Bigelow
Laboratory's Ocean Science and Education Campus will be developed in three
phases, the first phase being the BCBB facility.PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY UPDATE
September 2011
McIlvaine Company
TABLE OF CONTENTS
DaVita Opens Biorepository with Lab Expansion
Grand River Aseptic Gains FDA Registration
vivoPharma Opens U.S. Preclinical Facility
DMS Topline Medical Launches More Space
Coral Reef Research Center Anticipated at Florida University
Almac Group’s New Headquarters in Philadelphia
Gilead Sciences Expansion in Foster City
Thermo Fisher Scientific Expands
KLMK Awarded Contract with Louisiana’s Slidell Memorial Hospital
Eurofins MWG Operon Gets ISO Certifications
Pharmalucence New Production Facility in Massachusetts
Bigelow Centre for Blue Biotechnology Nears Completion
RASIRC Doubles Manufacturing Space
Thermo Fisher Opens Biomarker Center
GE Capital Closes $78 Million in Credit Facilities for JHP Pharmaceuticals, LLC
University of Houston Enhance its New Health and Biomedical Science Center
Pfizer Completes Move of Research Unit
DOE's Argonne Lab Plans Facility
Masters’ New Facility Gets DEA Registration
DPR Completes Construction on Isis Facility
Renovations for N.C. State Animal Medical Center
Fareva to Acquire and Expand Pfizer Plant
German Medical Device Testing Lab Acquired by UL
Johns Hopkins Personalized Cancer Center
Osmotica Pharmaceutical to Open Manufacturing Operation in Marietta, GA
Gilead to Purchase Facility from Genentech
Biotech Company to Build Stem Cell Lab
New Hospital to Open in Palm Beach Gardens and Partner with Scripps
Lone Star College - Tomball Opens New Buildings
Catalent Expands Aprilia Facility
Biocon Building Malaysia Plant
Lonza to Expand Vitamin B3 Production in China
DMS Topline Medical Adds Cleanroom
Lonza and Fosun Form Joint Venture in Shaghai
Aurobindo Forms Russian Manufacturing JV
Gerresheimer Regensburg Expands China Facility
SGS Adds Capabilities to its Poitiers Facility
Aurobindo Forms Russian Manufacturing JV
Baxter Completes Expansion at Halle Facility
Sick Bay Opens at Leicester Royal Infirmary
USP Opens Expanded Indian Testing Lab
Global Demand Drives New CSL Plant
Granules to Expand API and Intermediate Capacity
German Testing Lab Acquired by UL
SynCo Bio Aseptic Filling Plant
Boston Scientific Invests in R&D at Clonmel Facility
Work Begins on New Decontamination Unit
Takeda Gets Grant for Vaccine Plant
UK Invests $97 Million in London Translational Research Center
Roche to Invest in Canadian Research Centre
Univar Builds Cleanroom in France
Shionogi & Co., Ltd - Completion of New Pharmaceutical Research Building
Africa is the Next Drug Development Frontier for Quintiles
Modernization of Richter-Helm BioLogics Production Facility in Hannover
GenScript to Provide Assay R&D for Roche China Unit
U.S. Packaging Company Poised for China Growth
Teva Further Streamlines Ops with Czech Plant Closure
Dalton Adds Formulation Service to Manufacturing Offering
Gerresheimer Invests in Plastics with Two New Plants
Ireland Awards $21.6 Million for Systems Biology Center
QPS’ Taiwan Lab is First to get GLP Certification
PPD Opens Global Central Lab in Singapore
Preclinical CRO Porsolt Expands in France, U.S.
Lab Research Lands New Preclinical R&D Contracts
Bangladesh a “Huge Opportunity” for Growth
Asia Wins Amdipharm Manufacturing Contract
Tate & Lyle Cuts Ribbon at Australia Food Systems Site
Apotex Working to Get FDA Import Alert Against Two Toronto Plants Lifted
CRO Covance Sets up Offices in Latin America
Schering-Plough Opens Dutch Injectables Facility
Lonza to Set Up Singapore Cell Therapy Plant
Piramal Moves UK API Operations
Approval Granted for Expansion of the Institute of Life Science at Swansea University
Cobra’s Keele Bio-Facility Passes Inspection
Roche Acquires Lonza's Singapore Manufacturing Facility
Sinovac Wins Flu Vaccine Contract in China
Boron Molecular Completes Australian Cleanroom
Mantecorp Installs Tech to Cut Energy Use
Pfizer Inaugurates New $214m Swedish Biotech Plant
Pfizer Pays Venezuela $17m; U.S. Pharmacies Try to Block Wyeth Deal
GEA Lyophil Supplies Freeze Dryers to Chinese Zheiiang Hisun Pharmaceuticals
CRL and Quotient Form New European Lab
DaVita Clinical Research has opened a biorepository to help drug discovery teams develop personal medicines by understanding patient populations.
Samples are fed into the biorepository from patients visiting 1,700 sites across the U.S. to give data on treatments, prescriptions and hospitalization, as well as standard information on age, gender and morbidities.
“It is the characterization of our data and the annotation of this data to our sample sets that distinguish our biorepository services from the majority of the industry”, Mahesh Krishnan, vice president of clinical research at DaVita, said.
Kidney-focused CRO (contract research organization) DaVita can give clients sample sets targeted to specific patient populations across a range of therapeutic areas. Samples are ready for proteomic, genomic or metabolomic research.
Accessing this can help support development of personalized medicines and biomarker discovery and validation. DaVita also expects clients to use the biorepository to improve drug safety and clinical trial design.
Supporting research in these areas could also feed into other areas of DaVita’s business, such as biomarker analysis, health economics and outcomes research, and clinical development.
Samples are collected from consenting patients using IRB- (institutional review board) approved protocols and shipped to the biorepository. At the facility DaVita inventories the samples into its laboratory information management system (LIMS) before storing them in -80°C freezers.
All samples are de-identified to support confidentiality and compliance with regulations.
Central lab expansion
Addition of the biorepository follows the expansion of central laboratory capacity over the summer. Investments at the Florida site focused on analytical methodology, information technology and instrumentation.
“We are confident that, over time, our continued investments in both physical assets and an expanded assay list will position us to be a prominent player in the clinical trials support business”, Kevin Goudreau, vice president of commercial development, said.
Grand River Aseptic Manufacturing, Inc. is now FDA registered and will begin manufacture of cGMP product for its first commercial client. “This is a fabulous opportunity for our organization,” said Grand River’s president, Gregory Gonzales. “Obtaining a commercial product brings tremendous value to the selling cycle for continued growth.”
Grand River’s 11,400-sq.-ft facility has been fully validated and deemed ready for manufacture of injectable sterile products for clinical trials and commercial use. The company has a Class 100 aseptic filling suite along with lyophilization, analytical and microbiological services, and regulatory support. The facility has the capability to handle biotech, small molecule, biologic and protein pharmaceuticals.
Australian preclinical services firm vivoPharma has opened a new vivarium and laboratory facility in the U.S. as part of an effort to expand its global reach.
The contract research organization (CRO) said it plans to use the new preclinical services unit in Hershey, Pennsylvania as a “sounding board for building new business engagements and maintaining strong relationships with existing clients in the U.S..”
The U.S. opening comes just a few weeks after vivoPharm partnered with Michigan-based contract services firm MPI Research in a deal designed to further the development of effective oncology models for preclinical research.
At the time company VP of global development Fernando Felquer said “This partnership will bring in revenue which in effect opens up the U.S. market for us,” adding that an “alliance with a large American CRO will help to put us on the map.”
vivoPharma is one of a number of non-U.S. preclinical research organizations to have expanded in North America over the last 12 months citing the market's revenue potential as a major motivation.
Last August, for example, UK-based firm Cyprotex bought U.S. counterpart Apredica, highlighting the firm's position in the U.S. ADME toxicity testing services market as the major attraction and predicting sales growth as a result.
This forecast was confirmed last month when Cyprotex revealed that the performance of its U.S. operation was the key to the 43 per cent increase in revenue it achieved in the second quarter.
Also, in June this year French preclinical CRO CITox launched CIToxLAB, a new organization formed following its acquisition of Canadian preclinical CRO Lab Research in April .
Speaking ahead of the launch CITox executive chairman Jean-Francois Le Bigot told Outsourcing-pharma.com that a key driver for the acquisition had been LAB’s facility in Laval, Canada from where his firm “can serve the entire North American market.”
And, more recently another UK-based preclinical CRO and discovery services provider, Selcia, opened a new facility in Massachuesetts. Again the firm said that growth of its U.S. business was the main reason for the expansion.
DMS Topline Medical, a leader in reconditioned biomedical and diagnostic imaging equipment, parts and rentals, announced that it expanded its medical equipment service offering with biomedical depot repair services. In addition, DMS Topline Medical increased its warehouse capacity by 5,000 square feet to accommodate six bench repair spaces, a cleanroom, and added inventory of in-demand biomedical parts in support of biomedical depot repair services.
"By offering biomedical depot repair services, customers can leverage the experience and expertise of our professionally trained biomedical technicians," states George Fraza, General Manager of DMS Topline Medical. "Whether a healthcare facility is experiencing a reduction in manpower or is looking for a cost-effective alternative to replacing their medical device, our biomedical depot repair services offer phone technical support and repair diagnosis, loaner equipment options, and quick turnaround and warranty for repairs."
Biomedical depot repair services complement the company's existing medical equipment and parts portfolio of used and reconditioned patient monitoring equipment, such as central stations, defibrillators, EKG machines, fetal and maternal monitors, modules, patient monitors, telemetry and associated biomedical parts; ultrasound machines, probes and parts; and diagnostic imaging parts.
DMS Topline Medical's operations, sales and warehouse are located in Fargo, North Dakota.
HWI Global®, the Pittsburgh-based cleanroom design builder, reports the company is completing the final stages of a Class 10,000 Life Science Clean Room at Walter Reed Army Institute of Research in Silver Springs, MD under the direction of the U.S. Army Corps of Engineers.
The project includes four separate Clean Room work zones within the designated area, including an ISO 7 Clean Work Room to house two Bio-Safety Cabinets and two Incubators, and an ISO 8 Centrifuge Clean Room. HWI Global® has installed its proprietary Bio-Gard™ Modular Wall System, an aseptic, high-impact, Class 1/A bio-pharmaceutical wall system with heat-welded seams. The Company provided the complete design-build-clean room air handling and control system.
Deric Haddad, CEO, HWI Global® states, "Our goal is to complete the Walter Reed project before the end of the third quarter. We put a major effort into it and it looks like we have succeeded. This is an opportunity to showcase the latest variation of our Bio-Gard™ Modular Wall System -- an extremely aseptic, but high-impact, finished surface with heat-welded seams. We expect to demonstrate too many end users that our system has far greater performance features than the others around the industry. Its high-impact, finished surface provides the durability and longevity sorely needed in bio-pharma labs. We are delighted with our team's success and are set to balance and ISO certify on September 26."
HWI Global® was selected for this project by FLAD Architects, and Affiliated Engineers, both Life Science specialists from Gainesville, FL. HWI entered into a subcontract with John J. Kirlin, a Rockville, MD-based general contractor.
A new $34 million oceanographic research center at Nova Southeastern University in Florida will help students study coral reefs—about 84% of the nation’s reefs are in South Florida waters. Moss Miller LLC has completed major concrete work on the facility. The five-story, 86,000-sf Center of Excellence for Coral Reef Ecosystems Science Research Facility sits on 10 acres of the university’s Oceanographic Center. Designed by Cannon Design and ACAI architects to achieve LEED Silver certification, the center, upon completion in 2012, will enable the university to significantly increase the number of academic jobs available for graduate students.
Based in Northern Ireland, Almac Group recently began the first phase of its new North American headquarters in Philadelphia. Francis Cauffman leads the Building Team, planning 240,000 sq.ft. of space in two buildings: one, a 165,000 sq.ft. clinical packaging and production facility; the other, a 75,000 sq.ft. warehouse. The team decided to marry American and European themes throughout the design. Interior workspaces are open to promote a more egalitarian atmosphere, while a glass curtain wall lets natural light seep inside. Other materials, such as brick, zinc panels, and mullions, evoke Almac’s European properties.
Gilead Sciences, which was already planning a massive expansion of its corporate headquarters on Lakeside Drive, is now pursuing an even larger project that will nearly double the footprint of its campus, city officials say.
The biotech giant won approval from the city in 2010 for a renovation of its headquarters that would allow the company to increase its workforce there from 1,700 to as many as 3,400 employees. But the purchase of an adjacent property will enable Gilead to take its architectural makeover much further.
Gilead is being tight-lipped about the new plans, which involve a roughly 30-acre property the company purchased from Electronics for Imaging Inc. in 2009 for $137.5 million. A spokesman declined to comment other than to say, "As Gilead's business continues to grow, we are always evaluating needs to expand with regard to both laboratory and office space."
Gilead is a world leader in the field of antiviral medicine, developing and marketing drugs for the treatment of HIV, hepatitis B, influenza and other diseases. The company has 4,200 employees around the world, from Poland and the United Kingdom to Australia, and its net product sales in 2010 were $7.39 billion.
Gilead's expansion in Foster City shows the company -- which is branching out into other areas of drug research, including the treatment of pulmonary disease -- has a plan to grow and remain prosperous, said John McCamant, a biotech analyst and editor of the Medical Technology Stock Letter.
"They're a clear leader, and they plan on remaining a leader," he said. "They believe they're going to be a prosperous company going forward."
The expansion also demonstrates yet again the ability of high-tech and biotech companies to thrive in the midst of a historically sluggish economy, said McCamant, pointing to Apple's ambitious plans for a new campus in Cupertino.
"Biotech and high-tech don't live in the recession that the rest of the world does," he said. "People want to live here, (and) these jobs can support this kind of high-end economy."
Gilead's corporate headquarters sits on about 40 acres between Mariners Island Boulevard and Vintage Park Drive just east of the San Mateo border. The purchase of EFI's property at 301 Velocity Way, which includes a five-story office building, gives the company about 70 acres.
The initial expansion plan called for demolishing up to eight of Gilead's 17 buildings, most of them two or three stories in height, and replacing them with new structures as high as 10 stories as well as increasing the total number of parking spaces to roughly 3,000. That plan will now likely change as Gilead incorporates the EFI property into its vision for the headquarters, said Rick Marks, Foster City's community development director.
Though the company will now be able to increase the number of employees and the amount of lab and office space on the site significantly, it's not clear whether that will happen, Marks said. It's possible the company simply wants to spread out and provide employees with a more open, spacious environment.
Gilead has not submitted any formal plans yet, Marks said, and there is no timetable for the company to do so. "We're still in the talking stage, and they have a lot of corporate decisions to make," he said.
The Foster City Council approved Gilead's previous expansion plan despite environmental concerns, including worries from neighbors along Mariners Island Boulevard about construction noise.
Thermo Fisher Scientific said that it has established a new Biomarker Translational Center in Cambridge, Mass. The center is focused on mass spectrometry-based biomarker discovery research and the translation of those markers into the development of routine clinical assays. The firm said the new center combines its Brahms diagnostics product lines with the capabilities of its existing Biomarkers Research Initiatives in Mass Spectrometry Center.
West Pharmaceutical Services is expanding its R&D center in St. Petersburg, FL. The company’s development center will focus on new elastomer formulations, process technologies and products for its global component manufacturing network.
“The customer-focused activities at the advanced development center will enable West to optimize product development and manufacturing processes so we can help customers meet their business objectives, such as quality by design initiatives,” said Fran DeGrazio, West’s vice president, marketing and strategic business development.
“This investment enables us to continue to support our customers’ requirements for extremely clean pharmaceutical packaging and delivery system components by introducing new innovative technologies and by building on our established technologies, including the Westar ready-to-use process, FluroTec barrier film and Envision automated vision inspection system,” said Tyson Popp, vice president, R&D, West.
The development center will feature technologies for mixing, compounding, molding and finishing elastomer packaging components and is expected to be on-line by October 2011.
The investment is the second West has made in its manufacturing network this year. In March the packaging and delivery device maker ramped up production capacity for syringe and intravenous system components at its facility in Kinston, North Carolina.
This activity contrasts markedly with West’s activities last year, when the firm announced plans to close a facility in Pennsylvania and sell a plant in Cornwall, UK to reduce its costs and “keep our production capabilities and cost structure in balance with the expected changes in demand.”
The focus on packaging and delivery systems is also in keeping with comments made during West second quarter results presentation last month when it revealed that both business units saw ‘modest’ revenue growth in the period.
“Pharmaceutical Packaging Systems, stronger sales in Europe and Asia more than compensated for customer and product-specific sales declines in North America. Pharmaceutical Delivery Systems growth was due to increased contract manufacturing business and sales of reconstitution devices."
The Slidell Memorial Hospital renovation will include a 56,000-sf Emergency Room/Cardiology Expansion.
KLMK Group Inc. has been awarded the Project Management contract for the Emergency Department and Cardiology Expansion Project at Slidell Memorial Hospital in Slidell, La.
Slidell Memorial, and 182-bed acute care community hospital, is expanding their current facility. The renovation will include a 56,000-sf Emergency Room/Cardiology Expansion.
The new facility will allow for shorter wait times, faster assessments, quicker discharges and more inpatient private beds. In addition, it will allow Slidell to prepare for future community growth while adding new technologies, equipment and physicians.
“After issuing a Request for Proposal (RFP) and an extensive national search, KLMK Group provided the most comprehensive strategy and healthcare experience to assist in managing the construction of our expansion. We are confident that the expertise that KLMK brings to the project will ensure that Slidell Memorial achieves our goal of improving the quality of life in our community,” says Barry Winters, Director Materials Management at Slidell Memorial Hospital.
KLMK has been retained to provide program management services, from the design and preconstruction phase through transition, related to the renovation of the existing facility.
Construction on the new facility is scheduled to begin in March 2012 and be completed by June 2013.
Eurofins MWG Operon said that it has received two ISO certifications covering quality management systems for its Huntsville, Ala., facility.
The genomics services firm said that it received ISO 9001:2008 and ISO 13485:2003 certifications from BSI Group America.
Martin Kunz, CEO of Eurofins MWG Operon's U.S. operations, said that the certifications are "an important step in the expansion of Eurofins MWG Operon products and services beyond research use only applications and into the diagnostics market."
Dannon has opened a new $9m research and development center at its White Plains, NY headquarters, in order to improve collaboration between departments and bring new products to market more quickly.
The company said that the Dannon Discovery & Innovation Center is intended to increase collaboration between R&D, marketing, sourcing and supplier development, and other departments that play a role in innovation and bringing new products to the market.
The company’s vice president of Research & Development, North America, Albe Wendt said: “By physically bringing the R&D team closer to other core business functions, we will foster greater collaboration to accelerate pursuit of our mission - to bring health through food to as many people as possible.”
The center contains state-of-the-art manufacturing equipment, a sensory and consumer insights lab, and laboratories for quality analysis and fruit & flavor, the company said.
The company has also added dedicated office space for suppliers at the White Plains facility, with the intention of boosting collaboration, innovation and integration at every stage of the development process.
Senior director of public relations for Dannon Michael Neuwirth said: “The yogurt category has been propelled forward by developing innovative concepts for nutritious products… The Dannon Discovery and Innovation Center will help us further accelerate our growth.”
Neuwirth said that six of the company’s team members have decided to relocate to New York and about 20 new people have been added to Dannon’s R&D team in recent months.
“The relocation of the R&D team to our headquarters is a significant step involving the relocation of 6 highly-skilled team members and the creation of a state-of-the-art facility in which we can create new products that are readily scalable for commercial production,” he said.
Massachusetts-based radiopharmaceutical product supplier, Pharmalucence, is constructing a new pharmaceutical manufacturing facility at Billerica in Massachusetts, U.S.
The facility is intended to modernize production assets for use in the production of Pharmalucence radiopharmaceutical products and to support the company's continued expansion in aseptic fill and finish contract services.
The facility is designed to address scale, from small clinical trials up to full commercial scale production to clients worldwide.
It will also serve as the company headquarters. Investment on the facility is estimated to be $30m.
The first phase of construction started in the second quarter of 2011. The construction will be fully completed by mid-2012. Full drug production is expected to start by mid-2013.
The new facility will employ approximately 100 full time positions, including 25 new ones. During the construction phase, it is expected to create up to 150 construction jobs.
The new facility will consolidate the company's current operations based in four buildings at a single site. Pharmalucence currently leases a 45,000ft2, four-building complex on DeAngelo Drive in Bedford staffed by 85 people. Pharmalucence was established through a management buy-out of CIS-US in 2007.
Pharmaceutical manufacturing facility specifications
"The facility will provide manufacturing for the entire Pharmalucence product pipeline."The facility will span 70,000 sq. ft. at 29 Dunham Road. The property was acquired for $2.7m from RREEF in December 2010.
It will feature state-of-the-art automation and employ barrier isolation and equipment from Robert Bosch Packaging. Pharmalucence has chosen to implement what it believes is the most advanced approach to aseptic processes, with an eye towards the highest levels of regulatory compliance.
Pilgrim Software is providing information technology to allow Pharmalucence to advance from a manual to a fully automated compliance system.
The facility will be modular and is designed to accommodate two automated suites featuring barrier isolation. The first suite can automatically feed two 180 sq. ft. lyophilisers.
Once this system becomes operational, Pharmalucence intends to build a second suite that will be equipped to handle highly potent compounds. This second suite will mirror the design of the first, but share no infrastructure that would compromise the full separation of the high potency operation. The second suite will also feed two similarly sized lyophilisers.
Production of the Billerica plant
The facility will provide manufacturing for the entire Pharmalucence product pipeline. Pharmalucence manufactures vivo imaging agents used to diagnose and treat cancer and heart diseases. The facility will also undertake contract manufacturing services.
The project has been financed by a mix of federal, state and local funding as well as tax incentives.
To facilitate the expansion a $20m first recovery zone facility bond, a federally authorized tax-free bond was issued by MassDevelopment on behalf of Pharmalucence. The bond, which equals two-third of the total project cost, was bought by TD Bank.
The contract for the facility's architectural design, engineering and construction was awarded to integrated project services (IPS) in June 2011. IPS is a Pennsylvania based full-service engineering company.
Work on the project began in the third quarter of 2010 when the project plan was finalized and contractors and equipment vendors were selected.
The demolition of the property began in February 2011. By May 2011, the new filling line mock-up was constructed in Germany. The line design will be evaluated and refined by the third quarter of 2011.
"Pharmalucence is constructing a pharmaceutical manufacturing facility at Billerica in Massachusetts, U.S.."By the end of 2011, the first phase of construction involving offices and labs will be completed and the second phase involving the production area will begin.
Partial occupancy of the facility is expected by late 2011. The first lyophiliser will be delivered towards the end of August.
The 2012 schedule includes factory testing and installation of facility infrastructure and utilities, factory testing, delivery and installation of the new filling line, factory testing, delivery and installation of secondary production equipment, facility start-up and validation.
Upon conclusion of validation of all systems, FDA inspection and approval must occur prior to engaging drug manufacture. Pharmalucence is working towards facility approval between the first and second quarter of 2013.
Massachusetts-based radiopharmaceutical product supplier, Pharmalucence, is constructing a new pharmaceutical manufacturing facility at Billerica in Massachusetts, US.
The facility is intended to modernize production assets for use in the production of Pharmalucence radiopharmaceutical products and support the company's continued expansion in aseptic fill and finish contract services.
It will also serve as the company headquarters. Investment on the facility is estimated to be $30m.
The first phase of construction started in the second quarter of 2011. The construction will be fully completed by mid-2012. Full drug production is expected to start by mid-2013.
It will feature state-of-the-art automation and employ barrier isolation and equipment from Robert Bosch Packaging.
The facility will provide manufacturing for the entire Pharmalucence product pipeline.
The Bigelow Centre for Blue Biotechnology (BCBB) is a new research centre being built in East Boothbay, Maine, U.S. It will conduct frontline research on applying the ocean’s microbial ecosystems to biopharmaceuticals. The $10 million centre broke ground in September 2010 and is slated for completion in November 2011.
BCBB forms phase one of the 64-acre Ocean Research and Education Campus being built by Bigelow Laboratory. It will span an area of 24,740ft².
Bigelow
Laboratory's Ocean Science and Education Campus will be developed in three
phases, the first phase being the BCBB facility.
The campus will also house the Center for Ocean Biogeochemistry and Climate Change, and
these two facilities will be developed in phases two and three and are expected to be opened by May 2012.
A fourth science wing and administration building are being planned but are yet to be scheduled.
Bigelow Laboratory owns 64 acres in East Boothbay. The campus will be developed on 14 acres while the remaining property will be used as wildlife habitat, wetlands, and open space. The three facilities will occupy a total space of 70,000ft².
The $31 million campus will provide 200 jobs during construction and employ 100 full-time staff at full capacity. Bigelow's current leased facilities at the Department of Marine Resources will all be shifted to the new campus.
The BCBB provides frontline research facilities for companies in the pharmaceutical, aquaculture, environmental impact assessment, analytical instrument and biofuels industries.
The Lincoln County Economic Development Office projects BCBB will attract $34m new money to the state of Maine and help companies in acquiring new patents, intellectual property licensing and product development, in five years.
The three-storey facility will house the world's first microbial single cell genomics facility, an advanced flow cytometry laboratory and a bioreactor facility.
The Provasoli-Guillard National Center for the Culture of Marine Phytoplankton (CCMP), which will be a part of the facility, is claimed to be the largest such collection centre in the world.
In addition, there will be 12 private offices, a café a conference space and a molecular biology laboratory with shared facilities for imaging and sterilization. There will also be space to accommodate two mobile laboratory units.
The facility has been designed to receive LEED certification at the gold level. The buildings are designed to use maximum daylight and absorb heat. The exterior cladding of the façade will be zinc and wood.
Interior and exterior building materials will be selected based on their low carbon footprint and high recycle content. Low water flow fixtures will be installed to conserve water.
The natural landscape design will eliminate any irrigation requirement. High performance window, roof and wall systems will be installed to improve energy performance. The construction material will be recycled to minimize waste.
The facility is being financed through funds received from the Maine Technology Asset Fund (MTAF) and contributions from private sources. A $4.45m finance facility was granted by the MTAF in 2009. It represents the largest single grant from the state's $50m research and development bond.
The property at East Boothbay was acquired in 2005 through a $1.46m loan facility granted by the National Oceanic and Atmospheric Administration. An additional $2m was obtained through private sources to finalize the property deal and commence planning of the new campus.
The centre has been designed by Perkins+Will in collaboration with WBRC Architects and Engineers.
"The $31 million campus will provide 200 jobs during construction and employ 100 full-time staff."
The contract for site planning was awarded to Terrence J. DeWan and Associates. Consigli was contracted for construction management services. Fore Solutions was the LEED consultant for the project.
Knickerbocker Group was contracted as the civil engineer for the project. The company has provided the entire site engineering and environmental permitting services.
Cetero has strengthened its infrastructure with expansions in multiple clinical dermatology and transdermal delivery system (TDDS) services at four of its facilities.
Now the contract research organization (CRO) can conduct custom-designed studies in the two areas in its Miami, St. Louis, Toronto and Fargo facilities.
The firm also offers a higher level of preclinical analysis with the addition of two MicroMass LC/MS/MS systems to complement its current four LC/MS and four LC/UV and GC/MS systems.
Cetero says the new technology gives it the capabilities to evaluate the in vitro dermal absorption of the most challenging compounds currently in development or production.
Alan Copa, president of clinical operations in the Fargo facility said: “The ability to offer custom-designed studies and work as a true partner with study sponsors sets Cetero apart as the leader in dermatology and transdermal applications.”
It will also allow its pre-clinical dermatology research laboratory to further expand its ability to conduct testing of in vitro percutaneous absorption and semisolid release to GLP standards, including analytical method development and validation.
Copa added: “Our team understands how critical factors such as dose application and removal, skin conditions and diseases, lifestyle history and adverse event assessment (skin and systemic) will impact how the skin absorbs a compound, assuring the design of studies to control for those details.
“This understanding, combined with our advanced technology, allows our integrated team of dermatology experts to seamlessly leverage their knowledge into the design and performance of clinical trials.”
Cetero also says that its extensive collaboration with the FDA, the US Pharmacopeia and other international agencies should make regulatory approval less taxing.
In fact the company has gone beyond recent FDA guidance for transdermal delivery systems, which recommend that at least two “climatically different sites” should be used for assessing patch adhesion performance, and irritation and sensitization potential.
The North Carolina-based CRO has spread the study processes across all four enhanced sites, with what it says is “the same protocol and comprehensive final report within one full-service package.”
Copa added: “All studies at Cetero can be performed to FDA, International Conference on Harmonization (ICH), European Medicines Agency (EMA) and Organization for Economic Co-operation and Development (OECD) specifications as needed to facilitate regulatory approval.”
Cetero’s efforts to emphasize its compliance with regulations is understandable given that it is currently the subject of an FDA investigation.
In July, sponsors were faced with the prospect of re-doing their lab work after the FDA accused the company of faking records, and manipulating lab samples to meet approval criteria.
The alleged transgression was announced publically after the firm’s Houston facility received unsatisfactory responses to two 2010 investigations.
The investigation was first flagged up by Cetero themselves, after an employee raised formal allegations of regulatory violations in 2009.
However, the employee claims to have first reported wrongdoing in a meeting back in June 2007.
The results of the investigation are still pending.
Privately-owned US biotech NanoSmart Pharmaceuticals says it has started work on a delivery platform for cancer drugs after moving into a new corporate HQ.
NanoSmart, which is now based at Laguna Hills, California, is working on a human autoimmune antibody-based technology that, the firm claims, offers improved tumor targeting capabilities by focusing on areas of necrosis, dead tissue, found in many types of cancer.
CEO Henry Smith said that the new facility’s laboratory and administrative space allow the firm to begin formal development of its initial product pipeline.
"Our new location gives us a physical presence in Orange County, California and allows us to move forward with our strategic development goals. We are excited about the opportunity to develop our initial products and conduct formal, nonclinical studies leading towards our initial regulatory filings.”
RASIRC®, the steam purification company, announced that it has relocated its global operations to a significantly larger facility. The new 19,500 square foot space includes a Class 1,000 cleanroom for manufacturing products for the photovoltaic industry. RASIRC products deliver ultra-pure water vapor for semiconductor, photovoltaics, nanotechnology, and other manufacturing applications.
“Rapid growth in RASIRC products required a new facility to handle higher volumes,” said Jeffrey Spiegelman, RASIRC founder and president. “This expansion allows us to handle the increased production and doubles our R&D lab space.”
RASIRC is experiencing continued growth in demand for its products, particularly Steamers for photovoltaic passivation films for the solar industry and humidity control for semiconductor manufacturing. In the solar industry, RASIRC products deliver ultra-pure steam that is needed to form oxidation layers that improve solar energy capture efficiency. In addition, steam can be used in conjunction with phosphorous or boron doping to improve the emitter profile. For the semiconductor industry, ultra-pure steam is used for generating oxide films on semiconductor wafers in diffusion and rapid thermal processing. Additional uses include wafer cleaning of next generation films and atomic layer deposition for high K layers. RASIRC reduces costs, improves quality, and dramatically improves safety associated with these applications.
"RASIRC has grown rapidly over the last five years," said Spiegelman. “The transition from an R&D to a manufacturing company is demonstrated by the increase in our orders from both new and repeat customers. The market validation of our products has enabled us to move into a new and larger facility, significantly increase staffing levels, and enabling us to fund development of further innovation.”
Thermo Fisher Scientific Inc. announced at the Human Proteome Organization (HUPO) 2011 World Congress the establishment of a new Biomarker Translational Center (BT Center). The purpose of the BT Center is to accelerate mass spectrometry (MS)-based biomarker discovery research and its translation into the development of routine clinical assays for subsequent commercialization. Based in Cambridge, Mass., the BT Center combines advanced expertise from across Thermo Fisher including its Brahms product line and the team at the Biomarkers Research Initiatives in Mass Spectrometry (BRIMS) Center.
“Through the vertical integration with the unique talent in MS-based biomarker discovery and high-throughput quantitative assay development at BRIMS, we aim to expand our pipeline of new protein and peptide biomarkers with potential as clinical assays,” said Bruno Darbouret, director of research and development for B•R•A•H•M•S Biomarkers at Thermo Fisher. “Ultimately, this development effort will speed the commercialization of diagnostic tests that address life threatening diseases.”
Thermo Fisher, already a leading provider of specialty in-vitro diagnostic tests based on its patented Thermo Scientific Brahms biomarkers, understands clinical market needs and will apply core strengths in diagnostics development, validation and commercialization to define the disease areas of focus for the BT Center. The company’s well-established relationships with clinical researchers will provide access to clinical partners and patient samples for biomarker discovery and validation studies using Brahms Biomarkers.
For the disease areas chosen, the BRIMS Center will apply its competencies in quantitative MS biomarker discovery and multiplexed selected reaction monitoring (SRM) assay development to identify putative biomarkers and their clinically relevant isoforms. Subsequently it will develop robust, reproducible, targeted MS-based assays appropriate for the validation of putative biomarkers and ultimately for the clinical diagnostics market.
Thermo Fisher will own all intellectual property around the biomarkers and assays, and it will commercialize the assays as clinical diagnostic products and services after obtaining all requisite regulatory approvals.
“Efficient translation of MS-based biomarker discovery research into the development of routine clinical diagnostic assays is an important challenge in the field of personalized medicine,” said Bryan Krastins, group leader, BT Center. “Bridging this gap requires high-level competence in MS-based biomarker discovery and routine assay development for biomarker verification and validation. Understanding clinician and patient needs and having extensive experience in clinical validation are also essential to the transformation of novel tests into clinical routine assays. The new BT Center integrates all the capabilities needed to speed the clinical assay development pipeline from biomarker discovery to clinical assay development and validation.”
GE Capital, Healthcare Financial Services announced that it has closed, as administrative agent, $78 million in senior secured credit facilities for JHP Pharmaceuticals, LLC. In addition to refinancing certain existing indebtedness of the company, the credit facilities provide JHP with additional growth capital. GE Capital Markets served as joint lead arranger and sole bookrunner.
JHP Pharmaceuticals, LLC is a privately-owned pharmaceutical company headquartered in Parsippany, NJ, that develops, manufactures and markets mature brand and generic pharmaceutical products for the US hospital segment.
Aircuity, the smart airside efficiency company, announced that the University of Houston (UH) is leveraging Aircuity’s OptiNet demand-control ventilation (DCV) system, to develop a ventilation optimization program that will not only enhance indoor air quality, but significantly improve overall energy efficiency in its new Health and Biomedical Science Center (HBSC). When at full capacity, the annual energy savings for this facility are projected to be $239,270, which would give the project a simple return on investment of 2 years.
University of Houston will implement Aircuity’s OptiNet system in the building’s office, classroom, ambulatory surgery suite, vivarium and laser center areas of the Biomedical Center. Leveraging DCV technology, Aircuity’s multiplexed air sensing and measurement system will be able to continuously sense and analyze the building’s indoor environment and provide intelligent inputs to the building management systems, making adjustments to the ventilation flow as needed and allowing the facility to optimize airflow in an efficient manner.
Located in downtown Houston, UH has made great strides in encouraging green practices across their campus. As a signatory of the Presidents Climate Commitment (PCC) the University is investing in significant resources and cutting-edge technologies to help in the effort of climate neutrality.
Bringing together investigators from different colleges and departments in a first-class research facility, the 167,000-square-foot, six-story HBSC is a key clinical, educational and interdisciplinary research structure at UH. The center has been designed to facilitate collaboration across neuropsychology and neuroscience, measurement and statistics, biology and biochemistry, biomedical engineering, pharmacy, optometry, computer science and computational physiology.
Within the areas where OptiNet has been implemented, the ventilation system will continuously monitor the entire indoor environmental quality (IEQ) of the room, going beyond just temperature levels. The OptiNet system will be able to monitor the space for elements such as Carbon Dioxide (CO2), Carbon Monoxide (CO) and other airborne particulates. When the concentration of these agents increase above a prescribed limit, the OptiNet system directs the building’s ventilation system to increase the amount of fresh air delivered to the space being monitored. Increased ventilation levels will remain in effect until the environmental quality is back to a desirable level. This approach provides a more complete overview of the environment, ensuring that the rooms remain a healthy and productive environment.
Pharmaceutical giant Pfizer Inc. said that it has completed the move of one of its research units from Groton to Cambridge, Mass., and plans to complete the relocation of another group of scientists by the middle of next year.
Pfizer said that its cardiovascular and endocrine disease research unit completed its move to Massachusetts this summer and that its neuroscience unit would follow next year. The announcement came as the New York-based company said it had signed a 10-year agreement with the Massachusetts Institute of Technology to move the two research units into a new 180,000-square-foot research headquarters in Cambridge's Kendall Square.
"This is a very exciting period in Pfizer R&D," Pfizer Senior Vice President Rod McKenzie said in a statement. "By expanding our presence in one of the world's great centers of scientific and medical innovation, we will provide the best environment for our researchers to invent the next generation of medicines in areas of greatest need, such as Alzheimer's disease, schizophrenia, diabetes and cardiovascular disease."
Pfizer said 400 to 450 researchers—many currently working in Groton—would eventually populate the new Cambridge site at 610 Main St. South, which won't be ready for occupancy until late in 2013. The company added that scientists previously working in the Groton cardiovascular research unit were sent to an interim location at 620 Memorial Drive in Cambridge, and that researchers now in the local neuroscience unit would be making a similar interim move in the second quarter of next year.
Pfizer said the Cambridge site will recruit about 40 percent of its employees in the Massachusetts area, while 60 percent of the scientists will come from other company research sites, principally Groton. The company said Tim Rolph will continue to head up the company's cardiovascular unit, while neuroscience-unit chief Mike Ehlers will be making the move to Cambridge as well.
Pfizer said a third Groton research unit, involving the study of anti-infective medications, is in transition.
"We are building a research unit in Shanghai that will support our current and future anti-infectives portfolio," Pfizer spokeswoman Kristen Neese said. "As we build this new research unit in Shanghai, we will continue to run our existing clinical and pre-clinical programs in the U.S. to ensure uninterrupted progress on these important programs in areas of high unmet medical need."
The research moves are part of a major downsizing of local Pfizer operations that will eventually result in the loss of 1,100 positions in Connecticut by sometime next year.
About 3,400 Pfizer employees will remain at the Groton campus, which became the sole remaining company site in the region when the last worker vacated the former Pfizer Global Research & Development headquarters in New London in June.
While some local officials have worried about Pfizer's commitment to Connecticut as it moves many of its most important discovery scientists to Massachusetts, the company said its Groton campus will be more than a support center for R&D.
"Every new Pfizer medicine in development will come through Groton on its way to patients," Neese said.
She added that Groton will continue to perform many of the functions of discovery science, including early screening of potential therapeutic compounds, identifying and assessing the most promising drug candidates and on-site organic and synthetic chemistry work.
"The Pfizer Connecticut R&D laboratories will remain Pfizer's largest research site," Neese said.
"Colleagues at the site will continue to play a critical role in turning discoveries into medicines as Pfizer's Center for Discovery and Development Sciences. It is anticipated that the site will be involved either directly or indirectly in advancing the Pfizer's R&D portfolio."
The US Department of Energy broke ground on a $34.5 million facility located at the Argonne National Laboratory that will provide protein crystallization services for biomedical research and other scientific studies, according to ANL.
Located in Argonne, Ill., the Advanced Protein Crystallization Facility (APCF) was designed and will be built with funds from the State of Illinois.
The 50,000-square-foot lab will enable researchers to produce, purify, and characterize a range of proteins rapidly, and will specifically support genomics studies conducted by the DOE's Structural Biology Center (SBC) and the Midwest Center for Structural Genomics (MCSG) , both of which are located in Argonne's facilities.
The MCSG is one of four Protein Structure Initiative Centers funded by the National Institute of General Medical Sciences, and it "will be the cornerstone of the initial research at the APCF," ANL said.
"When the doors of this building open, it will create extraordinary new opportunities for biological, pharmaceutical, and biochemical research, spurring discovery, innovation and job creation at Argonne and throughout Illinois," ANL Director Eric Isaacs said in a statement.
"The biggest bottleneck in protein crystallography arises not when we're taking the crystallization data, but in the earliest steps of protein crystallization," Carol Giometti, director Argonne's Biosciences Division, which operates the SBC, said in a statement. "When the APCF opens, it could increase our productivity by a factor of five compared to where we are right now."
The APCF will be outfitted with high-throughput microfluidics and robotics instruments to enable protein crystals to be manufactured on a mass scale, according to ANL.
ANL said it expects the new facility to reap $110 million for research activities over a five-year period, creating 550 jobs, and that it will bring in extra funding to research centers such as the University of Illinois.
"The APCF will directly and indirectly enhance the efforts of many researchers," added Wayne Anderson, a professor at Northwestern University and director of the Center for Structural Genomics of Infectious Diseases.
"Not only will our projects benefit through use of the advanced technology at the APCF but also collaborations between investigators at a number of Illinois institutions will move more quickly, providing experimental results that will expand research programs and enhance drug discovery efforts."
Masters Pharmaceutical, a Cincinnati, OH-based pharmaceutical distributor, has received its DEA registration for a new distribution center in Fairfield, OH. The 148,000-sq.-ft. facility is licensed to distribute pharmaceutical products including CII-CV controlled substances and temperature controlled products to all 50 states and PR. The facility will be used primarily for third party logistics. Services will range from pick-pack and ship to complete order-to-cash process support.
“We are excited and committed to the space of pharmaceutical third party logistics. As the low cost provider in the industry, Masters TPL will allow pharmaceutical manufacturers to enhance their bottom line thru the cost containment advantages that we offer. At the same time Masters TPL provides a number of premium level services that other TPL providers cannot or will not provide,” said Denny Smith, chief executive officer, Masters Pharmaceutical.
DPR Construction announced that construction is complete on the new 176,000 sq. ft. research facility for Isis Pharmaceuticals Inc. in Carlsbad, Calif.
Developed by BioMed Realty Trust Inc., the build-to-suit project is the first structure in the new Carlsbad Oaks North Business Park development.
The research facility consolidates the majority of Isis Pharmaceuticals into one building to streamline operations and management. It also increases BioMed’s total leased space with Isis to approximately 204,700 sq.ft.
Highlights of the facility include an open environment and flexible designs, laboratories, an outdoor meeting and dining area and site walking trail. The owner is anticipating LEED certification from the USGBC for incorporating the latest in sustainable technologies and practices.
Designed by the architectural firm, DGA of San Diego, DPR provided construction services on the Isis Pharmaceuticals project. DPR Construction began building this research and design facility in June, 2010.
More than 100,000 sq. ft. steel and aluminum panels in a variety of systems and profiles were utilized on the Randall B. Terry, Jr. Companion Animal Veterinary Medical Center. The Randall B. Terry, Jr. Companion Animal Veterinary Medical Center ushers in a new era in veterinary medicine at North Carolina State University’s College of Veterinary Medicine in Raleigh.
Known as the Terry Center, the 110,000 sq. ft. facility is one of the nation’s largest vet hospitals and is more than twice the size of the original Small Animal Veterinary Teaching Hospital. More than 100,000 sq. ft. of Pac-Clad steel and aluminum panels in a variety of systems and profiles were utilized on the project.
Design for the project was provided by Atlanta-based FWAJDB Architects in conjunction with architect of record Small Kane Webster Conley Architects, Raleigh. Beginning with a new master plan for the entire biomedical campus, the project team took an approach that was sensitive to the landscape and unique elements, which made up the campus
Governor Bob McDonnell announced that Fareva, a privately-held international contract manufacturing firm that operates in four business segments-homecare and industrial, cosmetics, pharmaceuticals, and food, will acquire and invest $42 million in Pfizer's consumer products manufacturing site in Henrico County. Fareva will continue to operate the facility, which manufactures and packages brand-name products such as Advil, Chapstick and Robitussin.
Pfizer and Fareva also have reached a manufacturing and supply agreement that will enable the plant to continue production of Pfizer consumer products for the global marketplace. All of the nearly 500 Pfizer colleagues that are employed at the site will transfer to Fareva, and an additional 90 positions will be added.
Speaking about the announcement, Governor McDonnell said, "Fareva's acquisition of the Pfizer plant and retention of approximately 500 jobs is tremendous for Henrico County and the Commonwealth. In addition, the plant will add another 90 employees. This project is also significant because well-known Pfizer products will continue to be manufactured at the facility as Fareva expands into the North American market with its first U.S. site."
"We are thrilled that Pfizer and Fareva were able to strike this agreement and both retain and expand the Henrico County manufacturing plant," said Jim Cheng, Virginia Secretary of Commerce and Trade. "I look forward to the inevitable growth of this partnership that builds on Pfizer's brand success while opening Fareva to the U.S market."
Headquartered in Luxembourg, Fareva employs 5,500 colleagues and reported $1.2 billion in revenues in 2010. The company operates 28 manufacturing facilities in Europe and emerging markets.
Speaking about the pending acquisition, Fareva's Chief Executive Officer Bernard Fraisse stated, "We have been looking for the right opportunity to expand our manufacturing footprint into North America and establish our pharmaceutical and cosmetics businesses in the United States. The Henrico County site has a talented and motivated workforce and state-of-the-art manufacturing, packaging and warehousing facilities that are a perfect fit for growing our commercial portfolio in this region."
Pfizer states it “applies science and its global resources to improve health and well-being at every stage of life. The company strives to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Its diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with its responsibility as the world's leading biopharmaceutical company, Pfizer also collaborates with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.”
The Virginia Economic Development Partnership worked with Henrico County to secure the project for Virginia. Governor McDonnell approved a $650,000 grant from the Governor's Opportunity Fund to assist Henrico County with the project. Governor McDonnell also approved an $800,000 performance-based grant from the Virginia Investment Partnership (VIP) program, an incentive available to existing Virginia companies. Through its Virginia Jobs Investment Program, the Virginia Department of Business Assistance will provide funding and services to support the company's recruitment, training and retraining activities.
MDT, a leading test laboratory for the medical services industry, has been acquired by independent safety testing company UL. As a result, the two entities, mdt medical device testing GmbH (MDT) and md registration support Ltd (MDRS) based in Ochsenhausen, Germany, will become part of UL's Life and Health business unit.
MDT specializes in clinical and non-clinical testing services for regulatory and routine control purposes. Its testing services include clinical investigations as a clinical research organization (CRO) according to ISO 14155, and comprehensive non-clinical testing services such as physico-chemical and chemical analyses, physical testing, mechanical testing, biocompatibility testing, microbiological and virological testing, cytotoxicity testing and validation of cleaning, reprocessing, sterilization and packaging processes.
MDRS's advisory services enable customers to meet medical device registration requirements through technical documentation, risk assessment, clinical evaluation, evaluation of biocompatibility, classification of medical devices and quality management assessment pursuant to EN ISO 9011 and EN ISO 13485, respectively.
UL is an independent safety testing company with five business units -- Product Safety, Environment, Life and Health, University, and Verification Services. It has developed more than 1,000 standards for safety across several industries. It will now offer a complete suite of services that will help medical device manufacturers produce safer devices and products, including key medical device testing.
"The deepening of our service offerings will put the UL brand in front of a wider variety of customers -- including some of the biggest companies in the medical and health field," said Anil Patel, general manager of UL Health Sciences. "From sterile gauze and bandages to more complex devices such as bone screws, contact lenses, orthopedic, dental and other implantable devices, UL's testing capabilities will help manufacturers develop products that will keep patients healthy and mobile.”
MDT and MDRS will continue to be headquartered in Ochsenhausen, Germany. Dr Dieter Dannhorn will remain with the companies and serve as the general manager.
The Johns Hopkins Kimmel Cancer Center will use a $30 million donation from the Commonwealth Foundation for Cancer Research to fund a new center that will focus on genomics and personalized cancer medicine research.
Johns Hopkins will use the funding from the Richmond, Va.-based foundation to support the Center for Personalized Cancer Medicine, which initially will undertake three pilot projects focused on DNA mutations inside cells and epigenetic alterations.
The researchers at the new center, which began operations last month, will study genomic and epigenomic factors that affect leukemia and lung cancer patients' responses to treatment and develop tests for early detection of various types of cancer. The long-term aim will be for these genetic discoveries to inform the development of individualized immunotherapies such as cancer vaccines and pharmacogenomics-based treatment tools.
The Commonwealth Foundation also supports research at Memorial Sloan-Kettering Cancer Center, MD Anderson Cancer Center, the University of Virginia Cancer Center, and Virginia Commonwealth University's Massey Cancer Center.
Allergy Labs is an FDA licensed cGMP pharmaceutical manufacturer of over 500 different biological allergenic extracts for the diagnostic testing and therapeutic treatment of allergies via subcutaneous injection. The company also provides sterile depyrogenated vials and sterile diluents which are also manufactured at the Oklahoma City facility on fully automated lines. The company’s contract manufacturing group custom fills, private labels, packages and manages a wide inventory of vial sizes and fill volumes of diluent.
The company had been operating a very successful and fully operational line when in 2008 the decision was made to expand operations to a second filling line. To determine exactly what needed to be done and put a plan in place, Warren Johnson, VP and co-owner (with wife Rebecca), invited Bruce Anthenat, President of AWS Bio- Pharma Technologies, for a site visit to discuss unique and cost effective ways to help him expand the business. Together, Allergy and AWS Bio-Pharma established the project parameters and performed Pre- Engineering Activities.
The primary goals for the facility expansion were:
A new parenteral processing facility using modern design methods, state-of-the-art equipment and executed in a cost effective manner.
Expanded Warehouse/Storage capabilities
Initially produce injectable products (SVP) in 12 vial sizes from 2cc thru 100cc
Have one high-speed production line with the potential to add a lyophilizer (in the future)
Be the primary production facility for Allergy’s larger batch sizes (up to 700 liters)
Produce up to 400vpm of 2cc vials
Produce up to 200vpm of 10cc vials (a rather difficult to handle vial)
Produce up to 30vpm of 100cc vials
Be located on the existing employee parking lot (the existing parking lot was moved)
The expansion construction must not interfere with the daily operations of the existing facility
All new utilities (plant and critical) must be sized to accommodate the existing facility
Cost of the new facility (building, utilities and processing equipment) must fit within the owner’s budget
The new facility will be started up with existing products under the control of Allergy Labs
Additional capacity will allow new contract manufacturing opportunities
The finished project must be state-of-the-art and receive FDA and EMEA acceptance.
The resultant 13,000 SF expansion of the existing facility meets the company’s current and future needs.
In essence, Allergy Labs operates as two companies – as Rebecca Johnson, DPh, President and co-owner explains, “The allergy, or biological products we make are FDA licensed products. Allergy Labs was founded as an allergenic extract company in 1929. We manufacture concentrated allergenic extracts using biological source materials, including pollens, molds and foods for diagnostic testing. These same extracts are also used to compound customized diluted mixtures formulated for a patients specific allergies. In other words, these drugs are used for allergy immunotherapy, desensitization, and many people call them “allergy shots”. And as Warren Johnson explains, “This company has always manufactured diluting solutions and sterile empty vials to assist physicians with their allergy compounding needs. We also support our competitors by private labeling many of their allergy products. When my wife, Rebecca, and I bought the company 10 years ago, “private labeling” was what this service was referred to as, although it was certainly contract manufacturing and thus initiated our decision to expand out of the allergy sector into other injectable products. We manufacture injectable vasodilators, vasoconstrictors, a few CNS (central nervous system) drugs for which the trade name drug has come off patent. We perform the necessary validations, exhibit batches – the customer does the ANDA filing, and once FDA approved, we are ‘off to the races’”.
As mentioned the company can make over 500 different allergenic extracts for allergy testing and treatment. These biologicals are extracted in a glycerin solution and go through a multi-step intense filtration process to move the solution from coarse to sterile filters and finally into sterile, multi-dose vials. For the contract manufacturing portion of their business, the company obtains the active pharmaceutical ingredient (API), formulates the drug batch solution and fills into sterile vials aseptically. On the continuous fill line, vials travel through a vial washer, depyrogenation tunnel then to the filler, stopper and capper equipment. It is not until after they have a sealed finished vial before the vials are “handled” for inspection. This process significantly reduces the risk of contamination.
When the company decided to expand its production facilities they wanted to duplicate the success they had with the existing line 1 on the new line (line 2) in their new facility – but with enhancements as new technology would allow. As Lee Beaver, the company’s Director of Manufacturing explains, they looked at several new technologies and decided to incorporate those they thought would provide the most benefits. In particular, some of the new barrier isolation technologies were considered, but not implemented. “We considered using other technologies – but based on our experience with line 1, which we’ve had great success with, we wanted to mimic that success in line 2. We definitely improved the manufacturing in some areas on line 2 by implementing more operator/product barriers and particularly in the area of less product handling. We used conveyor systems and accumulation tables to move product from one area to the next as opposed to manually traying vials and physically carrying them to another machine. As far as aseptic filling is concerned, isolator and RABS (Restricted Access Barrier System) technology is out there, and some companies use them, but the cons outnumbered the pros when considering implementing these technologies into our operation. Set-up and sanitization procedures for these isolation or barrier systems would increase changeover time from one vial size to the next. Our operation can require daily vial size changeovers and that lost time is critical to us.”
Vials are filled, stoppered and capped under aseptic conditions.
As far as the changeovers go, the company does do it often, “There are approximately 15 different vial sizes we aseptically fill and assemble. Some customers want a 2mL fill in 2 or 3 different vial sizes and some request multiple fill volumes in the same size of vial. When providing contract manufacturing services, we have to be equipped to handle these special customer requests. Therefore, there is a vast array of vial sizes that we have to have our machines specifically made to handle.”
Having so many different vials to fill puts a large emphasis on the equipment vendors and the machinery they supply. But as Beaver says it’s really a two way street, “We rely on them a great deal. We, as the customer, supply them with our functional specifications: Here’s what we want to do - we want to handle these vial sizes at these speeds to meet our needs. They come back and tell us well yes we can or no we can’t. We don’t want to tell them how to make the machine because they are the specialists. They know their machine. We seek out and research equipment vendors, supply them with our specifications to determine what they can or cannot meet, narrow the field down to one, and let them build the machine. We rely on their expertise a great deal but at the same time we have specifications that we have to meet – but it’s definitely a partnership.”
The cleanroom corridor in the expanded facility.
The expansion was designed around a cleanroom "core"
One of the key features of the new expansion is how it was designed around a cleanroom “core” that was built with modular construction. Constructed in Italy, then shipped to the company’s site, the smooth installation and qualification of the clean room was significant factor in the project’s success.
As anyone who has ever done any renovation or building project knows – problems do crop up. But for Allergy Labs and their facility expansion – any problems were kept to the bare minimum. In fact the facility expansion was completed ahead of schedule and under budget.
Johnson explains some of the reasons this project went off so smoothly. “The first reason it went well was that this was our third expansion and although the first two did not include aseptic manufacturing space, we knew exactly what we needed in the aseptic area. The second reason is that I was actively involved in the day-to-day construction process, being more of a construction manager I suppose. Although some of my staff also helped in the planning processes, we were not held up for committee meetings, as I was always present to make necessary decisions to keep things moving swiftly. The third reason is that this project was started right at the economic downturn, so the contractors were available and always here on the job. We didn’t lose any time waiting.”
Director of Manufacturing Beaver echoes Johnson’s comments: “There really weren’t a lot of problems with the current production, manufacturing, or scheduling during construction. Our original building contains line 1 and the new building is separate and incorporates line 2. Perhaps the biggest issue was warehousing as we needed access to building 2 to store items for building 1."
Johnson adds. “There were some logistics issues that we had to work around. We had some temporary pads so that we could get in and out of our warehouse. The new building wraps around the old warehouse. But there was no interruption in manufacturing. In fact, we couldn’t have done this if we had any interruption in manufacturing. It just would not have worked.”
Not content to rest on their laurels, the company is already looking towards another expansion project, as Johnson details. “We are planning a new 35,000 sq. ft. expansion that will house a new shipping and receiving area. It will have new quarantine warehouse space, released product warehouse space and a large area that is set aside for future aseptic manufacturing, but that will be for the future as we still have a lot of capacity in the current building.”
He continues. “We need more space for another labeling area, and we need space for shipping docks as well. Shipping and receiving is currently rather small – but we do have some interests from some of our current customers to begin distributing their product – but that will be further in the future, so that area will be in anticipation of that possible future business.”
The folks at Allergy Labs are justifiably proud of what they have accomplished, especially considering the project was completed under budget and ahead of deadline. As Beaver points out, “I come from the Quality Assurance side, the validation side. Warren gave us a deadline to meet and I’m most proud of meeting that deadline with our staff. We worked hard – we validated the entire line in six months after construction was complete.
Johnson concurs, “I have to agree with Lee – I come from the production side – and what they accomplished is fantastic. For me – I really like the design. We didn’t have much space. When we started this project we were hemmed in – we didn’t have much land. It just so happens that after building 2 was built, the owner of the adjacent property finally agreed to sell – then the other properties also fell like dominos (not literally). So now we own the entire block, about 5 acres, whereas we used to own about 1 acre. When we originally bought this company in 2001, we only had about 40,000 sq. ft. and that included our parking lot!
“We built this nice facility to run 3 shifts – 24/7 and we did a great job of fitting a large amount of usable space into a small footprint.”
Promega said that it has broken ground on a new cGMP facility to accommodate business growth and customers who need US Food and Drug Administration-regulated molecular biology products. The firm said the 260,000-square-foot facility will employ an additional 100 employees over the next five years.
Osmotica Pharmaceutical announced plans to spend $20 million to open a research, development and manufacturing operation in Marietta, Georgia.
The deal is expected to create 156 jobs over the coming five years.
“It would be very difficult to go to an area that did not have skilled pharmaceutical people and just start up an operation,” said Osmotica CEO Forrest Waldon. “You need those people, a core group of people, in place to do that. The second thing is the state and county and the city have all done a lot of incentives to make it worth our while to call this home. They’ve been very cooperative with what we need to plan out the next five years of our life here.”
Gilead Sciences, Inc. announced that the company has signed a definitive agreement under which Gilead will purchase a clinical biologics manufacturing facility and certain process development assets located in Oceanside, California from Genentech, a member of the Roche Group. The agreement covers Genentech's Oceanside Clinical Plant (OCP), a 70,000 square-foot facility at 4049 Avenida de la Plata, as well as certain other process development assets. Gilead will hire certain of Genentech's biologics manufacturing specialists and process development scientists familiar with the facilities to assist with Gilead's operations. Genentech will continue to operate and maintain ownership of the Oceanside Commercial Manufacturing (OCN) facilities at One Antibody Way and other adjacent land. The companies expect the transaction to close in the third quarter of this year, subject to satisfaction of certain conditions. As part of the acquisition, approximately 55 current Genentech clinical manufacturing and process development employees will be offered employment at Gilead. All employees joining Gilead from Genentech will be working in the OCP facility.
The OCP facility is currently designed and equipped to produce biologic compounds for toxicological, Phase 1 and Phase 2 clinical studies. Initially, Gilead will use the facility for the process development and manufacture of GS 6624 (formerly AB0024), an investigational monoclonal antibody candidate in development for treatment of certain cancers and for fibrotic diseases, and another antibody which is currently in preclinical testing.
"This acquisition represents a unique opportunity to establish Gilead's biologics process research and manufacturing capability while bringing on a team of employees with strong expertise in biologics manufacturing and process development. This will enable us to accelerate internal biologics research and development programs and take advantage of external opportunities in the future," said Norbert W. Bischofberger, PhD, Gilead's Executive Vice President, Research and Development and Chief Scientific Officer. "We look forward to welcoming our colleagues in Oceanside, as we seek to advance development of GS 6624 and other novel therapies for life-threatening diseases with unmet medical need." GS 6624 was discovered by Arresto Biosciences, which was acquired by Gilead in January 2011.
About Gilead Sciences Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.
The Tampa-based biotechnology company Xcelience announced plans to expand operations and hire another 45 employees.
That made the company eligible for $135,000 in tax refunds from the state of Florida.
Xcelience focuses on helping pharmaceutical companies take an individual molecule of a potential drug and formulate it into versions to use in clinical trials.
The company was founded in 1997 as Tricon, though it changed hands several times amid pharmaceutical mergers. Now, it has headquarters near the airport and employs 68 people.
This round of hiring could include second-level chemists and managers for drug formulation.
While the pay will vary widely, the average will be about $46,000, the company said.
A South Korean biotechnology firm plans to manufacture portable dialysis machines and heart pumps in Newport, Vermont. AnC Bio US is purchasing an empty 90,000 square foot building in the city that it plans to transform into a biotechnology factory.
A portion of the facility will be set aside for a research laboratory. AnC Bio would produce stem cells and vaccines, and possibly develop artificial organs, at the Newport plant.
The proposed $100 million facility would employ 200 people in the economically depressed city on the Canadian border. Spin-off economic activity could lead to as many as 1,300 jobs in the area, according to officials from the firm.
The construction of the state-of-the-art laboratory and manufacturing plant will be funded through the EB-5 visa program, which allows foreigners to obtain a green card and a path to U.S. citizenship in exchange for making a $500,000 investment in a project that creates at least 10 permanent jobs. The EB-5 program is set to expire in 2012, barring an extension sought by Sen. Patrick Leahy, D-Vt.
The company hopes to produce an artificial heart for surgical procedures once it obtains approval for the device from the Food and Drug Administration. In an interview, Ariel Quiros, founder of AnC, said he believes that manufacturing biotech products in the United States will ease the FDA approval process.
The heart pump, called a Twin True Pulsatile Percutaneous Life Support System, has been used with success in other countries, officials say. The small, portable dialysis system will be ready to be manufactured soon after the pump is in production.
In addition to medical device manufacture, AnC Bio is a world leader in stem cell research, according to William Kelly, an advisor to the company who spoke at a recent press conference in Newport.
AnC Bio has been working on a process to repair damaged heart muscle with the help of adult stem cell technology. A patient, he said, would have a small amount of flesh removed from his thigh. That material would be processed and the few adult stems cells it contains would be extracted and cloned in the company’s laboratories. When injected into the heart, they would rebuild heart muscle, Kelly said.
The therapy, he said, has been tested on hundreds of people in Europe, Australia and the United States. “We are probably, right now, about 100 to 150 patients away in reaching approval in our ability to put this therapy on the market,” Kelly said.
When that happens, Kelly predicted, the process will “put Newport on the map.”
AnC’s research laboratory would also produce vaccines, according to Kelly.
In addition, Quiros told reporters that AnC would produce stem cells for other companies and develop artificial organs such as hearts, kidneys and livers.
Research will be conducted in an 11,000-square-foot laboratory in the Bogner building.
The company was originally a trading company, Quiros said, making purchases on behalf of the Korean government. AnC Bio took its present form and name in the late 1980s, at a time when South Korea was making the transition from being an exporter of cheap goods to its present status as a maker of high-tech products.
Quiros, who owns a farm in the Northeast Kingdom and has a long connection with the area, said Gov. Jim Douglas and a 30-person Vermont delegation to the company’s South Korean research facility proposed the U.S. branch of AnC Bio.
After the 10-day visit, Quiros said, he was bombarded with calls asking him to consider building a similar facility in Vermont.
About one-third of the 200 new jobs will be factory work, Stenger said. Another third of the jobs would require additional education, he said, adding that his company plans to work with Vermont Technical College and, possibly, the University of Vermont to make courses available.
The final portion of jobs, particularly those in the research area of the company, will require higher education, Stenger said.
Tenet Florida announced plans to build an 80-bed academic and clinical research hospital on county-owned land in Palm Beach Gardens, in partnership with The Scripps Research Institute.
The hospital will rise on a 30-acre wooded tract east of Interstate 95 that's zoned for biotech labs, offices, retail, a hotel and about 2,700 homes.
Palm Beach County Commission Vice Chairwoman Shelley Vana predicted the hospital would create an economic impact of about $402 million over five years.
Tenet senior vice president Marsha Powers said the hospital would emphasize orthopedics, oncology, senior care and digestive disorders, and collaborate with the new medical school at Florida Atlantic University, offering internships and residencies.
Construction should create 250 full-time construction jobs for two years, and the hospital itself will employ 250 to 300, once the state approves its permit application, said Scripps' chief operating officer, Douglas Bingham.
The state requires proof that new hospitals are needed before they can be built, and existing Palm Beach County hospitals have struggled with low occupancy amid the economic downturn.
Powers said the 80 beds would come from three existing Tenet hospitals in the region: St. Mary's, Palm Beach Gardens and Good Samaritan medical centers.
If the state permit application goes smoothly, it will enable ground-breaking to start in about a year, she said.
The creation of a biotech hub was a critical goal of the state's initial $310 million incentive grant to Scripps in 2005. Palm Beach County invested $208 million more, not counting a false start at Mecca Farms, an orange grove near the acreage that cost about $80 million more.
Since it launched, Scripps has attracted more than $188 million in research grants and hired about 400 scientists and support staff, in addition to attracting the Max Planck Society to build a Florida institute.
Bingham said having an academic hospital across the street from its labs and those of the Max Planck institute is an important element that will enable scientists to attract federal grants meant to accelerate research to patients' bedside, where it can make a difference.
"If you look at where most improvements are coming from in health care, it's from the academic research institutes," he said. "The dream is to make this a destination medical center and make it one of the best medical centers in the world."
Early on, Scripps' president tried to entice elite hospitals like Massachusetts General to operate a hospital here. But state rules complicated discussions.
The new hospital will be built within Scripps' portion of 70 wooded acres the county bought to allow the research institute to expand over the years. Tenet will sublease it from Scripps, county officials said.
On hand for the announcement was Florida Atlantic University president Mary Jane Saunders, who said the hospital will collaborate with FAU's Charles E. Schmidt College of Medicine, which last week admitted its first class of 64 students. The FAU med school will include a dual MD/PhD degree track, with the MD given by FAU and the PhD given by Scripps' Kellogg School of Science and Technology.
"Our students will start doing some clinical rotations right away, and then really spend time in hospitals in years three and four," she said. "The curriculum has a public health focus that requires research."
Lone Star College-Tomball Houston, TX will open three new buildings in time for the fall semester: the Lone Star College-Tomball Health Science Building, Performing Arts Center and Veterinary Technology Building.
The building construction totals $38 million, which was possible through a $420 million system-wide bond passed in May 2008.
The Veterinary Technology Building, located on the north side of the LSC-Tomball campus, is a 20,000-square-foot addition to the existing Large Animal Facility. Students of the Veterinary Technology program will take the majority of their classes in this new structure.
The two-story building will hold: a 124-seat lecture hall; reptile, avian and small mammal rooms; 12 canine runs; prep, surgery and recovery rooms; a computer room; and other instructional amenities. LSC-Tomball is currently the only college in the area to offer the Veterinary Technology program.
The Lone Star College-Tomball Health Science Building, located off campus next to Tomball Regional Medical Center, is a three-story complex with 60,000 square feet. It will house the Surgical Technology, Occupational Therapy Assistant, Nursing and Pharmacy Technology programs. Currently, LSC-Tomball is the only college in the area to offer the Surgical Technology program.
“The Lone Star College-Tomball Health Science Building made perfect sense because the medical programs, Nursing, Occupational Therapy Assistant, Pharmacy Technology and Surgical Technology, are LSC-Tomball are very popular,” Andi Atkinson dean of College Relations, said. “The building is also located next door to Tomball Regional Medical Center.”
The edifice will contain numerous classrooms, a medical library, simulation labs, an operating room, a cleanroom, a sterile room and additional educational resources. It is designed to simulate the actual work environment students will enter upon completion of their educational program.
The biopharmaceutical company MedImmune is expanding its Frederick manufacturing plant.
Frederick city and county officials joined the company in celebrating the official opening of a 337,000-square-foot addition.
The new space expands production capacity for products including Synagis, a drug that prevents a respiratory virus infection in high-risk children.
Gaithersburg-based MedImmune says it employs about 250 people in Frederick and expects to add more.
The company is a subsidiary of London-based AstraZeneca PLC.
Ash Stevens, Inc has begun a $6 million expansion of its manufacturing facility, with further phases planned to occur over the next six years, allowing the company to offer a range of process development, scale-up and manufacturing options for APIs.
Headquartered in Detroit, Michigan, USA, Ash Stevens, Inc. (ASI) was founded in 1962 to service the chemical research needs of the US Federal Government. The company has extensive experience in the process development and scale-up of commercial cancer APIs and has a longstanding relationship with the US National Cancer Institute. ASI has a total of 11 FDA-approved drug substances in its portfolio, employs more than 60 people, and holds a variety of patents ranging from medicinal agents to manufacturing processes.
As an established contractor, ASI has been conducting process development and manufacturing of APIs in Michigan since the 1960s, and has developed substantial expertise in high-potency active pharmaceutical ingredients (HPAPIs), including cancer drugs. Over the past five years, ASI has invested more than $15 million in its manufacturing facility located in Riverview, Michigan. These improvements have expanded the company’s capabilities while integrating new technology to create safe product development and manufacturing processes. In addition, ASI has diversified its customer base while growing science-related jobs in Michigan.
The company recently announced that it is in the initial phases of a multi-year expansion project to upgrade its capacity and capabilities at its Riverview facility. ASI is investing more than $6 million for the initial phases of the expansion, which include a new reactor bay and warehouse. Dr Stephen Munk, ASI’s president & CEO, says the investment will add significant capacity and additional capabilities to its existing facility as part of its on-going commitment to provide the company’s clients with the highest-quality service, safety, and on-time delivery of APIs.
The isolated reactor bay will house two 100-gallon glass-lined reactors and a 50-gallon hydrogenation vessel, and will also provide redundant capacity to a similarly designed existing bay that holds three 100-gallon reactors, as well as additional plant capacity and plant-scale hydrogenation capabilities. Later in the year, in June, ASI will occupy a new 10,000 square foot warehouse facility. Dr Munk says completion of the state-of-the-art reactor bay and warehouse facility will set the stage for the execution of the next phases of the expansion plan:
“The new bay and warehouse represent a self-financed $6 million investment for ASI,” he says. “The continuous upgrading and modernization of our operations is an essential component of our business model to provide our clients the highest-quality service while ensuring delivery of their API on time and on schedule from a safe and environmentally friendly facility. As we increase our efficiencies with larger equipment, we also enhance our cost-effectiveness, further benefiting our customers.”
Later phases of the expansion plan include a new large-scale reactor bay, process development laboratories, and additional facilities for handling highly potent APIs.
These new developments follow on from ASI’s investments earlier this year in parallel synthesis and calorimetry instrumentation at the Riverview facility, designed to enhance the speed and safety of scale-up. This new equipment gives the company’s process development chemists the ability to assess heats of reaction for the safe scale-up of industrial processes. The system captures real-time data and provides electronic records useful for post-experiment analysis. “Traditionally, an experienced scientist could conduct two concurrent experiments manually in the laboratory. With the new system, up to four experiments can be conducted simultaneously spanning a broad range of conditions,” says Dr Munk. The new safety enhancements also include a Thermal Screening Unit used to evaluate the onset of thermal decomposition of reaction components.
“These investments allow us to rapidly optimize chemical processes and better understand process safety parameters prior to scale-up,” he adds. “Our customers will benefit from increased time savings.”
ASI’s commitment to quality is demonstrated by the company’s completion last January of the requirements for SOCMA’s ChemStewards® programme and its subsequent certification of compliance with ChemStewards. The programme is SOCMA’s flagship environmental, health, safety and security (EHS&S) continuous performance improvement programme, and was created from industry’s commitment to reducing the environmental footprint left by member’s facilities. The fine and specialty chemical industry created ChemStewards to meet its special needs and is a mandatory requirement for SOCMA members engaged in the manufacturing or handling of synthetic and organic chemicals.
“ChemStewards certification sends a strong message to our employees and our community that Ash Stevens is committed to a safe and environmentally friendly operation,” says Dr Munk. “It gives our customers the assurance that we are committed to compliance with all applicable federal EHS&S regulations at our facility.”
Amid a struggling Michigan economy, Dr Munk points out that one bright spot is the biosciences community, which enjoys strong support from the state of Michigan. Earlier this year, Michigan became one of the few states with legislative biotech initiatives in both the house and senate. State Reactors at Ash Stevens' Riverview, Michigan API facility legislators agreed to form a senate task force on biotechnology and a house subcommittee on biosciences to grow resources for Michigan’s biotech industry.
The private sector in the state is also working towards a more robust biotech industry, as ASI and seven other drug development contract service providers have recently formed the Michigan CMC Alliance, which provides chemistry, manufacturing and controls resources and strategies to life science companies.
The Michigan-CMC Alliance is comprised of an informal association of life science companies providing complementary contract drug development and manufacturing services that span pharmaceutical CMC development. The scaling down of large pharmaceutical operations in the state of Michigan spawned a number of start-up life science contract and consultancy service companies in the state piloted and staffed by talented and seasoned pharmaceutical professionals. Synergies between various service companies in the state that include ASI provide an opportunity to offer a continuum of CMC services through interactive but individual expert service companies in one general location.
“By tapping into this support network, emerging contract companies don’t have to develop this expertise internally, thereby saving costs and ensuring flexibility that is especially critical during this weak economy,” said Dr Munk. Because of the companies’ good working relationships and proximity, clients can always rely on quality service from members of the CMC Alliance.
“The CMC Alliance benefits the biotech community by providing support for the growth and success of life science companies. ASI’s involvement in the CMC Alliance ensures that clients will have access to cGMP API manufacturing expertise.”
The eight companies representing the Michigan CMC Alliance include: Ash Stevens, Inc, providing GMP API development and manufacturing; BioSTAT Consultants, offering statistical services including design and analysis; Eurofins AvTech Laboratories, Inc, providing GMP and GLP analytical services; Global Clinical Connections, LLC, providing clinical supplies management; Pharmaceutical Development Consulting, LLC, a provider of formulation development and project management; PharmaMed Resources, LLC, specialized in quality assurance; ProReg Resources, LLC, a provider of regulatory consulting services; and Velesco Pharmaceutical Services, which offers formulation and analytical development in GMP manufacturing.
Catalent Pharma Solutions’ Consumer Health business has completed the first phase of a multi-million dollar expansion of its facility in Aprilia, Italy. The expanded site offers service from product conceptualization to formulation, development, production and packaging. Products manufactured at the Aprilia site include Vegicaps capsules, easy-to-swallow plant-derived capsules that are free from animal derivatives and gluten.
“We needed to expand capacity for both traditional gelatin and Vegicaps capsules to ensure reliable supply of strong customer demand,” said Gerry Purnell, European commercial director for Catalent’s Consumer Health business. “Customers are increasingly considering Vegicaps capsules because the technology accommodates a wide range of formulations and provides access to markets that require products free from animal derived gelatin.”
The site has been expanded to include a new dedicated gelatin production area and new encapsulation machinery for traditional gelatin production and Vegicaps capsules, increasing output by almost one third. Catalent has also added key processing equipment, such as a new turbo emulsifier to replace open roll-milling equipment. Capacity within inspection and drying areas has been increased and workflows and environments have been reviewed and enhanced to maintain safety and cGMP.
Stefano Arena, general manager of Catalent’s Aprilia site, said, “The improvements have been approved by the appropriate regulatory authorities, and we will continue to expand our facility in Aprilia throughout 2011 to bring more products, such as chewable capsules, to market. The ongoing expansion will not only benefit our customers in the consumer health market, but will also allow us to offer more services to the pharmaceutical and cosmetics sectors too.”
Biocon has begun work on the Malaysian biopharm plant that will serve its deal with Pfizer, and is now providing Lipitor ingredients.
When the RM 500m ($162m) plant opens in 2014 Biocon will use it to produce biosimilar insulin for its October 2010 agreement with Pfizer. Biocon will produce biosimilars and insulin analogs for Pfizer to market.
Biocon is building the plant in the Bio-XCell biotechnology park. Last year Frost & Sullivan said Malaysia is “an ideal location to manufacture generics”. Biocon plans to expand production at the plant beyond insulin by adding capacity for other biopharmaceuticals later.
Biocon is also collaborating with Mylan on biosimilars. “We view this [partnering strategy] as a long-term positive since it allows Biocon to participate in the biogeneric opportunity without significantly depressing its profitability”, Motilal Oswal Securities said.
Biocon has also begun manufacturing ingredients for Pfizer’s Lipitor (atorvastatin calcium), Bloomberg reports . In recent years Biocon has inked deals for supply of atorvastatin to generic companies and is an established producer of the simvastatin API.
Commenting on the statins market Motilal Oswal Securities said: “Biocon has tied up with a few generic companies for the supply of atorvastatin API. We expect intense competition among generic players in this market as the product is not fermentation based and hence has low entry barriers.”
Swiss supplier Lonza will open a new vitamin B3 manufacturing facility in China in 2012 that will significantly lower production costs for the vitamin and boost output by 40 percent.
Lonza supplies about half of the world’s vitamin B3 for the food, feed, cosmetic and pharma industries, and says new technologies will permit lower manufacturing costs when the facility in Nansha comes online, probably at the end of 2012.
Its capacity at that point will rise from 22500 tonnes to 37,500 tonnes – a 15,000 tonne increase.
“The new facility underlines our commitment to be the global leader in the nicotinates business and to deliver the food, feed, cosmetic and pharma industry with high quality vitamin B3 products,” said Roman Quinter, senior vice president and head of Lonza’s Nutrition Ingredients business.
“We will also take advantage of very promising innovations in technology and process development. These innovations will provide cost and efficiency advantages to all the company’s nicotinate facilities.”
Lonza, which this year marked 40 years of vitamin B3 supply, already a presence in Nansha with an engineering business unit, and had been supported by local authorities in the new venture.
The company said the new facility would help meet demand both in China and internationally.
The Swiss firm said it had it invested in a series of studies on the vitamin also known as niacin investigating both human and animal health potentialities.
Lonza began producing vitamin B3 in Switzerland and followed that with Chinese expansion, first in 1995 in Guangzhou, then in Nansha in 2003.
“Lonza’s multi-site concept, know-how and experience … have enabled us to become the leading partner to support the long-term growth for food formulators and end-use product manufacturers of human and animal nutrition products,” Quniter said.
Vitamin B3 has been shown to reduce the incidence of pellagra, a malady that causes dermatitis, diarrhea and dementia.
It has also been shown to improve bodily lipid profiles by increasing HDL cholesterol (good cholesterol) levels.
DMS Topline Medical, a leader in reconditioned biomedical and diagnostic imaging equipment, parts and rentals, announced that it expanded its medical equipment service offering with biomedical depot repair services. In addition, DMS Topline Medical increased its warehouse capacity by 5,000 square feet to accommodate six bench repair spaces, a cleanroom, and added inventory of in-demand biomedical parts in support of biomedical depot repair services.
"By offering biomedical depot repair services, customers can leverage the experience and expertise of our professionally trained biomedical technicians," states George Fraza, General Manager of DMS Topline Medical. "Whether a healthcare facility is experiencing a reduction in manpower or is looking for a cost-effective alternative to replacing their medical device, our biomedical depot repair services offer phone technical support and repair diagnosis, loaner equipment options, and quick turnaround and warranty for repairs."
Biomedical depot repair services complement the company's existing medical equipment and parts portfolio of used and reconditioned patient monitoring equipment, such as central stations, defibrillators, EKG machines, fetal and maternal monitors, modules, patient monitors, telemetry and associated biomedical parts; ultrasound machines, probes and parts; and diagnostic imaging parts.
DMS Topline Medical's operations, sales and warehouse are located in Fargo, North Dakota.
Lonza Group and Fosun Pharmaceuticals will pump $15.6m (100m yuan) into a joint venture in the Zhangjiang High-Tech Industry Zone, China.
Under the deal, API company Lonza and pharmaceutical management contract research organization (CRO), will manufacture, market and sell a portfolio of generic pharmaceuticals.
And according to Lonza’s head of corporate communications, Dominik Werner, the drugs will be aimed at the China market.
However he remained silent over which drugs would be produced.
He said: “The partners have pre-selected a defined promising portfolio of generic pharmaceuticals. “The joint venture will target a portfolio of generic pharmaceuticals specifically serving China’s pharma market.”
Werner also said that the Swiss firm’s existing API operations in China’s Guangzhou Nasha development zone would continue.
The company first established roots in the region back in 2008, in addition to its existing R&D setups in the country.
At the time Werner said that opening facilities in the region was the: “best possible approach to build up a strong in-house engineering competence.”
Contract manufacturing organization (CMO) Aurobindo Pharma has teamed up with Russian supplement maker OJSC Diod to establish a manufacturing joint-venture.
The new enterprise, Aurospharma, will operate a new manufacturing facility that is planned for in Moscow's Podolsk district, at which it will produce non-penicillin and non-cephalosporin generic drugs and over-the-counter (OTC) drug products.
The joint venture, ownership of which is split 50-50 by Aurobindo and Diod, will also take over Diod’s existing pharmaceutical manufacturing business CJSC Olifen.
The intention is to supply the Russian, Belarusian and Kazakhstahi pharmaceutical markets when the facility is fully operational at the end of 2013.
Vishnu Sriram associate vice president of Aurobindo said: “Establishment of a JV with the Russian Diod company perfectly weds with our international expansion strategy, in accordance with which we establish partnership relations with competent local companies in the target countries.
“The JV format gives us an opportunity to localize our production in Russia. Using the Russian partner’s marketing vision, we will be able to enter the growing and challenging Russian market with greater confidence and expedite our presence in the market.
Aurobindo’s formation of the partnership and plans for local manufacturing capacity are largely in keeping with current efforts by the country’s government to reduce its reliance on pharmaceuticals produced outside its borders – its Pharma 2020 strategy.
The policy – which seeks to encourage drugmakers to set up manufacturing operations in Russia to reduce the country's reliance on imports – has already attracted a number of firms with Novartis, AstraZeneca and GlaxoSmithKline (GSK) being some of the highest profile examples.
In a press statement Aurobindo said that: “This project fully complies with the priorities of the strategy for development of the Russian pharmaceutical industry for the period through 2020 approved by the Russian Ministry of trade.”
However, Aurobindo said it will supply the joint venture with antibiotic active pharmaceutical ingredients (API) and several other products from its manufacturing facilities in India which, at least on the face of it, does not appear to fit with the drive to boost production in Russia.
Gerresheimer Regensburg GmbH has announced plans to increase production of its medical injection molders four-fold in its China facility over the next 18 months.
The German packaging supplier will increase its capacity from eight injection molding machines – used to produce drug delivery systems like inhalers – to 30, and from 100 employees to 350, at its Dongguan facility by the end of 2012.
Stephane Pianigiani, managing director of Gerresheimer Medical Plastics Systems Dongguan, said that the expansions in China are all part of the company’s plans to reduce production costs by working in an up-and-coming area.
He said: “There’s always been reluctance from customers in the medical device industry to come to China, but that is changing,”
And according to Pianigiani, the company also plans to open another manufacturing site or medically-oriented injection molding facility in the country.
Of their growth strategy, he added: “In the medium to long-term we will not be a leader in China with only one plant in Dongguan.
“By January 2013, we will have another plant running.”
In November last year, the company opened a representative office in Mumbai, India, and said it was part of its plans to capitalize in the emerging market.
The office provided the firm with a new legal entity, giving the company the opportunity to operate within India in the future.
Jens Kürten director of corporate communication & marketing said: “We see a lot of opportunities, not only in India, but in South America, China, Russia, and other countries.”
Future plans for Gerresheimer also include providing more drugs for the areas local to their facilities.
Pianigiani added that over 95 per cent of the products made in Dongguan are exported to North America and Europe, and now the business plans to change that.
“We definitely see opportunity with the size of the population and the portion of the population that can afford that product,” he said.
SGS Life Sciences has added cell-based bioassays to the range of services available at its Poitiers, France facility in what it says is part of its new aggressive growth strategy.
As part of the expansion, the firm has added the latest generation of flow cytometers and a BL-2 (Biolsafety Level 2) suite, as well as recruiting a senior study director, who remains unnamed.
The Geneva -headquartered inspection, verification, testing and certification services specialists also plan to increase its personnel team in a bid to meet customer demands.
And according to Ferdinand Dabu, marketing director of life sciences services at SGS, the expansion is one of many to come.
He said: “There are very aggressive plans in SGS to grow our business by 2014.
“With such aggressive plans in place, this expansion is not a standalone effort. There is a global plan. We are going to need people in all regions for all of the business."
Dabu also said that Geneva HR teams are currently putting together a hiring strategy, and so the company is still unsure how many new employees there will be.
He added: “We have hired the study director for our project in Poitiers, and we’re going to hire international personnel throughout the year.”
The laboratory in Poitiers in now one of two GLP-compliant bioanalytical facilities in Europe owned by SGS, allowing them to offer services in support in method development and validation, pharmacokinetics by LC-MS/MS and immunoassays, biomarker analysis, immunogenicity testing and now cell-based bioassays.
And the firm hopes its offering will appeal to Big Pharma.
Dabu added: “One of the key things is that we want to capitalize on this opportunity largely driven by large pharmaceutical companies.
“We recently announced that we extended our biopharma capabilities with the acquisition of M-Scan , which offers chemical and biochemical testing as well as high-end GLP/GMP contract analytical services.
“This is our European center of excellence and with this expansion we have the opportunity of producing bioassays here before expanding in other regions.”
Contract manufacturing organization (CMO) Aurobindo Pharma has teamed up with Russian supplement maker OJSC Diod to establish a manufacturing joint-venture.
The new enterprise, Aurospharma, will operate a new manufacturing facility that is planned for in Moscow's Podolsk district, at which it will produce non-penicillin and non-cephalosporin generic drugs and over-the-counter (OTC) drug products.
The joint venture, ownership of which is split 50-50 by Aurobindo and Diod, will also take over Diod’s existing pharmaceutical manufacturing business CJSC Olifen.
The intention is to supply the Russian, Belarusian and Kazakhstahi pharmaceutical markets when the facility is fully operational at the end of 2013.
Vishnu Sriram associate vice president of Aurobindo said: “Establishment of a JV with the Russian Diod company perfectly weds with our international expansion strategy, in accordance with which we establish partnership relations with competent local companies in the target countries.
“The JV format gives us an opportunity to localize our production in Russia. Using the Russian partner’s marketing vision, we will be able to enter the growing and challenging Russian market with greater confidence and expedite our presence in the market.
Aurobindo’s formation of the partnership and plans for local manufacturing capacity are largely in keeping with current efforts by the country’s government to reduce its reliance on pharmaceuticals produced outside its borders – its Pharma 2020 strategy.
The policy – which seeks to encourage drugmakers to set up manufacturing operations in Russia to reduce the country's reliance on imports – has already attracted a number of firms with Novartis, AstraZeneca and GlaxoSmithKline (GSK) being some of the highest profile examples.
In a press statement Aurobindo said that: “This project fully complies with the priorities of the strategy for development of the Russian pharmaceutical industry for the period through 2020 approved by the Russian Ministry of trade.”
However, Aurobindo said it will supply the joint venture with antibiotic active pharmaceutical ingredients (API) and several other products from its manufacturing facilities in India which, at least on the face of it, does not appear to fit with the drive to boost production in Russia.
Baxter's BioPharma Solutions business has completed its latest capacity expansion at its cytotoxic contract manufacturing facility in Halle/Westfalen, Germany. The expansion included the installation of an additional large-scale, commercial lyophilization unit to increase freeze-drying capacity to support commercial cytotoxic manufacturing capacity. The freeze dryer was designed to meet international manufacturing and regulatory requirements.
"This latest investment clearly demonstrates our commitment to meeting our clients' increasing need for high-quality, cytotoxic drug production," said Dr. Burkhard Wichert, vice president of manufacturing for Baxter's Halle facility. "The expansion, which was completed ahead of schedule, will help support the continuous worldwide supply of oncology products for our customers and, ultimately, for patients who are afflicted with cancer."
The Halle manufacturing site provides lyophilization, process development, aseptic filling of cytotoxic, non-cytotoxic and highly potent liquid and sterile powder vials in clinical and commercial batch sizes, and sterile crystallization of cytotoxic APIs.
A new hi-tech disease detection facility, developed by the University of Leicester, has been unveiled for use in Leicester Royal Infirmary’s A&E department.
The Diagnostic Development Unit uses technology that could eventually be used to develop devices akin to the ‘tricorders’ from the TV series Star Trek, which were used to diagnose illness simply by waving them near a patient, said Professor Mark Sims, project leader and a space scientist at the University of Leicester.
The facility is designed to be able to detect the ‘sight, smell and feel’ of disease without the use of invasive probes, blood tests, or other time-consuming and uncomfortable procedures.
Scientists at the new £1m facility are using three types of technology in combination, which could speed up diagnosis.
One group of instruments, which was developed in the University’s Chemistry Department, analyses gases present in a patient’s breath.
A second uses imaging systems and technologies – developed to explore the universe – to hunt for signs of disease via the surface of the human body.
The third uses a suite of monitors to look inside the body and measure blood flow and oxygenation in real-time.
The technologies in the Leicester Diagnostics Development Unit have never previously all been used together, the researchers said, and some were originally used in planetary research.
Professor Sims, who led the project alongside Professor Tim Coats, Professor of Emergency Medicine at the University and head of accident and emergency at the Royal Infirmary, said the technology might also be a first step towards ultimately creating devices like those used in Star Trek.
He said: ‘We are replacing doctors’ eyes with state-of-the-art imaging systems, replacing the nose with breath analysis, and the ‘feel of the pulse’ with monitoring of blood flow using ultra sound technology and measurement of blood oxygen levels.
It is hoped that the equipment can be used in the diagnosis of a range of diseases from sepsis to bacterial infections such as C. Difficile and some cancers.
The Diagnostics Development Unit has so far identified more than 40 possible applications.
The researchers are using a £500,000 infrastructure grant from the Higher Education Funding Council along with a contribution from the University to equip the Unit.
The US Pharmacopeial Convention (USP) has expanded its quality testing laboratory in Hyderabad in an effort to further strengthen ties with Indian drugmakers and regulators.
The US pharmaceutical standards organization has added over 80,000sqft of floor space at the laboratory, which is at the heart of the city’s IKP Knowledge Park, and plans to hire an additional 20 scientific staff over the next 12-months.
A key part of this work will be the production of reference materials for the USP’s recently launched Medicines Compendium, which is a freely available portfolio of testing standards, procedures and critical quality attributes for drugs and active pharmaceutical ingredients (APIs).
Dr Williams,USP CEO, also explained that, in addition to providing pharmaceutical quality testing services and knowhow, the expanded laboratory will be a base for the USP’s synthetic and bioanalytical chemistry standards initiatives and play a role in dietary supplement analysis.
The USP has operated in Hyderabad site since 2006 when it opened the lab, at the time its first outside the US, after signing a memorandum of understanding (MoU) with the Indian Pharmacopoeia Commission (IPC) intended to raise “awareness of the importance of the quality and safety of medicines. “
The USP’s focus on India fits with the widely held belief that manufacturers in the country will play an increasingly important role in producing pharmaceuticals for the global market.
Speaking last month at Confederation of Indian Industry (CII) event Indian health Minister Sudip Bandyopadhyay said: “The next few years are going to spell big opportunity for Indian pharmaceutical companies with an estimated 61 drugs worth over $80bn reportedly going off the list of US Patent and Trademark Office (USPTO) between 2011 and 2013.
This was echoed by CII chairman Satish Reddy who said: “Indian firms produce about 60,000 generic brands across 60 therapeutic categories. India is also among the world’s leading five producers of active pharmaceutical ingredients (API), while in formulations India is the second largest producer in the world.”
The Hyderabad expansion also follows just weeks after the USP opened its first testing facility in Brazil and is a further indication of the importance of BRIC (Brazil, Indian, Russia and China) to the global pharmaceutical sector.
Medical manufacturer CSL is expanding its Broadmeadows operation to keep up with global demand for its Privigen product.
Construction is due to start any day, with a new manufacturing centre expected to open in 2015.
CSL spokeswoman Sharon McHale said the project would create hundreds of jobs, in the building phase and in long-term employment at the plant.
Privigen is an intravenous immunoglobulin treatment for people with immune deficiencies.
The product has sold well in the US and CSL has recently gained approval to market it in Europe.
“This new facility in Broadmeadows will complement Privigen capacity in Bern (Switzerland), enabling us to fully benefit from the growing demand for our next generation immunoglobulin products,” Ms McHale said.
She said CSL had a lot of plasma manufacturing expertise in Australia and this was important in the decision to build the additional plant in Hume.
CSL is also building a biotechnology centre at Broadmeadows for the late stage development of new therapies for cancer, bleeding disorders and inflammation. Construction began last November and it is expected to open in 2013.
Chemicals maker Granules India says it will expand manufacturing capacity for oral solid dose (OSD) APIs and drug intermediates in a bid to better meet the needs of clients.
Granules spokesman Vijay Ramanavarapu said: “We are increasing our solid oral dosage capacity from 6 billion doses to 18 billion doses by adding new equipment in our existing facility [in Gagillapur]”.
Ramanavarapu said that: “We are adding equipment for two new workshops here. The first new workshop will have an additional capacity of 8,000 tons and will be finished by March 2012. The second new workshop has a capacity of 1,200 tons and was just completed last month. “
He went on to say that the move follows analysis by Granules’ operational excellence (OE) team and is part of a wider project has seen the firm increase metformin and guaifenesin API capacity by 25 per cent and 20 per cent, respectively, over the last year.
And, within this, finished dosage manufacturing is seeing the strongest demand said Ramanavarapu, who went on to predict that it will be an increasingly important part of Granules’ business.
“All three divisions will grow in absolute value but finished dosages, which have higher margins, will grow much faster than the other divisions. We need this expansion to keep pace with our existing order book and are already looking at future expansion beyond these projects.”
Granules’ decision to initially focus on meeting the needs of existing customers makes some sense given that, according to the Economic Times, its top ten clients generated 40 per cent of its revenue each year.
However, while the existing client base is important, Granules intends to use the additional capacity to win new orders and contracts as Ramanavarapu explained.
“We are actively looking at new customers and developing our business development pipeline. Since we are focusing on finished dosages, we need to start developing the pipeline now in order to commercialize orders several years out.
Granules’ announcement follows a month after it forged a partnership with Belgian fine chemicals firm Ajinimoto Omnichem to establish a $20m (€14m) manufacturing joint-venture – Granules-Omnichem – in Vishakhapatnam, Andhra Pradesh.
However, according to Ramanavarapu that deal is separate from the latest expansion. “The JV will focus on high-value, low-volume products for innovator companies while Granules' existing model focuses on high-volume products.”
Baxter International has expanded freeze-drying capacity at its biomanufacturing facility in Halle, Germany citing growing pharmaceutical industry demand for cytotoxic contract manufacturing.
The US-based firm has added an extra commercial-scale lyophilisation unit at the plant, which is run by its contract manufacturing business, BioPharma Solutions business.
Burkhard Wichert, VP of manufacturing for Baxter's Halle facility said: "The expansion, which was completed ahead of schedule, will help support the continuous worldwide supply of oncology products for our customers and, ultimately, for patients who are afflicted with cancer."
Cytotoxics capacity at the Halle plant has been increased a number of times over the last few years with the last recent expansion, which also involved boosting its freeze-drying capabilities, being completed just last summer.
Baxter’s move is in step with a number of manufacturers, Lonza and SAFC to give two examples, which have recently moved to expand cytotoxics manufacturing capacity citing increasing demand.
News of the expansion comes after Baxter inked a definitive agreement to buy US-based medical device manufacturer Baxa.
The deal, worth around $380m, will add Baxa’s portfolio of technologies for the delivery of oral and intravenous drugs to Baxter’s delivery systems offering.
The acquisition bodes well for Baxter as the addition of Baxa’s products will complement its nutrition products and drug delivery systems.
“With these new products, the company will be able to offer a complete solution to meet the nutritional needs of the majority of patients.”
MDT, a leading test laboratory for the medical services industry, has been acquired by independent safety testing company UL. As a result, the two entities, Medical Device Testing GmbH (MDT) and Medical Device Registration Support Ltd (MDRS) based in Ochsenhausen, Germany, will become part of UL's Life and Health business unit.
MDT specializes in clinical and non-clinical testing services for regulatory and routine control purposes. Its testing services include clinical investigations as a clinical research organization (CRO) according to ISO 14155, and comprehensive non-clinical testing services such as physico-chemical and chemical analyses, physical testing, mechanical testing, biocompatibility testing, microbiological and virological testing, cytotoxicity testing and validation of cleaning, reprocessing, sterilization and packaging processes.
MDRS's advisory services enable customers to meet medical device registration requirements through technical documentation, risk assessment, clinical evaluation, evaluation of biocompatibility, classification of medical devices and quality management assessment pursuant to EN ISO 9011 and EN ISO 13485, respectively.
UL is an independent safety testing company with five business units -- Product Safety, Environment, Life and Health, University, and Verification Services. It has developed more than 1,000 standards for safety across several industries. It will now offer a complete suite of services that will help medical device manufacturers produce safer devices and products, including key medical device testing.
"The deepening of our service offerings will put the UL brand in front of a wider variety of customers -- including some of the biggest companies in the medical and health field," said Anil Patel, general manager of UL Health Sciences. "From sterile gauze and bandages to more complex devices such as bone screws, contact lenses, orthopedic, dental and other implantable devices, UL's testing capabilities will help manufacturers develop products that will keep patients healthy and mobile.”
MDT and MDRS will continue to be headquartered in Ochsenhausen, Germany. Dr Dieter Dannhorn will remain with the companies and serve as the general manager.
SynCo Bio Partners, a Dutch GMP contract manufacturer of biopharmaceuticals, has produced and despatched the first drug product batches from its aseptic filling facility, following the expansion of its Class A zone.
SynCo's aseptic filling facility is able to fill and lyophilise a range of biopharmaceuticals, including proteins, monoclonal antibodies, polysaccharides, nucleic acids, aluminium containing vaccines, RNA and live biotherapeutics for clinical and market supply.
Pierre Warffemius, chief executive of SynCo Bio Partners, said the expansion of the Class A zone adds to the firm’s already state-of-the-art contract manufacturing facility in Amsterdam.
Medical device developer Boston Scientific Corporation is investing €26m (£22.7 m) in R&D at its Clonmel facility in Ireland.
The investment, supported by the Government through IDA (Industrial Development Agency) Ireland, will enable Boston Scientific to significantly expand its R&D and technical capabilities related to the design of the company’s next-generation cardiac rhythm management devices manufactured at the Clonmel facility.
Brad Sorenson, vice-president of Operations for Boston Scientific, said: “This local funding will benefit our Cardiology, Rhythm and Vascular Group by enhancing our ability to provide R&D, design and manufacturing support for our leading medical device technologies.”
Boston Scientific is a major player in the medical technologies sector in Ireland having established operations in there in 1994 and is one of the country’s largest employers, with campuses in Clonmel, Galway and Cork.
Work has begun on a £5m project to build a state-of-the-art unit to sterilize surgical instruments at Colchester General Hospital and Essex County Hospital.
The Hospital Sterilization and Decontamination Unit (HSDU) will be located next to the Old Boiler House on the former Turner Village site on the edge of the Colchester General Hospital site. It will replace the existing facility, which is in the hospital’s Main Block and will be equipped with brand-new state-of-the-art equipment.
The HSDU re-processes instruments and equipment required for clinical intervention in the treatment of patients. The majority are theatre instrument sets which are cleaned and decontaminated, inspected, packed, sterilized and returned for re-use. Nick Chatten, Special Projects and Estates Director for Colchester Hospital University NHS Foundation Trust, which runs Colchester General Hospital and Essex County Hospital, said it was a significant investment.
“The Trust has outgrown its current HSDU and this replacement unit will be bigger,” he said. “When it is complete, it will mean Colchester will have one of the most efficient HSDUs in the NHS East of England region."
“For example, the new major re-processing equipment will benefit from the latest advances in technology and substantially reduce water consumption in comparison to the machines currently in use, resulting in an eco-friendly addition to the Trust’s estate.”
The main contractors for the project will be Rose Builders Ltd of Lawford and the new unit is scheduled to become operational in July next year. Its cost will be funded entirely from the Trust’s own resources.
The Trust has 34 whole-time equivalent staff working at its HSDU. During weekdays, cover is provided 24 hours a day with day shifts at weekends. The location of the new unit away from the main hospital will mean that it can be built without any major impact on the rest of the hospital.
Japanese drugmaker Takeda has been awarded JPY24bn ($313m) to develop a cell culture influenza vaccine and establish a commercial-scale production facility.
The award, from the Japanese government, will fund further development of Takeda’s production facility in Hikari, Yamaguchi Prefecture with the aim of making it fully operational for full scale production by 2013.
Takeda has been working on culture vaccines since August 2010 when it received a grant from the Government’s Pharmaceutical Development Support Center to set up process development and testing facilities in collaboration with US firm Baxter.
And, in December, the collaboration was strengthened when Takeda licensed rights to Baxter’s Vero vaccine development and production platform for an undisclosed sum.
Since then Takeda has been testing and developing the system in Hakari, installing pilot production lines and purification technologies which, as a result of the new subsidy, it will now expand to a commercial-scale.
In a press statement Takeda CEO Yasuchika Hasegawa said: “Takeda will fulfill its social mission as a pharmaceutical manufacturer, in collaboration with Baxter, by accelerating the establishment of the production facility and the supply system of new influenza vaccines in Japan, which will enable us to deliver these vaccines to society as early as possible.
The latest announcement marks the completion of Takeda’s move back into influenza vaccine development which, like some of its Japanese peers, it stopped more than a decade ago after the then government made such immunizations voluntary, reducing the size of the market.
The UK government has awarded £58.7 million ($96.7 million) to a research center at King's College London and Guy's and St. Thomas', a National Health Service trust with two hospitals in London, that will engage in translational research, including biomarker and drug discovery studies.
The Biomedical Research Centre will use the five-year funding to establish the School of Translational and Experimental Medicine and to capitalize upon earlier investments made in new facilities and training programs, according to Guy's and St. Thomas'.
"We will focus on pulling through early discovery of new drugs, molecules and biomarkers into the clinic – and then extending these beyond the hospital and into the wider community through close collaboration with primary care," Guy's and St. Thomas' Chief Executive Ron Kerr said in a statement. "Our scientists and clinicians are at the forefront of developing some of the latest diagnostic techniques and therapeutics so that we can tailor both diagnosis and treatment to individual patients."
The new funding for the Centre was part of a new round of £112 million for research from the National Institute of Health Research that includes £53.3 million to establish mental health research centers.
Tanzanian Pharmaceutical Industries (TPI) is set to open the doors to a new anti-retroviral drugs (ARVs) manufacturing plant.
The new $8.7m (€6m) facility – based in Njiro, a suburb of the Northern Tanzania city Arusha – now has all production machinery and processing lines installed and is on track to be fully operational on December 1.
TPI established the factory under the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement. Under the covenant, companies in developing countries, like Tanzania, to produce life-prolonging drugs that are more affordable.
Currently, a one-month dose of an antiretroviral drug (ARV) costs around $18. TPI claims that, when its new plant is fully operational, it will be able to sell a month’s supply of ARV for around $12.
CEO Ramadhan Madabida said: “Our target is to ensure that Tanzania and East African countries are self-sufficient in the supply of the ARVs and other essential drugs in the region.”
The plant, which will create 140 manufacturing and production jobs, will make Tanzania, which has a population of 35 million and a HIV/Aids strike rate of 7.8 per cent, one of only a few developing countries capable of producing its own life-prolonging tablets.
This was stressed by Madabida, who added that TPI also intends to supply the rest of the East African community (EAC) market.
The announcement follows Indian company Ranbanxy’s decision to both manufacture and supply ARVs in South Africa, as well as in its home country India.
However, unsatisfied with simply reducing the costs in the region, some experts are pushing the government to produce enough medication for the 130 million local sufferers.
EAC Principal Health officer Stanley Sonoiya, said: "Governments should support the private sector with either loans or grants so that the sector grows rapidly and meet people's demand in the region.”
Swiss international biotech giant Roche Holding AG, through its Roche Canada unit, said it will invest almost $200 million over the next five years at its Mississauga plant near Toronto, with a $7.8 million Ontario Government commitment.
A new Mississauga research centre, with a staff of 200, will manage all Roche’s clinical trials for new drugs in co-operation with the multinational’s five existing world research centers.
“This program reflects a shared commitment by Canada’s research-based pharmaceutical industry and the Province of Ontario to build long-term benefits and international leadership in life sciences,” Roche said in a statement.
More than 30 years ago Hoffman-La Roche built a multi-storey building at Vaudreuil to house a major Canadian drug research centre, but it never got into operation because the Federal Government reduced patent protection for new drugs. The building now hosts a major electronics distributor.
Univar is building a new facility to expand its capacity for white oils handling and distribution.
The US fine chemicals company says the investment will enable it to meet its expanded agreement to distribute ExxonMobil’s white oil brands Marcol and Primol across Europe, the Middle East and Africa.
The plant is scheduled to open in Lieusaint, France in June and will include a €600,000 atmosphere-controlled cleanroom, for filling, handling and distribution of the highly refined hydrocarbon product. The Class 100 cleanroom will be supplied and installed by Conditionaire, based in Paris, France.
The cleanroom will include a high efficiency particulate filter system, which generates more than 400 changes of the internal air per hour. In the heart of this room there will be a hygienic stainless steel filling machine, supplied by Pack'R, which will include quick change parts.
The plant will operate under Good Manufacturing Practice (GMP) guidelines. Univar says it will also introduce an in-house analytical department to maintain the highest standards of quality assurance.
White oils are used in the manufacture of pharmaceutical, food and personal care products, as well as having a number of industrial applications. These are currently produced at the Esso France refinery, a subsidiary of ExxonMobil in Notre Dame de Gravenchon, France.
Sheila Mowatt, Univar’s vice president, Supply Chain Operations EMEA, said: “The new white oils contract has been signed at a time when we are looking to reduce our reliance on outsourced providers. We have first class facilities and people at Univar and we are actively looking to give our customers and suppliers added value by using our extensive asset base.”
Shimadzu UK unveiled a 1,500 m² (16,140 sq. ft.) product evaluation laboratory at its central U.K. headquarters in Milton Keynes, Buckinghamshire. The center, which aims to focus on excellence in customized application solutions, has 25 analytical systems including the firm’s complete range of products and a wide selection of its array of LC, GC, LC/MS, GC/MS, and spectroscopy instrumentations.
The facility is supported by a dedicated on-site team of eight lab instrumentation professionals. “We are striving to make our new Evaluation Laboratory a center for excellence where existing customers or potential new ones can be safe in the knowledge that they can try out various pieces of equipment and run them through their paces before deciding what is the best system solution to meet their particular application requirements,” explains Colin Jump, Shimadzu UK’s managing director.
“Our goal is best-in-class equipment as well as post-sales service and support. The new center will help us to support our customers and their Shimadzu equipment throughout its working life. Shimadzu offers scheduled training courses at competitive rates for both basic and advanced equipment and software use as well as applications courses designed by our experts to meet a user’s requirements."
Shionogi & Co., Ltd. announced that it has held an inauguration ceremony of the new pharmaceutical research building, which was constructed on the grounds of the company's existing laboratories located in Toyonaka City, Osaka, where this building will become the central core of Shionogi's research operations.
With the completion of the new facility, Shionogi's drug discovery research operations, which were previously distributed amongst four sites in Osaka and Shiga Prefectures, are now integrated into the Shionogi Pharmaceutical Research Center (referred to as 'SPRC (spark)'), which is composed of the new building and the existing three buildings. Shionogi aims to achieve world-leading research productivity, aided by enhanced coordination among the integrated functions at SPRC.
The new building contains drug discovery research laboratories built to the highest standard, with cutting-edge laboratory equipment and information technology capabilities. At the same time, the facility is environmentally-sensitive and incorporates a specially-designed layout designed to stimulate creativity and support innovation by increasing communication and mutual collaboration among researchers.
'With the cutting-edge core facility, which will support maximal creativity and high productivity, we will concentrate all drug discovery research functions at SPRC. It will be the foundation for the growth and globalization of Shionogi for the next 10 to 20 years.' said Dr. Isao Teshirogi, President & CEO of Shionogi. 'Shionogi is dedicated to creating innovative new medicines through the research conducted at SPRC with a mission - to provide better medicines from Osaka to the world.'
As a research-driven pharmaceutical company, Shionogi is dedicated to the continuous improvement of research productivity and to increasing the speed of drug development, focused on generating high-quality drug candidates with strong global potential in-house, in the target therapeutic areas of metabolic syndrome, infectious diseases and pain.
Quintiles has targeted Africa as the next non-traditional area to develop new medicines and the opening of its office in Ghana, which is now fully operational, is a major step in this process, said Gillian Corken, head of Quintiles in Africa.
The Accra, Ghana office was established in June and Corken believes it “offers huge potential” to reach the estimated 760m patients in Sub-Saharan Africa. Quintiles’ office is now fully operational and has initiated a large malaria vaccine trial.
Corken explained that the vaccine trial demonstrates how Quintiles staff are able to “anticipate needs and roll up our sleeves and deliver”, adding that the Ghana office represents “the beginning of an exciting journey” for the company.
The office is based in the grounds of the University of Ghana at the Noguchi Memorial Institute for Medical Research. Alex Nyarko is director of the institute and will continue to work with Quintiles, as will David Ofori-Adjei who has entered into a partner-site agreement with the company.
Neels Barnard is heading clinical operations at the Ghana site and is living and working in the country. Assisting him are five clinical research associates (CRA) and one clinical trial administrator (CTA).
The CRAs and CTA will follow a comprehensive global training plan for their job description. Training takes the form of self study, audio distance, webinars and teaching in classrooms, all of which is intended to give staff the technical capabilities and soft skills needed to conduct trials.
Investigators at the institute will also receive training covering good clinical practices (GCP), protocols, regulations and ethics committees. This forms part of Quintiles agreement with the institute.
Since the establishment of the Ghana office Quintiles has stressed that it will “strictly adhere to ethical principles articulated by international guidelines such as ICH, the Declaration of Helsinki, CIOMS and the Belmont Report”.
Richter-Helm BioLogics GmbH & Co. KG completed the modernization of its GMP-production facility in Hannover in September 2009. Hence GMP-production capacity in a scale of 300L fermentation volume and corresponding down-stream capacity for the production of recombinant proteins, plasmid DNA and vaccines deriving from microbial fermentation is now available at the Hannover location.
Richter-Helm’s service portfolio for GMP compliant manufacturing of biopharmaceuticals roots in the Hannover facility. For more than 20 years, recombinant proteins, plasmid DNA and vaccines have been produced, which have met the extremely high quality standards for biopharmaceuticals. After successfully modernizing the cleanroom area for purification in 2008, the up-stream processing area, i.e. the area for fermentation and primary recovery of microbial cultures, of this facility is now state of the art. The construction work was completed in September and the new facility is presently undergoing qualification operations. After repeatedly improving its facility Richter-Helm has now cleanrooms of class D up to class A in B available at the Hannover location, which were designed and constructed strictly following a GMP room concept. Planned for production of biopharmaceutical test samples for all clinical phases, the facility is also suitable for market supply. Two bacterial vaccines which are approved and available at the market are already produced at this site.
Having invested into state of the art equipment and facilities once again Richter-Helm underlines the constant readiness for innovation and improvement which makes it one of the leading providers of services for biopharmaceuticals development and manufacturing.
The new facility now closes the gap between Richter-Helm’s research facility and the large scale production in Bovenau near Kiel. Richter-Helm has now all common fermentation scales up to 1500L available for GMP production at three different locations, to serve the customers’ needs for consistent quality from pre-clinical development up to market approval and beyond
US contract research organization (CRO) GenScript will provide assay development services for Roche’s drug R&D unit in China.
GenScript vice president Sally Wang said the firm will create assays for drug targets selected by the Swiss drug major, and predicted that “the work will involve multiple functions from both sides considering the nature of drug discovery and development process.
“The project GenScript is undertaking will contribute to Roche’s drug discovery portfolio and preclinical programs by providing unique assay for novel drug targets.”
The Roche unit, known as Roche R&D Center China (RRDCC), was established in 2004 at the Zhangjiang Hi-Tech Park in Shanghai.
Prior to the GenScript partnership that site and its 40 strong staff of scientists had focused on medicinal chemistry research for lead optimization, which Roche’s CSO Li Chen explained, provided a firm base to add biology R&D.
Dr Li said: “After the success of medicinal chemistry outsourcing, biology CRO is becoming a new trend in drug discovery. We expect a fruitful collaboration with GenScript in assay development.”
Li went on to say that while previously it was difficult to find a provider capable of the development of assays, in the last few years an increasing number of CROs have begun offering this type of service and the market is becoming more competitive.
Despite this growth GenScript believes that scope of its assay offering makes its stand out from the crowd, as Wang explained.
“There are not many CRO companies except GenScript which can provide one-stop bio-reagent services ranging from custom gene synthesis and molecular biology, custom protein expression and purification, to custom peptide synthesis, antibody production, and custom cell line development.”
And, GenScript looks set to further expand its offering. In June the firm secured some $15m (€10m) in venture capital funding for infrastructure development.
Wang said: “The investment fund will be strategically used for recruiting more industry veterans and talented scientists and for investing in state-of-art instrumentation and capacity expansion.
“This strategic investment will benefit our customers for them to receive assay services with quality and timely delivery in broader therapeutic areas which are offered by experienced staff.”
A new state-of-the-art packaging facility in Hainan Island, off the coast of southern China, will lead the expansion of U.S. company Shiner International in the country, according to its presentation at a business conference in New York.
The plant, which is expected to open later this year will double the company’s production of food safe packaging to 30,000 tons/year within two years, delegates heard at the Rodman & Renshaw Annual Global Investment Conference Asia Track.
It expects food safe packaging capacity to reach 50,000 tons/year by 2013.
Although China’s melamine milk crisis last year hit sales of all packaged food sold in supermarkets, it brought opportunities too. “This crisis gave us a big impact at first but now it turns out to be an opportunity too, since people are concerned more about the food quality and the government implemented the food safety law to control food quality.”
The company’s business has also been affected by global recession but the food business is now slowly recovering, she added.
Shiner's chairman, Yuet Ying told the conference: “With the increasing urbanization and rising consumer incomes in China, Shiner is positioned to continue its expansion and strengthen its placement as the leading supplier in China's domestic market. And it will increase its presence in international markets by increasing marketing through direct sales, produce superior product quality and technical content, while proving a cost efficient product for our customers."
At the conference, the company reported 2009 sales revenue at $34m; gross profit of $4.8m; gross profit margin of 14.1% and net income of $0.1m.
Food packaging sales during the first half of this year reached $5.4m which accounts for 36% of total sales. Shiner’s products are used to package a range of foods including biscuits, cookies, cakes, candies, nuts, meat, drinks and instant noodles.
Shiner predicted that for 2013 that sales revenue would grow to $180m, a 50% increase versus 2012 and gross profit would reach $37.2m. It forecast a gross profit margin of 20.7% and net income of $20.5m, a 71% increase on projections for 2012.
Rising consumer incomes are increasing demand for Shiner’s coating of BOPP film, said the spokesperson. “Food packaged in coated film has a much longer shelf life and a much better quality protection than packaged in bare BOPP film,” she said. “In the European and US market, about 20% of all the BOPP films are coated, However, in China, currently only around 0.5%. As more and more Chinese people move to the cities….the need for coated film will explode.”
About 60 per cent of Shiner's customers are located in China, with the remainder in South east Asia, Europe, the Middle East and North America.
Israeli generics giant Teva Pharmaceutical Industries will close one of its manufacturing plantsin the Czech Republic by the end of the year, resulting in the loss of around 400 jobs.
Teva has not yet issued a statement on the move, although the firm did tell Reuters that it plans to invest $58m (€39m) in its Czech manufacturing operations next year to boost production.
Regardless of the motivation for the latest cuts, Teva’s business development strategy over the last years seems to be to streamline and refocus its global manufacturing operations to improve efficiency.
In February, Teva said that its Croatian subsidiary Pliva would reduce its workforce by 790 employees as part of an efficiency drive designed to boost local active pharmaceutical ingredient (API) production.
And, earlier this month, the firm announced plans to close one of its plants in Ireland and relocate 315 jobs to operations in a number of countries in Eastern Europe, including the Czech Republic, where costs are lower.
In other news, Teva has invested $3.5m in US specialty cancer drug developer Rexahn Pharmaceuticals as part of a licensing deal for the latter’s candidate oncology medication RX-3117.
In a press statement company VP of innovative ventures Aharon Schwartz said: "Our agreement with Rexahn underscores Teva's commitment to bolstering its innovative pipeline through licensing of promising compounds.
The investment fits with both the recent expansion of Teva’s specialty pharmaceutical portfolio, including the addition of Barr’s women’s health division and comments made by the firm at its Q2 results presentation in July.
At the time, Bill Marth, president of North American operations, said: “we believe that the same type of capabilities that we have developed in the generic market, we can also apply to specialty or some other area that we might go after.
Dalton Pharma Services has rolled out a new formulation development service that completes the firm’s contract drug manufacturing offering according to CEO Peter Pekos.
The new unit will provide formulation development for liquid, solid, semi-solid and lyophilized versions of small-molecules, proteins, monoclonal antibodies and potent active pharmaceutical ingredients (APIs).
Pekos said that the Canadian contract manufacturing organization (CMO) has “also expanded our Analytical Services to serve our formulation development experts and as a result now offer dissolution testing and particle size distribution testing.”
Gerresheimer is increasing its presence in the pharmaceutical plastics business, which it believes is increasingly important, by opening an R&D centre in the U.S. and a production facility in Spain.
The pharmaceutical plastics sector has become Gerresheimer’s fastest growing business sector and the company has made strategic investments to ensure it has the capacity to meet rising demand.
Gerresheimer has achieved this by opening a production facility in Masalaves, Spain that it believes is the largest of its kind in Southern Europe. The plant will serve the Southern and Central European markets and is regarded by Gerresheimer as “a significant strategic base”.
From the facility Gerresheimer will produce pharmaceutical bottles and multifunctional dosage and closure systems, for delivery forms such as eye drops, nose sprays and tablets.
Gerresheimer has also invested to bolster its R&D capabilities, opening a technological centre in Peachtree City, Georgia, US. The site previously only housed a manufacturing facility but has now been upgraded with the addition of R&D capabilities.
Prior to the expansion Gerresheimer lacked a US site that could handle customized serial production of entire product and process development, with only its European sites having this capability.
Following the expansion the U.S. site will work on highly developed inhalation systems for respiratory diseases, as well as insulin pens, skin-prick aids and lancets for the diabetes sector.
Gerresheimer has experienced steady growth in these sectors and the expansion gives it the capacity to continue strengthening its market position. Following completion of the recent expansions Gerresheimer has 15 sites operating in the plastics sector.
This capacity has been created through acquisitions and targeting investments, which, coupled to organic growth, have helped accelerate the division’s growth over the past five years. The division now accounts for a third of group sales.
Ireland has granted €14.8 million ($21.6 million) to establish a center focused on systems biology. The five years of funding from Science Foundation Ireland (SFI) will start the Systems Biology Ireland (SBIR) center, which will be led by University College Dublin.
Several corporate partners are joining SBI in supporting the center, including Agilent Technologies, Siemens Ireland, Protagen, Ark Therapeutics, Hewlett Packard, and Servier.
QPS’ bioanalytical laboratory in Taiwan is the first in the country to be certified as compliant with good laboratory practice (GLP) standards by the Department of Health (DoH), according to unit president Vincent Yen.
The U.S. based contract research organization (CRO) said that certification enables its Taiwan unit to begin offering analytical support services for both preclinical research and clinical development.
Yen said that the DoH based its decision on the firm’s track record, infrastructure and library of standard operating procedures (SOPs) that are employed at all of the firm’s research labs worldwide.
He explained that the lab, which is located in Taiwan’s Nan Kang Biotech Park, houses API 4000 triple quadrupole mass spectrometers, Shimadzu VP-series LCs, Tomtec Quadra, managing those using Rees Monitors and a Watson LIMS system.
QPS’ CEO, Ben Chien, said: “We view this as an additional assurance to our sponsors that the QPS state-of-the-art, Asian bioanalytical LC/MS/MS facility has the same high quality and operational standards as our FDA-audited QPS U.S. facility.”
In the 1980s the Taiwanese government began to invest in biotechnology R&D, spending around 30 percent of its annual science budget on the sector which was, at the time, still relatively small.
This investment resulted in the development of three science bases: Hsinchu; the Central Taiwan Science Park and the Southern Taiwan Science Park, which generated revenues of $60.8bn in 2008 according to the National Science Council (NSC).
This infrastructure has proved irresistible to industry players like Applied Biosystems, Invitrogen, Dionex and Novartis which, in addition to German drugmaker Merck KGaA, all have an established presence in the country.
Despite Taiwan’s success in attracting the pharmaceutical industry, the country’s contract research sector, has until recently, remained relatively small according to center for drug evaluation (CDR) executive director Herng-Der Chern.
In an interview with BioSpecturm in March last year Chern said: “There is shortage of supply of skilled workforce in the segment because of the booming demand even though many CROs have set up intensive training course to nurture their staff.”
In response, the Taiwanese government instituted a “promotion plan” designed to attract contractors to the country.
The plan grants rights to CROs to submit investigational new drug (IND) applications and provides pharmaceutical sponsors with a number tax incentives relating to their outsourcing spend.
PPD, Inc. has opened its global central lab facility in Singapore to provide customized lab services in Southeast Asia. PPD also has an office in Singapore that provides clinical development services, including clinical trial management and monitoring, patient recruitment, site identification and regulatory affairs.
"Expanding our global central lab services into Singapore demonstrates our commitment to deliver high quality specimens and laboratory results for our clients in a growing biopharmaceutical market," said Steve Lobel, vice president, global laboratory operations, PPD. "We can expedite delivery of lab data through reduced transportation and shipping time at better logistics costs for our clients."
Porsolt, a French contract research organization (CRO) specializing in preclinical pharmacology services, has said it plans to open a new facility in Europe as well as boost its presence on the other side of the Atlantic.
The CRO has started construction of a new laboratory on a 10-hectare development in Laval, France. The first phase of the operation will see a 60,000 square foot facility completed in early 2010.
The new site will offer increased capacity for Porsolt's expanding cross-therapeutic area models and Good Laboratory Practices safety pharmacology expertise, according to the firm.
Porsolt’s chief executive, Mark Duxon, said the decision follows a period of good growth in 2008, and a growing awareness of the firm’s “cross-therapeutic area expertise,” which he believes has set the firm up for “sustained growth in the next five to 10 years.”
Porsolt has remained very focused on its core expertise – preclinical pharmacology – at a time when many CROs have pursued a strategy of broadening their service range in the hope of winning lucrative ‘preferred provider’ contracts.
The French CRO believes that concentrating on two core services - assessing novel substances for therapeutic activity and safety using animal models – is a more reliable model. The company has long argued that the best strategy is not to strive to become the biggest CRO, but to remain the best in selected areas of competence.
While the company is happy to remain a specialist service provider, it is keen to expand its geographic presence and has implemented a project to spearhead an expansion in the U.S.
Porsolt has hired two experienced PhD biologists from Big Pharma who will be permanently based in the USA to conduct business development support in that country.
The headcount in the US business development group will be further increased - in line with expansion of the company - in 2009 and 2010, the CRO noted. Porsolt already has a team of five business development staff located in Paris, France.
Martine Lemaire, senior director and head of business development, commented: "as our laboratory services grow and as we implement a new expansion strategy, we feel it is essential to have experienced personnel based in the US to offer direct face-to-face client interaction. “
New multi-million dollar R&D contracts with top three pharma and biotech players go some way to “alleviating” the negative impact of downturn, according to Lab Research CEO Luc Mainville.
The firm, which also signed an R&D deal with a European agrochemicals major, will undertake preclinical research on behalf the as yet unidentified drug industry majors at its testing facility in Laval in Quebec, Canada.
Over the last three years Lab Research has spent C$65m (€41.8) expanding the lab as well as two other testing facilities in Denmark and Hungary adding capacity which, Mainville said, had played a part in winning the new R&D contracts. He told Outsourcing-pharma that: “It is clear that adding scale and broadening our services to include bioanalytical, drug metabolism, reproductive toxicology and more inhalation have been key factors.
“But I think that it is a combination of our capabilities and high quality and flexibility as a mid-size lab that has contributed to each of these agreements.”
Mainville also highlighted Lab Research’s expertise and track record in safety pharmacology, infusion and primate modeling as being the key technical capabilities that had landed the new contracts.
He concluded that: “Clearly our ability to expand our client audience to include larger and sophisticated recurrent spenders has alleviated somewhat the negative impact of the recession.”
In a press release accompanying the announcement Lab Research said that the contracts are likely to lead to more deals later this year, adding that discussions are already ongoing for work to be conducted over the next two years.
The non-clinical contract research organization (CRO) predicted that the latest deals and subsequent agreements will contribute between five and 10 per cent of its total revenue for the current year.
Bangladesh represents a “huge opportunity” to pharma, according to the CEO of Amreteck Pharma who believes that CMOs will be attracted by the low costs, which undercut China, and help the industry grow to $10bn (€6.9m) in 10 years.
Speaking to Outsourcing-Pharma M Chowdhury, founder and CEO of Amreteck, explained that Bangladesh’s educated pharma workforce and costs that undercut India and China will attract multinationals and contract manufacturing organizations (CMO).
Companies including Roche and Sanofi-Aventis already have operations in Bangladesh, which is also home to 260 local pharma businesses. These local companies are growing at 20 per cent a year, according to Chowdhury, but there are concerns over the quality of medicines produced.
There is a lack of pharma production expertise in the country and good manufacturing practice (GMP) consultancy firms are expensive. To fill this void Chowdhury, who is from Bangladesh but is western educated and has worked at numerous pharmas, established Amreteck.
Chowdhury explained that Amreteck offers multiple services, at affordable prices, to help Bangladeshi companies improve understanding of the manufacturing process and reduce human error.
This covers the establishment of quality systems for all aspects of production, from raw materials through to final packaging. Amreteck then validates the operations.
Chowdhury intends to establish an office in Bangladesh next year. In addition to running the Bangladeshi operations the office will also support Armtek’s activities in India and China.
Export opportunities
Bangladesh’s status as a less economically developed country (LDC) allows it to manufacture therapeutics covered by active patents. This has enabled companies to export patent protected products to countries in Africa.
Chowdhury explained that the top five Bangladeshi pharma companies account for most of the exports, and also have better quality controls, but there are opportunities for growth.
The exemption from patent protection is due to expire in 2016. In preparation some companies have begun to invest in R&D but, Chowdhury explained, they lack an understanding of international protocols and regulations, for instance investigational new drug (IND) applications.
Consequently, Amreteck will also provide services to help Bangladeshi companies with regulatory processes.
UK API maker and contract manufacturing organization (CMO) Aesica Pharmaceutical has landed a multi-year deal to produce and package drugs on behalf of Amdipharm.
Under the deal Aesica is providing production and packaging services for several key products including Erythrocin (erythromycin), Hytrin (terazosin) and Loftly (buflomedil) at its secondary manufacturing facility in Queenborough in the UK.
The plant houses both solid and liquid dose manufacturing capabilities for, among other things, anesthetics and controlled drugs. It also provides blister packaging, sachet production and bottling capabilities as part of Aesica’s supply chain services offering.
However, as Aesica spokesperson Maria Koustareva explained, the collaboration, which is likely to be extended to other drug products, also covers wider aspects of Amdipharm's manufacturing and distribution operations.
These services will include the 2D-matrix technology that Aesica is preparing to introduce “on all cartons to keep up with the latest legislation worldwide and to prevent [the] distribution of counterfeit medicines.”
Koustareva was also upbeat about the general state of the pharmaceutical contract manufacturing market suggesting that, in Aesica’s experience, demand has continued “to grow despite the economic downturn.”
“Over the last 12 months Aesica has seen an increased amount of enquiries and business opportunities for contract manufacturing finished dosage forms and providing packaging services to its customers around the world.”
In a press statement that accompanied news of the deal Amdipharm’s managing director, Mick Cullen praised his firm’s new contractor, commenting that: “We have been very pleased with our growing relationship with Aesica based on their reliability, flexibility and responsiveness.”
Tate & Lyle is giving a boost to its Australian food systems business with the opening of a new R&D and manufacturing centre in Queensland.
The company, called Tate & Lyle Food Systems, has had a presence in South East Queensland for 19 years. It supplies stabilizer systems to food firms in Australia, New Zealand, Japan, Korea, South East Asia and the Middle East.
The new centre, which has cost AU$7m (around €4.1m at today’s exchange rates), will function as the headquarters for Asia Pacific, and will be used to help customers in their quest to develop healthier foods.
In Asia Pacific, just as in Europe and the U.S., consumers are seeking good tasting products that also have less macronutrients that are understood to have an impact on their health, such as saturated fat or sugar. There is also interest in boosting fiber intake, with foods that have fiber added.
Consumers are also watching their pennies closely, especially in the current economic climate, and foods that have a longer shelf-life – another attribute with which systems can help – are attractive as it helps reduce wastage.
However the new site will not just benefit the region in which it is located. Tate & Lyle has an global network of R&D centers and it draws on knowledge from all of these in the solutions it offers.
In 2007 the company acquired a 70 per cent share of GC Hahn, a German company specializing in stabilizer systems, which boosted its global competencies in this area.
Brian Walker, regional sales director of Tate & Lyle Food Systems, said: “Our facility in Queensland incorporates the latest in innovative design and technology in food hygiene and allergen control. Everything has been designed to have minimal impact on the environment with extensive waste management regimes in place and the best in occupational health and safety for our staff.”
The kinds of products into which stabilizer systems make their way include yoghurts, salads, ready meals and desserts.
Apotex Inc., the largest Canadian-owned pharmaceutical company, says it is working with U.S. regulators to correct problems at two of its plants in Toronto.
The U.S. Food and Drug Administration has issued an import alert banning products from Apotex plants in North York and Etobicoke.
Issued Aug. 28, the alert calls for "the detention without physical examination of all finished form drug products imported to the U.S. from these facilities," according to an FDA email in response to questions from The Canadian Press.
Apotex said that the alert relates to "observations made following routine audits for products destined to the U.S. only."
"We are actively working with the FDA to resolve the identified concerns as quickly as possible, and are optimistic that there will be a prompt resolution," Jack Kay, Apotex president and chief operating officer, said in statement.
Apotex, founded in 1974, employs over 6,500 people in research, development, manufacturing and distribution facilities worldwide.
Some 5,800 of the employees work at the Canadian operations in Ontario, Quebec, Manitoba, Alberta and British Columbia.
Covance says its new clinical development offices in Brazil and Mexico will increase access to treatment-naïve patients and, ultimately, save pharmaceutical sponsors money.
The new clinical offices, in Sao Paulo and Mexico City, will provide support for Covance’s Phase I to III clinical trial business in both countries and across the region as a whole.
Wayne Langlois, head of Covance’s local clinical development services unit, said the: “new offices increase our access to patients who are currently not receiving medical therapies and will enable us to shorten clinical trial cycle times.”
And, while such claims are usually made whenever CROs open new offices anywhere, on this occasion Langlois contention is supported by market analysis.
Last month, Business Insight’s published its “Emerging Clinical Trial Locations” report, which suggested that studies in Latin America are on average 50 per cent cheaper per patient than those conducted in the US.
The report also revealed that the number of trials being carried out in Mexico, Argentina and Brazil have increased dramatically over the last eight years, which lends further support to Langlois’ view.
While Covance has operated in the region for over a decade, opening its first office in the Argentinean capital Buenos Aires in 1997, the last 12 months have seen it accelerate its growth in the region.
Earlier this year for example, the contract research organization (CRO) set up new units in Chile and Peru again citing the improved access to patients as the primary motivation for the expansion.
And, from a wider industry perspective, Covance’s move fits with the current drive to improve access to patients that has seen most of the major CRO players expand their operations in Latin America over the last 12 months.
In April, Chiltern set up in Brazil through the acquisition of Vigiun shortly followed by AAIPharma, which bought the Instituto de Pesquisa Clinica in Sao Paulo, and PRA which opened a unit in June.
Prior to that, Swiss CRO PFC Pharma Focus entered the Latin American market through a partnership with Argentinean company Blanchard y Asociados.
Clearly the benefits of the Latin American market prove hard for a CRO to resist and are likely to continue to do so for the foreseeable future as the demand for trial participants continues to grow.
Schering-Plough has opened a new pharmaceutical manufacturing facility in Oss, the Netherlands, to help meet demand for the drugmakers' injectable drugs and hormonal products and boost its capacity to make biologics.
The addition of the new site makes Oss the largest pharmaceutical manufacturing centre in the Netherlands, said the company at the unveiling event earlier attended by Dutch Economic Affairs Minister Maria van der Hoeven.
The new 16,500 sq.m. (177,540 sq. ft.) factory has three separate production lines and was built on ground adjacent to the main production facilities of Organon, which was acquired by Schering-Plough for 11 billion Euros in November 2007. It cost 75 million Euros to construct and will employ between 80 and 100 staff.
The new Oss plant will initially be used to manufacture injectable drugs such as muscle relaxants Esmeron/Zemuron (rocuronium bromide) and Norcuron (vecuronium bromide) and their reversal agent Bridion (sugammadex).
It also has a dedicated production line for NuvaRing (etonogestrel/ethinyl estradiol), Schering-Plough's fast-growing contraceptive device which brought in sales of $115 million in the first quarter of this year, as well as other hormone-based treatments.
The high-tech plant is designed very much in keeping with the current trends in pharmaceutical manufacturing - lean, flexible facilities that can be used to make a range of products with minimal risk of cross-contamination between production lines and from operators.
It makes extensive use of automation in cleanroom areas and the freeze-drying suite, and boasts closed systems for air and water supply and purification, as well as its own dedicated water treatment plant.
Around 25% of the plant's manufacturing capacity has been earmarked for use by BioConnection, an innovative company designed to help smaller biotechnology companies make batches of their pipeline products for use in trials, as well as large-scale commercial production and other activities such as formulation development.
BioConnection was set up in 2005 as a collaborative venture between the Dutch government and Organon's former parent Akzo Nobel.
Swiss biomedical science firm Lonza is investing CHF30m (€19.7m) in a new cell therapy facility in Singapore, continuing its global expansion effort.
The plant, which will produce novel therapeutics on a contractual basis, will be located next to the firm’s existing mammalian manufacturing unit at the Tuas Biomedical Park in the West of the country.
Company CEO Stefan Borgas said the unit is the next step in Lonza’s efforts to expand in Asia explaining that: “Cell therapy is expected to be one of the most important innovation drivers of modern medicine.
"The facility will operate with cutting-edge technologies and a skilled labor force, allowing it to readily meet the needs of a broad range of customers and address the growing global demand.”
Beh Swan Gin, managing director of the Singapore Economic Development Board (SEDB), said the new unit “extends the highly successful Lonza-Singapore partnership from chemicals to biologics manufacturing and now, the production of cellular therapeutics.”
Construction is expected to begin early next year with the aim it becoming fully operation sometime in mid-2011.
Lonza has a network of 12 good manufacturing practice (cGMP) accredited cell therapy plants worldwide, including a facility in Walkersvillie, Maryland, US in which it invested $26m to boost cell production capacity in January.
The firm also works with Novartis and Genentech on the manufacture and development of biologics.
Efforts to boost scientific development has seen Singapore emerge as a hub for high-tech drug manufacture, with global pharmaceutical firms investing more than $500m in the country last year alone, according to the SEDB.
Before Lonza announced its latest move, Bayer, Schering-Plough and Takeda all expanded operations in the country both by adding manufacturing capacity and forging closer links with academia.
Lonza is also working with Baxter, Genentech, GSK, Novartis and Millipore to set up a $2m biopharmaceutical manufacturing training facility in the country.
Speaking at the recent BIO 2009 event in Atlanta, Yeoh Keat Chuan, executive director of the SEDB’s biomedical sciences unit said that: "Singapore is aggressively positioning itself as a home for business, innovation and talent in Asia to be future- ready.”
Piramal Healthcare is switching its UK API making operations to Morpeth, Nothumberland after a downturn in the Indian CMO’s international business cut capacity utilization at its former base in Huddersfield to just 35 per cent.
The firm gained control of the Huddersfield plant in 2005 through its £10m (€11m) acquisition of Avecia Pharmaceuticals in December 2005. Pirmal plans to shut down the facility, which contributed £19m to its earnings last year, but has not yet said whether it is seeking a buyer.
The move, which will result in the loss of 93 jobs and cost Piramal around £10m, will split the Huddersfield plant’s roster of manufacturing contracts between the Morpeth plant and facilities in Ennore and Ahmedabad in India.
Piramal said that the move will improve margins in its Pharma Solutions Business (PBS) by between 6 to 8 per cent over the next two years, according to a report in India’s Business Standard.
CEO Ajay Piramal told the paper that Piramal’s international business will shrink by around 5 per cent this year but predicted that this will be more than offset by a 15 per cent expansion of its Indian operations.
He added that although the global downturn has cut spending by its smaller customers, a greater number of contracts from a Big Pharma sector keen to reduce manufacturing costs would drive growth of the firm’s business in India.
The Morpeth facility, which houses active pharmaceutical ingredient (API) and finished dosage manufacturing capacity as well as clinical packaging and distribution units, was purchased from global drug giant Pfizer in June 2006.
The plant is approved by both the US Food and Drug Administration (FDA) and UK’s Medicines and Healthcare products Regulatory Agency (MHRA), employs a staff of 450 and already has a $350m (€260m) supply contract with Pfizer.
Approval has just been granted to expand the Institute of Life Science at the University of Wales Swansea in Swansea, United Kingdom. The project has been in the planning process since early 2008 and will involve the construction of a multi-storey bioscience laboratory complex adjacent to, and similar to, the existing ILS building. This £30 million ($49 million) initiative, known as 'ILS phase 2,' will incorporate cleanrooms and bespoke incubator facilities for biotechnology and nanotechnology research. Completion is slated for the third quarter 2011.
The scope of work involves construction of a multi-story building and plant room as well as laboratory construction including HVAC, cleanrooms, containment systems, benches and furniture, fume cupboards, bio-filtration, a reverse osmosis water system, an industrial gases area, laboratory furniture, bench-top instrumentation, autoclaves, and specialized flooring.
The Institute of Life Science (ILS) is a collaboration between Swansea University, the Welsh Assembly and IBM. Situated on Swansea University's campus, the ILS building is the research arm of the University's School of Medicine and contains state-of-the-art laboratory space for biomedical research.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has completed a successful audit of Cobra Biomanufacturing’s facility in Keele. The authorization followed a three-day inspection and evaluation of the company’s manufacturing, analytical and quality management systems, which demonstrated that the facilities meet cGMP standards.
Simon Saxby, chief executive officer of Cobra Biomanufacturing, said, “This is excellent news and ongoing confirmation of the commitment of the company to meet the needs of worldwide Regulatory agencies. The renewal of our Manufacturers and Importers Authorization for Investigational Medicinal Products MIA (IMP) license acknowledges almost 10 years of cGMP compliance at Cobra and provision of a reliable and responsive biomanufacturing service to over 75 clients worldwide.”
Genentech Singapore, a wholly owned member of the Roche Group, has exercised an option to purchase from Lonza its cell culture biologic manufacturing facility in Singapore for $290 million plus additional milestone payments of $70 million, the companies have announced.
The facility, which is mechanically complete, will be merged with Genentech Singapore's existing biologic manufacturing facility. As part of Roche's integration of Genentech's technical operations following the former's $47 billion acquisition of the latter, biotechnology production facilities in Singapore operating under the Genentech name will later this year be renamed Roche Singapore Technical Operations.
About 230 Lonza employees will join Genentech Singapore Technical Operations, for a total site headcount of approximately 325. Lonza continues to employ over 80 people working at its own mammalian manufacturing plant, set to come on-stream in 2011, and plans to ramp up this number to over 300 employees in the next 12 months and beyond.
The Singapore manufacturing facility is expected to produce Avastin (bevacizumab), has 80,000 liters of fermentation capacity, and is located on approximately 10 acres at the Tuas Biomedical Park, with an option for up to 20 additional acres. Genentech Singapore’s existing 1,000-liter Ecoli manufacturing facility is expected to receive FDA licensure for bulk drug production of Lucentis (ranibizumab) injection in 2010.
Basel-headquartered Roche has paid fellow Swiss firm Lonza $290m (€203m) for its Singapore biologics plant in a bid to secure long-term manufacturing capacity for biotech cancer drugs.
The acquisition is a result of an option provided to Roche’s subsidiary Genentech under a 2006 deal that would have seen Lonza manufacture the Avastin active pharmaceutical ingredient (API) on a contractual basis.
And, while U.S. Food and Drug Administration (FDA) clearance to produce Avastin is not expected until next year, Roche’s decision to exercise its option ahead of the 2012 deadline suggests it is keen to secure biologics capacity, particularly since acquiring Genentech.
Jim Miller, VP of Genentech Singapore, which will run the plant for the time being, stressed the importance of the country as a manufacturing destination, suggesting that “Singapore will play an important role in bringing important medicines to patients who need them.”
The facility, which is on a 10 acre site at the Tuas Biomedical Park, houses 80,000 liters of fermentation capacity. Roche said the plant and 230 of its workforce will be integrated into its other local manufacturing operations.
Roche’s interests in Singapore include an Escherichia coli (E.coli) production facility at which it plans to make components for its drug Lucentis when manufacturing operations are cleared by the FDA.
The Associated Press reports that Sinovac Biotech Ltd. has won a contract through the Beijing Public Health Bureau to supply the seasonal flu vaccine Anflu in Beijing. China-based Sinovac is one of four companies that won supplier contracts for seasonal flu vaccines. Terms of the contract were not disclosed. Earlier, the company said it completed clinical testing of a swine flu vaccine, and the product was successful at creating an immune system response to the virus. Sinovac is still evaluating the safety and effectiveness of the vaccine, and will apply for a production license for the China State Food and Drug Administration after the evaluation is complete.
Boron Molecular is a Melbourne-based fine chemical company which has its business based
on an exclusive right to globally exploit unique organo-boron technology assigned from
CSIRO. Many of Boron Molecular's customers are leading international pharmaceutical and
biotechnology companies which purchase the company's compounds to enhance their drug-
development programs.
Boron Molecular has completed construction of its new ISO-8 cleanroom manufacturing facility which consists of a fully automated glass-lined 630 liter reactor together with a 50 liter pilot plant system to support process development manufacturing.
Commissioning and validation of the new facility is underway with first production expected in the 2nd quarter financial year 09/2010. The new facility has been fully financed out of cash flow.
The new facility has been installed as part of a change in the business model from a company that was positioned to deliver novel boronic acids to the drug discovery market, to one which can now support this industry during their critical scale-up phase and even early commercialization.
Boron Molecular continued to expand its product library now with over 800 compounds/products.
Mantecorp is using the Control and Communication Link (CC-Link) open fieldbus network to improve the environmental credentials of its facility in Rio de Janeiro, Brazil.
Concerns about energy costs and environmental sustainability have created new pressures for all industries, including pharma, and Mantecorp has responded by installing the CC-Link system.
The technology, which is being used in conjunction with Mitsubishi Electric controls, is serving as the supervisory control and data acquisition system for the 3.3m. sq. ft. facility.
Using the technology enables communication and control of the site’s major systems. These include the air conditioning, refrigeration, energy management, filtration and water handling, steam and air sterilization.
By linking sensors in these systems, drives, valves, actuators and other devices to an automated control system conditions can be monitored and automatically adjusted to ensure an optimal operating environment.
By using this technology Charles Lukasik, director of the CC-Link Partner Association, believes the facility achieves “a new level of economic and environmental sustainability through the optimum utilization of air, water, heat, and power”.
Numerous companies in the pharma industry are attempting to adjust operations to reduce their environmental impact. These measures include making more efficient use of energy and altering manufacturing processes to make them more sustainable.
For instance, Millipore has set a five-year goal of reducing its greenhouse gas emissions by 20 per cent. To achieve this Millipore has launched a program to improve efficiency, install and purchase renewable energy and ensure employees are aware of their role.
In addition research is being conducted into green solvents, catalysts and desiccants that will not cause harm if they enter the wider environment.
Big pharma’s position towards the top of the recent Climate Counts’ survey suggests that these measures appear to be having some effect.
Pfizer’s new $214.8 million (€150m) biotechnology facility in Strangnas, Sweden was inaugurated, securing the country’s future in the company’s manufacturing network according to global manufacturing president Natale Ricciardi.
The new 6,000 sq. meter (64,560 sq. ft.) plant will be used to make active pharmaceutical ingredients (API) for Pfizer’s human growth hormone (HGH) drugs Somavert (pegvisomant) and Genotropin (somatropin [rDNA origin]) when fully operational in 2011.
A key focus of the plant will be growth of the bacteria Escherichia coli (E.coli) and yeast for the production of recombinant proteins, installing capacity that the US drug giant believes will accelerate the introduction of new drugs in the future.
However, Pfizer also stressed that the facility, which has been under construction since 2007 , was designed with flexibility in mind, explaining that the production of multiple biotechnology drugs is an option.
Genotropin, one of the best selling HGH drugs, was bought by Pfizer in 2003 through its acquisition of Pharmacia in a deal that included the Swedish biotech group’s existing Strangnas manufacturing unit.
That facility, which makes the anticlotting drug Fragmin (heparin), will be “connected” to the new plant in an approach the Pfizer said: “gives advantages in terms of materials and personnel flows.”
Ricciardi explained the decision to invest in Strangnas was based on the existing expertise and experience available in the country, and added that “Sweden will have a continued role in Pfizer’s global manufacturing network.”
Her comments will be reassuring for the local biotech manufacturing sector, which employs over 500 people, given the recent rapid growth of the industry in Asia in hubs like China, Singapore and India.
According to a number of reports, Pfizer has paid the $17m in back taxes to the Venezuelan tax authorities, after government threats to take control of the company’s manufacturing plants in the country.
Company spokesperson told the e-Taiwan News that the payment had been made, explaining that it follows a standard review of Pfizer's acquisition of pharmaceutical companies, including the 2003 purchase of Pharmacia.
Also, seven Californian pharmacies have sued to block Pfizer’s planned $68m acquisition of Wyeth on the basis that it will drive up drug prices, according to Bloomberg.
A company spokesperson told the newswire that Pfizer has not yet been served with the lawsuit and believes that it is without merit.
GEA Lyophil has won a contract to supply €15m ($21.5m) worth of pharmaceutical freeze dryers with automatic load and unload systems (ALUS) to a Chinese manufacturer.
The order, which consists of seven freeze dryers and five ALUS systems, will be supplied to Zheiiang Hisun Pharmaceutical for use in its facility in Fuyang in eastern China.
Hisun is planning to invest more than €100m in its Fuyang facility to make it one of the biggest pharma production sites in China. Once the expansion is complete Hisun will have capacity to produce anti-tumor, anti-infectives and biologics for the domestic and international markets.
US analysis group CRL will set up a new laboratory at Quotient Bioresearch’s facility in Cambridge in the UK, in a collaboration designed to expand the US company’s business on the global stage and extend Quotient's offering.
Kansas’ Clinical Reference Laboratory (CRL) plans to offer clinical analysis and testing services for trials conducted in the region, using the laboratory as its base of operations in Europe.
In return, Quotient said it will gain additional capability for services such as biomarker analysis and microbiology testing, for which pharmaceutical industry demand has grown significantly in recent years.
CRL Global Services has chosen to construct its own laboratory in Cambridgeshire, UK, embedded within the existing world-class facilities of Quotient Bioresearch. It will provide a further full service laboratory arm to CRL Global Services' existing global structure. The contract also provides for an immediate close collaboration between the companies on the development and delivery of new services, particularly in the areas of bioanalysis, biomarkers and microbiology.
Cambridge should be an ideal location for the collaboration given that it is part of the UK’s “golden triangle” where many of the world's leading pharmaceutical companies are based.
Additionally, while there are a number of laboratory testing companies operating in the region, including Azopharma which set up there last year, Quotient’s existing presence and local knowledge should help CRL win customers.
Although a Quotient spokesperson was not available for comment, a press statement issued by CEO Paul Cowan set out some of the other potential benefits of the accord with CRL.
He suggested that: “The collaboration brings exciting new opportunities,” adding that “working in tandem with CRL offers access to a well established, standardized global laboratory infrastructure.”
Quotient’s business development director, David Griffiths, reiterated the strategic sense of the partnership explaining that: “The established capabilities of the two companies are entirely complementary.”
Griffiths also suggested that the synergies provided by the collaboration with CRL will “deliver a joint offering significantly broader than available from each party working alone.”
CRL CEO Tim Sotos also stressed the deal’s synergies, highlighting Quotient’s track record in early phase drug development as something that could provide “significant added value” to his firm’s laboratory operations.
Proteomics International has received International Organization for Standardization accreditation from an Australian accreditation agency for its proteomics service lab, the company said.
The Perth, Australia-based company offers contract research services such as high-throughput mass spectrometry for protein identification, as well as biomarker discovery and other lead molecule services. The accreditation is for compliance with ISO/IEC 17025 lab standards, which covers single protein analysis, biomarker detection, systems mapping and comparison, and peptide sequencing of unknown proteins.
The ISO accreditation was granted by the National Association of Testing Authorities, Australia.
Drug developer Warner Chilcott said it completed its move to Ireland from Bermuda.
The company is now Warner Chilcott PLC rather than Warner Chilcott Ltd. Its directors approved the move in May, pointing to advantages such as a stable long-term legal and regulatory environment, tax treaties, and history of international investment. Shareholders later approved as well.
Earlier, Warner Chilcott, which focuses on women's healthcare and dermatology, reported that its second-quarter profit rose 67 percent on higher sales of birth control, hormone therapy and dermatology products.
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