives available."

"For anyone looking to invest the time is now, the location is New Orleans and there is the potential for zero capital gains on investments made in the Biosciences District that are held for a minimum of five years. An investor would earn millions of dollars in savings by locating their start-up in New Orleans."

Policing the Globe – the Scale of FDA Overseas Inspections

in-PharmaTechnologist assesses the scale of the challenge facing the FDA in effectively monitoring overseas facilities, using interactive graphics and textual analysis.

Despite its request for a 19 per cent funding boost in 2010 the US Food and Drug Administration (FDA) predicts that the number of foreign inspections will remain the same but import testing will increase significantly.

The agency is also working with its counterparts at the European Medicines Agency (EMEA) and Australia’s Therapeutic Goods Administration (TGA) to share the burden of international inspections.

Globalisation of pharmaceutical operations has significantly increased the pressures faced by regulators.

The latest figures show that there were 452 overseas inspections in 2008, with 566 anticipated for 2009 and 2010.

FDA overseas inspections 2002-2007

Although this is a significant improvement on the 220 that were inspected in 2002 it is still a small proportion of the total overseas facilities, which the US Government Accountability Office (GAO) estimates at over 3,000.

In addition, despite the steady increase in overseas inspections the number of warning letters issued to overseas establishments has remained low. These factors suggest that creative solutions, such as the joint inspections and outsourcing, may be necessary.

This was acknowledged by Janet Woodcock, now director of the FDA's drug research division, who told Reuters: "It is very difficult to see how we could actually cover the entire globe.

"If you consider many of these other plants aren't really inspected at all, putting in some type of program would be better than not covering them."

Novartis Plans Cambridge, MA, Expansion at MIT Site

Novartis has signed a lease for a 2-acre parking lot at 181 Massachusetts Ave. in Cambridge, Mass., where the pharma giant plans to build a new facility. The lot is owned by Massachusetts Institute of Technology.

The new facility would expand a presence that now consists of about 2,000 employees occupying more than 1 million square feet of space split among 10 buildings, near Kendall Square and in research parks along Massachusetts Avenue. Most of that is in the former Necco candy factory, where Novartis bases its global research unit, though the company has recently also located its vaccines and diagnostics division to Cambridge.

Novartis is expected to build a research facility on the site, though no final decisions have been made.

"We're committed to Cambridge. This is a long-term investment. We have found it particularly beneficial to have the relationship with MIT, Harvard, and the hospitals in the neighborhood," said Mark Fishman, president of the Novartis Institute for Biomedical Research.

Novartis also believes the Cambridge location gives it access not only to new recruits at MIT and Harvard, but opportunities to collaborate with researchers at universities and teaching hospitals, according to the Globe.

Novozymes Expands Davis, Calif., R&D Campus, with Enzyme Production for Cellulosic Ethanol in Mind

Intent on boosting its research efforts in the cellulosic ethanol field and other areas, Danish-owned Novozymes announced that it has opened two new buildings at its campus in Davis, Calif. The expansion adds 25,000 square feet of laboratory and office space, giving the company's Davis campus a total area of about 60,000 square feet.

Some 150 guests joined Novozymes executives and Davis Mayor Pro tem Don Saylor in formally opening the two buildings at a ceremony. Novozymes said the Davis expansion will enable it to develop the enzymes necessary for commercial production of cellulosic ethanol, as well as continue exploring new innovative enzymes. Novozymes said in a statement it will launch the enzymes in 2010.

"We have grown a lot in the past years and therefore need more space, both in terms of lab space and office space. With the addition of these new buildings we now have room to grow even further if that is required," Ejner Bech Jensen, president of Novozymes, said in a statement.

Medical Device Makers Adisco, Touch Bionics, Plan Expansions in Ohio and New York

Adisco, a computer numerical controlled machining company specializing in plastic parts for medical devices, as well as for fluidics and chromatography applications, will move its manufacturing operations to the Dayton, Ohio, suburb of Kettering, from East Berlin, Conn. The company will keep a presence in the Nutmeg State with a satellite sales office.

Adisco announced it has begun preparing to transfer equipment soon to a space at the National Composite Center, a business accelerator. Adisco expects to create 50 new jobs and enhance its new manufacturing technologies over the next three to five years. In return, Ohio's Department of Development awarded the company a 45 percent job creation tax credit worth an estimated $200,000 over six years.

The company told Manufacturing & Technology eJournal that it could invest as much as $5 million in additional equipment over the next five to seven years, and that it will hire "several" workers to start.

“Our intent is in implementing newer state-of-the-art CNC equipment as well as launching our proprietary processing techniques in polymer fabrication,” Richard Koczera, vice president of Adisco, told the trade publication.

Longer term, Adisco plans to move into a stand-alone facility in the Dayton region.

In Hilliard, Ohio, Scottish-owned Touch Bionics, a manufacturer of bionic prosthetic devices, will relocate its wholesale offices from Livingston, Scotland, to a new 5,600-square-foot facility at One Mill Run. The facility will house customer care, finance, a reimbursement assistance and clinical evaluation team, as well as sales and marketing functions, according to a written statement.

The new facility is one of two Touch Bionics is opening. The other will be a 7,500-square-foot facility in Bloomingburg, NY, to be built for the company's Livingskin production operations in New York.

“Our new production location will allow us to dramatically increase our Livingskin production capabilities to respond to increasing customer demand for both passive prosthetics and high definition coverings for the i-LIMB Hand," Mark Ford, Director of US sales and marketing, said in a statement.

The company will begin its Hilliard operation on June 1, and bring 20 jobs to the area, at a starting wage of about $65,000. In return, the company will receive a six-year, job-creation tax credit totaling $101,000 from the Ohio Department of Development. The credit requires the company to commit to keeping operations in central Ohio for at least 12 years.

Touch Bionics is projected to create about $139,419 additional taxes for the city during those 12 years.

MD Anderson Cancer Center Tops Out Alkek Hospital Expansion in Houston

The University of Texas MD Anderson Cancer Center has topped out construction of its $220 million expansion of the Albert B. and Margaret M. Alkek Hospital in Houston, McCarthy Building Companies of Dallas has announced. The project will add 12 levels totaling 500,000 square feet to the existing 12-level Alkek inpatient tower.

“As the demand for inpatient beds continues to rise, we are seeing occupancies in excess of 100 percent. Achieving this milestone resonates with everyone at MD Anderson as we seek to meet the needs of our growing patient population,” Janet Sisolak, MD Anderson Cancer Center project director, said in a statement.

Instead of the traditional topping-out practice of placing an evergreen at the highest point of the structure, MD Anderson faculty, staff and patients signed their names and wrote messages on three steel beams to be used in the construction.

The expansion will be completed in multiple phases. The first phase included selective demolition, temporary waterproofing activities and the installation of a tower crane and a personnel/material hoist. The second phase will consist of the core and shell construction. The third phase will include the construction of the first three inpatient floors and is expected to be complete in 2010.

Five additional patient floors will be built as shell space in addition to the construction of a mechanical floor, and the renovation of several areas within the existing building. Those areas include level 12, which contains special air filtering systems dedicated to patients with compromised immune systems.

The MD Anderson Alkek Hospital expansion began in January 2008 and is set for completion in 2010. HKS of Dallas serves as architect for the design-build project.

New Suite Operational at Roche’s Carolina API Plant

A new $60m (€43m) manufacturing suite is operational at the South Carolina, US plant where Roche makes APIs for some of its leading products, including for its anti-flu drug Tamiflu (oseltamivir).

The Florence plant also produces the active pharmaceutical ingredients (API) in Xeloda (capecitabine), Pegasys (peginterferon alfa-2a) and Xenical (orlistat) as well as several others in clinical development.

A company spokesman told in-PharmaTechnologist that the expansion “fills a need for strategic capacity for current and future products,” adding that “Roche will continue to invest in its own facilities as well as outsource where appropriate.”

He did not say whether the facility will produce components for any drugs made by Roche’s recent $47bn acquisition Genentech, but did confirm that none are made there at present.

Roche is in the process of recruiting 25 new process engineers and industrial chemists which, when complete, will bring the headcount at the 330,000 square foot facility to around 330.

While the Florence expansion project began in 2007 well before cases of H1N1 “swine flu” began emerging, the additional Tamiflu capacity it provides fits well with Roche’s efforts to ramp-up manufacture.

Earlier the Swiss firm told the Wall Street Journal it will “increase production to 36m treatments a month by year-end,” in response to a surge in demand for Tamiflu.

In the shorter term, Roche has donated 5.65m does of Tamiflu to the World Health Organization (WHO) and has announced plans to make 110m more over the next five months.

David Reddy, head of Roche’s global pandemic preparedness task force, said: “Roche has been rapidly increasing production of Tamiflu at multiple points in the supply chain,” explaining that “actual production output is dependent upon continued demand from governments for pandemic stockpiles of Tamiflu.”

Home of Hershey Chocolate Bars Bares Its Sweet Tooth for Life-Science Startups

The home of the Hershey chocolate bar has a sweet spot of another sort for startup companies in the life sciences and other technologies — namely the 80,448-square-foot Hershey Center for Applied Research opened two years ago this May.

The facility is the first of up to a dozen buildings totaling 1.2 million square feet envisioned for a 165-acre campus near Penn State University's Milton S. Hershey Medical Center and College of Medicine.

Along with owner/developer Wexford Science + Technology — whose Pennsylvania presence includes the University City Science Center in Philadelphia — HCAR is also working on the next phases of its expansion.

According to Wexford, the Hershey Center for Applied Research plans later this year to start construction on six new technology suites of up to 7,500 square feet in the second floor of the existing building, and a $1.5 million project designed to accommodate growing demand for space by startups.

In addition, HCAR and Wexford are seeking federal and state funds to help them construct a $40 million, 100,000-square-foot second building at the center.

BioRegion News spoke with Laura Butcher, HCAR's executive director, about the center and the broader challenge of nurturing and anchoring a concentration of life sciences businesses in a region of Pennsylvania located about 100 miles west of the state's traditional life-sci anchor of Philadelphia, and more than 200 miles east of Pittsburgh, which has grown its own cluster of startups using tobacco settlement funding.

Following is an edited transcript of that interview:

First, could you discuss HCAR's progress in the two years since its opening?

We’re about 65 percent occupied. Our current occupancy consists of several Penn State entities that came over and anchored the building; that academic presence is really essential in terms of developing new research park buildings. We have the Department of Pharmacology, which makes a lot of sense to be here, and the applied research center, because they work so closely with industry, as well as the tech-transfer office, and a sleep treatment and research center.

The concept is to fill the balance of the building with industry or research institutes that may be funded through federal or state dollars. We’ve had success on that front to date. We have four companies currently located in the research park. They all have ties in one way or another to Penn State. That truly is the hook to get companies to think about Hershey, Pennsylvania, as a good place to expand or relocate. And those companies range from a food science company that is actually a spinout of the Hershey Company, to a medicinal chemistry company, to a medical diagnostic company.

What has made HCAR attractive to those early-stage life-sci companies?

In this region, south central [Pennsylvania], there is a good amount of activity within the early-stage segment, because of the support that we have here in the region for young companies. Whether that’s through the Life Sciences Greenhouse of Central Pennsylvania, or Ben Franklin Technology Partners, an angel network or venture capital network, where we really have to work hard is at those later segments.

If you look at the business life cycle, you’ve got your formation stage, and your concept-stage companies. And then in the emerging and growing mature stage, south central [Pennsylvania] is not a mecca for the life sciences industry. So we’re really building that critical mass of activity as part of what we’re doing here at HCAR. In order to do that, we have been looking at what our strengths are, and really promoting those to companies — things like the strengths of the Penn State College of Medicine, and being that they’re number one for diabetic retinopathy, for instance. They’re building a new cancer institute. We're leveraging these strengths and translating that into the private sector to attract companies.

Being that we’re only an hour and a half away from Philadelphia, and an hour and a half from Baltimore, I think we have a real value proposition for those later stage companies.

What effect has the economic upheaval of recent months had on companies at HCAR?

What we’re seeing is that companies at those stages are just taking longer right now to make decisions because of the economy. We have a couple of examples of that right now, where the deals are just taking longer to close. On the early-stage front, the venture capital funding is more difficult to identify right now; however, the state programs that are robust in Pennsylvania are really in many ways making up for that lack of venture private sector investment right now.

How long are deals taking to close now, and how long was it previously?

To give you a case study: We have a Japanese clinical research organization, a phase 1 CRO, that was very, very close to closing a deal with us back in December of 2008. And because of the economy, they have delayed their decision by another year, because they want to wait out the recession. And they’re guessing that within a year, they’re going to be ready to pull the trigger. So it was a long process to begin with, most times. Companies certainly do not take these decisions lightly. And I think that what was a long process is becoming an even longer process by a year or more.

Are most or all of your startups tied to Penn State? Or can they come from another institution?

They all have Penn State connections, but they’ve come from diverse sources. One is a Penn State spinout company. It spun out of the Department of Pharmacology, which is located in our building and landed here. Another came from New York state, and they came here because of an SBIR grant with Penn State; they wanted the close proximity and access to the core facilities in the building, and the access to the [principal investigator]. Another one came from North Carolina because a faculty member was recruited to Penn State Department of Ophthalmology, and brought his company with him. And then the fourth one spun out of the Hershey Company, the chocolate company, which is literally a mile away from us.

HCAR has had plans for as many as a dozen buildings. Is it too soon to be looking at some of those actually getting built given the influx of companies? Where does that effort stand?

The master plan was developed for 12 buildings totaling 1.2 million square feet. And I think our story is really interesting because the land here that we're on, the 165-acre parcel, is owned by the Hershey Trust Company. And in turn, the research park is going to, and is currently providing educational opportunities to the Milton Hershey School Trust, which is the beneficiary of that $6 billion trust fund that the chocolate maker set up.

The Hershey Company sees this investment, and they treat it as a real estate investment, as a way for South Central [Pennsylvania], and Hershey in particular, to transition from being a legacy economy that was fueled by manufacturing, to one that is fueled by innovation now. So they see this project as being one of the key engines to allow this region to compete in the global economy many decades down the road. There is a very long-term perspective for this project, from the fiduciary organizations.

We are in fact moving forward with the second building. It's fully designed from an architectural perspective. The land development plans have been approved. And we're in the process of identifying an anchor tenant for that. The other interesting thing is that we can do greenfield development, so if an R&D company is interested in having an 80,000-square-foot facility, we could do that build-to-suit here on part of our campus. But it would be done as part of the campus in an environmentally sensitive way, because we employ [Leadership in Energy and Environmental Design] principles here.

How big would the second building be?

It's going to be 100,000 square feet.

You noted that where you are isn’t by itself a major magnet for biotech, unlike other areas in the Philadelphia region. How does your area mesh with the Greater Philadelphia's broader life sciences effort?

Pennsylvania competes very, very well in the life sciences industry. In fact, Business Facilities magazine within the last six months named Pennsylvania the number-one state for the biosciences industry. Deloitte came out with a study recently that [showed Greater Philadelphia's life-sci cluster] number-three to the Boston and San Francisco areas. Part of that is because of the existing critical mass of activity in Philadelphia, Pittsburgh, and the Lehigh Valley.

But part of it also is because of our commonwealth's commitment to the life sciences industry, a $2.8 billion commitment, and new funding coming online through the federal [American Recovery and Reinvestment Act].

When you put all that together, you put our location, our close proximity to Philadelphia together with our proximity to Penn State College of Medicine; our proximity to Washington, DC, the regulatory capital; New York City, the financial capital; access to international markets, and then this state support; [and proximity to] big pharma an hour and a half down the road, it really is a strong value proposition to make. And also, the cost is just a little bit more attractive here than you'll find in some of those metro markets.

One key advantage to the larger metro areas you cited is availability of workers. What efforts are taking place in and around HCAR to develop talent?

The workforce question we find is oftentimes at the top of the priority list for companies as they're making their decisions about relocation, or expansion. We don't have the level of workforce churn here in South Central [Pennsylvania] that you'll see in other metro areas like Philadelphia or Boston, for instance.

However, we do have a decent level of four-year degree students at the technician level, as well as graduate students coming out of the Penn State College of Medicine. But what we often have to do is supplement that by drawing workforce from the Philadelphia area to the South Central [Pennsylvania] region, and we often find that again, going back to the cost of living and cost of doing business here in bucolic Hershey that for some people, it's a very compelling option to come to South Central [Pennsylvania]. We're able to address that major need that industry has, but we have to get a little more creative than some other regions.

If you go ahead with the second building, what state funding can the park tap into? Can it use federal stimulus funding?

It's absolutely essential for us to have public investment for the second building. This first building had $5 million in Business and state funds from the commonwealth of Pennsylvania. The second building has a $4 million to 45 million gap. And the reason is that wet lab space is extremely expensive to build out. It can run $400 a square foot, easily. And in order to make that a viable option for leasing by not only early stage companies, but later-stage companies, those public investment dollars must be infused into the project, and [the resulting savings to HCAR and Wexford] passed on directly to the tenants in the form of reduced rents.

We're actively pursuing both state and federal funds. We are excited about the fact there are new federal funds coming through the ARRA that are targeted toward these types of projects that focus on job creation and innovation. And we're also applying for ARRA funds for the first building, to build out additional technology suites since our current suites are filled, so that we don’t have to turn away these young companies.

How much funding do you need for both the technology suites and for the second building overall?

The second building is a $40 million building.

At the first building, would you build out additional space or reconfigure part of existing space to accommodate the new tech suites?

It would be additional square feet. In the first building, the current technology suite space is on the first floor. This proposal we have into the [US Department of Commerce's Economic Development Administration] would be for six additional technology suites on the second floor. And similar to the current suites, they would be flexible, modular wet labs that range from 500 square feet to 1,000 square feet, with one-year commitments in terms of the lease, and 90-day out clauses. And the idea is that these companies come in here, and they're surrounded by ecosystem assets — capital, workforce, technical assistance. Once they pop, they'll take additional space, either in this building that we're in now, or in a future building.

The funding from the EDA or elsewhere is critical to making this work, because it still costs $150 a square foot to build out these tech suites. There's no way you can make it affordable to the young companies, and anywhere close to financially viable for the developer, unless you got these public funds in there.

How much funding will be needed for the suites?

It's a $1.5 million project, and we are requesting $750,000 from the EDA.

How do you plan to raise the rest?

The rest would come through a private match through the developer, Wexford.

What's the timing of constructing the additional tech suites?

Our understanding is that the funds are going to be targeted toward projects fairly quickly, within the next three to six months, because the federal government does want to get these dollars on the street, creating jobs. So that really would be our timeline.

How much of the second building will need to be leased before Hershey and Wexford can proceed with construction?

It's an interesting question, and it's a question of timing. Traditionally, banks required that new buildings like this have 30 percent of the building pre-leased in order to break ground. But in this economic climate, it's more challenging. Today if we were to ask the same question to the banks, they would probably say, more like 60 percent pre-leased. But we feel that number is going to improve in the coming months.

How will the types of tenants drawn to Hershey change as a result of the new tech suites and the second building?

It is staying within the existing mission. We are the Hershey Center for Applied Research. We don't have life sciences or bio in our name. And that's for a reason. We do focus primarily on the life sciences industry because of our proximity to the Penn State College of Medicine. However, if a company does really well in cleantech and nanotech, advanced manufacturing and IT, we can certainly accommodate those types of companies as well. And in fact, with this past [year's] budget, Pennsylvania just created an [$850 million] Energy Independence Fund that's really going to spur cleantech. Certainly we could accommodate those sectors as well.

Right now we're 100 percent life sciences. I believe that we really do have to diversify. And the reason for that is the timeline to success in the life sciences industry is longer than just about any other industry. So I think we need to attract some companies and organizations that have a shorter timeline to market, in order to continue to develop at a good pace. I think it's good that our development guidelines provide for some flexibility. They say that any organization that locates into the Hershey Center for Applied Research has to be either focused on innovation, research and development, or entrepreneurialism. It allows us to cast a wide net, and I think with time, we'll start to see more diversity in our tenant mix.

What efforts has HCAR made to broaden its tenant mix beyond the Hershey area?

We're doing really well with having discussions with foreign-based companies that are considering entering the US market. I think the reason for that is, going back to Pennsylvania's state government support, the commonwealth has contractors in 17 countries overseas whose jobs it is to bring new companies into Pennsylvania.

We've tapped into that network, and right now, for instance, we're working with a New Zealand company that is interested in being operational at HCAR by mid-2010. And for these international companies, I think where we're more able to really differentiate ourselves is, we provide a turnkey solution for them. Oftentimes, the last part of the discussion is the real estate piece. And then we talk about the research hook, whether it's the [ability to carry out] clinical trials or sponsored research, or the talent. And then it's about capital: What kind of an incentive package can the state put together? We're playing that concierge role to package all of this for these international companies. It helps them be more confident that they're going to have a soft landing and not a crash landing in the US market. And maybe we're doing well in that arena because we do have to try a little bit harder here in Hershey. And these foreign-based companies really appreciate that approach.

Which areas of the world are international companies coming from?

In addition to New Zealand, Japan and South Korea in Asia, as well as Belgium.

To what extent are these companies tied to particular institutions in or around Hershey?

No. It comes from these international contractors who are working with companies that are ready to enter the US market. The timing's right. They've just been great funnels for lead generation for us. We've worked really hard to put together a turnkey solution for them, and I think the process is starting to pay off.

To what extent does this international presence tie into the overseas attraction efforts of existing parks in Pennsylvania, particularly University City Science Center in Philadelphia?

It's definitely collaborative. We have the same developer [as Science City]. Oftentimes, companies that are looking at HCAR or the Science Center will look at both. They're going to be different from one another based on the academic centers they are associated with, location, cost, whether it is metropolitan or in a cornfield. We're very supportive when it comes to showcasing the options to these companies.

The competition is pretty much nonexistent. It's actually a very supportive environment where we're just showing these companies the options. Our offerings are so unique; my motto is, 'Once you've seen one research park, you've seen one research park.'

Acceleron Pharma Continues Cosmopolitan Lifestyle as Other Biotechs Flee to the Burbs

In Cambridge, Massachusetts, on the block bounded by Sidney Street and Emily Street, Acceleron Pharma (Cambridge) has just christened its second manufacturing facility. Simultaneously, the company is preparing to incorporate an additional 20,000 square feet at an adjacent site to expand its formidable research and development arm. By growing and expanding in the heart of Cambridge, Acceleron bucks the emerging trend of biotech companies who are seeking to enhance their bottom line by expanding into the more cost-effective suburbs.

Northfield Labs Pulls Plug on Blood Substitute Operations in Illinois

Northfield Laboratories, Evanston, IL issued a statement on May 8, announcing "that it has terminated the employment of substantially all of its operational and staff employees at its manufacturing facility in Mount Prospect, Illinois and headquarters in Evanston, Illinois." The action follows the Food and Drug Administration's (FDA) recent rejection of the company's Biologics License Application for PolyHeme, a human hemoglobin-based, oxygen-carrying red blood cell substitute.

Althea Technologies Completes $15 Million cGMP Manufacturing Facility in San Diego, CA

Executives of Althea Technologies joined with its lenders and San Diego Mayor Jerry Sanders in celebrating the completion of a more than $15 million, 30,000-square-foot commercial-scale cGMP manufacturing facility, within its headquarters campus in the California city's Sorrento Valley section.

Althea, a provider of services for biopharmaceutical development and manufacturing, cut a ceremonial ribbon to mark completion of the project, which expands the company's manufacturing capacity in response to growing demand by drug developers seeking to outsource production operations.

The manufacturing facility was designed to comply with both US and European manufacturing regulations.

Althea said all construction services for the new facility were provided by San Diego-based businesses. Althea obtained financing for the project through City National Bank, and the private equity firm Telegraph Hill Partners, which specializes in life sciences and healthcare investments.

Bayer CropScience's $10 Million RTP Expansion Set to Add 128 Jobs Over Five Years

Bayer CropScience, the plant biotech unit of German-owned Bayer AG, will carry out a $10.2 million expansion of its campus at Research Triangle Park, a project expected to add 128 new jobs over the next five years to the company’s current state-based work force of 476.

The company plans to open the Bayer CropScience Research and Development Innovation Center in Morrisville, NC, leasing existing laboratory and office space to conduct basic plant research across several technology and crop platforms. The Innovation Center will also house the company’s BioAnalytics and Regulatory Affairs functions, which support the development and commercialization of biotech products.

“This region is also a center of agricultural and biotechnology innovation, so when we were looking to expand our innovation capacity, it made great business sense to do so in this area,” Bill Buckner, Bayer CropScience CEO, said in a statement.

North Carolina Gov. Bev Perdue announced the expansion on May 6, soon after the state Economic Investment Committee voted unanimously to award an up-to-$2.3 million Job Development Investment Grant to Bayer CropScience tied to its promise of creating additional jobs. While wages will vary by position, the average annual wage for the 128 new jobs will be $101,018, not including benefits — more than double the $43,160 annual average wage for Morrisville and the rest of Wake County.

The JDIG is pegged to the number of jobs creates, then sustains at Morrisville each of the next nine years. For any year that Bayer CropScience meets its target number of jobs, the state will award a grant equal to half of the state personal income withholding taxes derived from the creation of new jobs.

Because Wake is considered one of North Carolina’s more prosperous counties, 25 percent of the JDIG award, or up to $774,000, goes to the Industrial Development Fund, created to encourage economic development in less prosperous counties. North Carolina credits the JDIG program with enticing employers to commit to creating more than 30,000 jobs, and spending $6.1 billion in the state.

Bayer CropScience, which employs 2,400 people in the US, specializes in crop protection, non-agricultural pest control, seeds and plant biotechnology. The company’s primary research and development site is its BioScience Innovation Center in Gent, Belgium.

25 New Jobs from TB Vaccine Manufacturing Plant Expansion in Maryland

Aeras Global TB Vaccine Foundation said May 4 it will create 25 new jobs from its expansion of its tuberculosis vaccine manufacturing facility at its Rockville, Md., headquarters, at 1405 Research Blvd., during a ceremony held that day to mark completion of the project.

Aeras added a 9,000-square-foot plant to the 6,500-square-foot facility it opened in 2006. The nonprofit foundation hopes to produce six vaccine candidates within the next few years, said Aeras President and CEO Jerald Sadoff.

The expansion cost was not disclosed, though Aeras did say it has spent $23 million in its manufacturing facilities since 2006. Whiting-Turner of Baltimore was the general contractor on the just-completed expansion, which generated more than 100 construction jobs, according to the newspaper group.

Established in 2003 with eight employees, Aeras has grown its staff since then to about 135 employees. He credited the region's talent pool, which includes students from the University of Maryland and Johns Hopkins University, as well as employees who came to Aeras from other life-sci companies.

Aeras and its partners have developed four vaccine candidates that are undergoing testing in clinical trials in India, Kenya, South Africa, and Uganda. Aeras has been awarded $23 million from the government of the Netherlands, and has received grants of $80 million and $200 million from the Bill & Melinda Gates Foundation.

Catalent Installing 10-Color Press at Irish Pack Printing Plant, a Capacity Expansion

Contract pharmaceutical services provider Catalent will install a 10-color press at its printed components facility in Dublin, Ireland, as part of an expansion of its European operations.

Victor Dixon, vice president of the Somerset, NJ, company’s printed components business, said the company will install a KBA Rapida 106, which he told the online news outlet “introduces a higher standard in pharmaceutical carton supply, and follows our investment in similar technology upgrades at our plants in the US and Puerto Rico.”

The press, capable of printing up to 15,000 packaging box sheets and medical device cartons per hour, will become fully operational early next month. The unit features a QualiTronic full-sheet scanning camera, originally developed for currency production, which examines each sheet at full production speed, comparing it to an approved master for inconsistencies or deviations.

The Dublin plant opened in 1989.

Catalent said the KBA press’ QualiTronic monitoring system can detect any minute color changes and automatically adjust the press without the need for operator intervention.

Mass. Life Sciences Center Awards $3.4 Million in Loan to Seven Early-Stage Bio Companies

The Massachusetts Life Sciences Center, the quasi-public agency that oversees Gov. Deval Patrick’s $1 billion, 10-year Life Sciences Act, said it has awarded through its Accelerator Program a total $3.4 million in loans to seven early-stage life-sci businesses based in the Bay State, out of 88 applicants.

The seven winners:

Eutropics Pharmaceuticals of Boston's Dorchester section, an oncology drug company that develops drugs for treating aggressive forms of myeloma, lymphoma, leukemia, and other cancers.

Good Start Genetics, a Boston molecular diagnostics company working to develop a low-cost, pre-pregnancy test for 50 genetic disorders that will replace single-disorder tests currently on the market. The company uses a process developed by team members from George Church’s laboratory at Harvard Medical School.

InVivo Therapeutics, a Cambridge medical device company developing technology to treat traumatic spinal cord injury by using biomaterials with combinations of drugs and cells. The company is commercializing research by Robert Langer of the Massachusetts Institute of Technology and Jay Vacanti of the Massachusetts General and Children’s Hospitals in Boston.

Pluromed, a Woburn maker of injectable plugs designed to improve outcomes in cardiothoracic surgery. Pluromed's LeGoo Internal Vessel Occluder earned the company the 2008 European Association of Cardio-Thoracic Surgery Techno-College Innovation Award for the most important technological breakthrough in any area related to thoracic and cardiovascular surgery.

Spectra Analysis, a Marlborough supplier of molecular spectroscopy systems and applications for chromatography.

Wadsworth Technologies, a Westborough medical device maker whose Dermaloc Wound Closure System applies tension to skin wounds to close them without anesthesia or sutures resulting in a novel, painless, rapid, needle-free and durable wound closure. The product is currently in clinical testing.

Wolfe Laboratories, a Watertown biopharmaceutical development company, will use its $500,000 loan toward constructing the first stage of an aseptic fill/finish manufacturing facility for pre-clinical development and clinical trials. Once the first stage of the aseptic fill/finish operation is functional and a base of clients is developed, Wolfe Laboratories said in a statement, it will pursue further expansion.

Bayer HealthCare Seeks $50 Million for Richmond, CA Campus

Bayer HealthCare has placed its 350,000-square-foot Richmond, Calif., facility for sale for the second time in two years, and this time has knocked off $100 million from its asking price, dropping it to $50 million.

Through broker GVA Kidder Mathews, Bayer HealthCare will market the former biotech home of Berlex, acquired by the unit of German-owned Bayer as part of its acquisition of Schering in December 2006. Bayer would use 100,000 square feet of the campus' office and laboratory space for three to five years, said Helmut Altmann, vice president of integration program management for Bayer.

That leaves 250,000 square feet available for lease at the site, which is being marketed under the name Hilltop Science & Innovation Campus — including 107,000 square feet of manufacturing capacity. Asking rent is $24 per square foot.

About 135 Bayer employees are housed at the site, where Berlex once employed 400 people and the multiple sclerosis drug Betaseron was developed.

New 9,000 Sq. Ft. Breast Health Center Opens in Phoenix

A new breast health center that has opened in Phoenix will include a tumor biorepository for researchers at the Translational Genomics Research Institute.

The new 9,000-square-foot Breast Health and Research Center will open next to the John C. Lincoln Deer Valley Hospital. TGen plans to help the non-profit center discover new ways to diagnose and treat breast cancer.

Massachusetts Loan Boosts Wolfe’s Facility and 7 Other Businesses

Wolfe Laboratories (WLI) has been given a $500,000 (€375,000) loan by the Massachusetts Life Sciences Center (MLSC) to construct the first stage of an aseptic fill/finish manufacturing facility.

The facility is a boost for the state’s production capabilities, which were under the spotlight last month when the Massachusetts Biotechnology Council (MBC) said the region is struggling to attract the manufacturing sector.

Completion of the facility will give WLI the capacity to provide aseptic fill/finish manufacturing to client producing therapeutics for preclinical development and clinical trials.

Janet Wolfe, president and founder of Wolfe Laboratories, said: "These funds will allow us to expand our capabilities, which our clients have been requesting, so that we can rapidly provide high quality IND-enabling drug development and manufacturing services to contribute to a sustainable drug pipeline."

WLI is constructing the facility to provide clients with integrated development and manufacturing services, which removes the risks and delays associated with transferring technologies.

The loan given to WLI is one of seven given to early stage companies, which form the first phase of distributing the states $1bn life science fund. A total of $3.4m was given to the companies, which were selected from 88 applicants.

Representative Peter Koutoujian said: “The Accelerator Program loans are a stabilizing resource in such uncertain economic times, especially for pioneering companies like Wolfe Laboratories doing important research necessary in the drug development process.

“It is important to promote early-stage companies such as Wolfe because they not only bring business into our cities and towns, but also save and improve lives through their research."

PharmaTek OKed to Make Cytotoxics at San Diego Plant

US chemistry firm PharmaTek Laboratories has a green light to start making high potency APIs and cytotoxics at its facility in California after meeting strict safety and control rules that govern their production.

Analysis and testing showed that control systems in place at the 18,000 square foot San Diego plant are effective at controlling airborne particulates down to levels of 0.1ug per cubic meter.

Company president Tim Scott said the clearance “allows PharmaTek to expand our development and manufacturing services to include highly potent and cytotoxic compounds, and do it in the safest possible way."

He went on to say that: "The results from extensive facility testing exceeded Pharmatek's expectations for the safe handling of category 4 compounds on a 5 band scheme."

Kevin Rosenthal, head of PharmaTek’s manufacturing operations, stressed that the airborne particulate results were just part of an overall program designed to ensure worker safety.

"Combined with the facility engineering controls, significantly lower particulate levels are achieved when respiratory protection factors and process specific enclosure systems are taken into account.”

In addition to the development space, the facility houses two certified and validated high-containment manufacturing suites designed with soft-wall enclosure systems, enabling PharmaTek to tailor production operations to a specific client’s needs.

The market for cytotoxic production looks set to continue growing over the next few years as a rise in demand for novel, potent medications to replenish pipelines coincides with Big Pharma’s efforts to cut back on internal manufacturing capacity.

While this will drive demand of all types of contract drug manufacture, the specialized handling skills needed to make cytotoxics and the investment required to develop such capacity is likely to limit the number of companies offering such services.

PharmaTek’s main U.S. competitors in the cytotoxics market are Cytovance Biologics and SAFC, which have both increased manufacturing capacity in recent years to try and keep up with demand.

Another factor likely to drive the market for cytotoxic drugs, and hence manufacturing capacity, is the incidence of cancer worldwide, which a World Health Organization (WHO) report suggested will grow 50 per cent, to 15m new cases, by 2020.

PathCon® Announces USP <797> Airborne Microbes Initiative

PathCon Laboratories, the pathogen control experts, announced on April 22 an initiative to assist pharmaceutical compounding facilities with US Pharmacopeia (USP) Regulation <797> compliance. The program provides a comprehensive laboratory analysis solution for facilities looking to evaluate the viable airborne microbial bioburden as described in USP <797>.

USP <797> became effective on June 1, 2008, and set forth the first enforceable requirements to ensure that compounded sterile preparations (CSPs) are of high quality in pharmacies and other facilities where CSPs are prepared. The regulations, issued by the USP and recognized by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), address viable airborne particles in compounding facilities and require that an “appropriate environmental sampling plan shall be developed for airborne viable particles based on a risk assessment of compounding activities performed.”

As part of the USP <797> viable airborne microbial program, PathCon scientists work with pharmacies and other compounding facilities to develop specific sampling protocols, incorporating appropriate air sampling devices, sample volumes, and suitable growth medium for bacteria and fungi as recommended in USP <797>. In addition, PathCon offers one-on-one consulting regarding specific sampling locations, collection methods, sampling frequency, and volume of air samples.

Althea Technologies Completes New State-of-the-Art Manufacturing Facility

Althea Technologies, Inc., a provider of services for biopharmaceutical development and manufacturing, recently hosted a ribbon cutting ceremony to mark the opening of its newly constructed state-of-the-art, commercial-scale cGMP manufacturing facility in San Diego, CA. Althea's employees and board of directors, together with City of San Diego Mayor Jerry Sanders, Matt MacKowski of Telegraph Hill Partners, Steve Cusato of City National Bank, and key invited guests, celebrated the commissioning of its new facility at the Althea campus in Sorrento Valley.

Co-Founders Magda Marquet and Francois Ferre remarked, "This is the culmination of a dream we envisioned when we founded Althea Technologies, which was made possible by the investment and support of our Althea team and our key partners at Telegraph Hill Partners and City National Bank."

The decision to create expanded capacity was brought about by the need in the region to keep pace with the growing needs of the industry to outsource biological and injectable product manufacturing. A significant segment of the biotechnology industry consists of companies focused on research & development, that do not have the expertise or capital to invest in a manufacturing facility. Manufacturers, such as Althea, allow biotech companies to keep focus on their core competence in R&D.

"The decision to expand our capabilities and design a new facility was made with careful consideration of our clients' needs," commented Dr. Shabbir Anik, Althea President and CEO. "The new facility was designed to provide flexible capacity and expand our services from early clinical development through Phase III and commercial supply. This expansion gives clients a more efficient and faster option to bring their products to the market," said Dr. Anik.

"We are very excited to launch our 30,000 square foot commercial-scale cGMP manufacturing facility because it allows Althea Technologies to take an integrated approach in the manufacturing of exciting new biotechnology derived therapies. The completion of this building marks a significant milestone in our ultimate goal of accelerating the development and delivery of novel therapies to the people who need them most," stated Dr. Magda Marquet, Co-Chairman and Founder.

Among the unique features of the new cGMP facility are its compliance with both U.S. and European manufacturing regulations and its state-of-the-art building management system that ensures a sterile manufacturing environment.

Althea Technologies successfully partnered with City National Bank and Telegraph Hill Partners to secure the necessary funding for the project. "The ability to undertake the construction of a commercial facility costing over $15 million to increase our production capacity and build on our service offerings is remarkable for a company the size of Althea," said Dr. Anik. As a company that prides itself on doing business with San Diego, all of the construction services were provided by San Diego-based businesses.

"The commercial expansion will enable Althea to contribute to the economic vitality of the region through the addition of personnel and the ability to help ensure the continued success of more biotech companies," said Dr. Franxcois Ferre, Co-Chairman and Founder of Althea Technologies.

NY Officials Tout Upcoming Facilities as Key to Retaining Bioscience Business

A series of new facilities under construction or in planning stages should help New York begin to address its inability to retain growing life sciences companies spawned from its numerous universities and others research institutions, speakers agreed at a panel discussion hosted earlier this week by the New York Biotechnology Association.

The facilities stretch the length and breadth of the state, from a $30 million public-private facility designed to create a life-sci presence in Syracuse and revitalize a section of the city; to a pair of New York City projects that have raised $81 million toward the expansion of a Brooklyn incubator and creation of a new site for incubator graduates at the Brooklyn Army Terminal.

In all, a total six facilities comprising more than 2 million square feet are in New York's pipeline of life-sci space, according to the panelists who spoke at "The Biotechnology Catcher's Mitt" during NYBA's 18th Annual Meeting, held at the New York Marriott Marquis hotel.

That includes New York City and its suburban Long Island and Westchester County regions, a market that now contains a combined 2.6 million square feet of life-sci space, Richard Charles, senior vice president in the life sciences group of commercial real estate firm CB Richard Ellis, said during the panel talk.

A dearth of suitable life-sci space, along with higher construction costs compared to top-dollar "class A" office space, according to Charles, has kept rents higher than those of neighboring New Jersey and most of the nation's other markets. Rents for lab space in New York City itself range between $55 per square foot and $70 psf, though those numbers drop to between $35 psf and $45 psf in Westchester County, and "around" $28 psf on Long Island, Charles said. By comparison, rents in New Jersey are in the range of between $28 and $34.

"It's outstanding, the fact that New York has several properties here under development. It's an expensive area for entry," Charles said. "New York City has some great institutions, and you pay for that proximity."

Under Construction:

New York is making progress on addressing its lack of life science space, however, with several facilities in the hopper. Furthest along are projects by two of the nation's publicly traded real estate investment trusts seeking to expand in the New York metro area.

They are:

Alexandria Real Estate — The Pasadena, Calif., REIT is building the first phase, a 16-story, 320,000-square-foot East Tower, at its Alexandria Center for Science and Technology at East River Science Park in Manhattan. Alexandria disclosed in February it is in talks with a tenant prospect for 100,000 square feet of the East Tower. But the lab space developer has blamed the economic upheaval for its decision to delay earlier plans to break ground this year on the second 389,000-square-foot tower of the project.

BioMed Realty Trust — The San Diego REIT is completing a $145 million set of three interconnected buildings comprising a 360,000-square-foot expansion of its now approximately 752,000-square-foot Landmark at Eastview office/R&D park in Tarrytown, NY. Most of the new space will be occupied by Regeneron Pharmaceuticals, which has promised to retain 440 jobs on the campus rather than move out of state, in return for a $4 million state grant and $5 million in tax breaks from Westchester County's Industrial Development Agency.

Also in New York City, the State University of New York's Downstate Medical Center is expected later this year to issue a formal request for proposals from prospective contractors interested in building out an expansion of its Advanced Biotechnology Incubator. The expansion would double the Brooklyn incubator's size from the current 24,000 square feet that houses 10 tenants, to about 50,000 square feet, and, like the existing facility, would feature labs starting in size at 500 square feet.

The RFP is expected to be issued this summer for the project, said Eva Brown Cramer, SUNY Downstate's vice president for biotechnology and scientific affairs.

Cramer, who is also a professor of anatomy and cell biology at SUNY Downstate, said SUNY Downstate has raised $25.2 million from the federal, state, and city governments for the expanded incubator. It would join a life-sci campus that also features a commercial synthetic chemical lab, and the namesake medical center, which Cramer termed "a wonderful location for clinical trials."

Five miles north of the incubator, SUNY Downstate also plans to convert a 525,000-square-foot former industrial building at the Brooklyn Army Terminal into a life sciences facility for companies that graduate from the incubator. BioBAT, also known as New York Science Center, welcomed its first graduate late last year, when the International AIDS Vaccine Initiative or IAVI opened a $17 million AIDS Vaccine Design and Development Laboratory within 36,000 square feet at BioBAT. IAVI retains 1,000 square feet at the incubator, which houses 10 tenant life-sci companies. State and city officials have committed $60.5 million toward BioBAT, which is being designed by Phase 3 Properties.

SUNY Downstate has raised more than $60 million to date for BioBAT/NY Science Center from the New York State and city governments. "Our concept is that when companies outgrow the incubator, they need a larger area to grow into," Cramer said. "There's a tremendous amount of research taking place in New York City and the metropolitan area, and a tremendous need for biotech space."

Smaller in size, but no less ambitious, are plans by the Central New York Biotechnology Research Center to develop a roughly 50,000-square-foot facility in Syracuse — part of a medical campus planned for the 14-acre site now occupied by the shuttered Kennedy Square apartment complex. Plans for the campus were announced last year by Gov. David Paterson.

The center is a venture of SUNY Upstate Medical University, SUNY College of Environmental Science and Forestry, the region's key economic development group Metropolitan Development Association of Syracuse and Central New York, and the Syracuse VA Medical Center.

The biotech research center has available $20 million it received from the state several years ago toward developing the $30 million Syracuse facility, and is working to raise the remainder.

"There really is, and has been forever, a dearth of wet lab space — just no space available, whether it is academic startups or companies that are already established and need some wet lab space," John Fieschko, the center's executive director, said from the audience. "We're hoping that in about a year and a half to two years to have the building ready."

Speaking with BRN after the panel talk, Fieschko said potential life-sci startups interested in the Syracuse site have ranged from traditional therapeutics developers to companies with a forestry focus. Albany Molecular Research approached the center seeking additional space, while another undisclosed stem cell company with a factory north of Syracuse contacted the center seeking space for a demonstration facility.

"A lot of professors have told me they've stared companies from the basements of their houses. It's those startups, as well as those established companies, that need space. It's really whatever the needs are. If we can fill up the building and we can get more funding, then we will build another one," Fieschko said in an interview.

He said the current amount of funding is enough to build part of the project, the building's shell. The center, three years in planning phases, has been working with King & King Architects and S/L/A/M Collaborative on a design for the facility. It expects, Fieschko added, to develop synergies with the state-funded Syracuse Center of Excellence in Energy and Environmental Systems, which focuses on alternative "clean" energy, indoor environmental quality, and water resources.

Also looking to grow more life-sciences startups is Cornell University's Cornell Center for Technology Enterprise and Commercialization. CCTEC Director Brian Kelly said the center has completed a roughly 8,000-square-foot center for life-sci business incubation, technology transfer, and economic development within the recently opened 250,000-square-foot Joan and Sanford I. Weill Hall, within Cornell's Ithaca campus.

The biotech incubator's name has been changed from the Innovation Development and Economic Applications Center, or IDEA Center, to the Kevin M. McGovern Family Center for Venture Development in the Life Sciences. The change followed a $7.5 million naming donation by the family of McGovern, a 1970 Cornell graduate and the chairman and CEO of McGovern Capital, a private investment firm and provider of intellectual property rights strategies. Cornell accepted the gift as part of its $650 million New Life Sciences Initiative, intended to boost faculty recruitment, student scholarships, and facilities.

"We hope that that will be able to sustain five to 10 Cornell companies that will probably have a turnaround of about 18 months," Kelly said.

CCTEC also nurtures startups through its "Big Red Triad" suite of services: A venture fund run by students in Cornell's Johnson Business School; a legal services group staffed by volunteers from the law school and overseen by outside law firms; and a business incubator that houses companies launched by Johnson School students. Cornell startups have also emerged from the Cornell Center for Life Science Enterprise, a venue for R&D, training, and technology transfer sponsored by the New York State Foundation for Science, Technology and Innovation, or NYSTAR.

Plugging the Brain Drain

Kelly said CCTEC hopes the new McGovern Center will allow it to retain startups like those that have left Ithaca and New York State in recent years. Of 85 companies launched from CCTEC since 1985, 50 are still active. And of those 50, five were launched last year — none of which are based in the Empire State.

Also in 2008, CCTEC signed 65 commercial agreements, received 242 invention disclosure notices, and filed 155 patents.

Speaking with BRN after the panel talk, Kelly said the dearth of space was just "a confluence of many factors" explaining why many of Cornell's startups have left Ithaca and New York state. Other factors he cited included the lure of good technologies developed elsewhere, especially in larger clusters with greater access to capital, and more entrepreneurs with experience in starting up biotech companies.

"Space is slowly emerging. What we truly need is what I would call real risk capital. Having some ability to access that is a going concern for all sectors," Kelly said.

But the economic upheaval of recent months has hampered the ability of startups to grow into the types of companies capable of filling larger space, whether in New York or elsewhere. A few startups have folded at Columbia University's Audubon Business & Technology Center, leaving it in the unusual position of having space available after years of being fully occupied and having to turn startups away, Carol Shuchman, Audubon's director of commercial leasing and development, said from the audience during the panel talk.

"The economy is hitting us as well," Shuchman said.

Audubon has housed 46 companies since the 100,000-square-foot incubator opened in 1995.

A Columbia U panelist — Orin Herskowitz, executive director of the university's tech transfer office, Science and Technology Ventures — said Columbia generates 10 to 12 startup companies a year, out of the 300 inventions generated there annually. Columbia is among the nation's top tech transfer schools, generating $130 million in IP licensing revenue each year, as well as launching 93 new companies since 2000.

"We've had a pretty good year so far, so we're likely to be up to well over 100 by the time this year wraps up," Herskowitz said.

Of the companies launched since 2000, 63 are still in business. Yet only "20-some-odd" of them are based in New York, Herskowitz added, saying: "These companies are landing in New York, in some cases, they're staying in New York. In some cases, they are not. "

"There's a lot of interest in trying to stay as local as possible. Practically speaking, could the intellectual property go out to Seattle, to the Accelerator, or to Boston? It can," Herskowitz continued. He cited Escoublanc, a startup using Columbia U Medical Center technology to develop treatments for metabolic disorders such as diabetes and obesity. Escoublanc moved on Jan. 2 from New York to Biogen Idec's incubator in Cambridge, Mass., after securing $6.65 million from the biotech giant, a financing tranche in a Series A round that could grow to $10 million based on milestones.

"A lot of the entrepreneurs would love to be in New York, and yet until we have employees come on board, [we] can't get there until these new facilities come on board. So I have to believe that there are more ventures coming out of Columbia that could land in New York, where there would be program space," Herskowitz said.

Not all of these ventures are expected to be in the life sciences, though he said all would benefit from proximity to Columbia faculty and staff.

"When you have these local interactions, the perception certainly from the faculty and I think from the investors, is that there's a cooperation that can be established that makes things a lot easier to get the science off the ground" locally, he said.

Also helping get startups off the ground, Herskowitz said, are some 40 PhD student interns working with Columbia-launched companies to help write business plans they hope will draw capital from VCs and other investors. The students are trained in economic analysis, patent analysis, and market landscaping.

Audubon is one of seven life-sci incubators operating across New York state, according to the NYBA web site. David Hochman, executive director of the 35-member Business Incubator Association of New York State, told the audience that the seven included two upstate incubators operating from former pharmaceutical facilities:

• East Greenbush: The University at Albany's East Campus has transformed the former Sterling Winthrop complex off Columbia Turnpike into a tech park with some 100,000 square feet of available wet lab space. The campus is home to the headquarters of Albany Molecular Research, the Cancer Research New York Neural Stem Cell Institute, and other life-sci employers — and starting in September, the new home of Tech Valley High School

• Rochester: The University of Rochester has converted a 40,000-square-foot former Wyeth laboratory building at 77 Ridgeland Road in nearby Henrietta, NY, into the Rochester BioVenture Center. High Tech Rochester manages the facility.

Hochman said his members run 40 incubators statewide; BIANYS estimates the total number at about 50.

Growth in New Jersey

The New York-Westchester-Long Island market is also dwarfed by the 13 million square feet of life-sci space available across the Hudson River in New Jersey — an inventory that balloons to 75 million square feet of space when the facilities of pharmaceutical companies are included.

And New Jersey is on course to expand its life-sci space as well. The state's Economic Development Authority is narrowing its list of preferred developers for the 100,000-square-foot third building at University Heights Science Park in Newark, a campus where 300,000 square feet of the planned 1 million square feet has been built out to date.

"We're very interested in the deal because of the surrounding institutions," namely New Jersey Institute of Technology, the University of Medicine & Dentistry of New Jersey, and the Newark campus of Rutgers University, said Warner Bonner III, principal in the life sciences space developer Phase 3 Properties, and moderator of the panel.

Bonner said during the panel talk that Phase 3 is among developers being considered by NJEDA for the third building, to be called Digital Century Center. The building, to be built at Norfolk and New Streets, will be designed for tenants in the life sciences and other technologies, such as nanotechnology and software development, he said.

Bonner said the sputtering economy has hampered developers like Phase 3 seeking to build new lab buildings. He said a prospective financing partner, Apollo Management, won't proceed unless Phase 3 can sign leases for at least 80 percent of Digital Century Center's space.

"Typically — up to six months ago, seven months ago — we would have needed 50 percent. So we have to meet with the economic development authority and make sure they can step up to that. We're going to need the authority to do that," Bonner said.

University Science Park accounts for most of the 1.7 million square feet of new life-sci space development talking place in New Jersey, Charles said.

Charles also cited one of New Jersey's faster-growing life-sci companies, the biopharmaceutical company Celgene, which he said is in the market for about 100,000 square feet of additional space in the Garden State. Celgene added space last year in two deals: Early in 2008, Celgene inked a sublease for 39,994 square feet at 106 Allen Road in Bernards Township, NJ, 16 miles west of the company's Summit, NJ, headquarters, then last fall agreed to sublease another 37,962 square feet in the same 132,101-square-foot class A building, the Liberty Corner Corporate Center completed in 1999 and owned by Mack-Cali Realty.

A Celgene spokesman, Greg Geissman, told BRN that the company has no specific plans to lease any new space, or expand its space at existing sites.

Charles said New Jersey has another advantage over New York besides more space, namely cheaper rent. Life-sci companies can expect to pay between $28 and $34 per square foot for lab space, a range that drops to between $8 and $14 psf for office-warehouse "flex" space.

Along with lower rents come lower tenant allowances, which Charles said range from $50 psf to $100 psf in New Jersey, compared with $100 psf to $150 psf in New York City and nearby suburbs.

$65 Million Cancer Research Centre Goes Up in New Orleans

Construction is under way on a state-of-the-art cancer research centre, one of the first new major construction projects to begin in the city since Hurricane Katrina.

Designed by international architects RMJM, the 175,000-square-foot facility will include flexible research space, office space and support laboratories for 72 principal research teams.

The 10-storey, bricks and mortar centre has been on the drawing board for most of the past decade. The design was completed shortly after Katrina struck.

“It has been a long time coming, but the project is definitely on course now,” said Steven Moye, president and CEO of the Louisiana Cancer Research Consortium, which will operate the facility. LCRC is a collaboration of the health sciences programs of three state universities.

“It is the first of many state-of-the-art medical facilities planned for the city and it will pioneer breakthrough advances in detection, treatment and prevention of cancer while fostering economic development in downtown.”

The research centre is located in what is known as the Greater New Orleans Biosciences Development District, that will also include the BioInnovation Center.

Three of the floors of the building being constructed by Brice Construction will be dedicated to cancer research laboratories for LCRC’s immunology, molecular signaling and molecular genetics research programs.

One floor will house a vivarium and LCRC’s executive offices. Four floors will be dedicated to parking. A large theatre-style meeting facility will be located on the first floor. With seating for 250, it can be used for scientific meetings as well as community events.

The remaining floors will be flexible “white box” spaces for future growth as laboratories, offices or clinical services. Construction of the $65 million building is expected to be complete in 2012.

“The design combines two strong forms: a raised sculptural volume designed as a symbol of hope,” said R. Stephen McDaniel, RMJM’s leader in designing healthcare and research facilities. “The other is a two-storey glass element parallel to Tulane Avenue, which includes the lobby and conference center.”

RMJM is an international leader in designing cancer research facilities. In addition to the LCRC, RMJM has designed the Champalimaud Cancer Center in Lisbon, Portugal, the Mitchell Cancer Institute at the University of South Alabama and the Cancer Institute of New Jersey in New Brunswick, N.J.

Other RMJM health and research projects include hospitals in New York City, Philadelphia, Singapore and Princeton as well as medical schools and biotechnology facilities in various locales.

For LCRC, the firm partnered with Lyons and Hudson Architects, with mechanical engineering by Vanderwell in collaboration with New Orleans-based Wink Engineering.

RMJM is a United Kingdom-based international firm of architects with offices throughout the U.K., Asia, the Middle East and the United States.

Xspray Grows with Demand for Manufacturing Tech

Xspray has doubled its personnel and laboratory space in response to demand for its manufacturing service, which is designed to overcome the drawbacks associated with micronisation.

The production of high quality particles and powders is critical to the pharmaceutical industry and Xspray believes its technology can improve this process at scales from discovery through to commercial manufacture.

Scalability is one of the key benefits of the technology, according to Xspray, and this has attracted pharmaceutical companies, prompting the company to expand its operations.

Per Andersson, Xspray's CEO, said: "Interest from pharmaceutical companies has been steadily increasing over the last twelve months or so. Despite the current economical climate we have secured three commercial agreements, which show that customers are convinced by the benefits of the technology.

“This is an important step for the company and confirms that we have a strong offering, capable of adding real value throughout the pharmaceutical process from development to production."

Xspray signed its first commercial agreement with a client in Q4 2008 and since then two “major pharmaceutical companies” have undertaken evaluation projects.

The technology:

Xspray’s RightSize Particle Manufacturing Technology uses supercritical fluid technology as a solvent for precipitation of an active pharmaceutical ingredient (API) in one step.

The process is done without additional excipients and produces highly crystalline particles of controlled size and good flow characteristics, according to Xspray.

Using the technology enables “simplified formulation” and offers “better control over dose variation”. In addition Xspray says that the mild operating conditions allow it to process APIs that are damaged by heat.

To cope with increased demand Xspray has recruited new staff, including Mikael Bisrat as chief scientific officer and Helene Derand as sales and marketing director, and expanded its laboratory.

This has allowed the company to add solid state characterization and analysis capabilities and its new good manufacturing practice (GMP) compliant facility will open in the coming months.

Virginia Commonwealth University School of Medicine Opens Research Center

The Virginia Commonwealth University School of Medicine has opened a new medical research facility that will house a variety of studies that will involve genomics, DNA sequencing, and proteomics efforts.

VCU held a ribbon-cutting for the $71.5 million, eight-story, 125,000 square-foot lab space, which includes an auditorium, a seminar space, and teleconference facilities.

The Molecular Medicine Research Building will conduct cancer research, studies of infections in transplant cases, and investigations of alcoholism and opiate addiction, among others, according to VCU. These studies may focus on identifying patients who are at risk for these and other diseases.

For example, specific genomics studies could entail using DNA microarrays to identify areas of the brain that are involved in alcohol addiction and the susceptibility of liver transplant patients to infection with hepatitis C, a VCU spokesperson told GenomeWeb Daily News.

Delays in Safety Study Push Back Opening of BU's National Emerging Infectious Disease Lab

A study looking into the safety of Boston University's newly built National Emerging Infectious Disease Laboratory has been delayed, which has in turn pushed back to at least the coming fall a court decision on the fate of the facility.

A court decision on the opening of the 192,000-square-foot, $198 million Biosafety Level 4 lab, entrenched in a long-running legal dispute, will be delayed until fall of 2010 at the earliest, and possibly later.

The study, which will be released for public comment, calls for the National Institutes of Health to perform supplemental risk analyses into the ability of the lab to contain 13 toxins to be studied there, and to ensure that it can be operated safely.

NEIDL is intended to perform basic and clinical research into infectious diseases, which in recent years have included West Nile virus, Ebola, avian flu, and HIV.

The supplemental risk analyses began last year but will take longer than the June 2009 timeframe projected late last year for completing a draft analysis report, NIH, BU, and Boston Medical Center Corp. stated in a legal filing submitted earlier this month to US District Court Judge Patti Saris.

"The NIH estimates that a draft of the supplemental risk analyses will be available for public comment during the winter of 2009-2010, followed by a final supplemental risk-analyses document that responds to all public comments made on the draft during the spring or summer of 2010, "the legal filing stated.

The corporation runs Boston Medical Center, a private, not-for-profit, 626-bed academic medical center that serves as the primary teaching affiliate for Boston University School of Medicine.

The supplemental draft risk assessment, conducted by Tetra Tech, is overseen by a panel convened in March 2008 by the NIH's Advisory Committee to the Director — four months after the National Research Council concluded that the NIH used flawed research methods in a draft supplemental environmental review.

That analysis concluded the NEIDL was safe, and did not make clear the reasoning behind those methods, or the findings derived from them.

The 16-member panel, which will next meet May 5 at NIH's Bethesda, Md., headquarters, is chaired by Adel Mahmoud, professor in the Department of Molecular Biology and Woodrow Wilson School of Princeton University.

According to the Jan. 9 edition of the NIH Record, the panel "will oversee the [supplemental risk assessment] study and report [its] results in June 2009."

The outcome of the panel process "will be a rigorous and comprehensive evaluation that will consider the questions and concerns raised by the public, the National Research Council, and the Federal and State courts with respect to construction of the NEIDL," the panel said in a Q&A posted on its web site.

"Upon review of the panel’s comments and suggestions, the NIH may do any or all of the following: conduct additional risk assessments, as warranted; revise the current draft supplementary risk assessments report, as necessary; solicit public comment on any new reports that may be generated; and submit final reports to the relevant authorities," the panel said.

The final supplemental risk assessment is supposed to incorporate comments from the NRC and from the public. The NIH, BU and the BMC proposed in the legal filing that Saris allow up to 45 days from when the final supplemental document is released and noticed in the Federal Register for filing of motions for summary judgment and/or permanent injunctive relief, followed by another 30 days for opposition memoranda.

"Based on the projected issuance of a final supplemental NEPA decision document, briefing should be completed in time for the court to hold a hearing in the fall of 2010," the NIH, BU, and the BMC wrote in the legal filing. They added that they "are cognizant of, and will observe, the limitations the Court has placed on the operations of the Boston-NBL pending the completion and review by the court of the supplemental NEPA analyses."

BU, citing the need for safety, has expressed support for the supplemental risk-assessment effort.

The delay has also pushed back BU's plan to temporarily use the lab as a venue to conduct training exercises for scientists as well as city, state, and federal officials interested in testing safety, health, and operational procedures.

"These exercises will provide the opportunity to test and revise the scientific standard operating procedures (SOPs); overlay emergency responses (internal and external) to simulated incidents; familiarize regulatory departments and agencies with laboratory operations; and, familiarize community residents with how research protocols will be conducted in the laboratories," BU said in its press release last August announcing the training.

"During the training exercises no research will be conducted and no research agents will be used in the building," BU added.

At the time of the announcement, BU anticipated launching the training exercises in February, but that timeframe has been pushed back to later this spring.

"We just slowed down the planning as the timing of the opening slowed. There is no rush to do it," BU spokeswoman Ellen Berlin told BRN on April 16.

BU would not say whether it could abide by an indefinite delay in the full use of NEIDL, or what, if any, consideration it has given to alternative uses if the process drags on past current projections for the draft and final risk assessments.

"We believe that this is an important process, and appropriate time should be spent on it," Berlin said.

The NEIDL, originally proposed in 2003, sits within a freestanding Albany Street building recently completed within BU’s BioSquare research park, where 582,000 square feet of space currently houses three buildings.

The lab has since been opposed by a coalition of critics consisting of neighbors, community activists, and researchers who contend that its BSL-4 facility would be unprepared to combat an accidental release of toxins outside its lab, and should instead minimize its risk to the community by operating in a less-densely populated neighborhood.

In 2006, the Boston-based Conservation Law Foundation and 10 residents living near the proposed lab site in the city's Roxbury and South End sections filed a series of lawsuits in federal and state courts to overturn city, state, and federal approvals for NEIDL.

Plaintiffs prevailed that year when Suffolk Superior Court Judge Ralph Gants vacated the state’s certification that the project’s original environmental report complied with Massachusetts law. Gants ordered a new environmental review with more information on the merits of a less-populated site for the lab as well as how well it could respond if a toxin escaped from the lab.

Following that decision, the NIH and BU agreed to prepare a draft supplemental review, address concerns raised in the federal case by submitting a risk-assessment report, and to appeal Gant’s ruling.

In the resulting “Draft Supplementary Risk Assessments and Site Suitability Analyses for the National Emerging Infectious Diseases Laboratory,” BU concluded that the lab poses no increased risk of transmitting Ebola, monkeypox, Sabia virus, or Rift Valley fever in the South End site where it is being built, compared with two alternative locations where BU has operated programs, including Tyngsborough, Mass., and Peterborough, NH.

That report was eventually skewered by the National Research Council, which led to the current NIH study. Representing the residents in their court challenge to NEIDL is Peter Shelley of the CLF.

The NEIDL is one of two National Biocontainment Laboratories — the other is at the University of Texas Medical Branch in Galveston — planned by the US National Institutes of Health to battle emerging infectious diseases in the years since the Sept. 11, 2001, terrorist attacks and a subsequent wave of anthrax attacks.

The NIH has also designated 13 regional biocontainment laboratories, all of them Biosafety Level 3. The closest one to NEIDL is 30 miles west of Boston in Grafton, Mass., where Tufts University on March 30 dedicated its $33.7 million New England Regional Biosafety Laboratory on the school’s North Grafton, Mass., campus.

Drake University Wins $60K Grant from Iowa Regents Board to Build PGx Training, Research Lab

Although the Pharmacogenomics Training and Research Laboratory will primarily focus on training students in the discipline, it could also enable R&D partnerships with industry players.

Salk Lands $5.5 Million Grant for Nutritional Genomics

The Salk Institute said that it will use a $5.5 million grant from the Leona M. and Harry B. Helmsley Charitable Trust to create a center to study nutritional genomics.

The La Jolla, Calif.-based institute will use the funding to launch the Salk Center for Nutritional Genomics, which will study the effects of nutrition and genetic interactions on metabolism, the immune system, cancer, and diabetes.

The money will be used to fund a metabolic core facility and an interdisciplinary fellows program, and will include the study of gene networks based on DNA sequencing.

"Given the fact that metabolism has clearly established itself as a common denominator in many research fields, I am very pleased that our scientists will have the opportunity to collaborate further and delve even deeper into this vitally important area of biological science," Salk President William Brody said in a statement.

The nutritional genomics center will "enable our researchers to develop new approaches to understand the metabolic changes associated with Type I and Type II diabetes, cancer and aging," Brody added.

"The study of metabolic control will provide fundamental answers that have profound implications for human disease and its treatment," Marc Montminy, a professor at Salk's Clayton Foundation Laboratories for Peptide Biology, added.

"Our scientists look at the genomics of metabolic control as the hub of a wheel whose individual spokes lead out to new insights into other disorders such as diabetes, cancer, neurodegenerative diseases, and aging," Montminy continued.

NanoLogix Expands Manufacturing Facility in Ohio

NanoLogix Inc. has begun construction on a 2,800 square foot manufacturing facility at its headquarters in Hubbard, Ohio. It will contain a production cleanroom, cold-storage vault, and shipping and receiving area to be used in the fabrication of BNP(TM) Ultra-Fast test kits.

The revolutionary new BNP(TM) kits provide accelerated detection of bacteria and pathogens -- 100 to 600% faster than conventional Petri plate testing. They will have broad applications in Homeland Security, human and veterinary medicine, processing and safety of food, cosmetics and drugs, research and development, and industrial and environmental testing.

One of the foremost bio-defense and biomedical research centers in the U.S. recently found in its tests that the BNP(TM) provided results up to four times faster than current Petri plate methods. Using the BNP(TM) they were able to view anthrax cultures in one-quarter of the time, and bubonic plague (Black Death) cultures in half of the time possible with the best traditional methods

The new facility will replace the company's current limited-production operation at its research and development laboratory in Cincinnati, boosting production capability to thousands of BNP(TM) kits per day. This provides the opportunity for expanded R&D of other NanoLogix products at the Cincinnati lab.

The BNP(TM) kit is based on NanoLogix's revolutionary sandwiched-membrane Petri technology. The company believes the BNP(TM) has a high potential of capturing a significant percentage of the annual multi-billion dollar Petri plate market in both the United States and internationally.

NanoLogix CEO Bret Barnhizer stated: "With the BNP(TM) kits, we believe we are on our way to establishing a new 'gold Standard' for microorganism detection that will have a revolutionary effect on medical testing, diagnosis and treatment. This production facility will enable us to capitalize on our technology and provide product to those who are rapidly becoming aware of the BNP(TM) potential".

The test kits provide users the ability for faster detection of a long list of pathogens, including E-coli, Salmonella, Listeria, Enterobacter, Staphylococcus, Anthrax and Bubonic plague.

In addition to providing ultra-fast viewing of microorganisms normally cultured on standard Petri plates, the BNP(TM) kits can be used to assist in early detection of some of the most dangerous pathogens in the world, including those that pose significant potential threats for use as bio-weapons by terrorists.

The BNP(TM) production operation is expected to create a dozen jobs in the economically depressed Youngstown, Ohio, area, with more to follow as product demand increases.

Packaging Updates

In light of growing interest in devising sustainable, cost-efficient pack and processing solutions, academic institutions are increasingly being supported and sought after by companies and retailers to find potential operational benefits.

UK-based retailer Tesco recently announced it was working with one veterinary university in England in a bid to encourage greater academic collaboration over supply chain challenges.

Groups like packager Sealed Air also announced a similar team up last year with South Carolina-based Clemson University to create a teaching, research and service facility.

And Coca-Cola has provided $400,000 to one U.S.-based university to encourage development of new sustainable forms of packaging through a scheme that could see other beverage and food manufacturers following suit.

The funding will be used to support a proposed Packaging Innovation and Sustainability Centre at Michigan State University (MSU), which has been devised to focus on evaluating pack sustainability from a scientific perspective.

Susan Selke, acting director of MSU’s School of Packaging, said that the centre was seeking further support from other commercial groups both in terms of initial and longer-term support that it hopes could come, in part, from the beverage industry.

New Winery, Brewery and Food Science Laboratory at the University of California

Greener brewing and wine production is on the syllabus at the University of California as construction begins on a new Winery, Brewery and Food Science Laboratory on the campus from June.

With completion of the 34,000-square-foot research centre expected by 2010, the university claims that the complex will provide scientific research, student training and even collaboration with industry.

REST OF WORLD

Hamner Health Partners With China Medical City

Source: The Hamner Institutes

Translational R&D Lab Opened in Scotland

A new $18.5 million core research laboratory for the Translational Medicine Research Collaboration (TMRC) has been opened in Dundee, Scotland. The TMRC is a collaboration involving four of Scotland's leading universities (Aberdeen, Dundee, Edinburgh and Glasgow), their corresponding health boards, Scottish Enterprise and global pharmaceutical company Wyeth.

The partnership aims to raise the commercial profile of Scotland's translational research in five main therapeutic areas: cardiovascular, women's health, neurology, oncology and inflammation.

Already the work of the partnership has created more than 100 high value jobs across the universities, National Health Service (NHS) and at the core laboratory. The new purpose built laboratory at Ninewells Hospital has the capacity to accommodate up to 120 staff, as opposed to 35 in its previous location.

"The presence of the TMRC in Scotland is a growing testament to Scotland's world-class reputation in medical and scientific research," said First Minister Alex Salmond. "In these times of global economic uncertainty these are vital assets and every step in their progress during the current downturn could protect a job or support a breakthrough.

"Already Scotland is recognized as an intellectual frontier, with the country now home to some 600 organizations working in life sciences. Only last month I was in Aberdeen to open the state-of-the-art Wyeth facility based in the Aberdeen Royal Infirmary on the Univ. of Aberdeen campus.

"The TMRC's new Core Research Laboratory will provide a vital central research facility for clinical and scientific research groups throughout Scotland," said Peter Downes, Acting principal at the Univ. of Dundee. "It will provide a world-class facility for the development and validation of biomarkers of disease which can be used to accelerate the discovery of experimental medicines by bridging a critical gap between preclinical and clinical studies."

"As one of the world's leading research-driven pharmaceutical companies, Wyeth is delighted to be a core participant in the TMRC," said Menelas Pangalos, EVP, Discovery Research, Wyeth Research.

The Scottish Government has provided support for the TMRC--$28 million in grant funding to support research and development. Wyeth is providing $52 million over five years to support the collaboration.

Lonza to Set Up Singapore Cell Therapy Plant

Swiss biomedical science firm Lonza is investing CHF30m (€19.7m) in a new cell therapy facility in Singapore, continuing its global expansion effort.

The plant, which will produce novel therapeutics on a contractual basis, will be located next to the firm’s existing mammalian manufacturing unit at the Tuas Biomedical Park in the West of the country.

Company CEO Stefan Borgas said the unit is the next step in Lonza’s efforts to expand in Asia explaining that: “Cell therapy is expected to be one of the most important innovation drivers of modern medicine.

"The facility will operate with cutting-edge technologies and a skilled labor force, allowing it to readily meet the needs of a broad range of customers and address the growing global demand.”

Beh Swan Gin, managing director of the Singapore Economic Development Board (SEDB), said the new unit “extends the highly successful Lonza-Singapore partnership from chemicals to biologics manufacturing and now, the production of cellular therapeutics.”

Construction is expected to begin early next year with the aim it becoming fully operation sometime in mid-2011.

Lonza has a network of 12 good manufacturing practice (cGMP) accredited cell therapy plants worldwide, including a facility in Walkersvillie, Maryland, US in which it invested $26m to boost cell production capacity in January.

The firm also works with Novartis and Genentech on the manufacture and development of biologics.

Singapore’s Biotech Sector "future ready"

Efforts to boost scientific development has seen Singapore emerge as a hub for high-tech drug manufacture, with global pharmaceutical firm’s investing more than $500m in the country last year alone, according to the SEDB.

Before Lonza announced its latest move, Bayer, Schering-Plough and Takeda all expanded operations in the country both by adding manufacturing capacity and forging closer links with academia.

Lonza is also working with Baxter, Genentech, GSK, Novartis and Millipore to set up a $2m biopharmaceutical manufacturing training facility in the country.

Speaking at the recent BIO 2009 event in Atlanta, Yeoh Keat Chuan, executive director of the SEDB’s biomedical sciences unit said that: "Singapore is aggressively positioning itself as a home for business, innovation and talent in Asia to be future- ready.”

Hovione to Invest €2 Million in Nano Drug R&D Unit

Portuguese contract manufacturing organization (CMO) Hovione plans to invest €2m ($3m) in a new R&D unit in the capital Lisbon, as expansion space at its active pharmaceutical ingredient (API) plant in Loures is limited.

The facility, which is being set up in co-operation with the Portuguese Institute for the Support of Small and Medium Enterprise (IAPMEI), will be based at the Luminar science campus that acts as base for Portuguese technology firms under a Government led program to boost innovation.

Peter Villax, vice president of Hovione’s pharma business unit, told in-PharmaTechnologist that: "We decided to go ahead with these new premises because it was the quickest solution to finding more space for our growing RD activities."

He also explained that Hovione’s total investment could reach €15m depending on the types of projects it is called upon to carry out by its customers and added that the unit will create around 40 new jobs.

The facility will act as a base for Hovione’s drug R&D efforts, with a focus on the design, development and characterization of nano- and micro-particles for novel delivery applications.

Capacity investment

Hovione's latest investment continues a long running program of infrastructure spending that has seen it boost capacity at several manufacturing locations, including in China where the firm has been progressively expanding for the last two decades.

In March last year, Hovione continued its Chinese growth, spending $20m (€14.3m) for a 75 per cent stake in Hisyn Pharmaceutical. More recently, the firm opened a new dedicated API manufacturing facility in Cork, Ireland from global drug giant Pfizer.

Speaking at the time Lorcan MacGarry, Hovione’s general manager in Ireland said: "We will be transferring to the Cork site a number of compounds over the next 18 months,” including approved APIs made at its plant in the Loures, Portugal.

Peru Lab Gains Drug Quality Accreditation

Peru’s National Center for Quality Control (CNCC) has attained ISO/IEC 17025:2005 accreditation, furthering its safety efforts and becoming one of the few Latin American countries to achieve this.

The accreditation certifies that the CNCC is providing valid and trustworthy information to the Peruvian Ministry of Health, helping to ensure the quality of medicines in the country and surrounding region.

ACLASS, an accrediting body based in Washington, DC, US, granted the certification, which was achieved through collaboration with the US Agency for International Development (USAID) and the US Pharmacopeial (USP) Convention.

Roger Williams, CEO of USP, said: “The importance of this accreditation should not be understated. Patients and doctors should be able to trust that the medicines they take or administer are of high quality.

“The work we all do in helping to ensure that is the case is vital and life-saving. There is no better way to demonstrate commitment to quality than to submit oneself to the objective scrutiny of public quality standards such as those offered by ISO.”

USP provided technical assistance through its Drug Quality and Information (DQI) program, which entailed conducting an assessment of the CNCC laboratory’s quality management system; providing ongoing monitoring of CNCC’s progress toward accreditation; and hosting a CNCC intern at its US headquarters.

The USP program operates in collaboration with the USAID to improve drug quality in developing countries and ensuring availability of medicines to treat life-threatening diseases including HIV/AIDS, malaria and tuberculosis. Peru has been a target of the program since 2002.

Lonza to Set Up Singapore Cell Therapy Plant

Swiss biomedical science firm Lonza is investing CHF30m (€19.7m) in a new cell therapy facility in Singapore, continuing its global expansion effort.

"The facility will operate with cutting-edge technologies and a skilled labor force, allowing it to readily meet the needs of a broad range of customers and address the growing global demand.”

Construction is expected to begin early next year with the aim it becoming fully operation sometime in mid-2011.

The firm also works with Novartis and Genentech on the manufacture and development of biologics.

Before Lonza announced its latest move, Bayer, Schering-Plough and Takeda all expanded operations in the country both by adding manufacturing capacity and forging closer links with academia.

Lonza is also working with Baxter, Genentech, GSK, Novartis and Millipore to set up a $2m biopharmaceutical manufacturing training facility in the country.

Quotient Bioresearch Buys Edinburgh Facility and Sets up New Clinical Unit

UK CRO Quotient Bioresearch has bought a clinical research facility in Edinburgh, Scotland, which in conjunction with an existing unit in Nottingham, England will serve as a base for its new Quotient Clinical unit.

Mark Egerton, managing director of Quotient Clinical, told Outsourcing-pharma that the new centre, which was previously owned by Charles River Laboratories, broadens the group’s Phase I offering and will serve as a base for its unique 14-C enabled development service.

Egerton explained that, despite the economic downturn, demand for the group’s services has increased approximately 300 per cent in the last 12 months, particularly its “first-in-human” to "proof-of-concept" offering.

He added that growth of the contract research sector over the next few years will be driven by pharma industry for efficiency and innovative science.

UEM Land, BiotechCorp To Set Up Biotech Hub

UEM Land Bhd and Malaysian Biotechnology Corp Bhd (BiotechCorp) are expected to sign a definitive agreement to jointly develop about 80 hectares in Nusajaya, Johor into a biotech hub in a couple of months.

"We have matters of land, infrastructure, facilities as well as equity to finalize before we can sign the documents," UEM Land strategic marketing and corporate communication director, Zulkifli Tahmali, said at the Malaysian Pavilion at the Bio International Convention 2009 here yesterday.

Both parties had on May 15, 2009, signed a memorandum of collaboration (MOC) to collaborate and cooperate with each other to develop and set up the hub to be known as "Bio-XCell".

UEM Land and BiotechCorp signed the MOC to govern the working relationship between the parties pending finalization of the definitive agreement.

It is the master developer of Nusajaya, which is part of Iskandar Malaysia.

UEM Land is part of the Malaysian delegation to BIO Atlanta this year to promote Malaysian biotech industry, including "Bio-XCell".

Zulkifli said UEM Land hoped to start construction by year-end.

"We will stay true to our developmental expertise and focus on the management of the project and facilities, while BiotechCorp will bring in the biotech expertise," Zulkifli said.

He said the biotech park in Nusajaya would benefit from its close proximity to University Technology Malaysia, a bioscience institution as well as Singapore's advanced biotech industry, and pool of human capital.

"Bio-XCell" would be able play a complementary role to the research park which has positioned itself as the place for cutting-edge technology," Zulkifli said.

He said the biotech park would be one of the important projects in Nusajaya as it would have tremendous spillover effects on the entire development of the area.

Nusajaya is a 9,600-ha development, which is currently home to eight signature projects, namely the Johor State New Administrative Centre, Southern Industrial and Logistics Centre, International Destination Resort, Residences at Nusajaya, EduCity, Medical Park and its jewel, the Puteri Harbour waterfront development.

XenoBiotic Laboratories (XBL) Opens in China

XBL-China's new 36,000-sq.-ft. laboratory in Nanjing has a 12,000-sq.-ft. vivarium and analytical instrumentation. With additional offices in Shanghai, XBL-China will provide bioanalytical and metabolism services to the standards comparable to XBL's New Jersey facility. Jinn Wu, president and chief executive officer of XBL, "The initial goal for XBL-China is to offer GLP-level bioanalytical as well as discovery PK services to support drug development programs being conducted in Asian countries. Additional services such as synthetic chemistry, formulation services, Phase I clinical trial conduct, and SFDA registration are planned for the future. This is a significant expansion for XBL and will allow us to provide services to global pharmaceutical companies." An open house ceremony is planned for October 2009.

XBL has also boosted its U.S.-based services with the addition of a large molecule bioassay/cell-based assay group, Debra LIMS, QWBA and in-house NMR services.

"With the addition of a state-of-the-art laboratory and expertise to conduct Quantitative Whole Body Autoradiography (QWBA) studies, in-house NMR (500 MHz) and the industry standard Debra LIMS software, we now offer a complete and comprehensive package of services for ADME studies," said Dennis Heller, XBL's vice president of Pharmaceutical Development. "In addition, we recognized the expanding need for quantitative bioanalytical services for biologics (biotherapeutics and biomarkers) and, as a result, invested in a new biologics group that will provide ELISA-based services for quantitative PK bioanalysis for biotherapeutics, immunogenicity screening and biomarker assays. Our biologics group is also developing key cell-based assays to screen the biological activity of macromolecules."

Minakem Adds EU API Capacity to Compete with Asia

Fine chemicals firm Minakem believes that manufacturing capacity added by its newly acquired API plant in Dunkirk, France will reduce costs and help it compete on a global scale.

The site, which was previously owned by UK drug major AstraZeneca, houses 450 m3 of active pharmaceutical ingredient (API) batch reactor capacity, has a history of corticosteroid production and separate micronization and injectables units.

Company spokesman Sebastian Poncet told in-PharmaTechnologist that the extra reactor capacity provided had motivated the acquisition as it will allow Minakem to reduce the amount it charges customers and keep pace with the Asian manufacturing sector.

Poncet explained that: “China and India are now part of the game and they have put pressure on margins in Europe for several years. The European players have to adapt their workforce to be more competitive, without compromising on quality.”

He went on to say that, while Asia has dominated the market in the last few years, recent high-profile problems with APIs sourced in India and China has “reminded to the pharma industry than relying 100 per cent on Asia for their supply chain is a huge risk.”

Poncet added that, increasingly, “[the pharma industry] try to [find a balance] with dual sourcing based on a geographical approach,” which will surely be welcome news for European API makers.

Chemical Synthesis Brought Under Minakem Banner

Dunkirk will serve as the base for all small molecule synthesis operations under the Minakem brand name, with the manufacture of budesonide, omeprazole and esomeprazole for AstraZeneca being one of the first contracts the firm has signed.

The group’ Minasolve bio-ingredients, PennAkem renewable chemicals and Furan chemistry divisions will continue to operate as separate business units.

France Helps Clusters Battle for Bio Business

HEM Pierre Vimont, Ambassador of France to the US, was at BIO 2009 discussing the measures his nation has taken to attract biotechs, including the introduction of the "most favorable R&D tax in Europe".

One of the themes to emerge from BIO 2009 is the desire of many different countries around the world to attract biotech companies, with European nations and US states offering incentives to promote themselves in a marketplace filled with low cost options in emerging markets.

To help attract business the ambassador said that the EUR1.5bn that the French government earmarked for biotech clusters from 2006 to 2008 would be matched over the next two years and that this, coupled to the low cost of clinical trials in the country, would help the sector progress.

France - most favorable R&D tax in Europe

"[We are] promoting innovation... and greater collaboration between science and industry" HEM Pierre Vimont, Ambassador of France to the US.

By supporting these bio clusters Vimont believes that France is promoting a model of "energy, intelligence and audacity". Vimont went on to suggest that the French government would continue to support biotech in the coming years, comparing the sector to other large scale projects it has undertaken, such as its nuclear power program.

Joining Vimont at the press conference were Philippe Archinard, president of Lyonbiopôle and vice chairman of EuropaBio, and Jim Greenwood, president and CEO of BIO, who said France had made "an extraordinary effort in the advancement of biotechnology".

Filling Machines Dominate Bosch’s Busy Achema Launch Program

A new 9,500 unit per hour sterilized syringe filler was a highlight of Bosch Packaging Technology’s busy program of machine launches at Achema 2009 in Frankfurt, Germany.

The FXS 2050 unit, which is intended to help mid-sized producers make best use of limited production space, combines Bosch’s peristaltic pump technology with a bag and tub opening system and is designed to minimize the need for manual intervention.

Product manager Klaus Ulherr suggested that the fully integrated approach to filling and closing can significantly reduce the ever present risk of contamination during these operations and help manufacturers ensure the quality of their products.

GKF Capsylon and MHI Could Fill Efficiency Gaps

The GFK Capsylon 3005 for capsules and the MHL 2020 for vials completed the roster of filling machines Bosch premiered at the show, with the watchword of the day being efficiency.

The good manufacturing practice (GMP) accredited GFK Capsylon unit is designed to handle both sticky and fine grained pharmaceutical powders at a rate of 175,000 capsules an hour and features an adjustable metering disk that Bosch claim will help minimize changeover downtime.

Improving speed and efficacy is also at the core of the MHL 2020 unit. Bosch designed the machine with the clinical trial and pilot product markets in mind and developed in-process monitoring technology that “ensures that each and every container is precisely filled and closed.”

Vial processing manager Dieter Bandtel said that the rationale for developing the MHL 2020 was precision and suggested that its ability to record fill parameters and minimize interaction will be a distinct advantage when dealing with toxic compounds.

Carton Machine Aims to be Cut Above the Rest

Bosch also used Achema to showcase its CUT 150 cartoning machine that betters the 120 carton per minute output of previous machines in the range.

The firm says that the improved cartoning rate is a product of the unit’s modular design and absence of drive chains that eliminate the need for chain switching stations or belt discs and help reduce the level of maintenance required.

Bosch also emphasized the CUT 150’s enhanced production security features, particularly its 2d matrix code track and trace serialization system that the firm believes will help protect against counterfeiting.

Piramal Adds Trial Packaging and Distribution Capacity at UK Plant

Piramal Healthcare’s new clinical trial manufacturing, packaging and distribution centre in Northumberland, UK will help pharma industry customers to “build cost saving at an early stage,” according to European strategic manager Martin Hunt.

Hunt told in-PharmaTechnologist that the 13,000 sq ft primary and secondary trial packaging unit, which expands the active pharmaceutical ingredient (API), formulations and packing site in Morpeth, is part of an effort to offer a “one stop shop” for the drug industry.

He said that: “clinical trials are a very important revenue stream for Piramal,” and added that the expansion enables the firm to offer customers everything from API development to trial scale manufacture and ultimately commercial scale production.

Ian Morgan, head of Piramal’s clinical trial services (CTS), also told in-PharmaTechnologist about the potential benefits of the integrated formulations and clinical trial packaging offering.

He explained that the trial centre can conduct primary and secondary packaging for both solid and liquid products, which are then labeled according to trial protocols before being securely shipped to global trial sites worldwide via the dedicated distribution centre.

Piramal also launched a new website to both publicize its CTS offering and allow existing customers to monitor the status of their projects using the firm’s in-house “TrakPack” monitoring system.

Morgan said that: “This interactive website is vital in the evolution of our business and will help our customers better understand our offering.”

Piramal has been building its clinical offering for the last few years, most notably with the acquisition of Tangent Data, a Romanian contract research organization (CRO) specializing in the central nervous system (CNS) in 2008.

Commenting at the time of the Tangent deal, Piramal said that it is planning on expanding further over the next three years, setting up operations in Western and Eastern Europe, South Asia and North America.

Ontario Grants $2.7 Million for Genomics at University of Guelph

Ontario has granted C$3.2 million ($2.7 million) for corn genomics research and DNA identification studies at the University of Guelph in Ontario.

The Ontario Research Fund has granted C$2.8 million for studies of the genomics involved in corn growth, and it has granted C$400,000 for the University of Guelph-based Canadian Centre for DNA Bar-coding.

These funds will be augmented in the future by private-sector support from the company Syngenta, the university said, bringing the total in cash and in-kind support for the four-year project to over C$8.5 million.

Most of those funds will go to studies conducted by the university's Department of Molecular and Cellular Biology that aim to identify genes that control plant growth. The researchers want to alter the genes' activity in order to improve the plant, specifically genes that regulate nutrient uptake so they can improve nitrogen efficiency.

Corn is an important commodity for Ontario, and is worth over C$1.5 billion per year to the economy.

"Current agricultural practices can be made more sustainable," Steven Rothstein, the principal investigator on the grant at the university, said in a statement. "There is much room for improvement, and significant increases in productivity can be achieved by understanding key plant genes."

Ontario's International Barcode of Life Project is gathering barcode records for half-a-million species over the next five years, the university said, and when it is implemented it will "revolutionize access to biodiversity information from complex environmental samples such as water and soil," the university said.

China Opens New Food Test Lab

The first food-testing laboratory in China recognized to reach international standards for pesticide screenings, melamine and heavy metal testing and microbiological analyses, was opened last month by Eurofins in Suzhou.

ISO 17025 status, which was awarded by the German accreditation agency DACH, is proof it offers “the only independent food-testing laboratory in China that can provide a full international-standard service from start to finish”, said the laboratory group Eurofins.

It added that customers also benefit from “in-depth understanding of the Chinese food industry” in addition to peace of mind that products they import from China comply with European legislative demands and standards.

“Before, they [customers] weren’t able to rely on or trust goods imported,” Dr Werner Nader, head of marketing and sales, food analysis, told FoodProductionDaily.com.

The Suzhou laboratory will allow the food industry to draw on reliable testing for exports from China, mostly to Europe, the USA and Japan, prior to shipment. Eurofins also operates and organizes services to control the supply chains of its customers, by sampling and auditing and inspection of those factories they buy from.

Meanwhile, a new service platform Eurofins Global Control is being launched to be adopted by the company’s laboratories in 30 countries where 150 facilities provide analysis in centers of food origin. The global presence and comprehensive analytical portfolio allows for the control of the supply chain by a neutral third party, said Eurofins.

The company believes testing and control to Eurofins standards will help minimize risks for industry and trade. For example, if goods have arrived in Europe out of specification, it is the responsibility of importers to pay for their disposal, and “all too frequently” goods turn out to be different from those allegedly tested prior to leaving their country of origin.

Eurofins has said it will “continue to invest in China to extend the laboratory’s capabilities as well as continuing its program of expanding into many other important regions of sourcing for food”.

Systems for control and traceability include chemical and DNA fingerprinting, routinely used for olive oil for example. Nuts and dried fruits from Turkey are tested by Eurofins prior to shipment to the EU and sealed containers are shipped only after ‘positive release’.

Prior to the accreditation of the Chinese laboratory, validation of methods was by Eurofins’ laboratories in Europe, notably the Dr. Specht and WEJ laboratories in Hamburg, Germany.

Eurofins scientists serve on governmental and industry standardization and technical committees including AOAC (Association of Official Analytical Chemists International), CEN (European Committee for Standardization) and ISO/CASCO (International Standardization Organization).

UK Grants nearly $6 Million for North/East England High-throughput Hubs

The United Kingdom has granted a total of £3.9 million ($5.8 million) to the University of Liverpool and to the Babraham Institute to start two high-throughput genomics hubs as part of a three-prong program to enhance the country's DNA sequencing resources.

The University of Liverpool will use £2.2 million ($3.3 million) from the Medical Research Council (MRC) and the Northwest Regional Development Agency to establish a high-throughput genomic analysis hub in the North of England as part of an effort to increase the nation's genomics resources and to advance academic medical science, the university said.

£2 million came from the MRC and £200,000 came from the Northwest Regional Development Agency. The initiative is part of a £7 million effort to support hubs in North and East England, and in Scotland.

These high-throughput centers will be available for use by all academic researchers in the UK.

This Northern hub will consolidate resources from four partner universities: Manchester, Sheffield, Lancaster, and Liverpool.

Supported in part by the Clatterbridge Cancer Research Trust, this hub will conduct tumor sequencing studies, and will pursue research into genetic susceptibility and personalized medicine.

In a separate announcement, the Babraham Institute said that it is using its £1.65 million ($2.5 million) grant to start a genome sequencing facility through a partnership with the University of Cambridge's Centre for Trophoblast Research. Funding for this center came from MRC and from the Biotechnology and Biological Sciences Research Council.

"There is a pressing need to understand the basis of genetic variation and to use it to define the most appropriate treatment for each patient with a particular condition," Professor Neil Hall, of the School of Biological Sciences and a principal investigator at the North of England hub, said in a statement. "Such research will benefit greatly from the new hub in the North of England by allowing much more productive sequencing technologies to be made available across the research community."

Sanofi-aventis Kicks Off €200 Million Conversion of French Pharma Plant into Biotech Facility

Sanofi-aventis said it will spend €200M ($266 million) to transform its pharmaceuticals production site in Vitry-sur-Seine, France, into a facility for researching, developing, then producing biotechnology products through alliances with smaller biotech companies. Starting in 2012, for example, the plant is expected to create the company’s first cell culture biotechnology platform designed to produce monoclonal antibodies.

The Paris-based pharma giant officially launched its plant conversion project, dubbed Biolaunch, in a ceremony attended by top Sanofi-aventis executives and government officials, including CEO Christopher Viehbacher and Luc Chatel, France’s secretary of state for industry and consumption at the ministry for the economy, industry and employment.

“Monoclonal antibodies will open the way to a new generation of better targeted and more effective treatments with fewer side effects,” Viehbacher said in a statement.

According to that statement, Sanofi-aventis will open its tech platform to other companies, based on their development or production needs.

Biolaunch is one of two new biotech initiatives for Sanofi-aventis; the company last month began a training program that combines instruction on theory and practice. The Vitry-sur-Seine site is subject to SEVESO II, a directive of the European community created to prevent major accidents involving dangerous substances, as well as to limit damage from accidents involving dangerous substances. That classification will end when the current chemicals activities will be transferred at the end of 2011.

Sanofi Invests €350 Million in Dengue Fever Facility

Sanofi-aventis is has made its largest ever investment in its vaccine capacity, using €350m ($479m) to construct a dengue fever vaccine manufacturing plant in France.

Vaccines have been identified by Sanofi, and several other pharmas, as a growth area in the coming years, with the prevalence of dengue fever meaning there will be a sizeable market for a treatment.

Sanofi is still developing the vaccine, which is currently in clinical trials, with regulatory submission possibly being sought in 2012. This would be a year before the vaccine plant is predicted to be operational, when it will begin producing 100m doses a year.

Christopher Viehbacher, CEO of Sanofi-aventis, said: “This new vaccine production centre is the largest investment ever made by Sanofi-aventis. It illustrates our commitment to providing solutions to unmet medical needs such as dengue, a disease that potentially puts almost half of the world’s population at risk.

“With this new plant, Sanofi-aventis will have invested in France over €1bn since 2005 in vaccine production, sustaining French industrial capacities and reinforcing Sanofi Pasteur as the world leader in vaccines.”

The facility is being constructed in Neuville-sur-Saone, near Sanofi Pasteur’s headquarters in Lyon, France. Sanofi is currently constructing or renovating 12 manufacturing facilities.

Successful development and regulatory approval of Sanofi’s dengue fever vaccine will provide a treatment for an increasingly large number of patients that are being affected as the disease spreads.

The World Health Organization (WHO) has stated that “the incidence of dengue has grown dramatically around the world in recent decades”, with 2.5bn people now at risk.

GSK Boosts Emerging Markets Presence with Aspen Deal

GlaxoSmithKline (GSK) is to take a 16 per cent stake in Aspen in exchange for a manufacturing facility and eight medicines, building on the companies’ relationship and the big pharma’s profile in Africa.

Over the past year GSK has built a relationship with South Africa-based Aspen by transferring commercialization rights to some products in certain markets between the companies.

The deal extends this existing relationship and reinforces GSK’s strategic focus on generics and emerging markets, which it has identified as additional revenue streams to soften the financial blow when it loses exclusivity on some products.

Abbas Hussain, president emerging markets at GSK, said: “Extending our strategic relationship with Aspen supports GSK’s strategy to accelerate sales growth in emerging markets.

“The combination of our commercial activities in Sub-Saharan Africa is highly complementary and will mean that together we can provide more medicines of value to more patients in these countries. At the same time, GSK will also benefit from investing in one of Africa’s leading healthcare companies with a formidable track record of delivery.”

Under the terms of the deal, which is subject to regulatory approvals and predicted to close this year, GSK will acquire 68.5m shares in Aspen, putting the value at around $418m (€306m).

In exchange for these shares GSK is divesting its manufacturing facility in Bad Oldesloe, Germany and eight specialist medicines. The Bad Oldesloe facility produces some of the drugs GSK divested to Aspen in June 2008.

Following completion of the deal GSK and Aspen will collaborate on the commercialization in Sun-Saharan Africa of their current and future portfolios. Although GSK believes it is contributing the vast majority of the current portfolio it envisages benefiting from the deal.

The company said: “Going forward, the collaboration will build a broader and more diverse portfolio for these countries, with Aspen’s extensive pipeline of new products expected to benefit from greater leverage through GSK’s existing commercial infrastructure.”

In addition GSK is transferring marketing and distribution rights of its pharmaceutical products in South Africa to Aspen, which is intended to take advantage of the latter’s “extensive commercial capability”.

Bristol-Myers & Biocon Open R&D Facility

Syngene International, a subsidiary of Biocon Ltd, and Bristol-Myers Squibb Company, announced the opening of a fully dedicated research and development facility for Bristol-Myers Squibb in Biocon Park, Bangalore. The work at the facility will span drug discovery & other research.

The 200,000 square-foot facility at Biocon Park is dedicated to helping advance Bristol Myers Squibb's work in discovery and early drug development, and is currently occupied by 270 researchers.

Construction on the facility began in March 2007, when Bristol-Myers Squibb and Biocon entered into an agreement to develop integrated drug discovery and development capabilities at Syngene, Biocon said in a release.

The facility will house 360 researchers by the end of the year and could accommodate as many as 450 employees in the future. Work at the facility will span the drug discovery and development process from initial hit to lead optimization to early pharmaceutical development to clinical nomination.

"To support talent development in India we are committed to working with academic institutions through fellowships and partnerships to ensure the next generation of graduates has a high level of expertise in drug discovery and development sciences," said Francis Cuss, MB, BChir, FRCP, Senior Vice President, Discovery and Exploratory Clinical Research, Bristol Myers Squibb. "Syngene's multi-disciplinary skills in synthetic chemistry, process chemistry and molecular biology have garnered international repute. This collaboration with Bristol-Myers Squibb is a testimonial to Syngene's global reputation and offers a powerful value-added capability base for Bristol-Myers Squibb," said Biocon Chairman & Managing Director Kiran Mazumdar-Shaw. In addition to expanding its research and development capabilities in India through its relationship with Biocon, Bristol-Myers Squibb has committed to supporting the development of scientific excellence in India.

Boost for Belgian Biomanufacture “Fundamental” says Genzyme

Biotechnology group Genzyme will boost biomanufacturing capacity at its plant in Geel, Belgium in a move that is “fundamentally important to future growth” according to site VP Sandra Poole.

The US firm has invested €46m (€62.5m) to install approximately 4,000 liters of additional bioreactor capacity at the facility in an expansion that will create around 80 new manufacturing jobs.

Poole explained that the investment “is a reflection of our commitment to Europe and is enabling us to bring our innovative therapies to a growing number of patients around the world.”

She added that the new bioreactors, which bring the total available capacity to 14,000 liters when completed in 2011, will be used for the production of therapeutic proteins to treat lysosomal storage disorders.

Catalent Adds 10 Color Printing Presses to Dublin, Ireland Facility

Catalent Pharma Solutions, a provider of advanced technologies and outsourced services to the global pharmaceutical, biotechnology and consumer health industry, announces the purchase of a next-generation 10-color KBA RAPIDA™ 106 printing press at its Printed Components facility in Dublin, Ireland. Due to be installed in June 2009, the KBA RAPIDA 106 is part of an ongoing investment in the Dublin plant to support the growth of European Printed Components business. The press is capable of printing 15,000 sheets per hour and features a unique combination of advanced systems that provide transparent assurance of print quality and product integrity throughout the print run.

Fitted with the unique QualiTronic™ full-sheet scanning system which KBA developed for its currency printing presses, the QualiTronic camera scans each sheet at over three million pixels of resolution in full production speed. The image is then inspected and compared to an approved master sheet for any inconsistencies or deviations. If any deviations are found, the sheet is marked for removal downstream. The system can also detect any minute color changes and automatically adjust the press in a closed-loop sequence, without the need for operator intervention.

The press also has a Simultaneous Plate Changing (SPC™) system for rapid make-readies and PlateIdent to reduce run-up waste and ensure correct sequencing. Its innovative 2-over-8 configuration offers the ultimate in efficiency, enabling for the first time the concurrent production and make ready of alternate jobs on a single press, reducing downtime to a minimum. This provides the flexibility needed to effectively service both high and low volume jobs without sacrificing the superb quality, resolution and color of true offset printing. The press also runs at low energy consumption levels, which supports Catalent's efficiency goals and benefits its customers through improved carbon footprint audits.

“The KBA Press brings a variety of innovative capabilities specifically tailored to meet the changing needs of our customer base,” said Victor Dixon, Vice President and General Manager of Catalent's Printed Components business. “It introduces a higher standard in pharmaceutical carton supply and follows our investment in similar technology upgrades at our plants in the U.S. and Puerto Rico. Our Dublin plant, which has served the pharmaceutical and healthcare market since it opened in 1989, has continually raised the bar for others to follow, and again leads its competitors with this investment.”

Sanofi Seeks Collaborators for €200 Million Biotech Plant

French drug major Sanofi Aventis has unveiled plans for a €200m ($268m) biotechnology investment at its manufacturing facility in Vitry-sur-Seine near Paris, under its collaborative Biolaunch project.

The investment will be used to install biotechnology manufacturing capacity at the plant which at present is used to produce Sanofi’s oncology, cardiovascular, anti-infectives and anti-inflammatories some of which are due to go off-patent in the next few years.

The core focus of the Biolaunch project is to develop a cell culture platform, R&D and manufacturing centre which, when fully operational in 2012, Sanofi will use to develop and manufacture monoclonal antibodies (MAbs) and biologics.

Sanofi CEO Christopher Viebacher said the project will create “a complete platform of expertise in biotechnologies,” adding that “monoclonal antibodies will open the way to a new generation of better targeted and more effective treatments with fewer side effects.”

He added that Biolanuch is “an opportunity for the company to do partnerships with biotechnology and research companies," explaining that such “collaborations can provide us with new products."

Sanofi’s focus on partnerships to bolster its pipelines, exemplified by its recent deal with Oxford Biomedica on eye disease, is not unusual among Big Pharma firms desperate to both cut costs and boost flagging pipelines.

Biolanuch will also include a training program to help with new biotech business activities that comprises special modules for both theory and practice, with participants gaining a “Biolanuch passport” syllabus.

Viebacher announced a major reorganization of the firm’s development pipeline that saw it cull 14 candidate drugs, including four that were in Phase III clinical trials.

At the time he said that said that Sanofi will shift its focus away from traditional drugs and “aim to increase the percentage of biotech products in its pipeline from 14 to 25 per cent over the next three years.”

Prior to that Sanofi demonstrated its commitment to expanding its biotechnology portfolio through the acquisition of California, US based cancer drug specialist BiPar for $500m.

Chávez sets up Pharma Site in Venezuela

Venezuela has inaugurated a state funded pharmaceutical manufacturing facility and allocated resources for a new complex as part of the nation’s attempts to provide subsidized drugs to citizens.

The pharmaceutical complex is being established to produce insulin, antibiotics and anti-retrovirals, which will be available at subsidized or production costs to Venezuelans and member countries of the Bolivarian Alternative for the Americas (ALBA).

In addition to establishing the facility the Venezuelan government has allocated $83m (€62m) to spend on the pharma complex in 2009 and 2010, with the intention of ensuring the nation has sufficient supply of therapeutics.

Speaking on his weekly talk show Aló Presidente Hugo Chávez, the president of Venezuela, said: "We are starting to make medicine of a high quality in a way that has never happened before in Venezuela. We're going to convert ourselves into exporters of medicine in the future. First, of course, for us, and later to share with other countries.”

Chávez added that the complex aims “to guarantee the right to health and life to the people, not only for those who can pay, as under capitalism where if you can pay you're guaranteed everything".

Once complete the complex will produce drugs for treating diseases including Chagas, malaria and tuberculosis, which Fernando Rodriguez Urbano, president of the factory, believes are not provided by the private sector because they are unprofitable.

Jesus Mantilla, Venezuela’s health minister, said the complex will have the capacity to supply all the countries of ALBA, which consists of seven countries including Venezuela, Bolivia and Cuba.

The current facility covers 1,805 sq. m. (19,421 sq. ft.) and houses an area for raw materials, a laboratory quality control section, production capacity and a warehouse. In addition a sterile area is dedicated to the production of TB treatments.

Located in Caracas in northern Venezuela the facility will initially employ 50 people, although this could rise to 110 in the future, and contains equipment from suppliers in Germany, China and Italy.

Raw materials are to be shipped from countries including New Zealand, China, Mexico, Germany, Italy and India, with Urbano stressing the importance of ensuring the quality of supplies.

German Budenheim OKed to Make Phosphates for Pharma

German industrial phosphate maker Budenheim has been certified to produce calcium phosphates as pharmaceutical excipients under ICH Q7A GMP guidelines.

The accreditation corresponds to both US Food and Drug Administration (FDA) and European Union (EU) good manufacturing practice (GMP) rules.

Budenheim, which will produce the chemical at its combined manufacturing and distribution centre near Mainz in central Germany, said that certification significantly expands the potential market for its products.

The firm went on to say that it will seek similar GMP approval for its sodium phosphate manufacturing facility in the near future in a bid to strengthen its position in the pharmaceutical excipients market.

Alps Bio Cluster Forms

A major collaborative effort between scientific agencies in five Alps countries is under way. The Alps Bio Cluster, funded primarily by the European Commission, will encourage cooperation among R&D centers, universities, startups and small and medium-sized companies by uniting academic, industrial and training resources. "We want to blend people from different cultures, from industrial to academic," says Valerie Ayache, director of Lyon-based biotech agency ADEBAG, the collaboration's project leader.

Ayache says the initiative grew from collaboration on conferences between her organization and counterparts in Switzerland and northern Italy. "We decided to deepen this cooperation and to have more means to work on long-term projects," Ayache says.

Other participating organizations are Lyonbiopôle from France's Rhône-Alps region, Bioindustry Park del Canavese and the Milan Chamber of Commerce in Italy, BioAlps from Western Switzerland, Tiroler Zukunftsstiftung (Tyrolean Future Foundation) from Austria's Tyrol region, and the German Research Center for Environmental Health and Weihenstephan University of Applied Sciences from Germany's Bavaria region.

"We can create companies in France, but it is difficult to develop them to a critical scale," says Ayache. "That's why we created the Alps Bio Cluster."

The Alps Bio Cluster is a collaboration of science organizations in five Alps countries.

Gedeon Richter Building Plant in Debrecen, Hungary

Gedeon Richter, one of Hungary's leading pharmaceutical and biotech manufacturers, is building a new $65-million plant in Debrecen, one of the country's biotech centers. Richter plans to establish a biopharma line for its range of domestic and international products, and says it will employ 110. The company is receiving direct subsidies from the Hungarian government to build the facility.

Dr. Lazlo Urge, CEO of ThalesNano, a Budapest-based laboratory equipment manufacturer, also serves as a member of the executive board of the Hungarian Biotech Association. He says the sector is thriving in Hungary. Biotech, combined with the pharmaceutical industry, employs about 15,000 in the country, with major concentrations in Budapest, Debrecen and Szeged.

"When the EU expanded a few years ago, the Hungarian biotech industry was more developed than [biotech in] the other countries that were joining at that time, and even more than in some countries that had previously joined the EU, so Hungary was well positioned," Urge says. "We have a good entrepreneurial spirit, and Hungary has always been very good in terms of the chemistry sector. Our established companies are expanding and new companies are being formed as well. The sector will grow steadily, at least those companies that are not dependent on VC investment."

Genzyme's Growth in Europe

Few, if any, biotech companies are expanding on as many fronts in Europe as Genzyme, with ongoing projects in the U.K., Belgium and France. Genzyme has seven manufacturing sites in Europe, three of which are currently being expanded. Genzyme employs about 2,300 in Europe, about 1,500 of which are in manufacturing.

The latest project is in Lyon, where Genzyme is building a new facility for development of anti-rejection drugs for organ transplant patients. The €110-million ($141-million) plant will replace an existing facility and will double its capacity.

Mark Bamforth is Genzyme's senior vice president of pharmaceuticals and operations. Genzyme expects the plant to be complete by the end of 2009, with production projected to begin in 2011 after regulatory approvals. Genzyme plans to hire 50 to join its current staff of 230.

Genzyme has had an ongoing expansion in Geel, Belgium, for several years. The current €300-million (US$385 million) project involves a new manufacturing plant to produce a recombinant enzyme. This project will add 120 jobs to the plant's current work force of 320.

Genzyme is quadrupling the size of its Waterford, Ireland, fill-and-finish facility with an investment of nearly €100 million ($128 million). The company is evaluating a possible expansion at its chemical facility in Haverhill, England.

Mark Bamforth, Genzyme's senior vice president, corporate operations and pharmaceuticals, says many of Genzyme's manufacturing locations have come about through acquisitions. He says future expansions will likely come at current sites or through acquisitions.

"Once we have a site, they each tend to be unique in either their technology or their skill of operations," Bamforth says. "We tend to focus on centers of excellence and build on a solid base that's already in place. We are product driven, not location driven, and we will continue to invest in the sites that we have."

Bamforth says biotech's biggest current challenge is weathering the current global financial downturn. "Clearly the financial downturn creates a significant risk for smaller companies that are not established," Bamforth says. "There are statistics about the limited cash supply of a number of companies that do not have their products to market yet. If this doesn't change, there are predictions that a third may disappear and either be bought or go bust. For the long-term health of biotech, that is a danger. For more mature companies, if their products are truly innovative, they are in a different situation."

Aoxing’s Drug Plant Gets GMP OK

China Aoxing Pharmaceutical, a specialist developer of pain management drugs, has received GMP accreditation for the new tablet production and packaging plant it has set up in Shijiazhuang.

The facility, which has been cleared by the State Food and Drug Administration (SFDA) for five years, will produce solid dose versions of narcotic painkillers like oxycodone and buprenorphine for the Chinese market.

The plant will also make the powerful narcotic pain management product tilidine, which Aoxing became one of the few manufacturers licensed to manufacture for the Chinese market in 2007.

Aoxing CEO Juan Yue Han said that the accreditation provides the foundation for the further development and strengthens the firm’s manufacturing base, positioning it for growth in China’s expanding drug market.

Since the SFDA began tightening up rules on drug production in 2006 the number of Chinese drugmakers that have gained good manufacturing practice (GMP) accreditation has increased considerably.

However, Aoxing claims that its facility is one of very few in China to have been cleared for the production of narcotic drugs, which necessarily require stricter control than other medications.

The company went on to say that the lack of manufacturing capacity, coupled with increasing demand for western pain medicines, means that the Chinese narcotic painkiller market is both “very under-served and fast-growing.”

Aoxing said it is working closely with the government and SFDA to ensure the strictly regulated availability to medical professionals of its narcotic drugs and pain medicines throughout China.

In addition, while Aoxing did not reveal any plans to make drugs for the export market, gaining GMP accreditation from the SFDA will certainly make it easier for the firm to gain similar approval from regulators outside the country in the future.

Novozymes Begins Work on Chinese bHA Plant

Novozymes Biopharma is building a new Bacillus-based hyaluronic acid (bHA) production facility in China to meet “increasing demand” for the substance that has drug delivery applications.

The facility is being built at Novozymes’ existing site in Tianjin in eastern China, which Novozymes says may become a cluster housing plants producing bulk active pharmaceuticals and other ingredients for the industry.

Preparatory steps for these potential expansions are incorporated into the current $35-50m construction, which when complete in Q1 2011 will provide pharmaceutical grade (Q7) bHA to the industry.

Thomas Videbæk, executive vice president of Novozymes, said: “Regulators are ever more cautious with regard to the safety of products and so a facility that is capable of delivering pharmaceutical-grade bHA is an essential part of our strategy in bringing HyaCare forward for use in medical device and pharmaceutical applications.

“China was an obvious choice as we already have a world-class manufacturing operation there with more than 20 years experience. This site will also facilitate expansion as business opportunities develop.”

bHA has been traditionally derived from rooster combs or strains of streptococcal bacteria but these methods are known to be pathogenic.

Consequently Novozymes has developed an animal-free bHA using non-pathogenic fermentation method, which produces a high quality product without using organic solvents, according to the company.

The bHA produced at the site will go towards meeting rising demand for the substance, which is widely used in medical device applications and in research into drug delivery methods, including anticancer therapeutics, tissue engineering, and bone regeneration treatments.

China Ramps up Stem Cell Efforts after U.S. Research U-turn

Construction of a new stem cell research and processing plant began in China’s Eastern Jiangsu province as part of a joint project between the Chinese government and Shenzen Beike Biotechnology.

The facility, which is located in Taizhou Medical City, will serve as a research hub for scientists from the US and China and is a clear indication of the government’s ambition for the Chinese biotech sector as Beike’s CEO Sean Hu explained.

"In the 1970's the US government provided the intellectual property support and venture capital companies offered the funding that allowed the US to leapfrog past Europe to become the leader in biotechnology and pharmaceuticals.

“China's Medical City is now doing the same and we are starting to see the results of these efforts. Beike feels honored to be able to help…fulfill its mission of making China the world leader in clinical stem cell technology," added Dr Hu.

The announcement could also be seen as an effort to shore up China’s stem cell sector in light of the removal of the US ban on embryonic stem cell research, particularly because the project will involve scientists from Stanford and the Texas Houston Medical Centre.

The Taizhou facility will include four hubs: a technology transfer centre to help move treatments from the lab to the clinic; a safety and stability testing unit; a clinical trials division; and Asia’s largest stem cell storage bank capable of holding 1m samples.

The integration of research, clinical development and industrial scale quality and processing is interesting, given the strength of China’s contract research and manufacturing sector.

One idea is that Taizhou could act as a research and manufacturing hub for multinational drug firms seeking to develop products for both the emerging Chinese market and US, Japan and Europe where demand for stem cell therapies is also expected to increase.

Comments by China’s Health Minister Chen Zhu lend further support to this idea. Zhu said that: “Biotechnology is China's fastest developing technology, and stem cell research promises to improve the quality of life for people everywhere.”

Covance Expands in Harrogate, UK

Covance (NYSE: CVD), one of the world's largest and most comprehensive drug development services companies, announced the significant expansion of the company's biotechnology services facility in Harrogate, UK. The company also became one of a few contract research organizations to receive a cGMP Manufacturing License from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.

The expanded biotechnology services facility includes upgraded infrastructure and equipment for biopotency, molecular biology, and protein chemistry services. As a cGMP-licensed manufacturer, Covance offers fully cGMP compliant biotechnology studies to help customers fulfill global regulatory requirements for biotechnology studies.

"We made these significant infrastructure investments and enhancements to help our customers get their products to market sooner," said Carl Martin, Ph.D, vice president of biotechnology services, Covance. "The additional capacity and scientific expertise will help us reduce lead times and provide faster project reports with the highest data quality for our customers."

As the leading specialist contract service provider to the global biopharmaceutical industry, Covance offers a comprehensive portfolio of biotechnology services that include cGMP cell bank production and storage, cell bank and viral vector safety testing, comprehensive viral clearance services, gene therapy fate studies, product characterization, biopotency assessment, cGMP batch release support, ICH stability testing, and immunochemistry support (TK, PK and immunogenicity analysis). Covance also provides toxicology and other services required for full development of a biopharmaceutical product.

Hovione Unveils Irish API Plant

API maker Hovione’s manufacturing facility in Cork, Ireland was unveiled at an opening ceremony just two weeks after the previous owner, global drug giant Pfizer, formally handed over the keys.

The plant can handle a large number of specialized operations such as hydrogenation and low temperature chemistry, and boasts a new, €70m ($91m) spray-dried formulations unit.

Under Pfizer the facility's main focus was the production of the active ingredient for the firm's biggest seller, the world leading hypertension blockbuster Lipitor (atorvastatin).

Before Hovione bought the plant last year Pfizer had been trying to sell it for 12 months as part of a wide-ranging to cut manufacturing capacity and prepare for the loss of patents on key products, including Lipitor.

Hovione said it will continue to make some active pharmaceutical ingredients (API) on Pfizer’s behalf, but stressed the production of its roster of drug actives as well as contract manufacture will be the main focus of activities at the site.

Lorcan MacGarry, Hovione’s general manager in Ireland said: "We will be transferring to the Cork site a number of compounds over the next 18 months,” including approved APIs made at its plant in the Loures, Portugal.

Over the last few years Hovione has increased API manufacturing capacity by around 50 per cent in response to the rising demand for outsourced manufacture that currently dominates the drug industry.

While the firm has established manufacturing operations in Portugal and China, the latter through its majority ownership of Hisyn Pharmaceutical, the Cork plant is the first it owns in Ireland's API producing hub.

A spokesperson stated, "We expect to have 80 team members running the plant for the first 18 months, this is the time it will take for the plant to be qualified and registration validation batches to be produced and put on stability. After this time we will have actual routine manufacturing campaigns; when we have a good percentage of the site filled headcount will increase."

She went on to say that, "Adding the Cork site to the Hovione group provided our customers with the best of both worlds: access to the kind of facilities that only Large Pharma can afford, with all the benefits associated with Hovione flexibility and speed, service and compliance.

Another factor in the decision to set up in Ireland were growing industry-wide concerns about some APIs and drugs sourced in Asia, which was a problem alluded to by Hovione CEO Guy Villax in December when the plant acquisition was announced.

He said that: “We have been manufacturing in China for over 25 years - we know very well what China can do for the Pharma industry, but we also know what it can't do - and it is for those reasons that we are now in Cork.”

Siro ClinPharm and ACT Team Up on Oncology

Indian CRO Siro ClinPharm is teaming up with New Jersey based pharma services firm Advanced Clinical Trial Solutions (ACT) to strengthen its position in the US cancer trial sector.

The partnership, financial terms of which have not been released, will add ACT’s clinical development and patient recruitment offerings for oncology drug trials to Siro’s existing portfolio of services.

In return, ACT’s US customer base will have access to Siro’s extensive network of Indian and European data management, patient recruitment, biostatistics and distribution services.

Siro’s US president, Patricia Terek, reiterated the projects’ core focus, explaining that the deal “will help meet the growing needs of our oncology customers to have access to operational capabilities in North America.”

Siro, which is India’s largest integrated clinical trials organization, entered the US market in July 2007 through its acquisition of contract research organization (CRO) Global Client Partners.

The firm also has operations in Germany, Greece, Estonia and Israel, that it bought as part of its takeover of Offenbach-based firm Omega Mediation in 2008.

While the ACT partnership clearly shows the value Siro places on the US market, recent comments by shareholder 3i India suggest that the Mumbai group plans to further strengthen its position in its home territory.

3i India’s Mahesh Chhabria told Livemint that: “We are currently looking at several proposals for comparatively large investments in the country’s pharmaceuticals, medical devices manufacturing, and health care and laboratory services industries, including large and medium hospital groups.”

Chhabria explained that two of the options under consideration are acquisitions by Siro in India, but said that no move would be made until the integration of Omega is completed later this year.

UK CRO Chiltern International has bought Brazilian counterpart Vigiun

UK CRO Chiltern International has bought Brazilian counterpart Vigiun, building on the South American presence it set up last year in Argentina.

Chiltern explained that Vigiun, which has been operating since 1999, is a specialist in conducting Phase I to IV trials, providing management, staffing and patient recruitment services to drug industry sponsors.

The UK firm highlighted Sao Paulo-based Vigiun’s track record in conducting trials of drugs for cancer, respiratory conditions and infectious disease as a key motivation for the acquisition.

Chiltern also said that Brazil’s 192m residents provide a vast pool from which to recruit trial subjects and added that Latin America is rich with experienced investigators and is known for high quality data and excellent patient retention in clinical trials.

John Vann, executive VP of Chiltern’s South American operations, said that: “The acquisition of Vigiun enhances Chiltern's growing presence in Latin America, which was established nearly a year ago when we began operations in Argentina under the leadership of Oscar Podesta, our General Manager for Latin America.”

Vann added that the expertise and experience of the two Vigiun founders, Eduardo Forleo and Elisa Halker who stay on under the deal, strengthens Chiltern's standing and ability to expand in the region.

These thoughts were echoed by Chiltern CEO Glenn Kerkhof who said: "Vigiun is an ideal complement to our existing Latin American operations and Chiltern's presence in 27 other countries as we serve the pharmaceutical and biotech industries globally."

Eduardo Forleo, who will manage operations in the country, said that: “Our business has grown to the point that it makes sense to join forces with a global CRO whose mission and values align with ours."

Sanofi Investment Targets China’s Diabetes Market

Sanofi-Aventis is investing a further $90m in its Chinese manufacturing facility and performing “the world’s largest diabetes genotyping project” in partnership with the Chinese Diabetes Society.

The infrastructure investment in diabetes treatment capacity is the latest move in Sanofi’s expansion into emerging markets, which has seen the company acquire generics businesses in Brazil and Mexico.

Sanofi’s $90m (€69.5m) investment will be used to increase capacity at its Lantus (insulin glargine) SoloSTAR facility in Beijing, China, which is expected to produce 50m units on its pre-filled injection production line when fully operational.

Christopher Viehbacher, CEO at Sanofi, said: “The new Lantus SoloSTAR investment signifies a new milestone of Sanofi-Aventis’ commitment to China. As the first multinational healthcare company to establish offices in China, we remain convinced of the strategic importance of the Chinese market.

“We are particularly dedicated to investing in areas that can help China address its public health needs. Lantus SoloSTAR is a result of five years of R&D at the highest level. The local production of Lantus SoloSTAR at the new manufacturing site is scheduled to start in 2012, and it will bring great benefits to the diabetes patients in China.”

As the Chinese population adopts a more western diet and lifestyle occurrences of diabetes are expected to rise and Sanofi’s presence in the country should position it to treat this patient group.

Diabetes genotyping project

Sanofi and the Chinese Diabetes Society are partnering to undertake what they describe as “the world’s largest diabetes genotyping project”.

The partnership intends to initiate a study involving more than 46,000 diabetic and non-diabetic patients to analyze in-depth genetic factors and improve understanding of the pathogenesis of type 2 diabetes.

By gathering this data Sanofi believes that it can improve early detection of at risk patients and create effective prevention strategies. In addition the study could define new molecular targets that may help the development of treatments.

hameln pharma Wins International Award for New Sterile Plant

The new sterile plant of pharmaceutical contract manufacturer hameln pharma has won the international Facility of the Year Award 2009 in the Operational Excellence category. Dr. Simone Dahlmanns, Operations Director and head of the construction project at hameln pharma, took receipt of the well-known award in New York at the end of March.

Hamelin/New York. Contract manufacturer hameln pharma, specializing in the production of sterile pharmaceuticals, has won this year's Facility of the Year Award in the Operational Excellence category for its new sterile plant. After a project term of 25 months at the company's headquarters in Hamelin, hameln pharma's new sterile plant was commissioned in April 2008 and its purpose is the aseptic production of parenteral drugs.

In competing for the well-known international "Facility of the Year Award 2009", which is held annually by the ISPE (International Society for Pharmaceutical Engineering) in collaboration with the Interphex trade exhibition and the Pharmaceutical Processing journal, hameln pharma's sterile plant has now outstripped more than 30 rivals in the Operational Excellence category.

The Facility of the Year Award is held in six categories. In the Operational Excellence category the award is presented to companies that implement exemplary, state-of-the-art management techniques in order to improve operational performance potential, promote excellent quality and achieve competitive manufacturing costs. Consequently, one of the appraisals by the international jury regarding the award for hameln pharma's new sterile plant ran as follows: "The process which this company operates in order to manufacture sterile products is outstanding. The project is up to date with regard to all Annex 1 regulations. For what they have built, the cost is genuinely low. This plant has consolidated so many processes."

At the Interphex trade exhibition, which took place in New York from 17 to 19 March, the Facility of the Year Award was presented to the winners of the six categories.

"For the entire team, winning the Facility of the Year Award 2009 in the Operational Excellence category is confirmation of the fact that we have genuinely made a great achievement over the last two years", says Dr. Simone Dahlmanns, Operations Director at hameln pharma and head of the construction project, at the presentation of the Facility of the Year Award in New York. Dr. Dahlmanns adds that to win an award for something accomplished together over a period of two years fills her with joy and pride. "Joy that by means of this award the jury is clearly documenting the fact that it appreciates the outcome of our work, and pride in the excellent results and the excellent team that accompanied, advised and supported me on this project."

However, competition for the Facility of the Year Award 2009 did not come to an end for hameln pharma upon presentation of the award in New York. The overall winner still has to be chosen from the group of six category winners. The ultimate winner of the higher-ranking Facility of the Year Award 2009 will only be announced in November 2009 though. "Until the name of the overall winner is announced it still remains exciting for us too", says Dr. Simone Dahlmanns.

hameln pharma's Award-winning Sterile Plant

Commenting on the concept of the award-winning sterile plant, Dr. Dahlmanns adds that from the planning of the new sterile plant to its implementation as a whole hameln pharma has always taken into consideration the philosophy of lean manufacturing and designed the layout of the new sterile plant in such a way that the production process is supported in an optimal manner. She says, for example, that the arrangement of the work areas is logically based on the sequence of the individual production steps – from the receipt of raw material, weighing and compounding to the filling process and ultimate shipment of filled vials and ampoules. "Material and personnel movements within the plant are thus organized as efficiently as possible".

She adds that the cleanrooms and the layout of the production line are absolutely functional. "In the new plant layout the configuration of the new filling systems is no longer linear but U-shaped", says Dahlmanns. She says that as a result they integrate logically into the production process as a whole.

Systematic standardization of rooms, systems, equipment, tools and processes boosts the productivity of the employees and hence the efficiency of the production process as a whole. Generous use of glazing throughout the plant helps employees to provide a flexible response to different situations. "70 per cent of all the inside walls are made of glass so they provide maximum transparency", says Dr. Dahlmanns explaining, "and that enables the employees, on the one hand, to keep track of the production sequence, monitor it and make it suitably efficient and economical. On the other hand, employees can consult colleagues during the production process without having to leave their own work area."

She adds that at operating level the construction work is being supplemented with projects to improve the value stream and boost efficiency: for example, set-up time optimization projects are helping to significantly improve general processing times, as is systematic management using the 5-S method.

"The 5-S method ensures safe, clean workplaces and avoids the unnecessary wasting of time searching for equipment and tools", says Simone Dahlmanns, "it makes it possible to detect defects and the need for maintenance at an early stage, especially in good time, and thus prevents outages."

Facility of the Year Award

The Facility of the Year Award is an annual program which is held by the ISPE (International Society for Pharmaceutical Engineering), the INTERPHEX trade exhibition and the Pharmaceutical Processing journal. During the FOYA program state-of-the-art projects are identified which demonstrate worldwide leadership as a result of pioneering engineering achievements, innovative technology or advantageous enhancements of existing technologies. The objective of the FOYA program is to show approval of and reward construction projects which use new innovative technology in order to improve the quality of pharmaceutical production, reduce production costs in the manufacture of top-quality pharmaceuticals and exploit benefits in project execution.

The Facility of the Year Award is held in six categories: Equipment Innovation, Facility Integration, Operational Excellence, Process Innovation, Project Execution and Sustainability. The overall winner of the Facility of the Year Award is chosen from the group of winners in the six categories.

Canada Awards $91 Million for Genomics Projects

Genome Canada said that it, along with national and international partners, has awarded C$112 million ($90.7 million) in new grants for genomics and proteomics studies of crop plants and bioproducts.

The Genome Canada Competition funding included C$53 million from the Canadian government and C$59 million from Canadian and international partners, and was awarded through the Genome Canada Applied Genomics Research in Bioproducts or Crops program, Genome Canada said.

The nation's Minister of State (Science and Technology), Gary Goodyear, and Chairman of Genome Canada's Board, Calvin Stiller, said that the funds were awarded to 12 researchers.

"These projects will promote job creation, strengthen the economy for future generations, and will also generate strong environmental benefits for Canada," Goodyear said in a statement.

"These remarkable grants will truly strengthen the work being done by these talented researchers which, in turn, will create groundbreaking solutions for serious environmental issues," Judith Woodsworth, who is Concordia University's President and Vice-Chancellor, in a statement about the funding the university was awarded under the program.

Marc Proulx, who is president and CEO of Génome Québec, said that the C$22 million for biofuel genomics studies conducted by Concordia investigators "confirm the critical importance of genomics in leading edge sectors and its contribution to solving problems linked to sustainable development."

The new awards from Genome Canada and its partners include:

Genome Alberta and Genome Canada researchers have won C$13.6 million to study synthetic biosystems for plant metabolite production.
The University of Calgary has won C$11.6 million to study metagenomics involved in hydrocarbon energy.
The University of British Columbia was awarded C$10.5 million for studies of sunflower genomics; C$3.4 million to study grape and wine genomics, and C$7.8 million (along with the University of Alberta) to study lignocellulosic feedstock for bionergy studies.
The University of Saskatchewan and University of Ottawa study won C$5.4 million to study Value Generation through Genomics.
The University of Manitoba received C$10.5 million to study microbial genomics for biofuels and biorefining.
The University of Saskatchewan won C$12 million along with Agriculture and Agrifood Canada for studies of the utilization of flax genomics.
Concordia University won C$17.4 million for research into genozymes for bioproducts and bioprocesses development.
McGill University won C$4.6 for population and functional genomics studies to identify and experimentally validate regions of genes for crop improvement.
The University of Toronto and Geosyntec Consultants have won C$10.9 million for research into bioproducts and enzymes from environmental genomes.
The University of Western Ontario won C$6.4 million to study genomics in agricultural pest management.

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Northfield, IL 60093-2743

Tel: 847-784-0012; Fax: 847-784-0061;

E-mail: editor@mcilvainecompany.com;

Web site: www.mcilvainecompany.com