PHARMACEUTICAL & BIOTECHNOLOGY

UPDATE

 

August 2009

 

McIlvaine Company

www.mcilvainecompany.com

 

TABLE OF CONTENTS

 

UNITED STATES

UCLA Aims for Summer 2010 Completion of New $155 Million Life Sciences Building

Covis Moves to New Headquarters in Boulder, Colorado

PCAS Joint Venture Sets Up U.S. Kilolab

Marine Biotechnology at UNCW Center for Marine Science Gets Grant for Construction

Southern Miss Builds Research Labs

Indiana University Bloomington Gets New Lab

Kaleida and University at Buffalo Build New Facility

Covance Delays Virginia Toxicity Plant by 2 Years

Dendreon Signs Leases for New Manufacturing Facilities Georgia and California

Nation's Newest NIH Regional Biocontainment Laboratory Opens in Memphis, Tennessee

Genentech Eyes 25 More San Diego Jobs at Oceanside Plant

A Year after Being Earmarked into Mass. Life-Sci Act, Pittsfield Bio Incubator Funding Blocked by Mix-Up

SGS Expands North American Operations in Chicago and Toronto

Millipore’s Massachusetts Mobius Plant Open for Business

Cord Blood Expands Labs in Las Vegas

Advanced Electron Beams Get Cash Boost for Aseptic Packing Technology

Glanbia Opens New U.S. Vitamin, Mineral Premix Facility

Millipore Acquires Drug Discovery and Development Services Firm BioAnaLab

Ector County Hospital Gets Funds for Expansions

Meridian Life Science (MLS) has Completed the Expansion of its cGMP Biotech Facility

Isogen's New Science Centre a "unique" Clinical Service Facility

NSA Opening Lab for Histology Services

California Health Centers Strive To Develop New Health IT Innovations

University of California-Davis Innovation Center

Monsanto Investing $15 Million in Prairie Facilities

Isogen Science Center Completes Media Fills and Begins Fulfilling Backlog

CML API Maker Has New Plant in Wisconsin

Compass Completes ISO Class 8 Upgrade

NIST Awards $55.5 Million for Four New University Research Facilities

Marine Technology and Life Sciences Seawater Research Building at University of Miami

Center for Advanced Science, Innovation and Commerce at Auburn University

Brockman Hall for Physics at Rice University (Houston, Texas)

Marine Biotechnology in North Carolina (MARBIONC) at University of North Carolina

Bausch & Lomb Says Grants Key to Choosing Madison, NJ, for New Global Pharma HQ

DoD Research Arm Leases 350,000 Square Foot in Northern Virginia

ImClone to Anchor Alexandria Center

Dow AgroSciences Builds in Indiana

REST OF WORLD

Environmentally Friendly Labs Opened by CSIRO in Australia

GEA Wins €15 Million Order from China’s Hisun Pharmaceutical

Vietnam to Build its Largest Food Complex

Medis’ Drug Packaging Plant Open for Business

AMRI Opens Lab in Hungary

EMEA Approves Patheon’s Puerto Rico Facility

Millipore Buys BioAnaLab to Expand in EU

Wuxi PharmaTech Services Grow

Plans for New Indian-Australian Research Academy

BSL-4 Opens in Germany

GSBTM to Commence Works for Incubator Facility in Savli Biotech Park

Monsanto Investing $15 Million in Prairie Facilities in Canada

 

 

 

UNITED STATES

 

UCLA Aims for Summer 2010 Completion of New $155 Million Life Sciences Building

A new life sciences building is set for the campus of the University of California, Los Angeles (UCLA). The project began construction nearly two years ago and is scheduled to be completed in August 2010. The $155 million building not only will replace the existing life sciences building, but will expand on the current offerings. The Department of Molecular, Cell and Developmental Biology; the Department of Physiological Science; and the Department of Ecology and Evolutionary Biology will be located in the facility.

 

 Designed by Bohlin Cywinski Jackson (Wilkes-Barre, Pennsylvania) to meet LEED standards, the 175,000-square-foot replacement building will feature two seismically separated five-story wings that will be connected by a basement. In addition to both dry and wet research labs, the facility will house a plant growth lab and vivarium space (allowing animal research).

 

Other members of the project team include KPFF Consulting Engineers (Los Angeles, California) for structural work and the Syska Hennessy Group (New York, New York) for building systems, as well as lighting and plant growth lab design.PCL Construction Services (Glendale, California) is handling construction of the building

 

Covis Moves to New Headquarters in Boulder, Colorado

A new Boulder-based biotechnology firm, which recently received $145 million in startup financing, has settled on its new home.

 

Clovis Oncology Inc. signed a lease for 5,844 square feet of space at 2525 28th St. to locate its headquarters. It expects to move into the space sometime this fall.

 

Clovis is focused on acquiring, developing and commercializing innovative anti-cancer agents in the United States, Europe and additional international markets. Currently in its startup phase, the firm employs fewer than 10 people.

The company is headquartered in Boulder and plans to establish additional offices in San Francisco and London.

 

PCAS Joint Venture Sets Up U.S. Kilolab

PCAS is setting up a kilolab in California, to target the small-scale synthesis market, which it believes will benefit its large-scale operations by establishing relationships earlier in development.

 

The current good manufacturing practice (cGMP) facility in Santa Rosa is the focal point of a joint venture between PCAS and Nanosys. Prior to the joint venture PCAS lacked a US facility and this hindered development of some aspects of the business.

 

Joseph Tessier, vice president of PCAS America, explained that US clients prefer to use local facilities for small-scale production. PCAS can now meet this demand and because the facility is in California it is ideally located to capture the biotech market.

 

Furthermore, Tessier believes the early-stage synthesis market is less competitive than its traditional sector, which is EU-based large-scale production. Tessier expects that some clients that use the small-scale facility will continue to use PCAS for late-stage supply needs.

 

Nanosys and PCAS operate in different markets and consequently the joint venture could benefit both. PCAS’ large-scale production operations will potentially gain a steady flow of clients and Nanosyn, which provides drug discovery services, extends its offering into material supply.

 

The Santa Rosa facility was fully equipped when the companies acquired it but the joint venture partners are planning to upgrade some aspects. Tessier explained that an R&D upgrade is planned and additional analytical equipment will be installed.

 

Operations have already begun at the facility, with the partners supplying some of the previous owner’s clients and establishing contracts with new customers, according to Tessier.

A facility in South San Francisco was originally targeted but this was taken off the market before the deal went through. The companies then identified the Santa Rosa, which became available after its owner, Seres Laboratories, went bankrupt.

 

Marine Biotechnology at UNCW Center for Marine Science Gets Grant for Construction

UNCW was recently awarded a $15 million matching grant from the National Institutes of Standards and Technology (NIST) for the construction. Construction on the 69,000-square-foot facility is scheduled to begin in November, if an additional $15 million in funding is raised.

 

Oklahoma Med-Research Foundation on Track to Consolidate Facilities Next Year

The Oklahoma Medical Research Foundation said it is on track to complete construction next year of a $125 million, 186,000-square-foot research center designed to fulfill its longstanding goal of bringing under one roof research efforts now scattered among several buildings.

 

Ground for the eight-story research tower was broken in May, and construction is set to be completed Dec 31, 2010.

 

Designed by the architectural firm Perkins+Will, the new facility, to be located directly north of OMRF’s main building at 825 NE 13th St. in Oklahoma City, will house laboratory, administrative, and clinical research space.

 

Southern Miss Builds Research Labs

A variety of construction projects are underway or are near completion at The University of Southern Mississippi's Hattiesburg campus and at two of its Gulf Coast teaching sites. These projects include facilities dedicated to student activities, residence life, classroom and laboratory space, research, economic development and athletics, among others. The Accelerator: Expected to be complete this fall, this polymer research facility located at The Garden (the university's innovation and commercialization park) will be three connected buildings that will include laboratories, business incubator space, and offices of the Mississippi Polymer Institute.

 

Construction projects at Southern Miss Gulf Coast include at the Gulf Coast Research Laboratory's Cedar Point site, with a marine research laboratory and offices complex to be completed in May 2010. A red snapper laboratory is set for completion in March of 2010.

An oceanographic support facility at the university's Center for Higher Learning, located at Stennis Space Center, is scheduled for completion fall 2009.

 

Indiana University Bloomington Gets New Lab

Indiana University Bloomington is home to the state of Indiana's first "select agent" laboratory for the study of pathogens. Select agent labs are safe and secure, and are rigorously regulated by the U.S. Centers for Disease Control and Prevention.

 

Approval of select agent labs is the sole milieu of the U.S. Centers for Disease Control and Prevention, a federal agency based in Atlanta, Ga. Not only must applicants justify having such a lab, they must also pass a series of inspections and tests. A CDC visit in June (2009) marked the final preliminary inspection. "We passed with flying colors," Marketon said.

 

The CDC will conduct regular inspections as long as IU's select agent lab remains open.

Everything about the lab had to pass the inspection. The electrical infrastructure, the disinfection stations, the lights, even the design. In addition, they had to pass inspections of safety and security procedures: what they will be doing on a daily basis, but also how they would react if even the most minor thing goes wrong. All lab employees are subjected to background checks by the U.S. Department of Justice. Even maintenance workers must be screened before they may enter.

 

Access to the laboratory is limited to a scant few.  Anyone who enters the lab must be accompanied by a "buddy," which improves supervision as well as worker safety. There will always be a "responsible official" on duty and on call, as well as a backup responsible official. The select agent lab's first responsible official is Sarah Null, who has worked in similar labs before. A detailed log of who enters, who exits and when, will be maintained and regularly inspected.

 

They are also coordinated with key staff at the IU Police Department and Bloomington Hospital for preparedness' sake.

 

The managing architect of the select agent lab was the Indiana University Architects Office and BSA LifeStructures of Indianapolis served as Architect/Engineer of Record. CDI Inc. of Bloomington was the lab's general contractor, Harrell-Fish Incorporated of Bloomington was the mechanical contractor, and Siemens in Indianapolis provided the lab's control systems. Commissioning the lab were George Butler Associates, Inc., of Lenexa, Kan., and VicoCon, Inc., of Kansas City, Mo.

 

The IU Select Agent Lab was funded by the IU Commitment to Excellence Fund and the College of Arts and Sciences.

 

Kaleida and University at Buffalo Build New Facility

Kaleida Health and UB broke ground for a new 10-story global vascular institute and research building.

 

The $291-million combined facility, to be located next to Buffalo General Hospital at Goodrich and Ellicott streets, will bring together Kaleida Health physicians and UB researchers in a collaborative effort to deliver state-of-the-art clinical care, produce major breakthroughs on the causes and treatment of vascular disease and spin-off new biotechnology businesses and jobs.

Construction of the building, designed by Cannon Design, Architects and Engineers, is expected to take approximately two years to complete, with doors opening in late 2011. Turner Construction is the general contractor for the project.

 

In 2007, the Commission on Health Care Facilities in the 21st Century, also known as the "Berger Commission," ordered the closure of Millard Fillmore Gates Circle Hospital. Kaleida Health decided to shift the hospital's cardiovascular and stroke-related services to the soon-to-be-built facility on the Buffalo Niagara Medical Campus.

 

The building will house four floors of Kaleida Health's $173 million merger of its cardiac, stroke and vascular operations, plus a new and expanded emergency department. It will also house research and development facilities, including four floors for UB's $118 million Clinical and Translational Research Center (CTRC) and a UB Biosciences Incubator.

 

The co-location of Kaleida Health physicians and UB researchers and faculty in the facility is expected to bring about advancements in care and treatment — and development of new medical technologies — that would not happen in isolation.

 

For Kaleida Health, the global vascular institute will consolidate heart, stroke, vascular and neurosurgery services in one location. The new building will also help fulfill Kaleida Health's vision to create a world-class, academically oriented medical center, second to none in the Northeast United States. In fact, in the coming weeks, ECMCC and Great Lakes Health plan to announce a significant investment in the global vascular institute, further consolidating heart programs in Western New York.

 

For UB, the Clinical and Translational Research Center will expand the university's focus on translating basic medical research into new treatments and technologies made available for patients. The Biosciences Incubator will provide laboratories and office space, and start-up services to companies spun off from UB medical discoveries. UB's incubator is expected to be at full occupancy after 2-3 years, with 130 employees. According to studies on the economic effect of biomedicine and biotechnology research, the UB CTRC and Biosciences Incubator are projected to produce an annual economic impact of $68,750,000.

 

The new building is made possible by a unique partnership between UB, a public university, and Kaleida Health, a private entity. This partnership is expected to save taxpayers $21 million through reduced construction costs and operational efficiencies. The building is an example of the type of projects UB is prohibited from doing on a regular basis by the state, unless it first goes through a cumbersome approval process. This is why UB is seeking the flexibility to pursue these types of public-private partnerships through the UB 2020 Flexibility and Economic Growth Act, introduced into the state legislature this year by the Western New York delegation.

 

When complete, the Kaleida Health-UB facility will house nearly 600 patient beds, 30 operating rooms, 17 interventional labs for cardiac, vascular and neurosurgical procedures, as well as four CT scanners and four MRI's. It is anticipated that the new emergency department will accommodate more than 60,000 visits, while the hospital will discharge nearly 27,000 patients.

 

Covance Delays Virginia Toxicity Plant by 2 Years

US CRO Covance has delayed the construction of a proposed $145m (€102m) preclinical toxicology testing facility at a 47 acre site at the Prince William Technology Park in Virginia.

 

Laurene Isip, head of Covance’s corporate communications department, told Outsourcing-pharma that work at the site, which was purchased from Eli Lilly in 2007 for $20m, would be put on hold for up to two years

 

Isip explained that: “Market conditions signaled a softening in the toxicology market that led to the decision,” but maintained that “the long-term outlook for our industry is very strong.”

 

Covance, like many North American contract research organizations (CRO), has struggled with falling demand for its services in the last six months, suffering particularly as a result of its focus on preclinical development.

 

For example, Covance’s second quarter revenue and operating income from early-stage development, which includes toxicology testing, fell 6 and 50 per cent to $200m and $27m, respectively.

 

And, while growth of its late-stage testing business did allow Covance to beat analysts Q2 estimates and raise its 2009 earnings forecasts, at present further investment in an underperforming preclinical business would be hard to justify.

 

In addition, the recently opened state-of-the-art toxicology testing facility in Arizona as well as its centre in Greenfield, Indiana, probably leave Covance’s early-stage development and testing unit with sufficient capacity at a time when demand is low.

 

While Covance’s decision to delay construction is obviously a blow for the development of the Prince William Technology Park, the move was greeted with optimism.

 

Further support for Covance’s long-term commitment to the Virginia site is provided by comments made by CEO Joe Herring who said that the firm has no plans to sell the site during a conference call late last year.

 

Dendreon Signs Leases for New Manufacturing Facilities Georgia and California

Seattle-based Dendreon used its most recent 10-Q quarterly report, filed with the US Securities & Exchange Commission, to announce the creation of two manufacturing facilities at opposite ends of the US, as the drug developer gears up to bring its prostate cancer treatment Provenge to market.

 

The company said it entered into a lease July 31 with Majestic Realty Co. for a $70 million, 160,000-square-foot building to be constructed at the Majestic Airport Center in the Atlanta suburb of Union City, Ga., near Hartsfield-Jackson Atlanta International Airport.

The lease term is "anticipated to commence in the first half of 2010" and runs an initial 10 and a half years, during which time Dendreon has agreed to pay Majestic a total $6.7 million in rent, with two renewal terms of five years each, the company disclosed in the filing. Dendreon said the lease includes a one-time purchase option exercisable prior to March 2011, and a 10-year expansion option for up to an additional 47,000 square feet.

 

In a statement, Georgia Gov. Sonny Perdue said Dendreon was among biotech companies introduced to Georgia's life sciences sector when the Peach Tree State hosted the Biotechnology Industry Organization's 2009 International Convention in Atlanta this past May. Carol Henderson and Annie Marie Baxter, project managers with the Georgia Department of Economic Development, assisted the company in its site search, according to the statement.

 

News of Dendreon’s interest in the site dripped out into local news reports in recent weeks, in part after Majestic won approval from Union City officials in June to build a building of 202,000 square feet.

 

“Union City is poised, with its Opportunity Zone and strategic location on Interstate 85, to be a key player in the Southeast as well as the United States,” Mayor Ralph Moore said in the statement issued by Perdue.

 

Dendreon also said it entered into a lease Aug. 7 with Knickerbocker Properties for 184,000 square feet of existing space at the Pacific Gateway Business Park, in Seal Beach, Calif. The lease term there is for ten and a half years, during which time Dendreon would pay Knickerbocker a total $13.6 million in rent, with two renewal terms of five years each. The lease includes a one-time purchase option exercisable during the first three years of the lease term, Dendreon added.

 

The lease signings are part of Dendreon's plans to ramp up production of Provenge. The company is pursuing final approval of the drug from the US Food and Drug Administration following successful clinical trials, though the application was tabled earlier this year to await additional results.

 

In addition to the leases, Dendreon also retained LifeTek Solutions "to provide consulting design and commissioning services" for the development of the Georgia and California facilities, as well as Phase II and Phase III of the New Jersey facility, at a maximum total cost of $5.9 million.

 

Nation's Newest NIH Regional Biocontainment Laboratory Opens in Memphis, Tennessee

Two years after starting construction, the University of Tennessee Health Science Center has officially opened a $25 million Regional Biocontainment Laboratory (RBL). One of 13 such labs in the U.S., the RBL received most of its $17.7 million funding from the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health.

 

 Designed by the Horrell Group (Memphis, Tennessee) and built by Inman Construction (Memphis, Tennessee), the 31,000-square-foot RBL is dedicated to the research of potential vaccines for naturally occurring and bioterrorism-related diseases. Research in Memphis will be limited to Biosafety Level 3 (BSL-3), unlike the two national bio laboratories in Boston, Massachusetts (the opening of which is on hold because of protest groups) and Galveston, Texas, which carry a Biosafety Level 4 (BSL-4) rating. The main difference between the ratings is that BSL-3 labs involve serious or potentially lethal diseases transmitted through the air, while BSL-4 labs involve potentially fatal germs that have unknown forms of transmissions. Eventually, up to 150 people could be employed by the lab, which is headed by Gerald Byrne, PhD.

 

The RBL is located in the UT-Baptist Research Park, the former site of Baptist Memorial Hospital, which was demolished in 2005. Overseen by the Memphis Bioworks Foundation, plans for the park call for up to 1.2 million square feet of laboratory, research, educational and business space to be built eventually.

 

Genentech Eyes 25 More San Diego Jobs at Oceanside Plant

Genentech will not only keep its Oceanside plant, and the plant's 480 jobs, in San Diego, but add 25 new jobs to the facility as part of Roche's reorganization following its $47 billion acquisition of the biotech giant, completed earlier this year — though the plant has changed general managers.

 

The 500,000-square-foot plant is responsible for producing batches of Genentech’s best-selling cancer drug Avastin, which generated $2.7 billion in US sales last year.

Genentech spokeswoman Caroline Pecquet told the Business Journal that the new Genentech — the name under which Roche will now operate in the US — plans to hire about 25 workers in Oceanside during the next year “in order to keep up with the product manufacturing increase.”

 

“All of Genentech’s current manufacturing facilities will continue to play an important role in the global manufacturing network," Pecquet told the newspaper.

 

Jane McVey, economic development director for the city of Oceanside, told the Business Journal that Genentech can expand within its corridors, since it doesn’t occupy all of the space it’s entitled to — about 1.37 million square feet.

 

Larry Sanders, previously senior director of Genentech’s South San Francisco manufacturing operations, has been named head of Oceanside product operations, succeeding Gary Harbour, who is leaving Genentech on Sept. 30.

 

A Year after Being Earmarked into Mass. Life-Sci Act, Pittsfield Bio Incubator Funding Blocked by Mix-Up

More than a year after funding for a $6.5 million biotech incubator for the William Stanley Business Park in Pittsfield, Mass., was earmarked into the $1 billion Massachusetts Life Sciences Act, the agency that oversees the park remains unable to collect the funding.

 

Pittsfield (Mass.) Economic Development Authority cannot receive the funding until it submits a detailed proposal to the Massachusetts Life Sciences Center for the incubator building, Susan Windham-Bannister, the MLSC's president and CEO, told the Berkshire Eagle of Pittsfield.

 

"We have not had a conversation with them [PEDA] yet, which says to me that they're not quite ready to go," she said, adding: "A lot of projects have not approached the center yet."

 

The center's spokesman, Angus McQuilken, told the newspaper that earmark recipients must submit a second detailed proposal to the Life Sciences Center so it can determine which projects are considered shovel-ready: "First you need to submit the project to the Legislature," McQuilken said. "The next step is to submit detailed information to the center so that we can vet it and evaluate it."

 

However PEDA's interim executive director, William Hines Sr., told the newspaper that he was confused about the center's stance, since PEDA had submitted detailed architectural drawings of the incubator building to the state Legislature in order to obtain the earmark on the bill.

 

The incubator is among $500 million in capital projects over the next 10 years for which funds were earmarked in the life-sci act.

 

Created in 2006 by then-governor Mitt Romney and expanded last year by his successor, Gov. Deval Patrick, the center oversees the spending of the life-sci act's billion dollars. The center has spent $48.5 million in public funds in a variety of projects during fiscal 2009, which attracted $359 million in private investment and created 950 jobs. In fiscal 2010, the center plans to award $25 million in tax incentives, but additional funding has yet to be determined.

 

SGS Expands North American Operations in Chicago and Toronto

SGS Life Science Services (LSS) is expanding its R&D / QC operations in North America by doubling its facilities in Chicago and tripling those in Toronto. The moves are in response to 10-15% annual growth in the market for pharmaceutical contract testing.

 

SGS has been operating its LSS division in Canada since 1984, and has been in its existing facility located in the Toronto suburbs of Mississauga since 1987. The new facility, also located in Mississauga, will triple the space from 15,000 sq. ft. to 46,000 sq. ft. The company anticipates doubling its technical resources to handle new business opportunities.

 

Concurrent with the move to the new Mississauga facility, the R&D / QC group will expand its capabilities in Canada by offering testing services for the analysis and characterization of biopharmaceuticals. The move is currently underway in phases and is expected to be completed by September.

 

In the U.S., SGS LSS’ sites include a 35,000-sq.-ft. facility in northern NJ, in close proximity to top pharmaceutical companies. In 2006, SGS expanded its U.S. market presence by acquiring Northview Laboratories, adding an existing facility in the Chicago suburb of Northbrook, IL. SGS LSS will move from the Northbrook facility to a new site in Lincolnshire, IL, doubling the facility size from 21,500 sq. ft. to almost 40,000 sq. ft.

 

As part of the move, SGS will increase its offerings in Stability Studies and Stability Program Management. SGS LSS plans to double its technical staffing by the end of 1Q10,. Modifications to the building are currently in progress, with move-in by the end of 2009.

 

“For SGS’ Life Science Services, the expansion at these two sites demonstrates our continued commitment to delivering excellent quality and service.” said Sohil Mana, Sr., vice president and regional business manager, North America. “The move also involves the implementation of Lean Projects to increase efficiencies in our laboratories. These projects will strengthen our performance by developing innovative solutions to lead the industry in on-time delivery. Given that outsourcing is a continuing trend within the pharmaceutical market, these recent expansions will contribute to positioning SGS Life Science Services as the preferred partner to the pharmaceutical and biotechnology industries.”

 

SGS Life Science Services' R&D / QC division performs method development and quality control testing for the pharmaceutical, biopharmaceutical, medical device, chemicals and cosmetics markets.

 

Millipore’s Massachusetts Mobius Plant Open for Business

Millipore has ramped up capacity for its Mobius range of single use bio-processing and manufacturing technologies with a new purpose built production facility in Danvers, Massachusetts.

 

The plant, which will also make components for the Mobius FlexReady Solutions line showcased at Interphex in New York in March, takes over from Millipore’s facility in California and is expected to employ a staff of 120 by the end of the year.

 

Christos Ross, director of the Danvers facility, told in-PharmaTechnologist that the ISO 9001-2008 certified, good manufacturing practice (GMP) standard site has been fully operational since June 9.

 

Ross explained that it has been designed with growth of the Mobius range in mind and is capable of distributing to manufacturers around the world.

 

Millipore’s VP of downstream processing Paul Chapman told in-PharmaTechnologist that while the Mobius range grew almost 40 per cent last year and is on track to expand even more in 2009, the market is increasingly competitive.

 

“The current economic situation is driving the trend for more operational flexibility with single-use solutions as biopharmaceutical manufacturers strive to reduce development time, shrink costs associated with conventional manufacturing and mitigate cash burn.”

 

He added that the range was specifically developed to meet these needs and help biopharma firms “reduce their capital investment while answering their call for flexible manufacturing.”

Chapman also said that: “Biopharmaceuticals are the fastest growing and most attractive category in the industry,” explaining that the number of biotech drugs in development has grown from just 10 per cent on the total pipeline to nearly 25 per cent in the space of a few years.

 

Edward Graham-Brown, Millipore’s VP of bioprocess strategic marketing, was also enthusiastic about the biopharmaceuticals sector and its growth potential. “It’s undeniable that new therapeutic paradigms like cell therapies, DNA vaccines, antibody fragments, will keep emerging and there will be a continued relevance for biotherapeutics in healthcare. “

 

He also suggested that, unlike small molecule drug manufacture which has tended to be relocated to regions where costs are lower, the complexity of making biotech medicines and investment needed made a similar shift unlikely.

 

Graham-Brown added that this, coupled with the industry’s efforts to reduce its manufacturing foot print in North America, should mean that demand for validated production bio processes continues to grow.

 

Cord Blood Expands Labs in Las Vegas

Cord Blood America, Inc., one of the largest umbilical cord blood stem cell preservation companies focused on bringing the life saving potential of stem cells to families nationwide and internationally, announced that work has begun at its new, 17,000 square foot facility in Las Vegas for conversion into a state-of-the-art laboratory for the storage of stem cells and for research and development.

 

"Our target for having a cord blood processing lab in operation, a testing lab, and a cryogenic storage area is the fourth quarter of 2009.  This will complete Phase One of the construction.  Currently architectural plans are completed and needed demolition of parts of the interior building is underway," said Matthew Schissler, CEO and founder of Cord Blood America.

"Phase Two will involve building out of the largest cryogenic facilities in the country, as well as a research laboratory, additional processing labs and a cleanroom," Mr. Schissler said.  "Completion is expected in 2010.

 

Cord Blood America recently announced it is opening a state-of-the-art laboratory for the storage of multiple stem cell products, including umbilical cord blood stem cells, in Las Vegas.  The lab will be used to process and store umbilical cord blood stem cells, to store other forms of stem cells such as stem cells from the peripheral blood stream and adipose tissues, and for research and product development.

 

Dr. Geoffrey John O'Neill, author or co-author of more than 75 publications about stem cells, and former Laboratory and Scientific/Medical Director for Cryo-Cell International Inc. in Florida, will serve as Laboratory Director.  Brian Pockett, with more than 30 years professional experience in operations, business development, marketing, sales and financial and grant development, including serving as a consultant on global distribution, product development, commercialization, investment and intellectual properties for some of the largest companies in the U.S., is Vice President of Laboratory Operations. 

 

Advanced Electron Beams Get Cash Boost for Aseptic Packing Technology

A US company that uses electron beams to sterilize aseptic packaging plans to use a $14m-cash-injection to develop new technology, increase sales and boost its finances.

 

Massachusetts-based Advanced Electron Beams (AEB) said the latest funding brings the total raised by the company to more than $50m. The company said it hoped to use the funding to develop its air pollution control space technology, where companies could use e-beams instead of burning pollutants.

 

Josh Epstein, director of marketing, told FoodProductionDaily.com the company is also developing a new, smaller emitter, with a narrower nozzle that will fit inside beverage containers. The product is expected to be introduced in September.

 

CEO Mitch Tyson added: “No one has been able to do that up until this point.”

 

He said he hoped the cash infusion would get the cash-flow negative company to break even.

 

AEB also announced it is expecting to receive two letters of non-objection from the Food and Drug Administration for new technology in the near future.

 

E-beams have been used for decades in the food and beverage sectors. They work by directing a shower of accelerated electrons through a high-voltage emitter towards a target. However, a number of developments in recent years suggests the technology is poised for substantial growth, said Epstein.

 

One advancement is the miniaturization of the technology. Where units often measured 20 feet by10 feet (approx 6m x 3m), they had now shrunk to one hundredth of that size. This means the systems can be integrated into beverage filling equipment, eliminating the need to bring containers to dedicated irradiation centers.

 

Another development is the growth of aseptic packaging, particularly in the beverage industry as demand “moves away from carbonated soft-drinks towards functional beverages, ready-to-drink teas and coffees and dairy-based drinks,” said Epstein.

 

E-beam technology offers a chemical-free alternative to conventional sterilization, as well as delivering reduced energy costs, a smaller processing footprint and a cut in water consumption as it eliminates the need for rinse water, he added. The process also results in lightweighting of packing design because no heating is involved in the sterilization procedure. The company said its technology help traditional aseptic manufacturers become more sustainable.

 

Epstein said that while capital costs for e-beam technology were “slightly higher” than conventional sterilization systems, payback could be achieved within 12-18 months on energy savings alone.

 

AEB is working with 12 original equipment manufacturers at various design stages, as well as 50 customers - 19 of which are Fortune 1,000 companies, said the marketing director. Around 75 per cent of its clients are in the food and beverage industries, with the rest from the pharmaceutical sector. The company has shipped 200 of its e-beams worldwide, mainly in the United States, Europe and Japan.

 

Glanbia Opens New U.S. Vitamin, Mineral Premix Facility

Glanbia Nutritionals has opened a new vitamin and mineral premix facility in Missouri, increasing its production capacity for the US market and cutting lead times for customers, said the firm.

 

The Irish nutritional ingredients group said its new 8,300m2 (89,308 sq. ft.) plant contains “the latest” milling, blending and packaging technology, and is also kosher, halal and HACCP certified.

 

“This will double our size in terms of capacity in the US. The main reason for opening this plant was that the US is a geographically big market and we wanted to be present in the mid-west,” said Dr Raimund Hoenes, CEO of Glanbia Nutritionals’ Customized Premix Solutions.

 

The plant will mainly supply customers in the mid-west and eastern parts of the United States, while the west coast will continue to be supplied by Glanbia’s Californian premix facility, purchased in 2006.

 

As a result, delivery times to customers in the mid-west could be reduced by around three days, explained Dr Hoenes. In turn, this will enable them to increase their speed to market.

 

Although the plant does not as yet have a supplement GMP certification, Dr Hoenes said it “easily” complies with these standards. The firm is still in internal discussions regarding whether it will opt for GMP certification or ISO 2200, which, it says, is “very similar” to GMPs and will encompass most of those requirements. The additional certification is expected to be achieved during 2010.

 

Production at the new plant has already started, with some key customers already receiving deliveries from the new location. Several of the firm’s major customers have also already conducted audits of the facility.

 

Currently, the plant is run by 20 employees, but this can easily increase as required due to its ‘modular’ design. This means that blenders at the facility are contained in separate housing, and can be operated as necessary without affecting product flow elsewhere, explained Dr Hoenes.

 

As well as the two US premix facilities and its plant in Germany, Glanbia also set up its first manufacturing facility in China last year. Located in Suzhou, near Shanghai, the facility focuses on manufacturing nutritional premixes, used predominantly in infant formula, but also in functional foods.

 

These facilities supply bespoke micronutrient mixes, including vitamins, minerals, amino acids and botanical ingredients, as well as blends made with other ingredients in Glanbia’s portfolio.

 

Other activities in the US include Glanbia’s acquisition in 2007 of the Canadian nutritionals business Pizzey’s Milling, which mills flaxseed for lignans and omega-3. In 2008 it also acquired the sports supplement firm Optimum Nutrition, marking its first venture into the finished supplements arena.

 

In addition, the firm this year opened a new R&D facility and pilot plant in Idaho. With a focus on the development of bars, beverages and baked goods made with Glanbia’s dairy protein and flax ingredients, the center is said to allow closer collaboration with customers on the development of nutritional products, as well as speed up delivery of prototypes.

 

Millipore Acquires Drug Discovery and Development Services Firm BioAnaLab

Millipore Corporation has acquired BioAnaLab, a European-based services provider that specializes in the analysis of biologic drugs and vaccines. The transaction enables Millipore to expand its biopharmaceutical services business into Europe and further strengthens its position as a preferred outsource partner to biopharmaceutical companies.

 

"As an increasing number of biologics enter the pipeline, companies are leveraging Millipore's ligand binding assay expertise to help them evaluate the efficacy of these drugs and achieve regulatory compliance," said Jonathan DiVincenzo, President of Millipore's Bioscience Division. "Our acquisition of BioAnaLab will allow us to build on our reputation as a trusted outsource partner in North America by establishing a presence in the fast-growing European biotech market. BioAnaLab will add cGMP support testing capabilities to our portfolio, a solid customer base, and a team of highly talented services professionals with expertise in emerging scientific disciplines."

 

Based in Oxford, United Kingdom, BioAnaLab was spun out of the University of Oxford in 2002 to meet the unique requirements of the biopharmaceutical industry. The Company helps its customers better understand the safety and efficacy of biologic drugs and vaccines by providing a broad range of services to assist with evaluating and advancing these therapeutics from the drug development pipeline to the market. Services offered by BioAnaLab include assay transfer/development, validation & sample analysis, pharmacokinetics/ toxicokinetics, immunogenicity, biological potency, and vaccine services. Millipore will bring substantial expertise in biomarker analytical services to strengthen BioAnaLab's current offering in that area.

 

"We are excited to join forces with Millipore as we work to become the world's leading provider of large molecule bioanalytical services," said Geoff Hale, Ph.D., Founder and CEO of BioAnaLab. "Through Millipore's global market presence, we will add new capabilities and increase our capacity to serve our customers across the world. I am particularly pleased to be joining a company that shares our passion for combining top scientific expertise with an uncompromising commitment to quality."

 

BioAnaLab's facility in Oxford, UK will complement Millipore's existing facility for large molecule bioanalytical services in St. Charles, Missouri. Both facilities are audited by their national regulatory agencies. Geoff Hale will remain with Millipore and become Director of Biopharma Services in Europe. He will work closely with Ron Bowsher, Ph.D., Millipore's Chief Scientist for Biopharmaceutical Services in the United States who recently received a prestigious award for his ground-breaking work in the industry.

 

Ector County Hospital Gets Funds for Expansions

The Ector County Hospital District Board of Directors spent about $355,000 for site preparation related to the ongoing construction of Medical Center Hospital’s Ambulatory Care Center, but the board’s big-ticket expenditures went toward equipment and renovations at the hospital’s main campus.

 

Included in the money appropriated by the board for the ambulatory care center is the construction of a new north-south access road, excavation and building pad preparation, and the next phase in the extension of water and sewer lines to the satellite care facility’s east-Odessa site.

 

But beyond the allocations for the project, the board also approved spending about $1.6 million for new equipment at the hospital, about $1.2 million of which is to go toward the purchase of new physiological monitors.

 

Also included in the total cost of equipment purchases was $80,000 for 29 replacement reclining chairs, $175,995 for two new surgical lasers, and about $100,000 for a neonatal portable incubator and stretcher.

 

Beyond the $355,000 allocated by the board for an access road and site-preparation work at the new care center, the board also allocated $102,590 for a total overhaul of the existing hospital pharmacy’s IV Preparation Cleanroom, which hospital officials say is out of compliance and could fail inspections by state and federal regulatory agencies if it is not completely renovated.

 

Although the $69,590 bid made by contractor Travis Clean Air for the bulk of the project was about $6,000 more than a competing bid by Carter-Health, trustees agreed to opt for the former at the behest of staff members who have worked with the company in the past and are satisfied with its products.

 

MCH Chief Executive Officer Bill Webster said the board normally chooses to go with the lowest bidder on most projects, but in some circumstances quality or standardization considerations “occasionally” lead it to spend a little extra.

 

“If we feel it’s a superior product, we’ll sometimes go with the higher price,” he said. “The lowest bid may not be the quality you want.”

 

The remaining $33,000 of the project’s total price tag stem from other costs related to renovation, including about $4,000 for a temporary cleanroom during construction and another $6,000 for seamless flooring.

 

Meridian Life Science (MLS) has Completed the Expansion of its cGMP Biotech Facility

Meridian Life Science (MLS) has completed the expansion of its cGMP biotech facility, which will enable the contract production of vaccines and viral based products for Phase I trials.

 

The expansion will help MLS supports its environmental vaccine contract that it struck with the National Institute of Allergies and Infectious Diseases (NIAID). Under the terms of the contract MLS produces eight Phase I vaccines for the NIAID.

 

In addition MLS said the facility will help meet increased demand from other clients, noting that it continues to see strong interest for contract R&D and Phase I and II vaccine production.

 

This demand can now be met by the expanded facility that is already being used for an ongoing Phase I vaccine production contract. Housed at the expanded site is a cell culture and viral production suite.

 

Projects can be performed in both mammalian and insect cell cultures and capacity for egg-based production of viruses is also available.

 

A separate sterility suite has also been added, which will be used to test incoming materials and finished products. MLS believes this further enhances its in-house testing capabilities.

The expansion, and original vaccine manufacturing facility, will be supported by a newly expanded pilot production laboratory.

 

By using all this capacity MLS will now be able to conduct two separate current good manufacturing practice (cGMP) compliant production runs simultaneously. The company views this as a significant step in improving its ability to serve clients.

 

In addition to the NIAID’s contract for eight vaccines, six of which will be produced at the expanded facility, MLS is also working with Australia’s Murdoch Childrens Research Institute (MCRI) and global health non-profit organization PATH.

 

MLS recently reached a milestone in its work for MCRI and Path when it completed the manufacture of a live oral rotavirus. MCRI contracted MLS to develop and manufacture the RV3 rotavirus vaccine for use in Phase I and II trials.

 

Meridian Life Science, Inc. provides contract R&D, process development, and clinical cGMP biomanufacturing of vaccines, viral challenge materials, gene therapies, virus-like particles, and recombinant proteins at its contract biopharmaceutical manufacturing facility in Memphis, TN. This business focuses on materials that will be used in Phase I and II clinical trials that are intended for use as "injectibles." As such, they are produced under cGMP Regulations for Biologics and Human Drugs under the auspices of the FDA. With 25 years of cell culture experience, virus production, purification, assay development and quality, Meridian has become a leader and trusted partner for Phase I/II cGMP biomanufacturing solutions. Meridian also supplies critical assay reagents, antigens, antibodies, and contract biological R&D and manufacturing services to the research, diagnostic, and biopharmaceutical markets. Meridian Life Science services its customers from three primary manufacturing operations in Memphis, Tennessee; Saco, Maine; and Boca Raton, Florida.

 

Isogen's New Science Centre a "unique" Clinical Service Facility

US firm Isogen says the combination of aseptic filling, engineering and containment know-how on offer at its new Science Center is unique among facilities serving the clinical market.

 

The Delaware unit, which has provided consulting services since January, has become fully operational, offering aseptic contract manufacturing, laboratory analysis and engineering services for both clinical and commercial scale batches.

 

Isogen spokesman Robin Uhl told Outsourcing-pharma that the: “Science Center is unique from other pharmaceutical facilities [because it] offers state-of-the-art isolation and containment technology.”

 

“In addition, Isogen is not just a filling facility...[it] delivers engineering and analytical services with chemistry, microbiology and material sciences laboratories on site. That is why we call it the Science Center.”

 

He added that: “The Isogen Science Center was designed to handle most classes of therapeutics, including potent, cytotoxic compounds, monoclonal antibodies, vaccines or any products that require special handling.”

 

The site also houses an engineering unit to help pharmaceutical and biotechnology customers with everything from quality and regulatory documentation to facility and process development and equipment procurement services.

 

Company CEO Les Edwards explained motivation for setting up the new facility and how it fits with Isogen’s approach to the clinical development market.

 

He told outsourcing-pharma that: “Through our consulting work, it became apparent that pharmaceutical companies had few good choices for manufacturing clinical trial supplies.

 

“My partner, Austin McDonald, and I launched Isogen to fill a very specific global pharma demand [for] affordable, high-quality filling that meets the unique needs of clinical and smaller commercial batches."

 

Edwards went on to explain that, unlike most manufacturing firms which provide commercial-scale production, Isogen is focused on delivering services that make small-scale production a reasonable business proposition.

 

He added that Isogen plans to double the science centre’s vials, syringe and specialty container filling capacity by the end of Q3 2010 to meet growing demand for these services, particularly for the rapidly expanding biopharmaceutical sector.

 

NSA Opening Lab for Histology Services

In response to rising demand from the pharma industry NeuroScience Associates (NSA) is opening a new laboratory that will quadruple capacity for its brain and spinal cord histology services.

 

The growth in demand is a consequence of the economic downturn, according to Bob Switzer, founder and president of NSA. He believes that the economic difficulties facing pharma companies “is creating unfortunate bottlenecks and budget constraints” that have led to businesses “outsourcing all or part of their neurohistology needs”.

 

In addition neurological disorders are receiving increasing attention from pharma companies as they attempt to replenish pipelines. For instance, Alzheimer’s was an area Pfizer shifted its focus onto when it restructured its R&D priorities.

 

To cope with this with this growth in demand NSA is opening a new lab, which Switzer believes will enable the company “to keep R&D work on pace and below budget for our clients”.

NSA processes these clients’ samples using its MultiBrain technology. This technology can stain 1000s of sections simultaneously and eliminate many human environmental variables inherent in traditional techniques, according to NSA.

 

Furthermore, NSA claims MultiBrain is up to eight times less expensive than other methods. NSA states that these characteristics allow it to produce finished slides from the brains or spinal columns of test animals in as little as three weeks per project.

 

The technology works by embedding up to 25 rats’ brains, or up to eight entire spinal chords, in a gelatine block. This is then frozen, cut into sections, stained and mounted onto slides.

Using the technology NSA has supported research into aliments including Alzheimer’s, Parkinson’s, Multiple Sclerosis, Huntington’s, stroke and neurotoxicity.

 

California Health Centers Strive To Develop New Health IT Innovations

Two California health care facilities are testing new, innovative health IT tools designed to improve care and reduce costs/

 

At Kaiser Permanente's laboratory for innovations in San Leandro, Calif., technology experts have developed hand-held LCD monitors that could boost the portability of electronic health records. Kaiser Sacramento Medical Center plans to test the electronic tablets this summer to determine whether to roll out the technology across Kaiser's entire health system.

 

Kaiser's innovations lab also has created a model for home-based health care. The model includes various IT tools that allow patients to connect with physicians, monitor vital signs and evaluate other health measures.

 

University of California-Davis Innovation Center

The University of California-Davis Medical Center also has an Innovation Center where researchers develop tools to improve health care efficiency and boost patient safety.

 

As part of UC-Davis' Center for Health and Technology, the lab serves as a hub for expanding telemedicine technologies to rural regions of California and around the world.

 

Javeed Siddiqui, associate medical director for the health and technology center, said, "We have to be better at delivering care more effectively and more efficiently. Technology will play a critical role"

 

Monsanto Investing $15 Million in Prairie Facilities

Monsanto has announced it will spend $15 million over the next two years on infrastructure projects in Manitoba and Saskatchewan.

 

The agricultural biotechnology corporation unveiled plans to construct a new, state-of-the-art Monsanto breeding centre to be located adjacent to the current site of Monsanto's corporate Canadian head office. The office is located at the SmartPark Research and Technology Park on the University of Manitoba campus in Winnipeg.

 

Monsanto also intends to upgrade and expand Monsanto's Crop Technology Research Centre (CTRC) in Saskatoon, with a total investment of $3 million.

 

Many of the canola hybrids developed by the breeding group will be tested and advanced at this facility, according to a Monsanto press release. As well, all canola trait development and field testing will be managed out of the CTRC.

 

"Canola is a key strategic commercial imperative for Monsanto's Canadian business and a significant crop for Western Canadian farmers," said spokesperson Ryan Baldwin.

 

"The investment at SmartPark will allow us to increase synergies between the breeding, product development, supply and commercial aspects of our business to ensure we deliver on the pipeline of new, beneficial crop technologies for our farm customers."

 

The Winnipeg centre will serve as the home to the majority of the breeding effort for Monsanto's canola business.

 

Approximately 40 staff involved in line development breeding, breeding support functions and the canola breeding management team will work at the new site, which will also include laboratory facilities for all canola quality analytics, double haploid breeding (tissue culture) and plant pathology.

 

Plant cultivation facilities such as growth rooms, soil preparation areas and warehouse space are also incorporated into the facility design and will accommodate activities related to canola plant breeding such as crosses, plant cultivation, drying and threshing.

 

The total cost for construction of the breeding facility is expected to be about $10 million and include an additional $2 million in capital costs.

Construction will begin immediately with an anticipated completion date of June 2010. Monsanto expects the new facility to be fully occupied by December 2010.

 

Isogen Science Center Completes Media Fills and Begins Fulfilling Backlog

Isogen LLC, has announced that its Science Center, a new 20,000 square foot, state-of-the art, contract aseptic filling and manufacturing facility, located in Newark, Delaware, has successfully completed its media fills and has begun fulfilling a backlog of customer orders to big, medium and small/virtual pharmaceutical and biopharmaceutical companies. The completion of media fills is a mandatory, three step process that tests a facility's equipment, processes and procedures to ensure product and deliverables meet quality standards. Successfully completing media fills is a major milestone for new pharmaceutical manufacturing facilities.

 

"We're excited to have completed our media fills and to be filling product for our customers! We are providing something very unique to our industry -- the ability to develop life-saving therapeutics more effectively and affordably within an environment that utilizes the latest technology and adheres to the highest global manufacturing standards," shared Les Edwards, Isogen CEO.

 

Isogen was launched to address the process, facility and capacity problems commonly associated with the $2 billion highly-niched, low-volume clinical and early-stage commercial, sterile, global filling market. Isogen offers a unique option to pharmaceutical and biopharmaceutical companies who are hesitant to invest over $100 million and four years to develop manufacturing capability prior to receiving regulatory approval. The Isogen Science Center helps bring novel and orphan drugs, many of which are life-enhancing and life-saving, to market faster.

 

"It is a tribute to the unrivaled dedication, hard work, and technical expertise of the Isogen team that our facility was conceived, launched and has begun delivering product to customers in just one year. That is a phenomenal accomplishment, perhaps unprecedented in our industry, and clearly, an indication of what the Isogen team can do for its customers and this market place," commented Austin McDonald, COO of Isogen.

Due to the combined experience of the Isogen team in deploying advanced technologies and starting up sterile processing facilities, The Isogen Science Center was built at a fraction of the time and cost it historically takes a pharmaceutical company to build a facility. The Center meets global manufacturing standards -- US, EU and Japan -- and was designed by the Isogen Engineering Team, along with Precis Engineering and in collaboration with Cyma Builders and AES Clean Technologies.

 

CML API Maker Has New Plant in Wisconsin

US group Cambridge Major Laboratories (CML) will begin transferring API production to its 125,000 sq ft manufacturing plant in Germantown, Wisconsin at the end of next month.

 

The new facility, which will be officially opened next week, is part of CML’s bid to be the leading western supplier of active pharmaceutical ingredients (API) and intermediates to the pharma and biotech industries.

 

While Asia looks set to dominate the sector for the time being, both as a result of lower production costs and available capacity, high profile scandals with APIs sourced in the region have raised questions about manufacturing standards.

 

As a result producers in Europe and the US have begun to claw back some of the ground lost Asian manufacturers, meaning that completion of CML’s new plant could be very well timed indeed.

 

Even if CML fails to achieve its lofty ambitions, the facility should still boost CML customer base according to CEO Michael Major.

 

He said that: “Without this site we would never be considered for large scale commercial manufacturing,” explaining that, in the past, the firm had lost out to rivals with larger manufacturing capacity, despite the innovative processes its chemists developed.

These thoughts were echoed by company CBO Brian Scanlan who said that: “In the past we have had to…divest opportunities to larger manufacturers due to a lack of capacity.

 

“Now we have the horsepower to take our clients new molecules from concept to full commercialization,” adding that “with all the hype surrounding drug safety and quality from offshore suppliers CML’s model has shown that US-based manufacturing is still alive and well.”

 

The facility features six good manufacturing practice (GMP) quality production suites that can make multi-ton quantities of both APIs and pharmaceutical intermediates.

 

Overall output capacity is 18,000 gallons although CML capacity can be increase by another 30,000 gallons for particularly large manufacturing projects.

 

CML highlighted the plant’s thermal oxidizer and reaction tank that, it claimed, offer both US Environmentally Protection Agency (EPA) air quality standards and optimized solvent usage.

 

The firm also explained that it will be to funnel projects from its three kilograms-scale development centers to Germantown when industrial production is required.

 

Compass Completes ISO Class 8 Upgrade

US firm Compass Pharma Services is now offering ISO Class 8 (Class 100,000) certified packaging services in a bid to capture a share of the expanding high-potency drug sector.

 

Compass’s new primary packaging suite, which was designed by local engineering group Manufacturing Automation Corp, can handle antibiotics, anti-folates, anti-metabolites and hormones.

 

The firm said the unit “has negative differential air pressure relative to surrounding gowning and secondary packaging areas,” and “high-Efficiency Particulate Air (HEPA) filters” designed to minimize contamination and improve operator safety.

COO Tony Fenno explained that: “Compass Pharma investments continue to position the company as a responsive contract pharmaceutical packaging partner for sophisticated, high-demand contract packaging services.”

 

Earlier this year Compass added micro and nano-fill technologies capable of packaging small volumes of potent pharmaceutical powders or liquids into blisters, vials and pouches.

 

Compass has also hired fellow New Jersey-based company Whitehouse Analytical Laboratories to provide laboratory services for its customers on an ongoing basis.

 

Demand for the specialized handling and manufacturing services has grown significantly in recent years as Big Pharma shifts its focus from traditional small molecules drugs to more potent compounds.

 

The contract sector has been quick to recognize and adapt to this demand, particularly in the Europe and the US where the ability to offer such high-tech services is increasingly seen as a way of competing against the booming Asian manufacturing sector.

 

For example, in the last six months alone companies as disparate as Covance, SAFC, Norwich Pharmaceuticals and Azopharma have all expanded high-potency and cytotoxic handling capacity.

 

NIST Awards $55.5 Million for Four New University Research Facilities

The U.S. Commerce Department's National Institute of Standards and Technology has awarded grants totaling more than $55.5 million funded by the $787 billion federal stimulus measure, the American Recovery and Reinvestment Act, to four universities toward the construction of new scientific research facilities.

 

The projects include:

 

         University of Miami (Fla.) — $15 million for a Marine Technology and Life Sciences Seawater Research Building, matched by $28.8 million;

         Auburn (Ala.) University — $14.4 million for a Center for Advanced Science, Innovation and Commerce, matched by an equal amount;

         William Marsh Rice University, Houston, Tex — $11.1 million for the new Brockman Hall for Physics, matched by $33.4 million; and

         University of North Carolina-Wilmington — $15 million for the new Marine Biotechnology in North Carolina, or MARBIONC, facility, matched by an equal amount.

 

NIST said it expects to award approximately $120 million in additional research construction grants under a new competition announced in May. Those awards will be announced by March 2010.

 

The new research buildings will provide state-of-the-art laboratory facilities supporting academic research across a broad range of topics affecting the Commerce Department's mission, including fundamental physics research, nanotechnology, aquaculture and marine ecology.

 

The American Recovery and Reinvestment Act of 2009 provided funding for the competitive program to help support the construction of new or expanded research science buildings. NIST allocated up to $60 million of its construction grant funding to meritorious but unfunded project proposals that were received in a 2008 research construction grant competition in order to move the Recovery Act dollars as quickly as possible. (See "NIST Awards $24 Million in Grants For New Research Facilities Dedicated to Quantum Measurement, Marine Ecology," Nov. 24, 2008.)

 

That competition provided cost-shared funding for the construction of new buildings or the expansion of existing science buildings as they related to the mission of the Department of Commerce and its agencies, including NIST, the National Oceanic and Atmospheric Administration (NOAA) and the National Telecommunications and Information Administration (NTIA). The competition was open to institutions of higher education and nonprofit organizations. Proposals were evaluated on the scientific and technical merits of the proposal, the quality of the design of the proposed facility and the adequacy of a project execution plan.

NIST expects to award approximately $120 million in additional research construction grants under a new competition announced in May. (See "NIST Announces Competition for Research Construction Grants," May 27, 2009.) Those awards will be announced by March 2010.

 

As a non-regulatory agency of the U.S. Department of Commerce, NIST promotes U.S. innovation and industrial competitiveness by advancing measurement science, standards and technology in ways that enhance economic security and improve our quality of life.

 

Marine Technology and Life Sciences Seawater Research Building at University of Miami

NIST Construction Grants Program: $15 million (32.3 percent)

Total: $43,764,000

The planned Marine Technology and Life Sciences Seawater (MTLSS) Research Building to be built at the University of Miami's Rosenstiel School of Marine and Atmospheric Science will house state-of-the-art seawater laboratories and multidisciplinary research facilities dedicated to two major areas of coastal studies—the destructive power of hurricanes and the biology of coastal waters.

 

Hurricanes are the costliest natural disasters that strike the United States. A better understanding of how structures withstand—or fail to withstand—wind, wave and surge forces during a hurricane could lead to improved construction standards and practices to enhance resiliency and to protect human lives. The building will include an 8,520 square-foot (792 square-meter) Surge-Structure-Atmosphere Interaction (SUSTAIN) research facility to study the physics and dynamics of hurricanes and the associated impact of severe wind-driven and wave-induced storm surges on coastal structures. When complete, SUSTAIN will be the only facility in the world capable of generating hurricane force winds in a three-dimensional test environment allowing studies of the interaction of wind and water during coastal storms.

 

The MTLSS also will include the 47,942 square-foot (4,454 square-meter) Marine Life Science Center (MLSC), a separately funded facility to support fundamental coastal biology research in areas such as coral reef biology, aquaculture, fisheries, biological oceanography and marine biomedical science. The MLSC will provide modern, technologically advanced facilities at the university. Both SUSTAIN and the MLSC will benefit from the building's ready access to fresh seawater. This integrated facility will provide significant new opportunities for interdisciplinary bio-physical research.

 

Research at the new MTLSS will support the mission interests of NIST: to improve the understanding of the design of disaster-resistant structures. The new facility also will advance the interests of the National Oceanic and Atmospheric Administration and the research goals of the University of Miami by providing a cutting-edge building that will provide an enhanced understanding of coral reefs, aquaculture, fisheries and marine ecosystems.

 

Center for Advanced Science, Innovation and Commerce at Auburn University

NIST Construction Grants Program: $14,427,000 (50 percent)

Total: $28,854,000

 

The planned Center for Advanced Science, Innovation and Commerce at Auburn University is designed to provide facilities for five major multidisciplinary research groups working on standards, measurement and forecasting related to the environment, biofuels and water and food quality and safety.

 

The 68,000 square-foot (6,317 square-meter) center will house five "research clusters," bringing together research teams that at present are dispersed in several different locations on and off campus. The five research clusters include:

 

* Ecosystem Health Forecast and Marine Aquaculture Research Cluster—continuing Auburn's long-standing and highly regarded aquaculture research program;

* Predictive Biology and Informatic Forecasting Research Cluster—applying genome-based research to fundamental issues of biodiversity ecosystem maintenance as well as the development of commercial traits and genetic enhancement of commercially important marine species;

* Water Quality Standard and Detection Research Cluster—supporting Auburn's research into improved sensor technologies for detecting biological and chemical contaminants in the water supply and investigating issues of water use and reuse, quality standards and water resource preservation;

* Biofuel Quality and Standard Research Cluster—addressing the need for improved quality and performance standards to support large-scale commercialization of biofuels; and

* Detection and Food Quality and Safety Research Cluster—to develop advanced sensors and measurement technologies to improve food quality and safety, including innovative in vivo sensors to monitor and accurately forecast the health of plants and animals.

 

The 21 research laboratories in the new facility will include two simulation labs, three genomics labs, three labs for predictive biology and informatic forecasting, four labs for ecosystem health forecasting and marine aquaculture, two labs for water quality standards and detection, two labs for biofuels and quality standards, two labs for bioproducts, two labs for detection and food quality and safety, and one lab for economic impact and forecasting.

 

The center's research on improved measurement technologies and standards in areas such as water, environmental quality and biofuels relates directly to the NIST mission, while its work in the areas of marine ecosystems and aquaculture will directly impact key mission areas of the National Oceanic and Atmospheric Administration.

 

The facility is expected to be completed by spring 2012.

 

Brockman Hall for Physics at Rice University (Houston, Texas)

NIST Construction Grants Program: $11,130,000 (25 percent)

Total: $44,520,000

 

The planned Rice University Brockman Hall for Physics will allow the university to create a state-of-the-art facility that meets the exacting requirements of modern physics. This building will consolidate activities research in fundamental and applied physics—which now are conducted in six different buildings across the campus—and promote collaborative interactions.

 

The 110,000 square-foot (10,219 square-meter) facility will include vibration- and noise-controlled laboratories located underground to support work in atomic, molecular and optical physics; biophysics; condensed matter physics; nanoengineering and photonics. In addition to vibration control, laboratories in the new building will have substantially better temperature, humidity and air-flow control than Rice's existing research facilities. The university has set a sustainable design goal for the building of a silver rating from the U.S. Green Building Council's LEED (Leadership in Energy and Environmental Design) rating system.

 

The Brockman Hall will include 16 physics labs, six engineering physics labs, faculty and graduate offices, conference rooms and a lecture hall. The building will house a significant portion of the Rice Department of Physics and Astronomy as well as faculty from the Department of Electrical and Computer Engineering who are pursuing research in applied physics.

 

Rice has long-standing research ties with NIST, and the new facility will support research in a variety of areas with direct relevance to NIST's mission, including nanoscale science and technology, atomic physics, quantum physics, optical technology, electron and optical physics, microelectronics, semiconductor electronics and biophysics.

 

Facility completion and occupant move-in are expected by spring 2011.

 

Marine Biotechnology in North Carolina (MARBIONC) at University of North Carolina

NIST Construction Grants Program: $14,980,000 (50 percent)

Total: $29,960,000

 

The planned new Marine Biotechnology in North Carolina (MARBIONC) facility at the University of North Carolina Wilmington's Center for Marine Sciences will be a state-of-the-art, research-to-product building for MARBIONC, a marine biotechnology research program in support of economic development for North Carolina.

 

The MARBIONC program focuses on the application of marine biotechnology to food, health and energy. Research areas include drug discovery based on compounds from marine organisms, detection technologies for both human-origin marine pollutants and biotoxins from microorganisms, algae farming for biofuels and mariculture (marine aquaculture). The program's economic development mission includes workforce development, and it offers a unique "business of marine biotechnology" postdoctoral training program to allow marine scientists to combine laboratory training with study toward a masters degree in business administration.

 

The 69,000 square-foot (6,410 square-meter) MARBIONC facility will include 12 laboratories and three large incubator laboratories for cultured research materials, as well as offices and meeting spaces.

 

Research at the new MARBIONC facility will support the mission interests of the National Oceanic and Atmospheric Administration in oceans and human health, marine ecosystems and aquaculture as well as NIST mission interests in new detection and measurement technologies.

 

The facility is expected to be completed by summer 2011.

 

Bausch & Lomb Says Grants Key to Choosing Madison, NJ, for New Global Pharma HQ

Bausch & Lomb has opened a new 30,000-square-foot global pharmaceutical division headquarters in Madison, NJ, a facility the company said will create 70 new full-time jobs.

 

“It’s all about people, and the best people in health care in the world are located in New Jersey,” Gerald Ostrov, CEO of the eyecare giant, told the weekly business newspaper NJ BIZ. He said B&L is in the process of recruiting executives to work at the Madison office, and it makes sense to locate a pharmaceutical headquarters where there’s already a sizeable work force from which to recruit.

 

New Jersey was attractive because its concentration of drug firms “opens up opportunities to partner with other pharmaceutical companies and to drive commercialization of new products,” Ostrov told the newspaper. The company also cited the state’s “vibrant pharmaceutical and biotechnology industries” as a key factor.

 

DoD Research Arm Leases 350,000 Square Foot in Northern Virginia

The research and development arm of the U.S. Dept. of Defense is moving to a 350,000-square-foot office being developed by The Shooshan Co. in Arlington, VA, officials from Arlington County said.

 

The Defense Advanced Research Projects Agency, known as DARPA, will move just a few blocks from its Ballston office to the new building in 2012.

 

"This is a big victory for the county and its workforce," U.S. Rep. Jim Moran of Virginia said in a statement announcing the deal. "Retaining DARPA in Arlington was a top priority for all involved."  DARPA, a $3 billion agency credited with developing the military’s stealth aircraft technology and components of the Internet, employs about 800 people at its headquarters on N. Fairfax Drive. It is currently developing a laser weapons defense system and an unmanned drone capable of flying uninterrupted for more than five years.

 

The new building, a sleek 13-story tower at 675 N. Randolph St., is being constructed to meet new DoD anti-terrorism guidelines. It is the first phase of Shooshan Co.’s Founder’s Square mixed-use development, which is planned at about 1.1 million square feet.

 

The project was designed by RTKL Associates and is being built on a brownfield site. Arlington County approved the development last summer.  The DARPA lease is one of the largest in the Washington, DC, market this year and illustrates the tremendous influence of the government on the region’s real estate dynamics. Federal agencies or big government contractors like Raytheon and Lockheed Martin account for nearly all of Washington’s top 10 leases in 2009.

 

ImClone to Anchor Alexandria Center

ImClone Systems has signed on to become the anchor tenant of the Alexandria Center for Science and Technology at East River Science Park.

 

Alexandria Real Estate signed ImClone to a 15-year, 91,000-square-foot deal, one of the Manhattan's largest relocation leases this year.

 

The biopharmaceutical company, which specializes in oncology care, plans to use the facility as its new research center. ImClone, a subsidiary of Eli Lilly & Co., is relocating from its headquarters of 25 years at 180 Varick St. John S. Isaacs and Timothy Dempsey with CB Richard Ellis represented ImClone.

 

ImClone plans to take occupancy on floors 10 through 15 of Alexandria Center's first office tower, when it delivers next summer. The 16-story building at 400 - 404 First Ave. will total 310,000 square feet.

 

Located on Manhattan's East Side, the $700 million biological science complex will be comprised of more than 1.1 million square feet of research and development space when finished, and provide for about 2,000 bioscience related jobs.

 

The city of New York is contributing $13.4 million for the construction of the park, while the state is putting up $27 million. Additionally, the New York City Investment Fund is providing $15 million for the project. $2 million in Federal Funds have also been secured.

The complex is located with an Empire Zone, which allows ImClone and other tenants a number of tax incentives based on investment and job creation.

 

Dow AgroSciences Builds in Indiana

As a growing and thriving life sciences company, Dow AgroSciences announces it has signed a 15-year lease with Indianapolis-based Browning for an 80,000 square foot building to be built on Browning’s Northwest Technology campus adjacent to Dow AgroSciences’ global headquarters in northwest Indianapolis. The innovative two-story building will house laboratories and offices for approximately 100 researchers working in various disciplines to advance Dow AgroSciences’ technology for agriculture. Groundbreaking for the new facility will take place in August 2009, and Dow AgroSciences anticipates occupying the new building by mid- 2010. Browning will serve as the building’s developer, owner and general contractor. Terms of the lease were not disclosed.

 

“As our company continues its commitment to discovering and delivering innovative solutions for the agricultural marketplace, it is critical that we increase the available space of our research facilities to support our current and future growth,” says Daniel R. Kittle, Ph.D., Vice President of Research and Development at Dow AgroSciences. “This expansion will enable us to accelerate investment in new scientific expertise, capabilities, and markets for our growing Seeds, Traits and Oils business.”

 

The newest facility is part of a global master plan for Dow AgroSciences’ research efforts as it develops and commercializes new products to help customers in agricultural and related market segments. The leased space will house existing employees as well as those added in the future according to the company’s long-term strategic workforce plan. Key areas of recruiting are focused on science and technology positions.

 

REST OF WORLD

 

Environmentally Friendly Labs Opened by CSIRO in Australia

Constructed at the rear of CSIRO Entomology’s original research and administration building at Black Mountain, the new AU$14.7m high-tech building’s biocontainment laboratories can accommodate 56 research staff.

 

Designed to comply with the Office of the Gene Technology Regulator’s PC2 safety rating, the new laboratories will facilitate collaborative research with many of CSIRO Entomology’s key partners including; rural industry research corporations, universities, multi-national companies and other CSIRO divisions.

 

“These new laboratories will enhance CSIRO’s ability to help Australian industries move to the bioeconomy, an economy with the potential to reduce Australia’s reliance on traditional sources of energy,” Senator Carr said.

 

The bioeconomy refers to economic activity derived from the application of biotechnology based science and research to sectors such as health, energy, environment and agriculture.

 

“CSIRO Entomology is contributing to this transition through its expanding biotechnology research portfolio. This portfolio includes projects such as turning insect silks into new sources of biopolymers, new bio-based polymers and biocides, second-generation biofuels and bioremediation of contaminated water,” Senator Carr said.

 

CSIRO Chief Executive, Dr. Megan Clark, said the new facilities replaced laboratories located in the Division’s original main building.“The research facilities in CSIRO Entomology’s 1929, heritage-listed building were obviously not designed with today’s strict biocontainment requirements in mind,” Dr. Clark said.

 

“Not only do the new laboratories provide CSIRO scientists and visiting colleagues with access to the best available equipment, but the new building has also been designed and built with ‘green’ considerations foremost in mind.”

 

Construction features include a highly insulated building envelope, clad with a recyclable material to internalize thermal mass and skylights to provide indirect natural lighting. Heating and cooling energy consumption issues are also addressed through the installation of; a 200,000 liter chilled water (thermal energy storage) tank, refrigerants with low or zero-ozone-depleting potential and a solar boosted gas-fired hot water plant.

 

GEA Wins €15 Million Order from China’s Hisun Pharmaceutical

GEA Lyophil, part of GEA Pharma Systems, has won a contract to supply Chinese drugmaker Zheijang Hisun Pharmaceutical with freeze drying systems and automatic loading units.

 

The deal, which is worth €15m ($21.3m), will see seven Lyovac freeze drying systems and two automatic loading units (ALUS) installed at two Hisun facilities in Fuyang and Taizhou in Zhejiang province.

 

Also under the contract, GEA will supervise the move in, installation, start up, site acceptance testing (SAT) and IQ/OQ execution of the units. Delivery is scheduled for the second half of 2010.

 

Heinrich Meintrup, managing director of GEA Lyophil, told in-Pharmatechnologist that the technology will be used in the manufacture of Hisun’s range of oncology drugs and set out some of the likely benefits for the Chinese firm.

 

“Hisun will gain high performance production lines delivered out of one hand fulfilling all FDA regulations,” adding that the lines “guarantee high throughout and reliably for efficient production of pharmaceuticals for the international market.”

 

Vibrant Asian market

Meintrup explained that Asia is a “vibrant and growing” market and is very important for GEA Pharmasystems, particularly because the eastward shift of the manufacturing sector has increased the need for equipment that “fulfills all FDA and other regulations for the production of pharmaceutical drugs for the international market.”

 

He added that the market “has high expectations in technology, reliability and stability of output” and requires “integrated solutions for production lines which GEA Pharma Systems is able to provide also together with strategic business partners. This provides a high degree of safety and guarantees a fast time to market.”

 

Vietnam to Build its Largest Food Complex

Vietnamese food company Vissan has unveiled plans to build the nation’s largest food processing complex worth $39m (700bn VND) in the southern province of Long An.

 

Occupying a 22.4ha (55 acre) site in the region’s Ben Luc district, the complex will include a slaughterhouse, a food processing system, freezer units and waste treatment facilities.

 

Key products will include Chinese sausage, with production estimated at 1,200t per year, tinned food, totaling 2,500t, together with hot dogs and pork-pies.

Construction is slated to start at the end of next year with an operational deadline set for late 2012.

 

Bui Duy Duc, the company’s director-general said: “The company will arrange with the ISO, HACCP and other standards of hygiene-food safety. Equipment slaughter, processing will use modern technology, in accordance with practice in Vietnam.”

 

Medis’ Drug Packaging Plant Open for Business

Czech CMO Medis International has completed construction of its new pharma packaging plant in Bolatice, just nine months after work on the 2,700 sq.m. (29,052 sq. ft.) site began.

 

The contract manufacturing organization (CMO) said that the facility will provide its customers with primary and secondary packaging services for pharmaceutical solid and liquid oral dosage forms, including both tablets and capsules.

 

Medis highlighted the plant’s Uhlmann high-speed blistering line as a key feature, claiming that the unit will save its customers both time and money.

 

Medis business development manager Petr Bulej said that US Food and Drug Administration (FDA) and European Union approved good manufacturing practice (GMP) accreditation is anticipated in Q4.

 

AMRI Opens Lab in Hungary

AMRI announced that it has finished the construction of a new state-of-the-art chemistry R&D facility in Budapest, Hungary. The successful completion and move into 32,300 square feet (3,000 square meters) of laboratory and administrative space marks a significant milestone in the company’s plan initiated in 2008 to transform its European hub into a higher value discovery services business through consolidation of multiple locations, equipment and operating costs.

 

In addition to the significant improvements in operational efficiencies and enhanced technology transfer, the new site provides capacity for the anticipated expansion of synthetic chemistry services, currently projected to double over the next five years.

 

Figuring prominently in the mix of services will be expanded offerings in parallel synthesis and medicinal chemistry, and the establishment of fragment-based drug discovery. The facility also includes a scale-up laboratory for non GMP synthesis for batch sizes up to 25 liters.

“The successful completion of this expansion increases the ability of AMRI to execute on its strategy to accelerate growth and expand its presence in the European marketplace,” said Chairman, CEO and President Thomas E. D’Ambra, Ph.D. “Critical to the decision to undertake this project was the company’s drive to cultivate a customer base relatively untapped. We believe this latest investment, along with our parallel investments in the US, India and Singapore, will further strengthen AMRI’s presence as a premier provider of a broad range of scientific services, capabilities and geographic choices around the globe.”

 

EMEA Approves Patheon’s Puerto Rico Facility

The EMEA has approved Patheon’s facility in Manati, Puerto Rico, allowing the CMO to import to Europe and improving its fortunes on the island that caused it financial problems in the past.

 

Patheon acquired its Puerto Rican facilities in 2004 but the contract manufacturing organization’s (CMO) financial results were negatively impacted by the operations until it restructured.

 

Some facilities were sold or downsized but Patheon chose to expand the Manati site to handle high-potency compounds.

 

The European Medicines Agency (EMEA) has now approved the Manati facility, following an earlier inspection by the Medical Products Agency of Sweden, and it can begin exporting.

 

Patheon believes the site will provide benefits and flexibility to clients. Furthermore, the CMO regards the approval, and the 19 successful inspections its facilities have had in 2009, as evidence of its commitment to quality and compliance.

 

In June 2008 Patheon gave details of a $2.8m (€2m) investment in the Manati facility. The expansion added a 3,386 sq. ft. dedicated high potency and controlled substance production area.

 

This includes three manufacturing suites, air lock containment areas and humidity controlled air systems. By adding three manufacturing suites Patheon is able to perform technology transfer, bulk production and packaging and storage in one area.

 

Included in the expansion is capacity for high potency compounds, with containment down to 1µg per m3 occupational exposure limits (OEL), and humidity controlled solid dosage forms.

 

The market for high potency manufacturing services has become increasingly competitive in recent years. Approval of the Patheon site comes months after SafeBridge Consultants granted Lonza’s facility in Visp, Switzerland with its “Potent Compound Safety Certification”.

 

Lonza was the first in continental Europe to receive the award but plenty of other CMOs are moving into high potency compounds, including Norwich, Penn Pharma and Metrics.

 

Millipore Buys BioAnaLab to Expand in EU

Millipore has expanded its European biotech services business by acquiring BioAnaLab, a UK-based company that provides analysis of biologics and vaccines.

 

The acquisition is intended to help Millipore prosper outside of its traditional base in the US. By acquiring BioAnaLab and leveraging its reputation as a trusted partner Millipore expects to establish a presence in the European market, which it believes is growing quickly.

 

Predicted growth in the market for biologics testing services is underpinned by the composition of many pharma's pipelines, which are increasingly composed of biotech products and vaccines.

 

Millipore believes it now has the capacity to meet this rising demand. The acquisition of BioAnaLab gives the company a facility in Oxford, UK.

 

From this site BioAnaLab offers current good manufacturing practice (cGMP) compliant services to assist with evaluating and advancing biologics through the development process.

 

In particular the facility performs assay transfer and development, validation and sample analysis, pharmacokinetics, toxicokinetics, immunogenicity and biological potency. This offering will be strengthened by Millipore’s expertise in biomarker analytical services.

 

BioAnaLab’s Oxford facility gives Millipore a Europe-based counterpart to its site in St Charles, Missouri, US. These US- and Europe-based facilities provide similar large molecule bioanalytical services.

 

Financial details of the acquisition are being withheld.

 

Discovery and development focus

The acquisition of BioAnaLab follows last year’s expansion of Millipore’s St Charles facility, which provides similar services.

 

Millipore invested $3.4m (€2.4m) in the facility and hired a further 60 employees, taking the total to 187, in an effort to strengthen its position in the discovery and development market.

 

This effort includes the 2006 acquisition of Serologicals, which had a presence in St Charles. Since then the company has invested in people and infrastructure to expand its capabilities.

 

Wuxi PharmaTech Services Grow

Wuxi PharmaTech’s China-based laboratory services grew by 23 per cent in Q2, outstripping expectations and resulting in the company revising its guidance for the business segment.

 

China has been identified as a primary driver of growth in the laboratory services sector and this has helped WuXi at a time when other areas of its business have faltered.

 

Revenues from China-based laboratory services totaled $44.8m (€31.7m) in the second quarter and WuXi now expects growth of 20-23 per cent this fiscal year, up from earlier guidance of 15-20 per cent.

 

However, WuXi reconfirmed that it expects total revenues to be $265-275m in fiscal 2009. This is because of poor performance in other business sectors, most notably manufacturing services.

 

Revenues generated by manufacturing fell by 69 per cent in the quarter, totaling $5.5m. WuXi attributed this decline to the inherent variability of the sector, delays, large projects last year that did not recur in 2009 and an increase in the proportion of early-stage contracts.

 

The fall in manufacturing revenues in the latest financial results follows an 81 per cent decline in the first quarter. WuXi now expects the manufacturing business to have revenues of $20-$30m in fiscal 2009.

 

U.S.-based laboratory services performed slightly better than expected, with revenues increasing by four per cent. This meant the sector generated $16.7m in the second quarter and WuXi now projects that there will be a slight year-on-year improvement in fiscal 2009.

 

For the whole business net revenues fell by three per cent to $67m. However, operating income increased by 22 per cent, totaling $13.6m in the quarter.

 

This increase is partially because of a decrease in operating expenses, which WuXi believes is a consequence of cost controls and improved operating efficiency.

 

Gross-margin for the quarter also improved but WuXi expects that it will decline in the second half of 2009 because of an increase in hiring and continuation of investments.

 

Plans for New Indian-Australian Research Academy

Architects have unveiled the first glimpse of plans for the A$10 million collaboration between research giants Monash University and the Indian Institute of Technology, Bombay (IITB). 

The two internationally-respected institutions have joined forces to create the IITB-Monash Research Academy, which will train a new era of researchers focused on solving some of the major issues confronting society and industry in both nations. 

 

The four-level purpose-built Academy will be located on IITB's Mumbai campus and is expected to be ready for occupation early in 2011. 

 

Officials today released plans for the new building, which will utilize state-of-the-art research collaboration technology. 

 

Acting CEO Professor Mohan Krishnamoorthy said the Research Academy was a unique venture in which some of India's best and brightest young minds undertook joint PhD research in both India and Australia. 

 

"The new building will be equipped with extremely sophisticated communication technology and video-conferencing facilities. It will consist of nine laboratories, offices, and workstations for 350 researchers," Professor Krishnamoorthy said. 

The contemporary-style building, designed by architects Venkatraman and Associates, will feature a spacious porch, an elevated plinth and corridors that overlook a central courtyard. Construction is scheduled to begin early next year. 

 

While planning and construction continues, teaching and research has already begun. The Academy has just welcomed its second batch of PhD students, bringing the total number of researchers to 36. 

 

Professor Krishnamoorthy said there was strong demand for entry to the academy. An astounding 1500 applications were received in the June 2009 intake. Twenty-two researchers were finally selected. It's hoped the academy will support 350 research projects by 2015.

The first intake of students, who began last year, are well into their research projects.

 

The Research Academy builds on the combined strengths of Monash University and IITB. It aims to create a community of academics and students engaged in finding solutions for complex problems in government, industry and the research community in Australia, India and the rest of the world. 

 

The Research Academy was formally opened in November last year. Research projects centre around six major themes: computational science and engineering, infrastructure engineering, biotechnology and stem cell research, clean energy, water and nanotechnology. 

 

These themes address future research and development challenges of industry sectors including petrochemicals, pharmaceuticals, automotive, infrastructure, biotechnology, life sciences, IT and financial markets. 

 

Students have a supervisor in both institutions, must study in both Australia and India and receive a dual PhD from Monash University in Melbourne and IITB in Mumbai. 

The Academy is a not-for-profit, autonomous institution with an independent Governing Board and a high-powered Advisory Council, which includes captains of industry and research luminaries. 

 

BSL-4 Opens in Germany

The Hamburg Bernhard-Nocht Institute for Tropical Medicine (BNI) has opened a $42 million expansion of its lab containing a Level 4 Biosafety Lab (BSL-4). The new Bernhard Nocht facility is only the second lab in the country to receive the highest security clearance for such research. A lab in Marburg in Hesse is the only other BSL-4 facility in Germany.

 

The new lab will be used to explore extremely dangerous pathogens, according to Germany's Federal Health Minister Ulla Schmidt. "The trends in the globalized world bring new dangers that include the rapid spread of dangerous pathogens. Tropical diseases are the face of climate change, even in our temperate latitudes a growing challenge."

 

Prof. Bernhard Fleischer from the Foundation Board of BNI first announced a trial operation for the stainless steel produced in laboratories. The overall adds 5000 m2 ( 53,800 sq. ft.)next to the 1914 Institute, with the expansion adding about 3,000 m2 (32,280 sq. ft.) of extra space to the facility. It is part of an EU-funded project for training of scientists in dealing with highly infectious pathogens.

 

The BNI now has the ability to compete against other secured facilities," said Schmidt. Schmidt said it was an important signal: "Even in difficult times, investment in science and research is what we need." The Minister praised the research institutes in Germany. "We have a very high international reputation." The federal government supports the BNI with an annual six million Euros.

 

The BNI already investigates dangerous diseases such as malaria, hemorrhagic fever, and tissue worm infections. The BSL-4 labs will allow the BNI to investigate highly infectious and deadly pathogens such as Lassa and Ebola viruses as well.

 

GSBTM to Commence Works for Incubator Facility in Savli Biotech Park

The Gujarat State Biotechnology Mission (GSBTM), the state government-run biotech initiative to boost the sector through support to the industry, is expected to commence civil works soon for its incubator facility in the upcoming Gujarat Biotech Park (GBTP), at Savli, Vadodara to support the start up biotech firms.

 

The GSBTM has finalized the design for a two lakh square feet lab space facility through a committee of experts from various fields of biotechnology, including the industry representatives. Plans are to float tenders for project management consultants and for construction works in a couple of months, informs Akshay Saxena, mission director, Gujarat State Biotechnology Mission.

 

The incubation centre, comprising facilities like modular wet labs, pilot plant, common equipment library, plant tissue culture facility and animal tissue culture facility apart from a green house, is a highlight of the Park developed under public private partnership. The incubation centre is included in the first phase of the project, which is in the stage of nearing completion.

 

The Mission is currently resolving some issues with the state ministry for revenue on the plot for incubator facility. The talks in the department level are on advanced stage and the dispute is expected to successfully settle shortly, according to sources from the state government.

 

"Our mission is to catalyze the growth of biotech segment in the state through consolidating and mobilizing the industry. We have also initiated programs to attract more companies into the state. Some of the top biotech companies have shown interest in setting their operations in the state, but nothing has been finalized as of now," said Saxena.

 

The Rs 2000 crore Biotech Park is developed by the Gujarat Akruti-TCG Biotech Ltd (GATB Ltd), a joint venture company of GSBTM, Government of Gujarat in collaboration with the Mumbai-based Akruti City Ltd and The Chatterjee Group (TCG) Ltd. While the first phase of the Park would be developed by the Mission, the second and third phases are to be completed by the private partners, as per the agreement.

 

As the part of phase I program, one company - the Mumbai-based Zytex Biotech - has already commenced production activities even as Bills Biotech and Laxai Avanti Life Sciences Pvt Ltd, a contract research organization, provides drug research and development services, are in the process of setting up operations in the Park. Another three to four companies has also started their projects in the Park, informs the Mission officials.

 

The private partner, Akruti City Ltd has already started civil works for the phase II development of the parks and has commenced marketing activities a year ago. The phase II project will be ready for operation in a few months, said Saxena. The phase II project includes setting up of multi tenant wet labs (MTWL) to enable new entrepreneur or establishment to set up their own laboratories and initiate the business activities without blocking their precious capital in land and buildings. The companies occupying space in the biotech park and whose construction is underway can hire suitable space for the shorter span.

 

Designed to complete in three phases, the project has been developed with the help of the credit ratings organization, Credit Rating Information Services of India Limited (CRISIL), Yes Bank, Corporation Bank and other investment advisors. The Akruti City has a major stake of more than 60 per cent in the consortium, while TCG would hold 23 per cent stake and the remaining would be held by the Gujarat government.

 

Monsanto Investing $15 Million in Prairie Facilities in Canada

Monsanto has announced it will spend $15 million over the next two years on infrastructure projects in Manitoba and Saskatchewan.

 

The agricultural biotechnology corporation unveiled plans to construct a new, state-of-the-art Monsanto breeding centre to be located adjacent to the current site of Monsanto's corporate Canadian head office. The office is located at the SmartPark Research and Technology Park on the University of Manitoba campus in Winnipeg.

 

It also intends to upgrade and expand Monsanto's Crop Technology Research Centre (CTRC) in Saskatoon, with a total investment of $3 million.

 

Many of the canola hybrids developed by the breeding group will be tested and advanced at this facility, according to a Monsanto press release. As well, all canola trait development and field testing will be managed out of the CTRC.

 

"Canola is a key strategic commercial imperative for Monsanto's Canadian business and a significant crop for Western Canadian farmers," said spokesperson Ryan Baldwin.

 

"The investment at SmartPark will allow us to increase synergies between the breeding, product development, supply and commercial aspects of our business to ensure we deliver on the pipeline of new, beneficial crop technologies for our farm customers."

 

The Winnipeg centre will serve as the home to the majority of the breeding effort for Monsanto's canola business.

 

Approximately 40 staff involved in line development breeding, breeding support functions and the canola breeding management team will work at the new site, which will also include laboratory facilities for all canola quality analytics, double haploid breeding (tissue culture) and plant pathology.

 

Plant cultivation facilities such as growth rooms, soil preparation areas and warehouse space are also incorporated into the facility design and will accommodate activities related to canola plant breeding such as crosses, plant cultivation, drying and threshing.

 

The total cost for construction of the breeding facility is expected to be about $10 million and include an additional $2 million in capital costs.

 

Construction will begin immediately with an anticipated completion date of June 2010. Monsanto expects the new facility to be fully occupied by December 2010.

 

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