The scientific instrument maker said the center will be used by engineers and staff who are working on a product pipeline to serve customers in China. Thermo Fisher opened a demonstration center in Beijing earlier this month and said it has increased its activities in China in the last five years.

Thermo Fisher makes laboratory equipment and test kits used in research, among other products.

Qiagen Prepares to Expand

Qiagen's Germantown campus consumes 230,000 square feet on 27 acres of greenery.

But plans to substantially expand the biological research and testing company are underway, both physically at the site and financially around the globe. Executives aim to double Qiagen's revenue to $2 billion over the next five years.

That trajectory will require a mix of organic growth within the existing company, as well as strategic acquisitions, said Chief Financial Officer Roland Sackers, continuing a growth model used at least since the company relocated its American headquarters to Germantown in 2002.

Qiagen produces kits used in research and molecular diagnostic labs to test for swine flu and the human papilloma virus.

The company breaks ground next month on a 50,000-square-foot manufacturing plant. A similarly sized research and office tower, as well as a 10,000-square-foot employee eatery, will follow. By the projects' 2012 completion date, building capacity will catapult about 50 percent, said Sean Augerson, the company's senior director of North American operations.

The $52 million construction projects will be funded in part by a mix of state and county aid, and the company expects to add at least 90 jobs. It will also relocate manufacturing employees from its Gaithersburg property, Augerson said.

The company reported that second-quarter earnings increased 25 percent, to $38.5 million, compared with a year earlier. "If you look at the last couple of quarters, we have a track record of a double-digit growth rate," said Sackers, who splits his time between Germantown and Germany, where most of Qiagen's European operations are located.

The growth rate in the United States, which makes up about 50 percent of Qiagen's business, was outpaced in both Asia and Europe, Sackers said. He attributed the slower period, in part, to fewer doctor visits as many Americans remain unemployed and without health insurance.

The company's U.S. sales also took a hit when compared with the same period last year, when swine flu panic lifted demand for the company's test kits, he said.

Qiagen said it expects sales to pick up as more Americans join the ranks of the insured thanks to the new federal health-care overhaul. The company also intends to build on the acquisition-minded reputation it has developed. Sackers said Qiagen has picked up about 15 companies worldwide in the past three years alone, including Frederick's SABiosciences at the end of last year.

The 2007 purchase of Digene, a local molecular diagnostics company, for $1.6 billion was the largest acquisition.

Sequenom Building New Lab

Sequenom is building a new 7,000-square-foot CLIA laboratory at its headquarters in preparation of a planned launch of its Trisomy 21 diagnostic test.

Ian Clements, senior director of investor relations for the San Diego-based molecular diagnostics company, said that the lab is slated to be up and running in the fourth quarter and will be outfitted with sequencing platforms from Illumina.

The new lab will perform validation for Sequenom's T21 non-invasive Down syndrome test. The company is currently collecting samples as part of a clinical study, and about 4,000 samples will be run at the new facility in connection with the final validation of the T21 test, Clements said.

After the launch of the test, planned for the latter half of next year, the test will be run out of the new lab.

Sequenom has a CLIA-certified and CAP-accredited lab, the Sequenom Center for Molecular Medicine, in Grand Rapids, Mich., which runs the company's cystic fibrosis and SensiGene Fetal Rhesus D Genotyping tests. A test for age-related macular degeneration, to be launched in the first half of 2011, will also be run out of the Grand Rapids facility.

Those tests are run on Sequenom's MassArray technology, however, while the T21 test will run on sequencing technology.

"This is basically an expansion of our lab network," Clements said. "The core of our sequencing expertise and knowledge is here in San Diego, hence it made sense to expand our network and build a CLIA lab here."

Sequenom anticipates getting CLIA certification and CAP accreditation for the San Diego lab in Q4 2010, he added.

It has not yet been decided whether the new space will be outfitted with Illumina's newest platform, the HiSeq systems, or its Genome Analyzer technology, though Sequenom has both platforms, Clements said.

He declined to disclose the cost of the new facility, but said "it's a reasonably modest investment." Space for the new lab is being converted from existing space that had been used for other R&D research.

He also declined to say how many employees will be manning the space.

Randox Labs Opens New U.S. Facility

Randox Laboratories has invested $7 million in a new facility in West Virginia, about 60 miles from Washington.

The 30,000 sq ft plant is expected to employ 130 people within the next two years.

Initially it will be a centre for technical support, research and development, and sales and marketing. But the aim is to start a manufacturing process there some time in the future.

Randox employs more than 650 people at its Crumlin plant, specializing in the production of healthcare diagnostic products, which are sold to customers in over 130 countries.

About a quarter of the company's business is in the North American market, and Randox chief executive Dr Peter Fitzgerald said that it was important for the company's success in the US that it should have a presence there.

"West Virginia is a good location," Dr. Fitzgerald said. "It's quite close to a number of Institutes of Health in the Washington area, and the transport links are quite good as well."

He said that the investment did not mean that there was any reduction in the company's commitment to its Northern Ireland operation.

"In fact," he said, "the greater the success of the business in North America, the faster the rate of expansion in Crumlin."

However, he said that there were plans to start manufacturing product in West Virginia at some time in the future.

"Our research and development there will start towards the end of this year, or early in 2011," he said, "and the products we research in the US will probably be manufactured there."

Biomet to Expand in Indiana

Medical device maker Biomet Inc. plans an expansion of its northern Indiana facilities that could add about 280 jobs by the end of 2012.

Company officials have discussed the plan with Kosciusko County officials as they've sought tax breaks on the $26 million project.

Biomet attorney Richard Helm says the expansion in Warsaw would retain about 80 jobs and lead to some manufacturing being moved there from New Jersey.

County Council President Harold Jones said he expected the council to approve the tax breaks next month after it gave an economic development area designation for part of Biomet's campus last week.

Biomet vice president Bill Kolter says the project would retain and expand its Warsaw distribution center.

The Indiana Economic Development Corp. announced the expansion late Thursday. It says Biomet plans to invest $26 million in the project by expanding its headquarters and research and development operations and upgrading equipment. The company also will transfer some manufacturing from New Jersey.

The state economic development agency offered Biomet up to $2.75 million in tax credits and up to $200,000 in training grants. The Kosciusko County Council has approved 10-year real and personal property tax abatements.

Biomet makes products used mostly by orthopedic surgeons for procedures like hip or knee implants.

Texas University, City Partnership Gets Grant

A partnership between Texas State University-San Marcos and the City of San Marcos has landed a $1.85 million award from the U.S. Economic Development Administration (EDA) in support of the new Science, Technology and Advanced Research (STAR) building.

The grant funds the construction of a state-of-the-art research and commercialization center at Texas State through the Office of Commercialization and Industrial Relations (OCIR).

“We are thrilled that an important technology partnership between the City of San Marcos and Texas State University will take a major step forward with the award of a significant federal grant,” said Mayor Susan Narvaiz. “This project will help us attract corporate research on alternative energy projects and establish San Marcos as a place for university graduates to find high tech careers.”

The new facility will serve as a technology accelerator for start-up and early-stage businesses, and will provide university and STAR tenants access to secure wet labs, cleanrooms and office space. Green and bio-technology companies will be a major focus, and backers hope that San Marcos' convenient location between Austin and San Antonio will work to attract corporate research interest from those cities' technology communities.

"This building will house 'spin-offs' from research conducted and intellectual property generated by university faculty, and 'spin-ins' from companies outside the state that want to come in and strategically work with the university," said Terry Golding, executive director of the OCIR. "Our mission is education with relevance, and this is expanding our university's research profile, and adding depth and breadth to our educational and research programs.

"It will have cleanroom facilities for materials development, and there is a dire need of wet labs for small business start-ups in this region," Golding said. "We see convergent technologies -- the merging of semiconductor nanotechnology with biotechnology as a major opportunity for economic development in the state. Our location along the I-35 corridor is ideal for linking the large biotech/medical activities in San Antonio and the semiconductor community of Austin."

Interdisciplinary partnership will be a major selling point of the STAR facilities, incorporating expertise from the McCoy College of Business Administration and the Materials Science, Engineering and Commercialization program at Texas State.

“The STAR project is a success story of collaboration among federal and local government, higher education, economic development and the private sector,” Mayor Narvaiz said. “These mutual investments will mean educational opportunity, environmental and technological advances, and 21st Century jobs for the future.”

Of the project's overall $6 million cost, Texas State has already committed $5 million. The university's share of the grant will go directly toward construction of wet lab and cleanroom facilities. The city's share will finance infrastructure improvements to the 40-acre site at Hunter Road and McCarty Lane.

"This is a very meaningful relationship between the university and the city for economic development in this region," said Golding. "We had great support from the San Marcos Partners for Progress and also people such as Pike Powers in Austin."

The EDA awarded the grant through the Global Climate Change Mitigation Incentive Fund, which is intended to foster the green economy by promoting economic competitiveness while enhancing environmental quality.

Medicago to Build Plant in RTP

Medicago is to build a 90,000 sq. ft. cGMP vaccine facility in RTP, North Carolina, US using a $21m (€16.1m) grant from the US Department of Defense.

Operation of the current good manufacturing practice (cGMP) facility will allow Medicago to scale up and automate production of its virus-like particle (VLP) vaccines. When fully operational the facility will produce 10m doses of influenza vaccine a day, with potential for future expansions.

This capacity could be used in the event of a pandemic. During the H1N1 outbreak Medicago demonstrated its plant-based VLP technology can develop a vaccine candidate in under a month, making it a potentially useful tool in a pandemic.

Recognizing this potential, the US Department of Defense is partly funding the project. "It is vitally important to our Homeland Security that we have a robust domestic vaccine supply”, said David Price, a North Carolina Congressman.

In addition to helping the US mitigate future threats, the facility will “ultimately bring hundreds of good paying jobs to the region” and be “another significant contribution to local recovery efforts”, said Price.

For Medicago, the facility will help validate its VLP technology and strengthen its position in the market for pandemic and seasonal vaccines. Operating a US plant will also increase the number of grants and funding opportunities that are open to Medicago.

The project is due to cost $42m. This is made up of a $21m grant from the Defense Advanced Research Projects Agency (DARPA), $7.5m from Medicago and $13.5m from Alexandria Real Estate Equities.

"We are delighted to be working with Alexandria as they are a leader in their field and it allows us to reduce the upfront capital required for the building of our new US commercial grade facility", said Andy Sheldon, president and CEO of Medicago.

Merck Rebuying Its Former Drug Ingredient Factory

Drugmaker Merck & Co. has agreed to buy back a central Pennsylvania factory from the contract manufacturer that bought it 2 1/2 years ago.

Merck and the owner of the Cherokee Pharmaceuticals plant, outsourcing firm PRWT Services Inc., said they "mutually agreed" to the sale.

PRWT spokeswoman Sherri Kyle-Jones said the deal came "as a result of the challenging environment in the pharmaceutical industry."

Drug companies have been slashing costs wherever they can, amid stagnant or declining revenue. They're being squeezed as blockbuster drugs get generic competition, research programs fail to produce enough lucrative new drugs and government health programs in Western countries demand lower prices due to weak economies.

The factory in Riverside, Pa., makes active ingredients for prescription medicines, along with agricultural chemicals and other products. Merck agreed to the repurchase because the factory supplies a key active ingredient for one of its drugs.

"They do make a product that's critical to our supply chain," spokesman Ron Rogers said.

He said the sale should be completed by Sept. 3; terms were not disclosed. Merck will then take about six months to decide the future of the factory, about 80 miles northwest of Philadelphia, and its 454 employees.

"We need first to gain a fuller picture of the current manufacturing portfolio, as well as the capacity and the financials," Rogers said.

The plant will continue its current production in the meantime.

Merck owned the factory for roughly 60 years before selling it in January 2008 to Philadelphia-based PRWT, which also operates subsidiaries called U.S. Facilities and PRWT Business Process Solutions.

"As a result of this decision, we'll now focus on our core business," Kyle-Jones said, describing that as providing drugmakers with payment processing, facilities management and other services.

The deal comes as Merck continues streamlining operations since buying fellow drugmaker Schering-Plough Corp. for $41 billion last November.

In July, Merck said it will close or sell eight factories and eight research sites around the world. With the repurchase of the Cherokee Pharmaceuticals plant, it will have 78 manufacturing sites.

Merck also has eliminated about 21,000 people from the combined Merck and Schering-Plough work force, leaving about 95,000 people.

Broad Institute Gets City Council Approval for New Building

The Broad Institute will consolidate some of its Cambridge, Mass., facilities into a single new building to rise as part of a mixed-use project approved near Kendall Square by the City Council.

The new 300,000-square-foot building will allow the institute to consolidate a portion of its activity on Ames Street, next to its headquarters. The Broad now occupies space at 7 Cambridge Center and three other buildings in Cambridge — its newest location at 301 Binney St., which it began occupying in June; as well as 5 Cambridge Center; and 320 Charles St.

The Broad would need the new building by 2014, when its lease at 320 Charles St. ends. Just which operations would be based there, and which at the headquarters, is impossible to say this far in advance of the move, an institute spokesman said.

"That said, there will undoubtedly be additional core faculty lab space in the new building, as well as it being the home of several of our scientific platforms, i.e., the groups of scientists with specific technological expertise and capabilities," Broad spokesman Fintan Steele said.

Steele said the Broad views the need for space consolidation as an issue going beyond convenience.

"The nature of the work here, which requires different types of expertise and resources around critical projects, is more effective with the daily personal interactions of the different scientists contributing to the success of the various projects. This is critically important to Broad's success and to the scientists who work here, and is the primary driver of our interest," Steele said.

The new building will be allowed under a rezoning for the district approved by the council at the request of Boston Properties, which completed the Broads's headquarters building and 10 others that comprise the 24-acre, approximately 2.7 million-square-foot Cambridge Center mixed-use complex.

The rezoning allows within Cambridge Center an additional 300,000 square feet of office and "biotechnology manufacturing" uses, raising the total to 1.6 million square feet. The site was previously zoned for up to 200,000 square feet of housing that was never built.

The zoning approvals came after Boston Properties offered commitments that include the creation of a 20,000-square-foot incubator for early-stage life sciences and other technology companies. The incubator would offer leases of between 250 and 7,500 square feet "with flexible lease terms (e.g., shorter duration, lower credit requirements) consistent with reasonable market leasing practices," according to a letter from the developer to the City Council.

"It is intended that such incubator space will attract young and entrepreneurial businesses to the Kendall Square area in the beginning stages of their development, and hopefully facilitate their success and growth within the city," Boston Properties wrote.

Asked what role the Broad Institute would play in filling or operating the incubator, Steele told GWDN that remained to be seen, "though we would certainly consider a role if it makes sense for everyone involved."

Empire BlueCross BlueShield Adds Seven Labs

Empire BlueCross BlueShield took steps to "significantly expand" its HMO and PPO/EPO & Indemnity Reference Laboratory Networks with the goal of "creating an environment in which labs compete on service, quality and choice."

As part of this move, Empire, which has 6 million members and is New York State's largest health insurer by membership, expanded its HMO Reference Laboratory Network "for all markets" to include LabCorp and its DIANON Systems and Centrex Clinical Labs subsidiaries.

The insurer has also Shiel Medical Laboratory for the areas of Brooklyn and Queens, two of New York City's five boroughs.

Meantime, to its PPO/EPO and Indemnity Reference Laboratory Network it has added LabCorp, DIANON, Centrex, BioReference Laboratories, Enzo Clinical Laboratories, and Sunrise Medical Laboratories.

Empire BlueCross BlueShield is the trade name of Empire HealthChoice Assurance, and Empire Blue Cross Blue Shield HMO is the trade name of Empire HealthChoice HMO.

They are independent licensees of the Blue Cross Blue Shield Association, which serves residents and businesses in the 28 eastern and southeastern counties of New York State.

PPD Opens Pennsylvania Lab

PPD has built a cGMP testing lab in Wayne, Pennsylvania hoping proximity drug industry hub will generate business.

The contract research organization (CRO) intends the 5,000 sq.ft. facility to provide laboratory as an extension to the vaccines and biologics centre of excellence network it established in March.

Magdalena Mejillano, VP of cGMP lab services said: “Expanding our cGMP lab operations into Wayne puts us in close proximity to a large concentration of pharmaceutical and biotechnology companies based in the Northeast.”

Mejillano predicted the expansion would enhance PPD’s ability to serve clients in part of the US more effectively, particularly in terms of “delivering more flexible resources for onsite staffing programs at client sites.”

NSF Awards $7.5 Million to Create Sustainability Labs

The National Science Foundation has awarded the UCLA Henry Samueli School of Engineering and Applied Science $7.5 million to renovate its current infrastructure for use in sustainability research.

Core mechanical, electrical and plumbing infrastructure at UCLA's Boelter Hall will be renovated to create state-of-the-art collaborative labs — or "collaboratories" — for research on renewable and alternative energy production and storage, sustainable infrastructure, and environmental engineering. The renovation project is scheduled to begin in August.

Within Boelter Hall, which currently houses UCLA Engineering's departments of chemical and biomolecular engineering, civil and environmental engineering, and computer science, four research collaboratories will be constructed — one for sustainable water systems, a second for energy frontier research, a third for sustainable infrastructures and a fourth for biomolecular engineering–enbaled sustainability.

"Adequate state-of-the-art research infrastructure is very much needed to maintain the excellent upward trajectory of our school," says Vijay K. Dhir, dean of UCLA Engineering. "We are thankful to the NSF, as this is a great opportunity for us to create better and more suitable space for the significant research that our faculty conducts on a daily basis."

Among the research goals for the new laboratories:

The development of technologies for the biosynthesis of pharmaceuticals, to replace current processes involving organic solvents, and the conversion of renewable resources into pharmaceuticals.
A study of the effect of biofuel combustion products on mammalian cells.
The discovery, development and optimization of new methods for designing metabolic pathways, enzymes for biosensors and biodegradable polymers.
The biotransformation of pollutants, nanoparticles and pathogens to solve hazardous-waste problems and improve public health.

"The four collaboratories will be designed to the specs with input from the faculty," says Jane Chang, UCLA Engineering's associate dean of research and physical resources. "The end-users will also be monitored by sensors in terms of their energy and utility consumption. This information will then be centralized to enable our fifth, 'virtual' collaboratory on embedded networked sensing.

"Several of our faculty are interested in using this information to study not just how energy and utilities are being utilized in different ways by very different types of research but also how they can disseminate this information and encourage human behavioral change," Chang says. "We are pursuing some very unique ideas here for the first time. It's very exciting."

In addition to providing infrastructure for research, the renovated facilities will be used by undergraduates, graduate students and postdoctoral researchers for research training. The outcomes of some of these research activities could translate into technologies that industry can commercialize and society can use to provide new energy streams, enhance environmental stewardship and mitigate the adverse consequences of environmental change.

The NSF award was funded under the American Recovery and Reinvestment Act of 2009. As a direct response to the economic crisis, the Recovery Act's main mission is to create new jobs, save existing ones, spur economic activity and invest in long-term growth.

"What we are doing here will definitely stimulate the local economy through intensive renovation and construction," says Chang, who is also the principal investigator for the project. "By creating state-of-the-art research space for the faculty in the form of a collaboratory, they can consolidate their research activities and establish more collaboration. And as their research program expands, they'll hire more graduate students and postdoctorates."

Another unique aspect of the project is that it is part of a large-scale intra-campus collaboration. The total budget for the renovation approaches $12 million, and both UCLA Engineering and the campus are committed to providing the necessary resources to ensure that the project is successfully completed in three years.

"We received a lot of support across campus. From the former vice chancellor for research, Roberto Peccei, and the vice chancellor for finance, budget and capital programs, Steve Olsen, to the associate vice chancellor for general services, Jack Powazek, all have contributed to making this project a reality. We are very thankful to them," Chang says.

Epeius Biotechnologies Expands

For Epeius Biotechnologies, “we wanted to create a single-product-dedicated research and production facility that would bring biotech manufacturing into the 21st century,” says Frederick Hall, president, CEO and co-founder of Epeius.

Epeius Biotech is a privately held biopharmaceutical company that's focused on the development and commercialization of oncology-based products and tumor-targeting gene delivery systems. Epeius is a spin-off from a Univ. of Southern California, Los Angeles, incubator with several USC investors. It's leading oncology product, Rexin-G, is designed to seek out metastatic cancers and deliver a selective and highly active genetic payload against a broad spectrum of chemotherapy-resistant tumors. Rexin-G was granted Orphan Drug Status by the U.S. Food and Drug Administration (FDA) for pancreatic cancer in 2003. The following year, Epeius obtained the licensing rights for core molecular biotechnologies from USC and for retro-vector tumor-targeting systems from BioFocus, Saffron Walden, UK.

Rapid advances in clinical development provided Epeius with the opportunity to generate revenues starting in 2006 from the export and sale of Rexin-G to The Philippines and other Southeast Asian countries. In 2008, Epeius again obtained FDA Orphan Drug Status approval for two additional cancer indications and formed a strategic alliance for commercial production of Rexin-G.

The design, development, and construction of the Epeius' production facility has become an integral component of the overall Rexin-G story and serves as a guide as to how small biotechs can develop the capabilities to successfully manufacture new biological drugs.

“Frederick Hall is quite the evangelist of drug development on a small scale that allows tight cost controls, rapid development, independence from the politics and delays of big pharma, as well as quality and efficiency,” says Mike Buckwalter, publications director for Terra Universal, Fullerton, Calif. Terra is a strategic partner with Epeius.

Hall's vision for his production facility had three components:

1) He wanted a facility that could support current and potential future GMP protocols for sterile drug manufacturing that met Epeius' specific functionality requirements and exceeded FDA validation requirements.

2) He also wanted a facility that utilized the modularity of Terra's existing cleanroom designs to make modifications and refinements as the final design proceeded. An over-designed facility was conceived to the maximum performance limits which were then balanced against acceptable economics.

3) And finally, says Buckwalter, Hall wanted “a physical, visible, and palpable embodiment of the engineering sophistication that went into his development of Rexin-G. He wanted a facility that would reflect a literal landscape of the elegant molecular design engineering.”

Initially, Hall sought advice from FDA lab consultants, before deciding to work with (and extensively modify) the Terra modular design. Following three years of design and six months of fabrication the results are impressive.

The resulting Epeius production facility is a modular 500-m2 stainless steel and glass laboratory sitting in a 4,000-m2 (43,040 sq. ft.) hanger-like free-standing facility in Carlsbad, Calif. The lab floors are seamless epoxy and the lab ceiling is 3.5-m tall. There are BSL-2 areas, negative pressure containment in most processing areas, and division of the lab facility into two separate production suites—one for Rexin-G and another for scale-up future products such as tumor-targeted vaccines.

Unlike other conventional modular labs, the double-walled stainless steel and glass modular cleanrooms designed and constructed for Epeius are completely free-standing structures with the inherent rigidity and durability one expects from a free-standing type of construction.

“Implementation of a project this complex is always a process of discovery,” says Terra's Buckwalter. “Success hinges on the ability to accommodate change. Our BioSafe Clean Rooms are now very different structures from their original design as a result of our work with Hall and Epeius.”

“We had a perfect partnership with Terra,” says Hall. “They had a keen sense of our mission.”

Hall likes to refer to his design as having the economy of an instrument. “It's like having a UL-type certification,” he says. “The modularized arrangement is like a plug-and-play instrument.”

The modular design allows the incorporation of many features that would normally be considered complex and expensive options with other rigid structures, while the dedicated space allows for faster FDA validation. “We know where all our electrical connections and lines are,” says Hall referring to the electrical panels that are built into the double-envelope stainless steel walled structure.

The mostly stainless steel and glass construction materials also are suited to the production of biological products. These materials are rugged enough to be entirely UV-sterilized, while all the stainless steel is treated to be antibacterial. There are also ports for hydrogen peroxide for additional sterilization capabilities. “The controlled environments in the dual structures allows it to be simple and overbuilt at the same time,” says Hall. “The sterilization capabilities also make it an order of magnitude cleaner than it needed to be [for FDA certification].”

The design also exudes an aura of technology, with numerous touchpad controls, clean room gowning areas, large open spaces and tall ceilings, and the knowledge of the type of cancer-fighting biologics being researched and produced behind those walls.

Hall also points to the elegance of the stainless steel and glass design, noting that while it was designed primarily as a facility for the production of cancer drugs, it also serves very well as a showcase for Epeius investors, FDA inspectors, potential collaborators, and prospective scientist-employees. The ability to see through to every corner of the facility from the outside provides visitors with confidence as to the high level of biological research and production being performed.

In the end, the dedicated modular production facility created for Epeius followed a faster development cycle than could be done for a conventional production facility design. The developers believe that this type of design can be franchised for other biotech organizations. It allows the biotech firms to compress their development cycles, keep their capital investments at a minimal level (that might have killed some small biotech programs), and bring their innovative products to the marketplace faster. This design approach also allows small biotech firms to bring their products to the commercial phase without relying on the resources or control of a major pharmaceutical backer. The molecular design and operations of the facility serves as a flagship for Epeius to globally expand its biopharmaceutical operations.

As noted by the FDA regarding Epeius Biotechnologies' state-of-the-art production: “The progressive R&D program and implementation of significant improvements in Rexin-G BioManufacturing Protocols is in accordance with the basic needs of the cancer patient and in harmony with the 'Critical Path Initiatives' outlined and encouraged by the U.S. FDA. In this regard, the general mandates for 'Moving BioManufacturing Into the 21st Century' are met by (i) the adoption of new technological advances, (ii) accommodations of significant innovations in manufacturing science, (iii) reduction of product variability, and (iv) incorporation of scalable, aseptic, single-use, and disposable technologies.” Clearly, Epeius and Terra have followed these criteria.

ATMI Doubles Bioprocess Tech Manufacturing Capacity

ATMI completes expansion at US bioprocess tech plant days after citing life science business growth as an important part of its second quarter gains.

The Connecticut-headquartered firm said it had significantly increased manufacturing capacity at its plant in Bloomginton, Minnesota after a two-year project and investment of $45.5m (€3.4m)

ATMI said that the expansion, which houses a 2,500 sq.ft. Class 1000 cleanroom, applications laboratory and a separate development lab, makes the plant a hub for its single-use bioprocess tech business, including the 2D and 3D vessels it launched earlier this month.

The move doubles ATMI’s global bioprocess vessel production capacity, which is now split between the Bloomington US and its manufacturing facility in Hoegaarden in Belgium.

In a press statement CEO Doug Neugold explained that the expansion was a “direct response to the growing needs of our North American customers for additional single-use bioprocess vessel manufacturing capacity.

“Creating an exact copy of our Belgian facility for change management and supply chain security reasons also helped us to quickly replicate cGMP procedures.”

ATMI’s investment is an indication of the firm’s desire to build on the gains made by its life sciences business in the second quarter.

The division contributed revenue of $7.5m (€5.7m) for the three months ended June 30, which, although only a fraction of that contributed by its microelectronics business, still represents growth of 27 per cent.

Neugold said that ATMI’s life sciences business had “won orders for multiple new applications at major producers, indicating the continued acceptance and adoption of single use technologies by an expanding customer base."

Four Oaks, NC Lands 187 Jobs

Becton, Dickinson and Company, based in New Jersey, plans to build its 700,000-square-foot East Coast distribution center in Four Oaks. The new jobs with an average wage of $28,771 a year will make the company the town's largest employer.

"This is going to be a boon for Eastern North Carolina," said Four Oaks Mayor Linwood Parker, noting that BD will pave the way for other companies to locate in the business park. He estimates that 3,500 people could eventually work in the park. "It brings Four Oaks Business Park from a concept to an actual park," the mayor said.

BD's distribution center is scheduled to open in 2012, with employment reaching 187 within three years.

"BD is very pleased to expand its operations in North Carolina," said Charles Goldstein, vice president of research for the company. "North Carolina is a very attractive place to research-based companies like BD."

The company was lured in part by a $2.3 million incentives package. That includes a $1.7 million grant from Johnston County, which will pay out the money over seven years if the company delivers on its planned $38.4 million investment. Also, the company will get a $600,000 grant from the One North Carolina Fund, a state program that provides incentives for companies to grow.

The Town of Four Oaks is paying for water and sewer to the site with a $737,958 grant from the N.C. Rural Economic Development Center. The town has to match that grant and is seeking other grants to cover the match. Johnston County is also chipping in $1 million for the business park's roads and infrastructure.

The incentives are much smaller than what the state has given to other employers recently. When Talecris announced last year that it would add 259 jobs over seven years at its Clayton plant, it got a $20 million package of tax breaks and financial assistance. The Talecris jobs, however, carried an average annual salary of $51,066; BD's average is below Johnston County's average annual of $31,408.

BD's announcement is a major step for the Four Oaks Business Park, which had failed in earlier bids to attract tenants.

Mayor Parker said the BD announcement was the result of years of planning by the town, starting with the new Interstate 95 interchange at Keen Road, where the park's located. The planning continued with the town's subsequent decision to restrict development at the interchange so it wouldn't become "just another plastic interchange," Parker said.

"This didn't start yesterday; this started over 20 years ago," he said.

The new jobs will have a big effect on the entire town, the mayor added. "I think you're going to see retail growth and housing growth," Parker said. "As the park grows, the number of people living here will grow along with it."

Town commissioners voted last month to extend Four Oaks' extraterritorial jurisdiction, which will bring the entire business park and surrounding land under the town's land-use-planning authority.

BD already has 900 employees at five locations in North Carolina, including Wilson, Durham and Burlington. Its ties to the state run deep, as founders Maxwell Becton and Fairleigh Dickinson were natives of Kinston and New Bern. The company was among to first to have a presence in Research Triangle Park in the 1970s.

BD also looked at Mebane and Norfolk, Va., as possible sites for the distribution center, Mayor Parker said.

Mocon Moves U.S. Headquarters

U.S. testing instrument maker Mocon has moved to a bigger HQ and manufacturing centre to help it keep up with what it describes as growing demand for its range of products and services.

The new facility, in Minneapolis, offer 27 per cent more laboratory, testing and production capacity than Mocon’s previous base as well as a unit to train users in the correct use of the firm’s testing equipment.

CEO Robert Demorest explained that through the investment Mocon will be “expanding our capability for engineering and product development, testing, production capacity and customer service."

He went on to say that: “This investment will enable Mocon to provide even greater value to the global medical, pharmaceutical, food and beverage, packaging, environmental and oil and gas markets.”

Miller Construction Completes Renovation for Cleveland Clinic Florida

Miller Construction Company’s veteran healthcare team has completed a $2.2 million renovation and expansion project for Cleveland Clinic Florida that demanded expertise in air quality, infection control and complex compliance issues.

The multi-phase project at the Cleveland Clinic Florida campus in Weston included constructing a second floor atop a one-story section of the hospital to accommodate a 10-bed expansion of the Post Anesthesia Care Unit, plus renovating adjacent space to add five beds to the Intensive Care Unit.

As general contractor, Miller completed the project within budget and on schedule in just five months. The firm trained and involved every subcontractor in stringent protocols for infection control – a key consideration whenever construction occurs near a hospital unit with immune-compromised patients.

In other projects, the team created a dialysis suite and reconfigured and expanded the hospital’s pharmacy, including addition of a cleanroom and negative pressure room built to USP 797 standards. “Working in the heart of an operational ICU and PACU, we focused on keeping highly sensitive electrical and mechanical systems functioning smoothly, while minimizing any disruption to the hospital’s staff and patients,” said Wayne Hannaka, vice president of Moss Miller Healthcare.

This spring, healthcare specialist teams from Miller Construction Company and Moss & Associates joined forces to launch Moss Miller Healthcare, a unique company designed to meet growing demand for hospitals, clinics and research institutions across Florida.

Going forward, the team’s new projects at Cleveland Clinic Florida and other healthcare facilities will be under the Moss Miller Healthcare banner.

Moss Miller Healthcare’s executive team members have overseen over $2.5 billion collectively in medical facility construction projects.

Miller Construction Company has a 20-year track record in meeting stringent requirements of Florida’s Agency for Health Care Administration (AHCA). Fully 100 percent of Miller’s 55 hospital and other healthcare facility projects passed in all final AHCA inspections.

Moss & Associates has an executive team whose members directed construction of landmark medical centers from Miami to Orlando and Tampa Bay. The firm has offices in Fort Lauderdale, Miami, Tampa and Ocala.

Florida County Approves $28 Million One-Year Loan for Jackson Lab Campus

Bypassing the federal stalemate that has blocked the use of $130 million in state funding approved this past spring, officials in Florida's Collier County have approved using $28 million in existing county funds as a one-year loan to The Jackson Laboratory toward the first-year startup costs of its planned personalized medicine campus near Naples.

The Board of County Commissioners opted for the one-year loan after it postponed until September a vote on matching the state funding with $130 million in county funds. The state and county funds were components of an economic incentive package for Jackson Lab that included a commitment by the laboratory to raise $120 million for the project through a philanthropic campaign.

Headquartered in Bar Harbor, Me., Jackson Lab plans next year to open a translational genetics research institute set to employ 244 people by 2020, within a temporary facility that will give way two years later to a permanent campus within 50 acres to be donated by developer Barron Collier Cos.

The county commissioners approved the loan 4-1 on Tuesday afternoon, with Tom Henning voting against it. A majority of commissioners also rejected requests by Henning and numerous opponents of the proposed $130 million county award for Jackson Lab to let county voters decide the issue through a referendum.

Fred Coyle, chairman of the commissioners' board, noted Jackson Lab's plans announced last week for a research, training, and clinical partnership with the University of South Florida — what he said was "a very major substantial announcement that could change one's perception of the economic viability of this process."

The actions and comment from commissioners came during a 10-1/2 hour meeting streamed over the Internet and highlighted by a public hearing on the Jackson Lab plan in which dozens of the 109 people who signed up to speak addressed the commissioners.

How the county would raise its $130 million remains unclear.

Commissioners favoring the loan said it demonstrated Collier County support for the Jackson Lab project despite the stalemate that has blocked the use of state funding. In May, Crist and state lawmakers approved the state's piece of a three-year, $130 million funding package for Jackson Lab. The laboratory was allowed to receive its first $50 million portion during the current fiscal year, which began July 1.

But the money was approved under the assumption that Congress would approve $24 billion in additional Medicaid funding, including about $1 billion for Florida. The Medicaid money was removed from a bill that passed the US House of Representatives, and the US Senate has not restored the funding, despite support voiced for that idea by Senate Majority Leader Harry Reid (D-Nev.).

Amneal Pharmaceuticals Receives Five Generics Industry Awards

Amneal Pharmaceuticals is pleased to announce that the company has been honored with the Distribution Industry Award for Notable Achievements in Healthcare (DIANA) for Best Generic Product Manufacturer with Sales to Healthcare Distributors of Less Than $100 Million by the Healthcare Distribution Management Association (HDMA). The award recognizes pharmaceutical manufacturers who set the standard of excellence in best business practices with HDMA healthcare distributors. HDMA members independently voted for companies they believed demonstrated overall exceptional performance as a generics manufacturer and supplier.

The DIANA was announced at the June HDMA Business & Leadership Conference in Orlando, FL and rounds out a total of five major industry awards that Amneal has garnered in the past 18 months. Currently the 10th largest U.S. generics manufacturer in number of prescriptions dispensed, according to March 2010 data from IMS Health, the fast-growing pharmaceutical firm also earned the following honors:

These prestigious awards recognize excellence across the entire Amneal organization – quality, supply, pricing, account management, customer response, leadership, innovation and collaboration – affirming the generic maker’s core focus on maximizing value creation in managing its wholesaler-distributor accounts.

“Since we launched our own label only three years ago, Amneal is extremely honored to receive industry-wide recognition by these top wholesalers-distributors,” said Jim Luce, Executive Vice President, Sales & Marketing. He continued, “We’re tremendously proud of what we have accomplished. Yet more significant than the actual awards is our customers’ validation of Amneal’s guiding principles, business philosophy and aggressive yet strategic growth plan. Our relentless focus on these fundamentals enables us to maximize value for our customers and, most importantly, our customers’ customers.”

Amneal Pharmaceuticals LLC, headquartered in Hauppauge, NY is a U.S.-based firm that develops, manufactures and distributes generic pharmaceuticals regulated and approved by the U.S. FDA. Known as “Generic’s New Generation”, the company utilizes its newly expanded R&D and manufacturing capabilities to conceive breakthrough developments with lasting impact for a robust product pipeline. Rapid ANDA approvals and diverse product acquisitions are key to Amneal’s aggressive growth strategy, as is the company’s strong commitment to deep customer relationships and maximum value creation. Amneal delivers high quality products, superior service levels and dynamic value throughout the pharmaceutical industry.

REST OF THE WORLD

Aesica Plans High Potency Expansion

Aesica will build a “high containment” manufacturing plant to expand its high potency drug formulation capabilities in line with growing demand.

The £3m ($4.6m) facility, at the UK contract manufacturing organization’s (CMO) site in Queenborough, Kent will produce, package and ship both liquid and solid dosage forms when fully operational in summer 2011.

Commercial director Adam Sims said within drug industry “the use of more potent compounds has made high containment drug manufacturing a key focus for customers outsourcing their products.”

Aescia is one of a number of CMOs to have invested in high potency handling and manufacturing capacity in recent years. Notable examples include SAFC, Patheon and Catalent.

In addition to housing capacity for potent active pharmaceutical ingredients (API) and intermediates, the new plant will be one of only a handful in the UK capable of making Schedule II controlled drugs.

This capability further strengthens Aesica’s position in the sector, which received a significant boost after its facility in Cramlington, Northumberland was cleared to make Schedule II compounds last year

Aesica’s new investment fits with comments Sims during an interview with

in-pharmatechnologist in February, when he explained that consolidating the firm’s position in Europe was a key business goal.

Aesica had already begun strengthening its formulations business with the acquisition of fellow UK-based company R5 Pharmaceuticals.

BioMérieux, Singapore Invest $2.2 Million to Research TB Biomarkers

The Institut Mérieux, its in vitro diagnostics firm BioMérieux, and the Singapore government are investing S$3 million ($2.2 million) to investigate biomarkers to identify individuals who may be at risk for developing tuberculosis and to help guide drug therapies.

As part of the project, a joint laboratory is being created at Biopolis, a scientific R&D hub located in Singapore. There, researchers from BioMérieux and Singapore's Agency for Science, Technology, and Research's Singapore Immunology Network, or SIgN, will study the immune cells in the blood of patients infected with TB but whose disease is inactive. The cells will be compared with those of patients who have active TB and those of healthy controls in order to identify potential biomarkers for TB infection and TB re-activation.

In addition to aiding in the diagnosis of the disease, the research could help clinicians assess and monitor patient response to TB treatment and manage those who have developed drug-resistance to Mycobacterium tuberculosis, SIgN said in a statement.

More than 2 billion people worldwide, nearly one-third of the population, are infected with M. tuberculosis, and about 10 percent of these will develop the disease eventually, SIgN said.

"There is an urgent need to understand and find new ways to eradicate the disease — through prediction, early detection, and effective treatment — and this timely collaboration seeks to accomplish exactly that," Paola Castagnoli, scientific director of SIgN and one of the lead researchers in the project, said in a statement.

UK's Norwich Research Centre Opens

The UK's Norwich Research Park has opened a £5 million ($7.9 million) facility designed to provide lab space for researchers whose startups have outgrown the campus' incubator, but still need proximity to NRP's workforce of nearly 3,000 scientists as they try to translate their discoveries into commercially viable technologies.

The new NRP Innovation Centre consists of more than 30 office and laboratory units constructed and fitted out within a refurbished 4,215 square-meter (43,000 square-foot), three-story building within the research park.

"Some tenants are expected to come from elsewhere on the Norwich Research Park, although not all by any means. Tenants are being sought amongst science, innovation, and technology organizations from around the world," said Peter Treglown, a spokesman for the innovation center.

The innovation center was funded by the UK government's bioscience funding arm and regional development agencies in Norwich. The Biotechnology and Biological Sciences Research Council (BBSRC) contributed land and buildings for new facilities, along with £500,000. The East of England Development Agency chipped in £1.4 million, the Greater Norwich Development Partnership added £1 million, and the University of East Anglia will chip in £500,000.

The remainder comes from the partners that have collaborated to develop the research park. NRP has some 9,000 people working in more than 30 science and IT companies, as well as research institutes that include The Genome Analysis Centre (GAC), the Institute of Food Research (IFR), the John Innes Centre (JIC), and The Sainsbury Laboratory located at JIC.

GAC, IFR, and JIC are partners in the research park, as are UEA and The Norfolk and Norwich University Hospitals NHS Foundation Trust. The trust runs hospitals that provide secondary and tertiary acute care for a territory or "catchment area" of up to 822,500 people.

NNUH is the innovation center's first tenant, having agreed to base its clinical microbiology team within the center's top floor of about 14,000 square feet. The space will house seven laboratories, 14 offices, walk-in freezers and cold stores.

The innovation center building was completed in the 1980s for use by the Ministry of Agriculture, Fisheries and Food, and recently refurbished. It is managed by Colney Innovations Limited — jointly owned by IFR, JIC, UEA, and BBSRC — which will work to provide at the innovation center 'follow-on' space on commercial terms for science-related companies based at NRP, while also managing the existing Norwich Bio-Incubator, the research park said in the statement.

The Bio-incubator, owned by the John Innes Foundation, consists of 12 laboratories ranging in area from 550-1,000 square feet.

According to the innovation center's website, offices ranging from 168.9 square feet to 368.1 square feet net, and laboratories ranging from 202.3 square feet to 866.4 square feet net, are available for lease on the ground floor and middle or "first" floor.

"Tenants can, of course, take as many suites as they want," Treglown said. "The standard leases are for periods of three to five years. We would expect many businesses to have grown sufficiently after that period to consider larger premises elsewhere on the Norwich Research Park. Alternatively, leases can be extended for further periods."

The innovation center is "currently in advanced stages of negotiations with a number of further tenants," he added.

Cancer Research UK Opens Biopharm Production Unit

Cancer Research UK has established a £18m ($28.4m) biopharm manufacturing unit to produce complex experimental drugs, such as monoclonal antibodies.

Establishing the production unit gives Cancer Research UK the capacity to support scientists as they transition compounds from the laboratory to the clinic. Cancer Research UK began work on the plant in 2007 and the first product manufactured at the site has now entered clinical trials.

The product, an antibody called Chi Lob 7/4, was discovered at the University of Southampton, UK. A Phase I clinical trial, using material produced at the new site in Hertfordshire, UK, is now treating patients who are no longer responding to conventional treatment.

Peter Johnson, the trial’s lead, said: “Having experimental medicines readily available from our own medicine manufacturing centre will be an enormous boost to clinical trials such as this one which is testing a promising new antibody to treat people with cancer.”

Operating the unit will allow Cancer Research UK to be more cost-effective and efficient when producing clinical trial materials. This makes better use of its resources and helps accelerate the passage of treatments into clinical trials.

Cancer Research UK has equipped the unit to produce biologics, such as monoclonal antibodies, plasmid DNA and recombinant proteins. Housed at the plant are a 30L continuous fermenter and 100L spinners, as well as downstream processing, cell banking and vial filling capabilities.

The unit is compliant with current good manufacturing practices (cGMP) and licensed by the UK Medicines and Healthcare Regulatory Authority (MHRA) for the manufacture of investigational medicinal products (IMPs).

These capabilities complement Cancer Research UK’s other manufacturing plant in Glasgow. The Glasgow unit, at the University of Strathclyde, develops and manufactures parenteral and oral sold-dose forms for use in clinical trials.

GSK Inks R&D Deal with Aptuit

GlaxoSmithKline (GSK) and Aptuit, Inc. announced that they have finalized an agreement for Aptuit to acquire operations at GSK’s Medicines Research Centre in Verona, Italy. The arrangement, which is effective as of July 1, 2010, provides for ongoing employment of the staff at the centre and for Aptuit to supply GSK with R&D services from the facilities. Financial terms have not been disclosed.

Under the agreement, Aptuit will gain the scientific expertise and knowledge at the research centre through the transfer of the facility’s approximately 500 staff from GSK to Aptuit. This will help maintain the life sciences research and talent pool in Italy. In addition to becoming an important member of GSK’s contract research organization network, acquisition of the operations will also allow Aptuit to provide integrated development services to its global customers.

“Aptuit was built to provide an integrated drug development capability and streamline the drug development process. This is a strategic acquisition of GSK’s research business in Verona that further strengthens scientific expertise and capabilities within Aptuit, extending our integrated discovery and development offerings,” said Tim Tyson, Chairman and CEO of Aptuit. “This partnership is an example of the developing new model of outsourced R&D collaborations. Verona staff are recognized industry-wide for their drug development expertise and will be an excellent addition to the Aptuit team.”

GSK announced in February its proposal to cease discovery research in select neurosciences areas such as pain and depression, which impacted research at the Italian facility.

Moncef Slaoui, Chairman of GSK Research and Development said, “I am pleased that both GSK and Aptuit have developed this innovative approach. It provides a modern option for drug discovery expertise to remain as part of the science research community in Italy and offers the opportunity to assure continuity of employment for the GSK staff at the site. This arrangement would not have been possible without the input of the Italian government and unions.”

The Verona Medicines Research Centre expands Aptuit’s global footprint to 19 locations – a global network of operations that provides a full suite of development services. The agreement also enhances Aptuit’s ability to serve customers working to develop compounds for high-value and strategically important therapeutic areas such as neurosciences discovery and development, as well as cardiovascular and infectious diseases.

Aptuit will combine its existing capabilities with the Verona Medicines Research Centre’s expertise in drug discovery, lead optimization, active pharmaceutical ingredient (API) development and manufacturing, and pre-clinical and clinical drug development. This will create a unique, industry-leading drug development capability.

Thermo Fisher Collaborates to Establish Tokyo Biomarker Research Center

The intent of the collaboration between Thermo Fisher's Biomarker Research Initiatives in Mass Spectrometry (BRIMS) Center and Toshihide Nishimura, professor at the Tokyo Medical University Hospital and Gyorgy Marko-Varga, professor at the Tokyo Medical University Hospital, and Lund University, Sweden is to establish and support a new Biomarker Research Center in Tokyo, Japan. The new Center will focus on biomarker discovery and quantification, disease mechanisms, therapeutic drug monitoring and disease pathophysiology.

The BRIMS Center is the archetype for the coming Tokyo Biomarker Research Center. The goal is to bring to the collaboration Thermo Fisher's expertise in mass spectrometry-based assays, workflow development and technology integration, as well as its extensive network of collaborators engaged in similar research.

"In Japan there is an urgent need to develop more targeted disease detection and treatments for a rapidly growing patient population," said Murray Wigmore, senior director of commercial operations in Japan, Thermo Fisher Scientific. "The Tokyo Biomarker Research Center will be developed as the model to replicate the excellence of BRIMS in international markets."

The aim is for the collaboration to result in the Tokyo Biomarker Center which will have dedicated laboratories based at Tokyo Medical. Correlation of protein expression and quantitative regulation for diseases of key concern in Japan such as lung cancer, chronic obstructive pulmonary disease

(COPD) and cardiovascular disease will be performed to discover biomarker candidates related to drug response. The research center will also house an archive with comprehensive tissue and blood sample collections, along with access to complementary clinical and demographic data. The archive will include samples from drug responder and non-responders, and material from clinical studies performed in Scandinavia and other European countries.

Charles River Cancels Merger with WuXi

The proposed merger between Charles River Laboratories and WuXi AppTec fell apart. Citing investor concerns about uncertainties surrounding the deal, Charles River has officially withdrawn its $21.25 cash and stock offer for all of WuXi’s shares. The large American firm must now pay its China counterpart a $30 million breakup fee.

In an open letter to customers, which was obtained by ChinaBio^®, Dr. Ge Li, Chairman and CEO of WuXi AppTec, said “short-term financial concerns” were the reason its merger with Charles River Labs was not completed. Dr. Li expressed regret that the failure of the merger would slow WuXi’s evolution into a company with a broader set of CRO capabilities.

In deciding to end its merger with WuXi AppTec, we argue that Charles River is passing up a one-time opportunity to establish near-complete global dominance in its industry. The deal significantly undervalued WuXi because it ignored WuXi’s strategic value as the dominant player in the world's most important emerging market.

Radient Sells China Subsidiary Jade Pharmaceuticals

Radient Pharmaceuticals announced a new plan to sell its China subsidiary, Jade Pharmaceuticals. Jade has signed a letter of intent to merge with Shanxi BaoTai Pharmaceutical Co., a privately owned company located in Taiyuan China. When the transaction is closed, Jade plans to merge the combined entity with an unnamed public company, and the public company will move its listing to the NYSE Amex.

Quintiles Announces New European Headquarters

Quintiles, a fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide, announced that it is re-locating its European headquarters to within 30 minutes of Heathrow Airport at Green Park, Reading, England.

Bringing together talented and engaged employees from each of its four business pillars in a state-of-the-art facility, the move supports Quintiles' integrated service offering. It is designed to create an even higher level of collaboration and effectiveness among Quintiles' European team to better serve the company's biopharmaceutical customers.

Dr. Dennis Gillings, CBE, Quintiles Chairman and CEO, explains: "Our customers are facing an increasingly complex set of challenges which we refer to as the New Health. To help our customers succeed in this new landscape, we are constantly looking at how we can raise our game around team work, customer service and quality - three of our core values. This move to a technologically advanced single site will be a big step forward for our highly talented team and the customers they serve." The five storey, 120,000 square foot building at 500 Brook Drive, Green Park, is fully equipped with advanced technology to allow Quintiles employees to work seamlessly with colleagues around the globe. Designed and built to the highest sustainability standards, the building has been awarded strong ratings for energy efficiency (EPC) and environmental impact (BREEAM). In May 2010, the British Council for Offices named 500 Brook Drive the winner of its Commercial Workplace Award and it is shortlisted for the National Award, to be announced in October 2010.

This investment by Quintiles follows the opening of its state of the art laboratory and office facility in Edinburgh, Scotland in 2009 and the expansion of its Phase I facility in London, completed in March 2010.

Quintiles employs more than 2000 people in the United Kingdom and in 2010 was named one of the UK's 50 best workplaces by the Great Place to Work Institute. It is anticipated that the building will be occupied during late 2011.

UK Trade & Investment Chief Executive, Sir Andrew Cahn, commented: "Quintiles' decision to consolidate their 500 Thames Valley employees at Green Park, and its continued investment in operations in Edinburgh and London, demonstrates the company's commitment to the UK. We greatly value the benefits these investments bring at a local, regional and national level. The company is a leading player in the healthcare industry and we will be working closely with the company to ensure their long term success in the UK." Rory Carson, Associate Director of Asset Management at Global Real Estate Investment Manager PRUPIM, comments: "We are looking forward to welcoming Quintiles to Green Park in 2011 when they will become members of a vibrant business community of over 4,000 people. As one of Europe's leading office parks, Green Park offers occupiers a great work: life balance set within a stunning landscaped environment. A high level of amenities and excellent transportation links to Heathrow and London all combine to meet the needs of large international occupiers like Quintiles".

Colorcon Acquires Indian Coatings Business

Colorcon, Inc. has acquired India-based Pharmaceutical Coatings Pvt. Ltd., which includes the company's full product portfolio and a new facility in Goa that is currently under construction. The acquisition adds to Colorcon's existing range of tablet film coatings for pharmaceutical solid oral dose development.

The acquisition brings Tabcoat TC, an organic, hydro-alcoholic, or aqueous solvent system that can be adjusted to meet customer needs, and the nature of the active ingredient in the formulation.

Jean-Claude Deneuville, president of Colorcon, Inc., commented, "We are excited about this opportunity to expand our film coating offering. The acquisition broadens and strengthens our ability to respond to the specific needs of companies in the fast growing Asia/Pacific region. We will ensure the same high quality level of expertise, technical service, production and logistics support for these products that our customers have come to expect from Colorcon."

QPS Acquires Xendo Drug Development

QPS Holdings, LLC has completed its acquisition of Xendo Drug Development BV (XDD). XDD, a European CRO headquartered in Groningen, The Netherlands, will be known as QPS Netherlands BV and is a wholly-owned subsidiary of QPS Holdings.

XDD has large and small molecule bioanalytical labs and a 24-bed clinical pharmacology unit (CPU) located at University Medical Center Groningen (UMCG). The CPU performs clinical pharmacology studies across all major therapeutic areas and provides comprehensive safety monitoring. XDD also has an extensive database of healthy volunteers as well as special and patient populations.

"Pooling our strengths will enable XDD and QPS to serve our clients even better. Our leading capability in conducting high quality bioanalysis and Phase I studies, combined with our well established expertise in ADME, genotyping and drug development process will make QPS an ideal drug development partner for our pharmaceutical and biotech clients worldwide," said Ben Chien, chairman, and chief executive officer of QPS holdings.

"Joining the QPS organization enables XDD to realize its ambitions for global growth. In terms of activities, size and location, QPS and XDD are a perfect fit. Our combined operations in Asia, Europe and the U.S. position us ideally to expand our portfolios in the increasingly consolidated pharmaceutical and biotechnology sector, our primary market," said Koos Koops, XDD's former chief executive officer. Koops will head the XDD -QPS Netherlands division of QPS.

Japan's Largest Generic Drug Maker to Expand

Nichi-Iko Pharmaceutical Co., Japan's biggest generic drug maker, will break into the markets in Thailand, Malaysia and Hong Kong in the next business year as its first overseas business expansion, its president and chief executive officer said.

"We find it necessary to compete worldwide" as competition is growing tougher in the domestic market, Yuichi Tamura said at a press conference in Bangkok.

Generic drugs, which contain the same active ingredients of the original formulation, are produced and distributed after the patent protection of the original drugs expires. Demand for the inexpensive drugs is expected to increase in Southeast Asia against the backdrop of the region's rapid economic growth, according to Nichi-Iko.

Nichi-Iko will sell seven to 13 generic drugs, including a cholesterol-lowering agent, in the three markets as soon as authorization is given by local authorities through sales routes established by DKSH Group of Switzerland, a leading market expansion service provider with focus on Asia, it said.

The company, based in Toyama Prefecture, will target affluent consumers in the three economies where generic drug sales are estimated to total the equivalent of 150 billion yen.

It hopes to capture a 1 percent share of the three markets combined within five years' time as part of its plan to join the world's top 10 generic drug makers during the period by doubling its sales to 130 billion yen, it said.

Nichi-Iko is now studying a market advance into Beijing, Shanghai and other Chinese cities, as well as Singapore and the United States, Tamura said.

RPG Partners to Expand in Western Europe

ResearchPoint Global (RPG) has partnered with Pivotal SL to expand in Western Europe and strengthen its oncology capabilities.

Partnering allows US-based RPG to offer clients local knowledge and clinical resources in Spain, where Pivotal is based, and Portugal. Pivotal has also implemented and completed clinical trials in other Western European countries, including Italy, France and the UK.

RPG plans to leverage Pivotal’s experience of the Spanish market. The US firm said Spain boasts numerous world-renowned investigators and proven investigational sites, a well organized regulatory process, universal health coverage and experienced clinical research staff.

Furthermore, Spain has particular experience in a number of therapeutic areas, including oncology, acute cardiology, infectious diseases and AIDS. Pivotal covers all therapeutic areas but has particular experience in onco-haematology, cardiovascular, anti-infectives and CNS.

Matt Walker, executive vice president of marketing and business development at RPG, said this experience will benefit all regions it operates in. This will be achieved by leveraging Pivotal’s team and therapeutic expertise for client protocol reviews and other program design efforts.

Before the Pivotal deal RPG had a number of partnerships throughout Central and Eastern Europe (CEE) and Scandinavia, as well as one in Germany, but was lacking a strong presence in the west of the continent.

Pivotal is a full-service contract research organization (CRO), which also offers pharma consultancy, and employs 110 people. These include seven medical staff working in a medical and pharmacovigilance hub.

The Spain-based CRO also has a data management and biostatistics division which uses a fully integrated suite of Oracle software, including Oracle Clinical, RDC, Siebel CTMS and Argus Safety.

Ibrahim Farr, founder, chairman and CEO of Pivotal, said the company had achieved double-digit growth for several years and become a reference CRO in its region. Joining with RPG will extend its geographic reach.

Mylan Plans Plant in Hungary

Mylan hopes new solid-dose packaging plant in Hungary will help it increase market share in Eastern Europe.

The facility, a 10,000 sq. meter (107,600 sq. ft.) unit at the Komarom Industrial Park, will be refitted for tablet and capsule production. Mylan also plans to install blister packaging and bottling lines, as well as high potency drug handling capacity at the site over the next few years.

The non-branded drugmaker, which paid €67m ($87m) for the plant according to a report, said that the investment will create 400 new manufacturing and warehousing jobs.

Comments by COO Rajiv Malik suggest the firm sees significant potential in both the Hungarian and wider Eastern European drug markets.

Malik explained that: “After conducting a broad search for a suitable facility with the potential to expand, the opportunity in Komarom turned out to be an ideal fit” adding that the plant will support “dynamic business growth.”

He went on to say that: “We are also looking forward to increasing our market share…across the country.”

The investment fits with the development and gradual expansion of Mylan’s business in Eastern Europe as a whole, which has accelerated considerably since its $4.9bn acquisition of Merck KGaA’s non-branded drug business in 2007. That deal, in addition to units in Poland, Slovakia, Slovenia and the Czech Republic, gave Mylan its foothold in Hungary and the foundation for its latest expansion plan.

Mylan’s efforts to strengthen its Hungarian business and its recent entry into the U.S. injectables market may also be part of a wider response to Big Pharma’s increasing focus on new markets and non-branded pharmaceuticals in the face of looming patent expiry.

The last few years has seen most pharmaceutical firm's build generics capacity, with Sanofi’s purchase of Laboratorios Kendrick and Medley, GlaxoSmithKline (GSK) investment in Aspen and Novartis ’ acquisition of Ebewe injectables unit being notable examples.

These deals, which have continued in 2010 as evidenced by AstraZeneca's recent tie up with Torrent, have seen Big Pharma firm’s begin to build in emerging and non-western markets where generic drugs predominate and where companies like Mylan generate a significant amount of their revenue.

So, although Mylan has not said that future Big Pharma competition was a factor in recent investment decisions, it seems unlikely the firm will not have at least considered such trends when deciding where to spend its money.

Himachal Govt. Approves Biotechnology Park

Shimla: Himachal Pradesh Cabinet in its meeting granted permission for development of a biotechnology park over an area of about 35 acres at village Aduwal near Nalagarh in district Solan, on public-private partnership (PPP) model, attracting an investment of Rs 200 crore and generating employment to about 500 persons.

The park will consist of a biotechnology incubation centre to be housed over an area of about 1.07 acre and biotechnology industrial cluster to be developed by private promoter/developer over an area of about 31.93 acres, while it will be contributing significantly towards skill upgradation, technological improvement and capacity building of the youth of the state.

Plans for a Biomedical Institute in London

The Chronicle of Higher Education's Aisha Labi says plans to build a $1 billion biomedical institute in London are still on despite the severe cuts in public spending. The aim of the interdisciplinary institute, Labi says, is to figure out the underlying causes of some of the world's most "challenging" diseases. Those planning the center — the UK Centre for Medical Research and Innovation, as it's called — also hope it will eventually become a training ground for Britain's scientists. Nobel Prize-winning biologist Sir Paul Nurse will become the center's first chief executive, Labi reports. It's expected to be up and running by 2015.

Merck Partnering with Sinopharm On Vax

Merck & Co. said it will team up with Sinopharm, a huge Chinese distributor and maker of pharmaceutical and other health products, to market vaccines and potentially other drugs.

In its latest move to expand in emerging markets, Merck will form a joint venture with Sinopharm, cooperating on vaccines for diseases such as human papillomavirus in China. Human papillomavirus, or HPV, is a sexually transmitted disease that causes most cases of cervical cancer. Merck makes Gardasil, one of two vaccines approved to prevent HPV.

Merck said the companies will discuss teaming up to sell Merck's drugs in the country, the world's third-biggest economy with a population of more than 1 billion people. Merck's prescription medicines range from diabetes pill, Januvia, and heart drugs Cozaar and Hyzaar to Remicade for rheumatoid arthritis and Singulair and Nasonex for allergies.

Sinopharm, short for China National Pharmaceutical Group Corp., is China's largest pharmaceutical and health industrial group under supervision of the State Council. Its ten businesses include drug distribution and sales, pharmaceutical production, traditional and herbal medicines, medical device manufacturing and six institutes working on biological products.

Last year, the entire group had revenue totaling 65 billion yuan, about $9.5 billion. According to its website, the company is aiming to increase revenue by about 50 percent in 2012 and to become one of the top 500 global corporations in 2015.

The companies did not disclose terms of their agreement.

Merck, based in Whitehouse Station, N.J., is the world's second-largest drugmaker by revenue and is a top maker of both standard children's vaccines and vaccines for adults.

Like other major pharmaceutical companies seeking new revenue sources as blockbuster drugs lose patent protection, Merck has said doing more business in emerging pharmaceutical markets like China is a central part of its strategy.

"Innovative partnerships are key element of our approach," Merck Chief Executive Richard T. Clark said in a statement.

Sales growth of prescription drugs have slowed in the U.S. and Europe, while growth is picking up in countries including Brazil, China, India and Russia. They each have large populations, a growing middle class and a government investing more money in health care.

In May, Merck executives forecast that sales in emerging markets will bring more than 25 percent of all pharmaceutical and vaccine revenue by 2013, up from about 17 percent now, as the company puts more resources there.

McIlvaine Company,

Northfield, IL 60093-2743

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

E-mail: editor@mcilvainecompany.com;

Web site: www.mcilvainecompany.com