PHARMACEUTICAL/BIOTECHNOLOGY INDUSTRY
UPDATE
January 2011
McIlvaine Company
TABLE OF CONTENTS
Bayer Schering Pharmaceutical's New R&D Centre
The Commercialization Center for Innovative Technologies (CCIT), New Jersey
Xcellerex FlexFactory Biomanufacturing Facility
Fraunhofer Plant-Based Vaccine Factory in Delaware
Teva Production Halts in Irvine
Perrigo will Buy Drugmaker Paddock
N.C., China Team Up for Biotech
BA Buys Hill Top to Expand in North America
Scripps, Vanderbilt Launch Biomedical Chemistry Institute
BioMed Spends on Three Facilities
IDRI Receives Defense Grant to Develop Novel Flu Vaccine
Affinity Completes cGMP Plant Expansion
Johns Hopkins to Build Center for Personalized Medicine Research
BASi and Pharmasset Forge Partnership
Mortgage for Hospital in Wheeling
Duke, Browning Tapped to Build Indianapolis Hospital
JV to Build Seton Medical Center
2011 Facility of the Year Awards (FOYA) Winners Announced
2011 Facility of the Year Events
Schott Joins Naigai in Packaging Market
ShangPharma Opens Fengxian Facility
Famar Plans to Acquire Sanofi Site for Sterile Dose Expansion
Genzyme to Build Additional Plant
Actavis Pharma Manufacturing Plant
Sustainable energy suitable elsewhere?
Cambrex’s India Site Receives EU GMP Certification
Carclo Technical Plastics Completes Cleanroom
UPS Expands Global Healthcare Network with New Facilities
Dendreon Building Germany Plant
Alpha Biologics cGMP Biomanufacturing Facility, Malaysia
Merck KGaA Sets Up Indian Centre
Ecron Expands in UK and Thailand
Dr Reddy’s Russian Growth with R-Pharma
Advanced Cell, Roslin to Team on Stem Cell Bank
ProJect Pharmaceutics Opens Munich Operations
PX’Therapeutics Opens Facility
Tristel to Build Cleanroom Operation
Boehringer Ingelheim is to acquire a California, US manufacturing facility from Amgen to expand its contract biologics production capabilities.
Acquiring the Fremont site builds on the West Coast biologics expansion Boehringer began by allying with Avid Bioservices. The 100,000 sq. ft. Fremont facility currently has 360 employees and houses a pilot plant and process development laboratories for biologics.
"The technological expertise at Fremont and the state-of-the-art facility will enable us to further strengthen our global contract manufacturing business including new biological entity process development and manufacturing efforts”, said Wolfram Carius, of Boehringer.
Amgen obtained the Fremont facility in 2006 through the $2.2bn (€1.6bn) acquisition of Abgenix. When Amgen acquired Abgenix the Fremont site produced panitumumab, a monoclonal antibody marketed as Vectibix.
Boehringer has provided contract production services to Amgen for 10 years and the site acquisition builds on and strengthens this relationship. Furthermore, the deal enhances biologics production expertise and capabilities at Boehringer.
Amgen will continue to have a presence in the San Francisco Bay Area biotech community through its research facility in the south of the city.
The deal is expected to close in March.
Boehringer has a biologics production plant in Biberach, Germany that, according to the company, produces three of the world’s best selling biologics. Also, Boehringer has a production network, including Avid, which allows it to offer contract manufacturing at sites around the world.
Using this expertise Boehringer is supporting Kemwell as it builds a contact biologics production facility in Bangalore, India. The Bangalore site is using process technology from Boehringer to simplify tech transfer and scale-up if clients want to move production to the Biberach plant.
Expertise and experience gained by Boehringer from contract manufacturing will also support its in-house biologics pipeline as products move towards commercialization.
Bayer Schering Pharma announced its plans to open a new R&D facility in San Francisco, California in May 2010.
The new facility will be located within 455 Mission Bay Blvd, the third building of Alexandria's Center for Science and Technology which is a 13-building life science complex near the University of California's Mission Bay campus.
Bayer considers the new R&D centre as its US innovation centre. The facility will serve as the science hub of the company and allows it to expand its global research network.
The facility is currently in the build out stage and is pursuing LEED Silver Certification. Scheduled to begin operations by the end of 2010, the facility will operate with 65 scientists who will be shifted from Bayer's Richmond site. The Richmond site will be subsequently closed.
The building was originally to be occupied by Pfizer's Bio-therapeutics and Bio-innovation Center. In July 2009, however, Pfizer opted out after it restructured its entire facility network following its $68bn merger with Wyeth.
Bayer will occupy only half of the 200,000ft² space that Pfizer had agreed to lease. The remaining half will be leased to Nektar Therapeutics, a biotechnology company that will relocate from San Carlos, Sonora, Mexico.
The Mission Bay location will allow Bayer to operate in the heart of an expanding biomedical research community.
The existing biotech cluster within the area includes companies such as Merck, Celgene, and FibroGen and a number of other smaller biotech firms.
Being in Mission Bay will also benefit Bayer in obtaining an enterprise zone designation that would result in tax credits for a few employees for a period of five years.
In addition, Bayer will be entitled to be exempt from San Francisco's 1.5% payroll tax for approximately seven years.
The new centre will occupy 49,000ft² of space within a new 210,000ft² complex that accommodates two five-storey buildings. Each building includes 105,000ft² of space and has a robust building shell design.
Bayer's new centre will occupy the third and fourth floors besides a part of the ground floor. It will accommodate laboratories that can be customized into highly functional wet and dry lab areas. It will also have space for administrative activities. The second floor will be occupied by Nektar Therapeutics which had subleased 102,000ft² of space from Pfizer.
The buildings have been constructed of structural steel and feature a fully unitized skin system. Additional features within the building include generous slab-to-slab heights, 100lb live-load floor rating, robust mechanical, electrical and plumbing design, and an emergency generator for critical operations.
The state-of-the-art R&D centre will be used to conduct research in the fields of oncology, women's healthcare, cardiology and diagnostic imaging. Haematology research programs with an emphasis on coagulation factors and discovery of new biologic drug candidates will also be carried out.
"Bayer's new centre will occupy the third and fourth floors besides a part of the ground floor."
New product development and marketing of new therapies will be carried out at the centre in collaboration with academic research institutes and small biotechnology companies within the Mission Bay campus.
Scientists will move around the campus to partner with a number of innovative thinking life science companies centered within the campus. Partnerships and collaborations will be established in areas ranging from research benches to clinics.
The facility has been developed by Alexandria Real Estate Equities. The labs have been designed by Alexandria in partnership with Bayer Schering Pharmaceutical and Flad architects. Alexandria Real Estate Equities had obtained permits amounting to $10m for tenant enhancements in the building.
The contract for the construction of laboratories was awarded to San Mateo-based BN Builders. The interior architect for the building is Flad Architects based in Madison, Wisconsin.
The Commercialization Center for Innovative Technologies (CCIT) is a major incubation facility in the US catering to companies from the life science and biotechnology industries. The facility is located in New Brunswick on the campus of the Technology Center of New Jersey, a science park with nearly 400,000ft² of research and laboratory facilities housed in four independent buildings. The facility operates through the New Jersey Economic Development Authority's Strategic Partner Advantage Network (SPAN).
In June 2010, the facility was designated as a Soft Landings Incubator by the National Business Incubation Association (NBIA). In 2008, CCIT became the first incubator in New Jersey to obtain this distinction. Soft Landing, launched in 2005, is a recognition awarded to incubators that have been successful in assisting international companies entering the US market. This recognition has been earned by only 15 out of 5,000 incubators worldwide.
The CCIT offers the maximum number of incubation wet labs in New Jersey. The project was launched in 2002 with 20,000ft² of space. An expansion in 2005 extended the facility by 26,000ft², and added 10 wet labs, customized conference facilities and space for administrative activities. Prominent tenants at CCIT include Chromocell Corp, 3D Biotek, Orthocon, Neurotez, Accelalox and CSPC Dophen Corporation.
The 46,000ft² facility is built on a 50-acre site and accommodates administration, production and laboratory areas. It includes plug-in ready wet and dry laboratories totaling 6,000ft². Each lab varies between 800ft² and 1,000ft² in size.
The labs have optimal interdependent designs and are installed with a fully adjustable modular lab casework system. The equipment area features 120V/208V electric receptacles. Multiple communication outlets are equipped to provide LAN service, T-1 lines and voice over IP system, interconnecting workstations, printers and servers.
All lab units are temperature controlled and use once through 100% outside air HVAC system. Each lab unit includes six inch flammable storage chemical fume hood base cabinets. One secured storage unit and one private office are also available.
The facility also houses shared facilities including conference rooms, office equipment, autoclaves, audio and visual presentation equipment and safety showers. There is a break room with dining facilities, and a shipping and receiving zone. An additional 20,000ft² of incubator space is rented out to multiple tenants.
The facility leases lab space to suitable startup companies and small businesses that are not more than five years old and have the potential to contribute towards the growth and diversification of New Jersey's economic base.
The CCIT assists non-domestic companies with customized incubation services throughout the phases of their business cycle. On a fee-for–use basis, the facility provides a host of services including onsite managerial and financial consulting, technology commercialization planning, links to small business development resources, and access to the network of service providers as well as to the facilities, services and research programs of universities.
Through collaboration with Rutgers University, CCIT facilitates resource sharing between the university researchers and the tenant companies.
Tenant companies are also assisted in the areas of government contracting, grants and finance. Companies secure funds for pre-proof to concept research as part of the Edison Innovation Commercialization program.
As part of the Edison Innovation Growth Fund, companies can obtain up to $1m in funds for commercialization projects reaching proof of concept stage.
Companies can also obtain up to $5m in loans and raise funds through a tax certificate transfer program. The tax certificate transfer program allows companies to sell their tax credits to other companies. Assistance is also available in areas of accounting, regulatory compliance, clinical development, human resources, insurance, law and marketing.
BioBAT, a research and biomanufacturing project, is a non-profit partnership between New York City Economic Development Corporation and the State University of New York Downstate Medical Center through the SUNY Research Foundation. Also called the New York Science and Technology Center, the proposed project will be developed at the Brooklyn Army Terminal (BAT), a 97 acre, two building complex located on the Brooklyn waterfront.
Construction of the $60m project had begun by the end of 2010. The project is expected to create over 1,000 full time jobs.
The centre will provide life science research, development and manufacturing space to multiple tenants ranging from start up to late stage companies. Every year, universities in New York City churn out nearly 20 early stage bioscience companies that fail to secure space. The project aims to support such companies associated with nine of New York City's premier academic medical and research institutes. The project will additionally provide space to companies that are looking to relocate to New York from other states.
In 2008, the International AIDS Vaccine Initiative became the anchor tenant, occupying 36,000ft² on the eighth floor of the building, for its AIDS Vaccine Design and Development Laboratory. The first tenant for the new BioBAT facility will be Apath, a company focusing on Hepatitis C research in SUNY Downstate's incubator in Brooklyn.
The project will be developed in a phased manner.
Construction work was originally scheduled to start in 2009 but was stalled due to the global financial crisis.
Phase one of construction, involving 56,000ft² of space including three floors (the dock level, level one and level two), will be completed by 2011. Phase one will also include infrastructure and base building work, and the development of an energy source for power. The second phase of development will involve the construction of modular wet lab space, office space and necessary support systems including HVAC, plumbing and electrical systems.
Building A
The bioscience center will occupy 500,000ft² of Building A, the first building within BAT's 4m ft² of building space. Building A is an eight-storey building that has remained idle for several years.
This facility will house research laboratories, research support facilities, commercial offices and manufacturing areas. Tenant spaces from 5,000ft² to 56,000ft² will be available for bioscience research, manufacturing, universities and non-profit research organizations.
The project is being financed through city and state funds. Approximately $12m has been invested by New York City. State funding amounts to $48m.
"The project was originally contracted to Phase 3 Properties, a San Diego-based developer."
The initial funding will be directed towards infrastructure upgrades and to prepare the initial space for renting. Additional funding will be generated through tenant rents and federal tax credits.
In addition, in June 2010, the project received a $2.5m grant from the US Economic
Development Administration (EDA) to renovate a section of Building A. The EDA grant will be used towards the project's second phase.
Contractors
The project was originally contracted to Phase 3 Properties, a San Diego-based developer. The company, however, left the project in 2009 as it was unable to secure the required funding.
The city is looking for a replacement construction and leasing manager.
Formerly known as US Army Military Ocean Terminal or the Brooklyn Army Base, the Brooklyn Army Terminal (BAT) was constructed in 1919 and served as the largest US military supply base during World War II.
Designed by renowned architect Cass Gilbert, the terminal shipped 85% of army equipment and personnel. It was sold to New York City in 1981. Following a large scale $127m renovation, the terminal was transformed into a commercial industrial complex by 2001. Space at BAT is leased and managed by the New York City Economic Development Corporation.
Xcellerex's new biomanufacturing facility is under construction in Marlborough, Massachusetts, U.S. It will be the second facility in Marlborough to be based on the Xcellerex's FlexFactory biomanufacturing platform.
The facility broke ground on 9 June 2010 and is expected to be completed by the end of 2010. It will expand the production capacity of Xcellerex and play a crucial role in offering biomanufacturing services and supporting the contract manufacturing operations of the company.
The facility will operate at a 50% lower cost than a conventional facility.
The cGMP facility will accommodate modular, configurable, production trains designed around disposables technology. Each production train will include disposables-based unit operations that will be enclosed in a self-contained, one-time use controlled environment module (CEM).
Due to the use of CEMs, the need for cleanroom facilities will be eliminated. Operations in the CEMs will be, however, based on typical cleanroom standards.
All CEMs will be located in a common controlled manufacturing suite. The CEMs will not include multiple airlocks or gowning and re-gowning rooms. Access to the equipment will be provided through iris ports. As operators will not enter the CEMs, the risk of cross-contamination will be minimized substantially.
The production trains will feature Xcellerex XDR single-use bioreactors with working volume of 2,000l. Xcellerex XDR single-use bioreactor is a fully-integrated system with a capacity to demonstrate proven stirred tank performance for a host of cell lines.
The bioreactors feature stainless steel dimpled jacketed kettle with multiple zones supporting a turndown ratio of 5:1 that avoids the need for an additional seed reactor. The bioreactors are equipped with mass flow controllers, peristaltic pumps and probe transmitters.
The system also includes an optimized single-use bioreactor bag assembly that features an SP Class VI LDPE fluid contact layer, C-flex tubing for adding liquid, a harvest line, a disposable pressure sensor, sampling and probe ports, filtered gas lines and a high-performance bottom mounted magnetic agitator system that facilitates the loading and coupling of single-use bag assembly.
Compared to conventional models, the bioreactors require a smaller footprint, not exceeding 18ft. in width, 5ft. in depth and 14ft. in height.
The turnkey design of the bioreactors allows rapid installation and start-up and batch-to-batch changeover within less than an hour. Due to the single-use design, clean in place (CIP), steam in place (SIP) and cleaning validation infrastructure are not required. Compared to fixed stainless steel hard piped vessels, the flexibility of the overall process increases.
The facility will additionally be equipped with XDM QUAD single-use mixing systems and an XDM disposable assembly system.
The facility will conduct cell fermentation, media preparation, buffer preparation, purification and product mixing using the company's patented FlexFactory biomanufacturing platform. The technology allows biomolecule production in all widely used cell lines including mammalian, E. coli, fungal, yeast and insect.
The facility will provide transitional biomanufacturing services to clients installing their own FlexFactory facilities. Clients will be able to access the FlexFactory platform and XDR single-use bioreactors until their own facilities are ready.
The facility will conduct complete biomanufacturing operations from fermentation through purification to bulk drug substance for clinical and commercial production of mammalian cell and microbial / yeast products. It will also coordinate fill / finish operations, stability and clearance studies for its clients.
The operations from the FlexFactory facility will be physically transplanted to the client's facility once it is ready.
The Marlborough facility will provide contract manufacturing services to clients that do not have their own manufacturing capacity. Xcellerex will also use the facility to demonstrate the FlexFactory platform to potential clients who are interested in evaluating the platform for their future expansions.
Fraunhofer CMB opened a new cGMP plant-based vaccine facility in Newark, Delaware, in April 2010. The facility is a partnership between Fraunhofer's two centers (the Center for Molecular Biotechnology (CMB) in Newark, Delaware and the Center for Manufacturing Innovation (CMI) in Boston, Massachusetts), the Boston University College of Engineering and iBio, a Newark-based biopharmaceutical company.
This first-of-its-kind facility develops vaccines and therapeutics using natural green plants. Fraunhofer CMB developed the plant-based system over a period of eight years including a three year collaboration between Boston University and the two centers of Fraunhofer-Gesellschaft, Europe's largest applied research organization.
The $15m facility is expected to play a crucial role in addressing and containing future pandemics and emerging biological threats.
Construction of the facility was completed in 2009 and validation took place in 2010. The facility is equipped for rapid and cost-effective production of vaccines in comparison to the traditional method of vaccine production.
The facility is 13,000ft² and is located on the first floor of CMB's 56,000ft² building in Newark, Delaware. Designed to be cost, time and space efficient, the facility is fully automatic and houses lighted, irrigated growth modules and processing stations.
It is equipped with Fraunhofer CMI designed, robotically operated, custom engineered machines (including seeding and harvesting machines) and specially designed multi-plant trays. The robots execute all the operations within the facility.
Production
The facility produces large quantities of vaccines and therapeutics using natural green plants that are not genetically modified. Specific proteins are produced from tobacco plants.
The material for the first human clinical trial of plant-produced H5N1 influenza vaccine that began in September 2010 was produced at the facility.
The facility has the capacity to grow tens of thousands of plants in a single batch.
The facility uses Fraunhofer CMB's proprietary viral vector technology developed by the company for iBio. Using the technology, host plants are hydroponically grown in multi-plant trays. A seeding machine separates picks and plants the seeds on the growth trays into an array pattern. To facilitate recirculation of nutrients and allow consistent, optimal growth of biomass, the trays are kept under controlled light and temperature conditions.
The trays are handled and moved around different processing stations within the facility by robots. The robots glide up and down the narrow aisles within the facility. After several weeks of growing, the robots carry the plant trays to a machine where all aerial parts of the plants are vacuum-infiltrated with agrobacterium carrying expression vectors.
Through virus replication, the viral sequence of the expression vectors amplifies with the clones target sequences resulting in production of a target protein. Following several more weeks of growing, the target is accumulated in the plant tissue within leaves.
"The facility uses Fraunhofer CMB's proprietary viral vector technology developed by the company for iBio."
Before downstream processing is carried out, the robots take the plant to a harvesting machine for biomass harvesting. The harvesting machine removes the plants from their respective trays and the protein is purified and extracted following a routine chemical separation procedure.
Unlike traditional vaccine production methods, the facility completes the entire process of vaccine production from seeding to harvesting within a span of six weeks. The recovery of large doses of bulk drug substance is completed within two weeks from the time when the plants reach a certain growth stage. Due to complete atomization, any potential process contamination caused by human contact is also eliminated.
Finance
The facility has been financed through state and private funding. The state of Delaware granted $5m. The remaining $10m was sourced internally from Fraunhofer-Gesellschaft.
The Defense Advanced Research Projects Agency sanctioned $4.4m under the Accelerated Manufacturing of Pharmaceuticals program to support phase I trials of H1N1 flu vaccine manufactured at the facility.
Teva has confirmed it will cut 200 jobs this year after a voluntary hold was placed on all manufacturing at its Irvine, California, US facility.
Denise Bradley, a Teva spokesperson, said that manufacturing and distribution was put on pause at the site in April 2010 and remains at a standstill.
She said: “Prior to this reduction, we have not laid off any employees as a result of this voluntary production hold. The jobs which are being eliminated are all various production jobs and support staff at the facility.”
Teva maintains that the job cuts and manufacturing hold are not part of a phased exit and said it is committed to working towards resuming production at the facility in the foreseeable future, though Bradley said she has “no estimate on timeframes.”
This is the second blow to the company in under a year as the Israeli generic drug maker slashed 70 jobs when it discontinued production of Propofol, the drug associated with the death of Michael Jackson.
Though Teva stressed the drug was not linked to Jackson’s death, the firm said it was forced to discontinue the medicine as it generated at best only marginal profits and was difficult to manufacture.
In 2009, Teva initiated a recall of more than 57,000 bottles of injectable propofol after 41 reports of patients falling ill with flu-like symptoms. Some of the recalled vials of the sedative were found to be contaminated with endotoxin bacteria, which resulted in several lawsuits being filed over the drug.
The decision to suspend production and lay off employees at the Irvine plant was prompted by quality control after the company received an FDA warning letter for violating current good manufacturing practice (CGMP) regulations.
In the letter, the FDA criticized Teva of failing to test each lot of raw materials used in Propofol injectable emulsion for levels of bacterial endotoxin, and said the firm were unable to determine the cause of a higher than usual level of the bacteria found in three vials of the Propofol drug.
The Irvine plant was obtained by Teva in 2004 when the firm shook hands on a $3.4bn (€2.5bn) deal to acquire US-based Sicor. The transaction came as part of Teva’s plan to secure itself the position as the world’s leading generics manufacturer.
Over-the-counter drugmaker Perrigo Co. said it will buy generic drugmaker Paddock Laboratories Inc. for $540 million.
Perrigo said Paddock has about $200 million in annual revenue, and Perrigo, based in Allegan, Mich., said it is expanding its portfolio of generic specialty pharmaceuticals, or drugs that require special handling.
Paddock Laboratories is based in Minneapolis and is privately held. According to its website, it sells around 80 products.
Perrigo said the deal should close during its fourth quarter, which ends in June.
Perrigo had $2.27 billion in revenue in its latest fiscal year, which ended June 26.
Perrigo said it expects a tax benefit of about $95 million connected with the deal. It will pay for Paddock using $310 million from bank debt agreements, $80 million in cash on hand, and $150 million from a new loan Perrigo took out from Morgan Stanley, JPMorgan, and Bank of America.
As Chinese and North Carolina officials met in Durham, executives with North Carolina's largest utility were in Washington to sign a partnership with ENN Group of China to develop new clean-energy technology.
Charlotte-based Duke Energy, which announced plans last week to buy Progress Energy of Raleigh, will collaborate with ENN Group to develop an "eco-city" in Langfang, China. Plans call for the companies to adapt what they learn there to help develop other green cities in China and the United States.
North Carolina and Chinese officials signed an agreement Tuesday to create a biosciences gateway in Research Triangle Park for pharmaceutical, biotechnology and other businesses that want to expand in either country.
The partnership is tied to Chinese President Hu Jintao's three-day visit to the United States and signals China's interest in increasing economic ties with North Carolina.
"Our purpose today is fairly simple: We want to learn how North Carolina can collaborate and build strong partnerships with you," Gov. Bev Perdue told a delegation of more than 100 Chinese politicians, investors and business leaders in Durham. "We need to know: What can our state do better?"
Perdue noted that she's planning a return visit to China in the fall and hopes to call on businesses interested in adding jobs in this state.
The agreement calls for a 150,000-square-foot research facility that's expected to open in 2013 on the RTP campus of the Hamner Institutes for Health Sciences. The nonprofit Hamner will work with Chinese investment firm XY Group to identify opportunities for companies, universities and others.
Though details about the deal's potential to create new jobs were vague, Chinese officials who toasted the agreement over champagne with Perdue, N.C. Commerce Secretary Keith Crisco, U.S. Sen. Kay Hagan, U.S. Rep. David Price and others emphasized that it will lead to more economic development in this region.
"This campus will be a very important gateway for Chinese companies that want to do business in North Carolina," XY Group CEO Yunsong Yang said.
Since most business in China is done only with the blessing of the government, having the deal implemented during the U.S. visit by China's president elevates North Carolina's stature in that country, Hamner CEO William Greenlee said.
The deals are part of a larger expansion planned at Hamner, founded in 1974 to study the safety of chemicals. The center's master plan calls for adding up to 1 million square feet of space in six additional buildings on its 56-acre RTP headquarters campus over the next five to seven years, he said.
The initial research facility could mean about 400 more jobs at the campus in 2013, Greenlee said.
The news signals that China is open for North Carolina companies eager to expand in the fast-growing country. China is this state's No. 2 trading partner after Canada, and exports continue to surge.
"We now have a governor who understands why it's so important to have a strong trade relationship with China," said L. Duane Long, chairman of Longistics, an RTP company that handles logistics, warehousing and transportation.
Longistics will open an exhibition center in Suzhou, about 60 miles west of Shanghai, in March. The center is designed to accelerate the export of products from North Carolina and other U.S.-based companies to China. Plans call for Longistics to add 500 companies within five years.
T2 Biosystems has moved into a newly renovated 20,000-square-foot facility, more than doubling its size in Cambridge, Mass. The new space includes state-of-the-art laboratories to support the company's assay and instrument development as well as to support its diagnostic tests and systems.
India-based BA Research has acquired Hill Top Research to expand its North American contract research capabilities.
Acquiring Hill Top gives BA dermatology-focused Phase I to IV clinical trial sites in the US and Canada. Adding these sites gives BA a presence in North America; enhances its dermatology expertise, particularly in transdermal patch safety testing and moves it into cosmetics services.
Integration and investment is now in the pipeline to accelerate growth and service expansion. “There will be new investment in our people, equipment, and facilities to improve our core competencies and to extend into new areas”, said John Murta, CEO of Hill Top.
Services offered by Hill Top span safety and efficacy testing and contract research. Hill Top has expertise in transdermal patch safety testing. A skin irritation scoring system and adhesion scoring scale from Hill Top were included in US Food and Drug Administration (FDA) guidance.
By integrating these capabilities with its India-based Phase I to IV offering BA believes it can improve the service it can offer its, and Hill Top’s, clients. BA also has dermatology capabilities, performing pharmacokinetic and bioequivalence studies on transdermal and topical formulations.
These services are provided from a 150,000 sq. ft. facility that houses nine clinical units, 400 beds and 11 intensive care unit beds. BA also has separate volunteer screening areas, sample processing and storage capabilities and ambulatory collection.
Hill Top will retain its name and operate as part of the Cliantha Group. In addition to BA and Hill Top the Cliantha Group includes Xylopia, a pharma formulation laboratory, and BAAP Diagnostics.
The Scripps Research Institute will team with Vanderbilt University to create a new institute that will integrate research in chemistry and medicine in order to advance personalized medicine, metabolomics, and drug discovery, the partners said.
The Human Chemical Sciences Institute will involve research and training at Scripps’ campuses in San Diego and Jupiter, Calif., and at Vanderbilt’s Institute for Chemical Biology and its School of Medicine.
The cross-institutional and interdisciplinary research institute will conduct research that capitalizes on each institution’s different assets, including Vanderbilt’s genomics, bioinformatics, and drug discovery capacities and Scripps’ synthetic and bioorganic chemistry capabilities.
With seed funding coming from both Scripps and Vanderbilt, the research at the institute will focus on drug development, personalized medicine, and metabolomics efforts that will study small-molecule metabolites that could lead to diagnostic and therapeutic biomarkers.
“The goal of the Human Chemical Sciences Institute is to impact medical care through a chemistry-focused view of the human metabolic state, disease, and the effects of treatment,” explained Jeffrey Balser, vice chancellor for health affairs and dean of Vanderbilt University School of Medicine, in a statement.
“The chemical sciences provide the basis for current understanding of human physiology, pharmacology, and drug discovery,” said Richard Lerner, president of Scripps Research. “Yet there remains a gulf between academic research in chemistry and medical practice. The time is right for a new initiative that seeks to accelerate the understanding of human chemistry in health and disease,” he added.
The institute’s metabolomics research will be led by Gary Siuzdak, senior director of the center for metabolomics at Scripps California, and Alex Brown, associate director of systems analysis at VICB.
The personalized medicine program will be run by Daniel Salomon, associate professor in the department of molecular and experimental medicine at Scripps California, and Dan Roden, assistant vice chancellor for personalized medicine at Vanderbilt.
The institute’s drug discovery efforts will be headed by Craig Lindsley, director of medicinal chemistry for the Vanderbilt Program in Drug Discovery, and Patrick Griffin, chair of the department of molecular therapeutics at Scripps Florida.
BioMed Realty Trust has bought a life science facility in San Diego, US, and two life science buildings in North Carolina for around $40m (€30.9m).
The real estate investment trust said the new research and development (R&D) facility in Torrey Pines, California, cost $24.9m (€19.2m) and is being leased to the University of California San Diego (UCSA) until 2018.
The facility, which is located opposite the University Science Centre – also owned by BioMed - measures about 48,300 sq. ft. in size and house laboratory, office and manufacturing space to support life science research and development efforts.
Rick Howe of BioMed told Outsourcing-Pharma: “3525 John Hopkins Court represents a premier location and facility in Torrey Pines submarket of San Diego, one of the most important centers of biotechnology innovation in the world, and affords us the opportunity to further expand and enhance our relationship with UCSD, a preeminent life science research institution.”
The company continues to widen its assets with the addition of two life science buildings in the centre of the Research Triangle area of North Carolina. BioMed said it paid $8.6m (€6.6m) for the Patriot Science Centre, a 48,400 sq. ft. laboratory and office building, and $6.1m (€4.7m) for the Weston Parkway life science research facility, measuring 30,600 sq. ft., in Research Triangle Park, North Carolina.
The firm revealed that the two properties are 88 per cent leased.
“Completion of these acquisitions puts an exclamation point on a most productive 2010 for our acquisitions and leasing team,” BioMed said.
“Our portfolio, which now totals over 12 million rentable square feet, is very well positioned to capitalize on this momentum and the continued strength of the life science industry,” said the company.
Howe describes the life science industry as one of the stronger economic engines for the United States. “It is one sector where the US continues to have a competitive edge globally as the dominant provider of research in the life science arena,” he said.
The US Infectious Disease Research Institute (IDRI) has received a multi-million dollar grant to develop a pandemic flu vaccine from DARPA and the Army Research Office.
The funding will support the development of a single dose influenza vaccine, to be widely administered in case of an outbreak.
The proposal will allow IDRI to combine cutting-edge vaccine adjuvant technology with a microneedle delivery device for intradermal vaccine delivery.
Adjuvants are compounds used to improve the body's immune response to vaccines.
This method has proven benefits over conventional administration methods and may enhance protection, as well as allowing for a reduction in the amount of antigen needed.
Catalent Pharma Solutions announced an expansion of its development capabilities for oral controlled release dosage forms. This major expansion will enable Catalent to offer formulation development and optimization services in its Winchester, Kentucky facility and complements that site’s existing pilot scale and commercial capabilities for controlled release tablets and capsules. The addition of formulation development and optimization services in Winchester will allow products to move through the development stages to commercialization within the same site; reducing the need for additional technology transfers and facilitating a faster time to market. This expansion also builds upon Catalent’s existing controlled release development capabilities in Somerset, New Jersey and Schorndorf, Germany.
US CMO Affinity Life Sciences has completed the expansion of its manufacturing plant, adding capacity for cGMP lyophilisation and biomarker development.
The facility, in Milford, New Hampshire, is a key part of the contract manufacturing organization’s (CMO) effort to build its position in the rapidly expanding assay development sector according to company president Tod Gavron.
“With the additional space, we will improve our overall production and provide greater flexibility with regards to project scheduling and scope. We are also pleased to provide on-site lyophilization services.”
Demand for biomarkers has increased markedly in recent years as the drug industry has sought to improve the efficacy of clinical development by reducing attrition rates and, more recently, to develop companion diagnostics.
Industry need for lyophilisation is also set to expand as, increasingly, innovative pharmaceutical companies focus on the production of biologic drugs that require this type of processing.
Johns Hopkins University announced that its Whiting School of Engineering has received a $30 million gift, which it will use to build a facility to house personalized medicine initiatives by the school as well as other areas.
The gift is from John Malone, chairman of Liberty Media and an alumnus of Johns Hopkins. He received his master's degree in industrial management from the school in 1964, and a PhD in operations in 1967.
The $30 million will go toward construction of a 56,000-square-foot building on the university's Homewood campus, where it will be home to two planned interdisciplinary research efforts, including work into personalized medicine. Research at the building, to be called Malone Hall, will bring together engineers, life scientists, and medical researchers from across the university in an effort to integrate information science into the practice of medicine with an initial focus on cancer, the school said in a statement.
"The approach grows out of the recognition that genetic and epigenetic differences among patients explain, at least in part, why traditionally developed drugs help some people and not others," the school said.
Malone Hall also will be headquarters for the Systems Institute, which will use a multidisciplinary approach "to re-engineer entire systems of national importance, including medicine, healthcare delivery, network-enabled systems, information security, national infrastructure, and education," Johns Hopkins said.
Clinical Research Advantage, Inc., (CRA), a provider of a range of research services to pharmaceutical companies and clinical research organizations (CROs), announced its expansion into the Colorado Springs market with the opening of two local area offices.
CRA has forged a partnership with a leading medical practice in the area whose physicians serve as principal investigators of the clinical trials it manages and oversees. As a leading trial management organization (TMO), CRA helps clinical trial sponsors bring drugs to market more quickly and efficiently. CRA offers an innovative mechanism for medical professionals to conduct phase II-IV clinical research trials. With CRA, pharmaceutical and biotech companies as well as various study sponsors have a resource for conducting clinical trials seamlessly, efficiently and effectively. CRA is comprised of dozens of community-based investigators based throughout the country, and its sites are headed by an experienced staff of clinical research coordinators.
Local CRA offices in Colorado Springs include one at Colorado Springs Health Partners in Briargate – 2405 Research Parkway in Briargate (office of Kari Uusinarkaus, M.D.; Dennis Schneider, M.D. and Gordon Golden, M.D.); and on the east side at 6340 Barnes Road (office of John Speer, M.D., Max Nevarez, M.D., Royce Solano, M.D. and Alan Garscadden, M.D.).
Current plans call for several more sites to open in the Colorado Springs area by summer 2011.
The new offices and principal investigators focus on trials and maintenance studies relating to the various diagnoses as well as others within the realm of family and internal medicine. At Briargate, studies underway include irritable bowel syndrome-diarrhea, hypercholesterolemia, Type II Diabetes Naïve (not currently being treated with anti-diabetic medication) and acute coronary syndrome with or without Type II Diabetes. Upcoming studies include Type II Diabetes and hypertriglyceridemia. At the east office, studies being conducted include those for chronic obstructive pulmonary disease, irritable bowel syndrome-diarrhea, pediatric influenza vaccine, and Type II Diabetes with cardiovascular risk. Upcoming studies at this office include opioid-induced constipation and Type II diabetes.
Concurrent with the office openings, CRA named Monica Garcia, BS, CCRC, to the post of region manager. Garcia heads the Colorado Springs-area operations and has worked with CRA for the past six years. She is certified through the Association of Clinical Research Professionals, an industry trade organization that serves as a resource for clinical research professionals engaged in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings.
Since CRA was acquired in 2007 by Mark Hanley, who serves as chief executive officer, and David Bruggeman, president and chief operating officer, the company has grown from six to 23 sites, doubled the number of employees and substantially increased the revenue base.
An agreement to provide exclusive toxicology services, pharmaceutical analysis and bioanalytical services are at the heart of a new partnership signed by life sciences company Bioanalytical Systems (BASi) and clinical-stage pharmaceutical company Pharmasset.
BASi, based in the Purdue Research Park, Indiana, has signed a Preferred Provider Agreement (PPA) with Pharmasset, located in Princeton, New Jersey.
Anthony Chilton, BASi president and chief executive officer, said: "The agreement between Pharmasset and BASi is an important strategy and commitment for both companies. It represents a significant step in BASi's strategy to work closely with our partners in the pharmaceutical industry.
Pharmasset's main focus is the development of oral therapeutics for the treatment of hepatitis C virus (HCV). Its secondary focus is the development of Racivir for the treatment of human immunodeficiency virus (HIV). Research and development efforts focus on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication.
Pharmaceutical development company BASi provides contract research services and research instruments and supplies to the world's leading drug development companies and medical research organizations.
The company focuses on developing innovative services and products that increase efficiency and reduce the cost of taking a new drug to market.
Novartis will build a $36 million research lab and create 100 new high-paying jobs in Holly Springs, North Carolina, where it opened a large vaccine plant last year.
The expansion puts Holly Springs at the forefront of the Swiss drugmaker's efforts to develop vaccines to replace drugs that will soon lose their patent protection.
The new facility will include a small plant where vaccines can be tested before being manufactured on a large scale. The jobs will pay average wages of $106,200.
Novartis opened a $600 million vaccine plant in Holly Springs last year. That facility, which will eventually employ about 350 people, is expected to begin commercial vaccine production in 2013.
For its latest expansion, Novartis was awarded state and local incentives worth as much as $4.7 million if it meets hiring and investment goals. That's on top of more than $40 million in potential incentives the company was given to open the vaccine plant.
The company has room to expand. To lure Novartis to town, Holly Springs borrowed $8.3 million to buy the company 167 acres of land and spent $12 million on road improvements and other infrastructure upgrades.
Wheeling Hospital secured a $63 million, 25-year, fixed-rate mortgage at 5.35 percent as part of the Fast Track HUD 242 program, to construct an additional patient tower at the hospital, located in Wheeling, WV.
Arranging the financing was Nick Nicholson, a vice president with Berkadia's Washington, D.C. office.
Wheeling Hospital currently has 276 beds for patients. Its new add-on tower is set to rise seven stories at 140,000 square feet. The tower will feature a new pediatric unit, a cardiovascular ICU, as well as an expanded emergency department, according to the hospital’s planners
Health and Hospital Corporation of Marion County has chosen Duke Realty Corp. and Browning investments to develop a faculty office building for the New Wishard Project in Indianapolis.
Indianapolis-based Browning Investments and Duke Realty have worked on several commercial real estate projects in the Indianapolis metro.
The New Wishard project, scheduled for delivery at the end of 2013, includes a 327-bed inpatient hospital. Wishard project leaders registered the 1.2 million-square-foot campus to achieve U.S. Green Building Council (USGBC) Leadership in Energy and Environmental Design (LEED ) Silver certification that will make it the first newly built hospital in Indiana and one of 10 in the country certified LEED Silver or higher.
The project to construct a new Wishard will create 4,400 jobs. Marion County voters overwhelmingly approved a measure allowing the project in the November 2009 election and Wishard began work immediately.
Duke Realty, one of the largest publicly traded REITs in the U.S., has offices in 18 U.S. cities and owns and manages more than 134 million square feet. In the Indianapolis area, Duke Realty has developed nearly $500 million of property in the past two decades, including Park 100, Parkwood Crossing and Anson.
Privately owned Browning Investments, founded in 1977, has developed, built, leased and/or managed more than 15 million square feet, including 6.5 million square feet of office -- mostly in the Indianapolis metro -- including development of the North Meridian Corridor.
LHP Hospital Group, Inc. (LHP) and the Seton Family of Hospitals have formed a joint venture to construct the $100 million Seton Medical Center Harker Heights in Bell County, TX.
The 180,400-square-foot, 83-bed hospital is slated to open in the third quarter of 2012. Groundbreaking is scheduled for the first quarter of 2011.
Growth in Bell and the surrounding counties was a factor that drove the decision to joint venture with LHP Hospital Group, said Charles J. Barnett, president and CEO of the Seton Family of Hospitals.
The hospital campus will include a 60,000-square-foot medical office building being developed by Rendina Companies, one of the nation’s largest full-service health care real estate development firms, in joint ownership with specialists who will occupy the building.
A public biotech lab has opened its doors in New York City, reports Wired. Genspace is the brainchild of journalist Dan Gruskhkin, biomedical researcher Ellen Jorgensen, Russell Durrett, and Sung Won Lim. The lab is in compliance with biosafety level 1 regulations and anyone can use it with a $100 a month membership. Wired notes that the lab is made of found and donated parts and equipment, and it has restaurant-table lab benches as well as centrifuges, incubators, and microscopes. "Now we have a secure lab space where we can do quality, professional-level science," Jorgensen tells Wired.
The Utah facility of Sabinsa Corporation has been audited and receives the International Food Standard (IFS) certification by Det Norske Veritas (DNV), as the company continues to invest in quality assurance for an increasingly globalized market.
Initially developed by European retailers, IFS has developed into a leading food safety and quality standard worldwide for auditing food processing facilities and facilities that pack loose food products. The standard is now widely accepted by retailers across the world, including the world’s biggest, including Walmart and Carrefour, explained Sabinsa.
“IFS is an International Food Safety Management Standard conform to the Global Food Safety Initiative (GFSI). Besides numerous other requirements, the standard integrates the seven principles of the Hazard Analysis and Critical Control Points (HACCP) system adopted by the CODEX Alimentarius Commission,” explained Benoit LeGall, Quality Control Manager for Sabinsa’s Utah facility.
LeGall added that HACCP standards and good manufacturing practices (GMPs) are complimentary approaches, and “HACCP should come in addition to a GMP system”.
“GMP is an absolute essential in our industry as it provides the foundation for the development and implementation of successful Quality Management Systems as well as a confidence in product safety. GMP is the prerequisite for all GFSI standards including IFS,” explained LeGall.
“HACCP is an internationally recognized system that focus on product safety at all stages of the food chain and provides a systematic preventive approach to address physical, chemical, and biological hazards. This approach is more structured to the control of hazards compared to the traditional GMP inspection and quality control procedures,” he added.
“The dietary supplement industry is regulated by FDA and GMP is a minimum requirement for US manufacturers (Part 111 in US Code of Federal Regulations). HACCP is not mandatory in US but, to my mind, it should be part of the Quality Management System of every responsible manufacturer,” said LeGall.
“Now that we have completed the criteria’s for IFS, version 5 certification, our customers can be sure that Sabinsa manufacturing is held to the highest level of commitment for quality and safety,” he concluded.
INC Research has shifted its headquarters to new and larger offices as part of the firm’s wider plan to ramp up its clinical trials outsourcing operations in Research Triangle, US.
“This move better positions us to accommodate future growth of our clinical trials outsourcing services,” said INC Research CEO, James Ogle.
INC’s Corporate Learning Centre, which focuses on internal training and certification programs in project management and therapeutic clinical research, will be set up within the 120,000 sq. ft. space between the firm’s new location at 3201 Beechleaf Court in Raleigh, US, and its existing office at 4800 Falls of Neuse Road.
The CRO’s Project Solutions Lab which provides simulation training for staff will also be housed at the new plot. INC said it has sealed a multi-year deal to occupy the area to accommodate current work being carried out and to allow future growth for the business.
“This is an exciting stage in the history of INC Research,” said Ogle, who explained: “We have continued to enhance and expand our global drug development capabilities based on consumer demand.”
Over the last year, the firm launched its Alliance Partnership division which is responsible for creating and managing clinical delivery collaborations with pharma and biotechnology customers.
With an eye to expanding clinical trial research operations across the globe and to strengthen its presence in emerging markets, INC expanded its global medical management team in September with the addition of three new medical directors in Buenos Aires in Argentina, China’s capital of Beijing and Gurgaon in India.
Furthermore, the company acquired MDS Pharma Services’ later-phase clinical trials business in 2009 in a $50m deal which covers the Phase II, III and IV clinical operations of MDS Pharma.
The acquisition was made as INC had planned to expand its footprint in international markets, including South America, Asia and Africa.
INC now employs over 2000 research staff and conducts clinical trials in more than 40 countries around the world.
US CRO Dedicated Phase I (DPI) says plan to set up first in human (FIH) unit at Phoenix hospital reflects growing drug industry demand for studies in this setting.
CEO Jason Bonanza said that: “We have seen some of our major Sponsors move trials to hospital-based units overseas, mostly with biologics. Our goal is to meet the strictest demands when it comes to safety in FIH trials.”
The deal, details of which have not yet been announced, is part of an exclusive agreement with Integrated Medical Services (IMS), a network of 128 multi-specialty physicians with 41 offices in 13 Arizona cities.
“Partnering with a hospital and IMS are both steps toward establishing a wider network of resources that are the basis for providing more efficient and cost effective services to our pharmaceutical sponsors.”
Bonanza added that DPI is working to design an advantageous floor plan within the hospital, and the first hospital-based studies are expected to begin at the additional site in 2012.
When operational the hospital unit will work with DPI’s existing 70-bed clinical research facility which is also based in Phoenix.
West Pharmaceutical Services plans to move into new 171,000 sq. ft. headquarters, with office and laboratory space, in Pennsylvania by 2013.
A build-to-suit lease agreement has been inked to initiate construction of a global headquarters in Exton, Pennsylvania, two miles from its current office in Lionville. The new building will have 130,000 sq. ft. of rentable office area and laboratory and research space covering 41,000 sq. ft.
West entered into the agreement in anticipation of the expiration of the lease on its current headquarters. The lease on the new building will begin on January 16, 2013, and 30 days after substantial completion of the building and tenant improvements.
An initial 15 year lease has been agreed and West expects annual base rent in 2013 to be $4m (€3m), including landlord funded tenant improvements. All building management, operations and repairs will be performed by the landlord and reimbursed through monthly expense payments.
West has the option to extend the lease by two additional terms for a total of 10 years, purchase the building, and has a right of first offer to rent space in five nearby premises owned by the landlord.
Failure by 530 Regency Drive Associates, the landlord, to substantially complete base building work and lab space by May 4, 2012, or the entire site by December 1, 2012, will lead to damages being paid.
West currently employs 325 people at its headquarters in Lionville, a site housing analytical laboratories and research space, as well as corporate and administrative offices.
The Fred Hutchinson Cancer Research Center said it will use a newly-acquired building adjacent to its campus in Seattle's South Lake Union section for research support facilities as well as offices — and possibly could expand its lab research space as a result.
"This offers an outstanding opportunity to expand our solid tumor, infectious disease, and immunotherapy research as well as work toward the goal of consolidating all of the Center's research activities onto one campus," Doug Walker, chairman of the Hutchinson Center's board, said in a statement.
The Hutchinson Center paid $36 million to acquire the 177,000-square-foot building, at 1100 Eastlake Ave. E., from the Blume 1100 Partnership, a group of investors led by Seattle developer Bruce Blume, CEO of The Blume Company
The Hutchinson Center said in the statement that it plans to occupy the building in June 2012.
Vindonwestech, a member of the Vindon Healthcare group, opened their brand-new pharmaceutical and biological stability storage facilities in Kennesaw GA, on Veteran's Day, 11 November 2010. The mayor of Kennesaw, Mark Mathews, performed the official opening ceremony, which was attended by invited guests from the pharmaceutical and biopharm industries as well as local dignitaries.
Vindonwestech currently provides environmentally controlled storage products and services to companies in the pharmaceutical, biological, cosmetic and heritage industries throughout the US. This move will dramatically improve the company's storage capabilities.
Patrick Jackson, business development director, said of the new facility: "Vindonwestech is looking to the future. Our new storage suite offers biological storage down to -80°C and ICH and unique stability storage conditions. We're grateful for support we've received in the US along the way. We're keen to progress and we're now well placed for even more growth."
Alliance Medical Products (AMP) operates a state-of-the art cGMP facility in Irvine, California, US.
The facility offers contract manufacturing and analytical services to the pharmaceutical and biotechnology industries. It is designed and equipped to support initial stage small batch clinical manufacturing through to commercially marketed products.
The facility was installed with a high volume vial filling line in September 2010. The new line is expected to further expand AMP's capabilities to provide a comprehensive range of developmental, clinical and commercial contract manufacturing services to large and small pharmaceutical and biotechnology customers.
The facility is spread over 53,000ft² and houses Class 100, 1,000, 10,000 and 100,000 clean suites. The configurable aseptic filling suites are installed with five automated filling lines for commercial products and three semi-automated filling lines for clinical manufacturing.
The automated filling lines can operate at a batch capacity of up to 1600l. Filling lines include a Cozzoli inline filler, a Capmatic monoblock dropper filler, a Capmatic 8 head moving beam filler, a Bosch monoblock cartridge filler and an IMA tube filler. The IMA tube filler received commercial approval in October 2010.
The new vial filling line is a high volume eight head Conquest line with a production capacity of 150,000 vials per batch. The line is equipped with an inline vial washer, depyrogenation tunnel and 12 automatic spindle inline cappers.
Designed to support nitrogen purge or blanket, the new line can fill vials ranging in size between 2ml and 150ml.
The semi-automated Class 100 vertical flow filling suites are designed to provide efficient materials and people flow. They are equipped with stainless steel and disposable container mixing options and sterile filtration.
The facility also accommodates an automated carton and bundling area, automated labeling area, customer work area, three autoclave sterilizers, SCADA integrated formulation rooms and on-site chemical and microbiological laboratories. There are 16 stability chambers that run on power back up. All the stability chambers are equipped with Stability Trac tracking systems and operate on ICH guidelines, and custom temperatures and humidity.
The facility is additionally equipped with water for injection (WFI), vial and bottle depyrogenation, and automated vial and bottle washing capabilities.
The facility specializes in manufacturing difficult-to-produce formulations. It does aseptic filling of solutions, suspensions, emulsions, sterile ointments and gels. It also undertakes powder filling of solid dosage forms. The facility is equipped to develop combination drug delivery products including drug coated implants, drug delivery devices and sustained release delivery systems.
Laboratory services provided by the facility include analytical testing, microbiological testing, USP / EP / BP / JP compliant testing, method qualification / validation and stability study programs meeting all ICH guidelines. Additional services include final formulation, process development, process scale up, clinical trial production, CMC documentation services, sterilization development and validation, and Phase IV marketing trial repackaging.
The plant can operate at batch sizes ranging up to 150,000 units per shift. The Cozzoli inline filler operates at a capacity of between 5,000 and 30,000 vials per shift. The Capmatic eight head moving beam filler fills between 10,000 and 150,000 vials per shift.
The operating capacity of the Capmatic monoblock Filler ranges between 5,000 and 30,000 vials or dropper bottles per shift.
The Bosch monoblock cartridge filler is designed to fill between 5,000 and 30,000 cartridges per shift.
Operating at a similar capacity, the IMA tube filler fills between 5,000 and 30,000 gel or ointment tubes per shift.
The facility can fill a broad range of container closures, including 2ml to 100ml vials, 5ml to 500ml screw cap bottles, 3ml to 30ml dropper tip bottles, 1gm to 50gm squeeze tubes, 0.5ml to 10ml cartridges and 50ml to 250ml bags.
The semi-automated filling lines operate at batch sizes up to 5,000 units per shift. Fill volumes range from 0.5ml to 500ml.
Six pharmaceutical manufacturing facilities constructed in Germany, Switzerland, Sweden, and the U.S. have been selected as Category Winners in the seventh annual Facility of the Year Awards (FOYA) program sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine. A seventh facility was selected to receive an Honorable Mention. The winning companies and respective award categories are:
F. Hoffman – La Roche Ltd, winner of the Facility of the Year Award for Process Innovation for its “MyDose” Clinical Supply facility in Kaiseraugst, Switzerland
MedImmune, LLC, winner of the Facility of the Year Award for Project Execution for its Frederick Manufacturing Center (FMC) Expansion facility in Frederick, Maryland, USA
Merck and Company, Inc., winner of the Facility of the Year Award for Facility Integration for its Global Clinical Supplies Manufacturing, Packaging and Warehouse expansion project in Summit, New Jersey, USA
Novartis Vaccines and Diagnostics GmbH, winner of the Facility of the Year Award for Equipment Innovation for its “MARS Project” (Marburg Site) facility in Marburg, Germany
Pfizer Health AB, winner of the Facility of the Year Award for Operational Excellence for its Project Pegasus – Bio 7 Manufacturing facility in Strängnäs, Sweden
Pfizer Manufacturing Deutschland GmbH, winner of the Facility of the Year Award for Sustainability for its SPRING & E-MAP (Strategic Plant Restructuring & Energy Master Plan) project in Freiburg, Germany
Shire HGT, Facility of the Year Award Honorable Mention for its Project Atlas, Building 400 facility in Lexington, Massachusetts, USA.
The Facility of the Year Awards program recognizes state-of-the-art pharmaceutical manufacturing projects that utilize new and innovative technologies to enhance the delivery of a quality project, as well as reduce the cost of producing high-quality medicines. Now in its seventh year, the awards program effectively spotlights the accomplishments, shared commitment, and dedication of individuals in companies worldwide to innovate and advance pharmaceutical manufacturing technology for the benefit of all global consumers.
The Facility of the Year Awards program is truly global, as submissions over the past seven years have been received from more than 25 different countries and territories. Each of the submissions was reviewed by an independent, blue-ribbon judging panel consisting of global senior-level executives from all aspects of the industry.
There will be several opportunities to learn first-hand about the facilities being honored as “best in their class.” These opportunities include:
INTERPHEX2011 – Meet the Category Award Winners at the Facility of the Year Awards Display Area at booth number 1571 in the exhibit hall of the Jacob K. Javits Convention Center in New York City, New York, USA. This is your opportunity to meet personally with representatives from companies of the Category Winners to discuss the success stories associated with these pharmaceutical manufacturing facilities. To register, or for more information, visit www.interphex.com.
ISPE 2011 Annual Meeting – Hear presentations from the winning teams and learn first-hand who will win the coveted Overall Facility of the Year Award during ISPE’s 2011 Annual Meeting, 6-9 November in Grapevine, Texas, USA. For more information, visit www.ISPE.org.
Feature Articles – Comprehensive coverage will appear in Pharmaceutical Processing magazine and Pharmaceutical Engineering magazine.
German technology group Schott and Japan’s Naigai Glass Industry Company have teamed up to enter the country’s pharmaceutical packaging market.
Under the Schott Naigai brand name the new Osaka-based company will manufacture vials for the Japanese pharmaceutical industry using Schott’s Fiolax tubing glass.
Jürgen Steiner of Schott said: “The founding of Schott Naigai is an important milestone in our global growth strategy. This will allow Schott to significantly strengthen our market position inside the world’s second largest pharmaceutical market.”
Under the deal, Schott said it intends to gain entry into the Japanese market, while Naigai will benefit from access to Schott’s global production and R&D network. It added that there are no plans to jointly develop new packaging solutions.
Speaking of demand in the Japanese market, Steiner said: “Japanese pharmaceutical companies are looking for high quality packaging solutions, and require special cosmetic quality. We also see a trend in increasing quality requirements in Japan in the future.”
Steiner also claimed customers of the joint venture will benefit from Schott’s global diversification, which boasts numerous production sites and an integrated tubing production line.
He added: “This is especially interesting for Japanese export-oriented pharma companies with a multinational production set up.”
In addition, the German firm will contribute its automatic inspection system to the deal, which it claims is more reliable than human eye inspection.
Schott holds 80 per cent of the shares in the partnership, while Naigai owns the remaining 20 per cent.
In upcoming years Schott Naigai said it plans to expand its capacities by adding new production lines and continuously “ramping up, step by step,” with the aim of reaching a vial market share in Japan of above 10 per cent.
ShangPharma has opened a multi-purpose pharmaceutical development cGMP manufacturing facility in Fengxian, China, and started operations on the initial phase of production.
The pharma and biopharma research and development (R&D) outsourcing company, said its state-of-the-art facility will be named China Gateway Pharmaceutical Development Company and will operate as a wholly owned subsidiary of the firm.
The expansion will enable ShangPharma to boost its service offerings in process and formulation R&D, analytical method development and validation and current good manufacturing practice (cGMP) manufacturing of drug intermediates and active pharmaceutical ingredients (APIs) for preclinical development and clinical trials.
A ShangPharma spokesperson said: “With the newly added capacity in the Fengxian plant, the company will be able to support its clients’ projects all the way through Phase II and into Phase III development.”
The contract research organization (CRO) added that further plans may be made to expand the manufacturing facilities to 460,000 sq. ft. if it experiences a strong demand for commercial manufacturing of FDA – or EMEA – approved drugs.
Last year, ShangPharma raised $87m (€65m) through an IPO on the New York Stock Exchange, of which the firm planned to spend $15m on the new Fengxian site.
Some of these proceeds have been spent on equipping the Fengxian facility with a pilot plant boasting six separate bays with reactor capacities of 200 to 3,000 liters, as well as other specialty bays for high temperature, cryogenics, and highly toxic and pressurized reactions such as hydrogenation.
Additionally, ShangPharma said there are two cleanroom suites rated at Class 100,000 (ISO Class 8) for isolation, 10 kilo-lab suites for non-cGMP and cGMP manufacturing, alongside an R&D laboratory for analytical, formulation and process development activities.
According to the China-based firm, there is an area of the new facility dedicated to analytical support, and testing of raw materials, intermediates and final products will also be carried out at the site.
A separate quality assurance (QA) department has been added to allow the company to ensure materials are manufactured to keep in line with standards set out by cGMP guidelines.
In addition, there are separate buildings for utilities, materials management, warehouse storage and waste water treatment with room for further expansion to support commercial manufacturing activities.
Testing of raw materials, intermediates and final products will be carried out at the site. An independent quality assurance department will ensure that materials are manufactured in accordance with cGMP requirements and that established standard operating procedures are followed, the firm said.
Famar Plans to Acquire Sanofi Site for Sterile Dose Expansion
Famar plans to acquire a Sanofi-aventis site in Madrid, Spain to further expand its sterile dose capacity and capabilities.
Integration of the site into Famar’s manufacturing network, which includes 11 European sites, will strengthen its solid and sterile dose contract production capabilities. After closing the deal, due to occur in mid-2011, Famar will supply Sanofi and invest to continue its sterile expansion strategy.
Famar will make a multi-million Euro investment in a new sterile workshop with several lines, and hire the 330 staff Sanofi employs at the plant, said Herve Mouneyrac, corporate development director at Famar.
Since acquiring a plant in St. Remy sur Avre, France from Abbott in 2007 Famar has invested to quadruple lyophilisation capacity. Demand for sterile dose production services is strong, said Mouneyrac, and the Madrid site will complement the French plant and help Famar serve clients.
Buying the plant is also an opportunity to strengthen Famar’s relationship with Sanofi, said Mouneyrac. Famar bought a Sanofi plant in L’Aigle, France in 2001 and is looking to strengthen ties with the new acquisition.
Following closure of the deal Sanofi will continue to source certain products from the site “on the basis of a strong and sustainable supply agreement”. No further details on the supply agreement are available at this time.
The Madrid site will, on completion of the deal, become the first Famar site in Spain, a country it views as having a “very promising market”. Famar currently has 11 sites located in Greece, France, Italy and The Netherlands, employs 3,100 people and has a turnover of €380m ($512m).
In recent years Famar has invested to expand its sterile dose capacity. Expansion of the Saint-Rémy site has given Famar 200 m. sq. (2,152 sq. ft.) of lyophilisation capacity and aseptic vial filling capabilities.
Solvias says its new combined corporate office and analytical lab in Kaiseraugst, Switzerland will improve the speed and efficiency of its contract analysis services.
The CHF70m (€54.6m) facility, which is already operational ahead of its official opening next month, houses corporate offices and a 6,400 sq.m. (68,864 sq. ft.) laboratory that will provide a range of pharmaceutical analysis services.
CEO Hansjorg Walther said that, while the immediate benefit is extra capacity for long-term and follow-up stability analysis, the firm plans to roll out a number of new testing services at the site over the next few years.
“The new building’s infrastructure offers potential to broaden the service offering of Solvias. In the medium term we will be able to offer formulation development and analysis. We also plan to expand our existing capabilities for handling highly potent and highly active substances.”
Walther also suggested that having a broad range of analysis and manufacturing services under one roof offers improved in inter-departmental communication as well as giving Solvias the ability to adapt its staff capacity to the demands of specific projects.
“Beside this,” he continued “we have made considerable progress in case of sample management as we concentrated the sample management on one spot which enhances the logistics between different departments.”
The new lab and corporate facility will work in concert with Solvias’ chemical development centre in nearby Basel, which provides active pharmaceutical ingredient (API) manufacturing to Phase IIa.
Walther also set the new facility in terms of Solvias’ wider efforts to adapt its business to the changes in the pharmaceutical and biotechnology industries.
“We are going to align our offer more strongly and in a more differentiated manner to the demands of large pharmaceutical companies as we see a good potential in this area.
He also predicted that integrated synthesis, analysis and solid-state characterization services will also be of interest to small and mid-sized pharmaceutical and biotechnology companies "even if demand from such firms remains on a lower but stable level because of their financial situation.”
Genzyme will build an additional manufacturing plant in Geel, Belgium, to support the long-term growth of Myozyme® and Lumizyme® for Pompe disease. The company held a ceremony in Geel to mark the start of construction of the new €250 million plant, which will include 8,000 liters of production capacity, a complete purification installation, and ample room for additional future capacity expansions. Commercial approvals for the new site are expected to start late 2014.
“The expansion of our Geel facility is a critical element of our manufacturing strategy and is fundamental to our mission”
Genzyme currently produces Myozyme and Lumizyme at an adjacent plant in Geel, where it is increasing production capacity to 12,000 liters with the addition of a third bioreactor scheduled for approval by the end of this year. Genzyme is also continuing its 160 L production in the U.S. for patients with infantile-onset Pompe disease. The investment in Geel is part the company’s program to increase its overall biologics manufacturing capacity four fold. About 150 new jobs will be created as part of the expansion, bringing the total workforce at the site to nearly 600 people.
“The expansion of our Geel facility is a critical element of our manufacturing strategy and is fundamental to our mission,” said Scott Canute, Genzyme’s President, Global Manufacturing and Corporate Operations. “We are committed to delivering a reliable supply of high quality medicines to our patients. This investment ensures continued supply to our patients in the Pompe community for the long term.”
Genzyme believes that its Pompe disease treatments represent a commercial opportunity that is comparable to that of Cerezyme for Gaucher disease. The company estimates that there are about 10,000 Pompe patients worldwide; approximately 1,400 Pompe patients are currently treated with either Myozyme or Lumizyme, which are the only treatments approved for the disease. Myozyme is currently available in 48 markets worldwide and Genzyme expects to increase this to 60 markets by the end of this year.
"Our strong track record of results, the expertise and dedication of our workforce along with the partnership with the authorities in Belgium, have been instrumental in bringing this exciting new investment to our site," said Piet Houwen, General Manager of Genzyme’s Geel manufacturing site.
Actavis has expanded its renewable energy powered pharmaceutical manufacturing site in Iceland for tablet manufacturing and packaging.
Speaking about the €8m ($10.8m) expansion, Claudio Albrecht, Actavis CEO, said: “This latest investment increases the production capacity in Iceland by 50 per cent, giving us a significantly increased launch capability for the EU market. This is our principal development and launch site for Europe.”
Albrecht said the Hafnarfjordur manufacturing site produces many of Activis’ generics and specializes in new product launches. He added that the site exports 96 per cent of its products to European markets and following the expansion, production capacity will rise to around 1.5bn tablets.
As the site is 100 per cent powered by geothermal energy, Actavis claims it is the most eco-friendly pharmaceutical facility in the world and said the expansion will support the Icelandic economy by adding 50 jobs to a workforce of 300 people.
The facility is ISO 14001 and OHSAS 18001 certified and is powered by electricity from hydropower and geothermal heating, “giving it a zero carbon footprint for tablet manufacturing and packaging and using no fossil fuels,” said Albrecht.
Iceland boasts a plentiful supply of geothermal energy which is ideal for powering a manufacturing plant, but solar power is similarly well-suited for sites in California, and other drugmakers have also recognized the benefits of employing sustainable energy sources.
In 2009, Novartis invested $7m (€5.3m) in over 4,100 solar panels at its Vacaville, California, pharmaceutical plant. The firm said the panels benefit the environment and generate less expensive electricity, contributing 20 per cent of the site’s energy requirements.
Meanwhile, GlaxoSmithKline (GSK) last year began adding a rooftop solar array to its Northeast Regional Distribution Centre in Pennsylvania, US. Once completed, GSK’s solar system will be made of 11,000 Suntech panels, producing 3.4 MW of electricity each year and making the buildings entirely self sufficient. This came as part of the drug giant’s strategy to reduce electricity usage by 45 per cent by 2015.
Cambrex’s Hyderabad, India plant has received a GMP compliance certificate, accepted throughout the EU, from the DKMA.
Good manufacturing practice (GMP) certificates from the Danish Medicines Agency (DKMA) are accepted by all European Union (EU) health authorities. Gaining certification allows Cambrex to accelerate rollout of products in the EU and offer finished dosage forms to clients.
“This commercially important and significant milestone for Cambrex confirms our commitment to quality in every aspect of operations management and reflects our efforts to sustain and continuously improve quality platforms”, said Ashok Narasimhan, President of Cambrex Zenara.
Cambrex acquired 51 per cent of Zenara in November and intends to buy the remaining 51 per cent in 2016.
Carclo Technical Plastics, a provider of injection molding and contract manufacturing services for medical, optics and electronics operations, has completed a new injection molding and assembly cleanroom at its Mitcham, Surrey, UK facility in an investment worth £1.2m.
The investment was made to support a major customer, which the company has not named, in the development of a dry powder inhaler. The Class 7 cleanroom will be used for molding the components in production volumes.
The facility also has the capability to laser mark, ultrasonically weld and camera inspect a subassembly. The completed device will be filled by the ultimate customer and will be used in the treatment of asthma and chronic obstructive pulmonary disease.
The £1.2m investment includes injection molding machines from Krauss Maffei.
Carclo said its customer has invested approximately £3m in tooling from various European toolmakers and bespoke automation from Lambert Engineering and Hi-Tech Automation.
“We are delighted to have completed this new facility on time and within budget,” said Patrick Ward, managing director of Carclo Technical Plastics. “Carclo has long been involved in inhaler manufacture and this is an exciting program for the Mitcham operation.”
Carclo Technical Plastics reported operating profits of £2.6m to 30 September. Sales increased by 11.4% helped by strong growth from medical diagnostic and LED optical products.
The company is part of Carclo plc, which has manufacturing operations in the UK, US, Czech Republic, India and China. Typical products include drug delivery devices and diagnostic consumables.
Soy ingredients company Solae opened a food application centre in Shanghai, promising to cut product development times for Asia-Pacific customers.
The company already has three other food application centers around the globe. The new facility will target food processors in the fast-growing Asian economies such as China and India as well as established markets like Japan and Australia.
“Asia represents an enormous part of the growth opportunity that Solae sees around the world. When people’s incomes increase, they upgrade their diet and that often means more proteins, whether its meat, dairy or others,” said Tony Andrew, Asia Pacific senior sales director.
Household incomes in China increased an average 13 per cent in the past six years, according to brokerage firm CLSA Asia-Pacific Markets.
The 3,000-square meter (32,280 sq. ft.) facility will focus on food, beverage, bakery, confectionery and meat products. It contains laboratories for product development, sensory analysis and quality testing, allowing Solae to work more efficiently with regional customers and access local tastes. It is expected to halve the turnaround time for project development work.
Solae has already worked with local processors to create new categories, said Paul Paulsen, director of product development and application discovery, technology and innovation. In the mid 1990s, the company helped Chinese meat processors to create a shelf-stable ham sausage, similar in appearance to a hotdog sausage, now widely available as a snack across China.
“Most have a significant amount of soy protein, as much as 50 per cent,” said Paulsen. Adding soy both reduces the product cost and allows it to undergo the heating process that makes it shelf-stable. These snack sausages are now increasingly common in other markets such as Vietnam and Indonesia, added Andrew.
“Both portability and price point are important. [Soy] offers a combination of economics and stability.”
Solae is hoping to develop other new categories in its Shanghai application center, as well as looking at product improvement. It currently sees strong demand across the region in beverages and a growing interest from bar manufacturers, particularly in more developed markets such as Australia and Japan but also in new places, such as Korea.
The trend for nutritional bars is emerging there thanks to the product’s similarity to a traditional food item, kang jeong. “Nutritional bars are a natural extension of this product, a more convenient modern version,” said Andrew.
Solae uses Chinese soya to manufacture soy protein isolates and other products at three factories in the country.
siRNA-focused CRO Cenix BioScience has set up an R&D subsidiary in Belgium, citing growing demand for this type of specialized contracting.
The new unit, which will be named Cenix BioScience BVBA, will provide contract siRNA discovery development services to partners in pharmaceutical and biotech industries.
CEO Chris Echeverri said that setting up the new business “represents a very logical "next step" addition to our current range of offerings, it was of obvious strategic value for us to follow this path.”
“However," he continued "to achieve this, some notable technical obstacles first need to be addressed adequately, namely the need for more robust and efficient in vivo siRNA delivery solutions, and so, this will be our immediate development focus.”
Echeverri also cited a considerable upsurge in demand in the last eighteen months, which helped the firm to a record financial performance in 2010, as a reason for investment in the new R&D unit. This demand, he explained, comes from risk-averse pharma firms that recognize the potential of siRNA but often lack the technical knowhow to make such development projects a success.
He said that: “Many groups have spent a lot of resources building up own RNAi screening facilities, only to find that it takes more than two full years before such teams, no matter how well-equipped, become truly effective in benefitting the pipeline with these capabilities.
“This means that pharmas can only justify such activities internally if they have fully confident about having sufficient internal, sustained and long-term need for their output, otherwise, it makes far more sense to rely on an external partner for this.”
Technical challenges are also serving to slow the growth of competition in the contracting sector according to Echeverri, who reiterated that: “RNAi-based contract research represents one of the most complex, challenging types of CRO offerings out there.
“These are large, very complex and highly customized projects, and therefore, the entry barriers, build-up costs, running costs and inherent risks are all quite considerable.”
This type of contracting, he continued, requires considerable technical knowhow which “means CROs face huge risks in building this up, and therefore, those very few, such as Cenix, who have already accumulated strong and well-diversified experience in this area have a huge competitive advantage."
United Parcel Service (UPS) will open four global healthcare distribution centers to accommodate its fast growing healthcare business and a rising global customer base.
The Atlanta, US-based company said the new units, to be located in Asia, Europe, the U.S., and Canada, reflect rising demand from healthcare companies and an increasing trend toward outsourcing.
Bill Hook, VP of global strategy at UPS Healthcare Logistics, said: “We are seeing increasing demand from healthcare manufacturers wanting more agile supply chains. This clear industry is driving companies to look for more global solutions and deeper supply chain partnerships.
"We're working with customers not just on transportation and warehousing but in highly strategic partnerships and more tactical initiatives around specific activities such as new product launches," said Hook.
UPS expects to spend $100m on building the facilities in Venlo, the Netherlands; Burlington, Canada; Louisville, Kentucky, as well as its first healthcare centre in Singapore, China.
The firm said the new facilities will cater for pharmaceutical, biotech and medical device companies, and will help manufacturers meet regulatory requirements for healthcare products.
Paying particular attention to these requirements, UPS have added temperature-sensitive capabilities to the healthcare facilities to handle its global customer’s storage and distribution needs of high-value products.
UPS’ healthcare operation in Singapore will be the first of the four to open in the first quarter of this year. The unit will serve as an import-export facility, and will offer cold chain capacity for temperature sensitive products as well as postponement services such as re-labeling and kitting.
Both the Venlo and the Burlington facilities will begin operations in this year’s second quarter, with Burlington specially designed to meet all regulatory compliance and quality assurance (QA) needs of healthcare products.
Last to open in the fourth quarter, the healthcare facility in Louisville will be situated close to UPS’ Worldport global air hub to allow next-day delivery for air shipment orders. UPS said the site is also equipped with temperature sensitive and vault storage capabilities.
The additional sites will bring the number of global UPS healthcare facilities to 30, with a total 4m sq. ft. of dedicated healthcare distribution space.
PPD and Taijitu Biologics have launched a new joint venture to help drugmakers develop the next generation of monoclonal antibody (MAb) drugs.
The new entity, BioDuro Biologics, will be headquartered in Singapore and is designed to leverage the antibody discovery platform created by Taijutu’s German biotech research partner MAB Discovery.
North Carolina, US-based PPD, which has invested $25m in the JV and holds a majority stake, said the move is intended to help it cater for the expanding biologics market.
In a press statement PPD executive VP of lab services Lee Babiss suggested that: “Developing a best-in-class, innovative technology platform for the discovery of monoclonal antibodies allows us to continue to deliver highly valued discovery services for our clients in the growing area of large molecule drug discovery.”
The investment fits with PPDs efforts to building its drug discovery services offering over the last few years, which began with its acquisition of Beijing, China-based BioDuro in November 2009.
More recently the contract research organization (CRO) set up its vaccines and biologics centre of excellence and expanding laboratory capacity at a facility in Wayne, Pennsylvania it acquired from Merck & Co.
The decision to base BioDuro Biologics in Singapore, which is well established as a global hub for development thanks to decades of infrastructure investment by successive governments, also fits the growth plan PPD has undertaken in recent years.
This began in December 2008 with the opening of a new research and development (R&D) laboratory the CRO said was designed to cater for growing demand from customers in Southeast Asia.
The following year PPD further built its presence with the creation of a second laboratory to provide analytical services for drug developers working in the country.
Dendreon is to build a Provenge production facility in Germany, due to be operational in 2013, and in the meantime is to outsource to a CMO.
Construction of the Germany plant is due to begin in 2011 with the aim of gaining regulatory approval in 2013. Dendreon expects to receive a European decision on the Provenge marketing authorization application (MAA) around the same time as the Germany plant gains approval.
To accelerate the timeline for approval in the European Union (EU) Dendreon is to outsource to a contract manufacturing organization (CMO). Qualifying a CMO can be done faster than plant construction and Dendreon expects to save 12 to 18 months by outsourcing to support filing.
An MAA will be filed when technology transfer to the CMO is complete. Negotiations with a CMO, which possesses appropriate equipment and has previously worked on similar projects, are in the final stages. Dendreon has previously used US CMOs so they are comfortable with the transfer process.
Once constructed and approved Dendreon will meet commercial supply requirements using its Germany plant. Provenge has a short shelf-life and consequently Dendreon has located its facility to be close to as many patients as possible.
Dendreon says 20 per cent of patients can be reached in a four hour drive and 50 per cent within eight hours. Overland transport is preferred by Dendreon but planes can also be used to make delivery to almost all of Europe viable.
The Germany plant will support the first phase of the European expansion, with other sites possibly being constructed in the future. Output from the Germany plant is expected to be similar to Dendreon’s 160,000 sq. ft. site in Atlanta, GA and 184,000 sq. ft. premises in Los Angeles, CA.
As demand in Europe increases Dendreon may add more facilities to support operations in Germany. Dendreon will make decisions on the capacity and location of facilities when reimbursement negotiations have progressed.
Dendreon expects to spend $125m (€97m), split evenly between capital expenditure and operating expenses, to bolster capabilities in 2011. One-off start-up costs from US production facilities will continue throughout the first three quarters and total $90m in 2011.
These one-off costs are expected to contribute to a GAAP (generally accepted accounting principles) loss of $310-350m in 2011. Revenues in 2011 are predicted to be $350-400m with 50 per cent of sales being made in the fourth quarter.
By then Dendreon expects to have increased US production capacity 10-fold by making sites in New Jersey, Atlanta and Los Angeles fully operational. This will eliminate the capacity constraints Dendreon faced in 2010.
Dendreon shares have risen almost eight per cent to $38.16 following release of the news and its presentation at the JP Morgan Healthcare Conference.
Catalent Pharma Solutions announced an expansion of its development capabilities for oral controlled release dosage forms. This major expansion will enable Catalent to offer formulation development and optimization services in its Winchester, Kentucky facility and complements that site’s existing pilot scale and commercial capabilities for controlled release tablets and capsules. The addition of formulation development and optimization services in Winchester will allow products to move through the development stages to commercialization within the same site; reducing the need for additional technology transfers and facilitating a faster time to market. This expansion also builds upon Catalent’s existing controlled release development capabilities in Somerset, New Jersey and Schorndorf, Germany.
“This latest investment in our modified release group continues our long established heritage in this field and offers our customers a more comprehensive service at our Winchester facility and across our network,” said Ian Muir, President of Catalent’s Modified Release Technology business.
This new formulation and process development area is expected to be open for business in early December and is representative of Catalent’s commitment to growth and is in line with customer needs. Maintaining this momentum, a major expansion of development and commercial capabilities in Catalent’s Schorndorf, Germany oral controlled release facility is underway for a planned launch in 2012 and will allow global and European customers to take advantage of Catalent’s extensive expertise in solving the most complex formulation and scale-up challenges.
Alpha Biologics, a contract biomanufacturing service provider, commissioned a new cGMP biomanufacturing plant in April 2010. The plant, located at the Penang Biotech Park in Malaysia is dedicated to the production of mammalian cell secreted proteins.
The plant broke ground in June 2006 and was built at an investment of $18m between 2007 and 2009. It was constructed in compliance with the FDA and EMEA guidelines.
The design incorporates a flexible layout that was reviewed by the Centre of Drug Evaluation and Research (CDER) at the FDA and declared suitable for clinical studies and early market product development.
The facility has multiple cleanrooms and functions that enable parallel working processes, thus reducing timelines and the eventual cost to the customer.
The plant spreads over an area of 5,000m² (53,800 sq. ft.) and accommodates upstream process development laboratories, cGMP manufacturing space and support areas.
"The design incorporates a flexible layout that was reviewed by the CDER."
The manufacturing space includes process suites, isolation suites, two independent DSP suites and separate final filtration / viral removal suites. Class 10,000 (Grade C) process suites with Class 100,000 (Grade D) support areas are encircled by a return corridor, which provides visitors an inside view through the windows.
Waste material is disposed of via the return corridor, avoiding their crossover with clean items.
There are three isolation suites used for USP-cell banking and associated operations. These suites are equipped to develop master cell banks (MCB) and working cell banks (WCB), bioreactor seed or small scale product manufacturing for pre-clinical studies.
The bioreactor suite is equipped with seven bioreactors with capacities ranging from 10l to 500l (3 x 10l, 1 x 70l, 2 x 250l, 1 x 500l). The bioreactors can be operated in batch, fed-batch or perfusion mode - and the flexible design of the facility allows utilization of bioreactors in different combinations in a closed system. There are two recovery suites for cell harvest clarification, with medium to large scale ultra filtration capabilities.
There are two purification suites for pre- and post-virus processing, equipped with chromatography and ultra-filtration skids and dedicated cold rooms. The final filtration / viral removal suites are installed with chromatography for final filtration and bulk aliquotting.
Upstream process development laboratories are located on the ground floor of the facility and are designed to allow the scale up of cell cultures in bioreactors of different capacity. Work in the upstream process laboratories is carried out with identical equipment to the cCMP manufacturing suites.
The bioreactor suite has three bioreactors of 10l, 70l and 250l capacities, all operable on batch, fed batch and perfusion mode. Purification equipment includes both small and large scale chromatography and ultra-filtration systems.
This use of identical equipment ensures smooth technical transfer to cGMP manufacture, with a few operational changes and cleaning validation to reduce normal timelines for process development and cGMP manufacture. This, in turn, results in major cost savings for clients.
"The bioreactor suite has three bioreactors of 10l, 70l and 250l capacities."
The facility also includes microbiology and quality control laboratories for environmental testing, analytical laboratories for in-process assays and a buffer preparation unit with 50l, 120l, 250l and 1000l preparation vessels.
There is also a cell bank and product storage zone for -20°C, -80°C and liquid and vapor phase nitrogen storage.
Additional equipment in this part of the plant includes process washing machines, sterilizing autoclaves and CIP station.
The facility is dedicated to the production of proteins secreted from mammalian cell cultures, including monoclonal antibodies and recombinant proteins. Hybridoma, CHO and NSO cell lines are the most common cell types used.
Prior to cGMP manufacturing, the facility develops cell lines and master and manufacturing working cell banks. The facility also produces supernatants, membrane fractions or other product options.
The facility has been designed to combine bioreactors with perfusion technology whenever required, to increase production capacity by 20 fold. This combination of stirred tank processes and perfusion enables ultra-efficient production of secreted protein for pre-clinical or clinical trial studies or early market use.
Instrument supplier Mocon has taken its business to new heights, literally, by installing two testing units at a Government pharmaceutical laboratory in Lhasa, Tibet.
Minneapolis, US-based Mocon set up oxygen and water vapor permeation analysis equipment at the lab, under a contract with China’s State Food and Drug Administration (FDA) that has seen it supply 40 units to 20 centers countrywide.
The Lhasa project came with some unique hurdles according to spokesman Guy Wray, who said that the Mocon installation team found working at the lab at 11,450 feet a challenge that “knocked them around” when they first arrived.
However, this brief period of altitude sickness aside, the installation was completed successfully.
From a technical standpoint Wray said that: “Barometric pressure is the issue. It is the driving force of the gases,” explaining that the OX-Tran 2.21 unit features pressure compensation that “normalizes” the results so the are comparable with those obtained at sea level.
Both the OX-Tran and the Permatran water vapor units will be used for the analysis of packaging for pharmaceutical and Tibetan herbal remedies, specifically for high barrier technologies such as aluminum foil.
The SFDA contract followed Mocon’s decision to set up a sales office and laboratory and service centre in Shanghai and to retain Beijing –based Danbell Equipment Company as an agent.
At the time CEO Robert Demorest said that: “We’ve seen firsthand that Chinese companies want their technology to match the rest of the developed world. Consumers there are now starting to demand the same quality and safety levels that are found in the West.”
But, while the SFDA contract certainly supports the idea of increasing pharmaceutical industry demand in China, Mocon’s activities in Asia have not been entirely focused on the country as evidenced by the testing laboratory it opened in India in 2009 .
The facility, which is run by Mumbai-based firm Hemetek, provides barrier and headspace analysis, leak detection and burst testing for pharmaceutical, food and beverage packaging sectors.
UCB announced that the company has initiated a project to build in-house biotech microbial manufacturing capacity in Bulle, Switzerland to secure demand for its core product Cimzia® (certoluzimab pegol). The new manufacturing unit should be operational in 2015 and requires an investment of EUR 250 million in two steps.
Belgium’s UCB expects to beat its guidance for 2010 due to higher than expected drug sales.
The biopharmaceutical firm predicted that revenue from its epilepsy treatment Keppra in Europe, where it is yet to face generic competition, will help it beat the €3b ($4bn) and EBITDA of €700m it previously forecast.
UCB also cited several of newer biopharmaceutical products as important performers in 2010.
Key among these was the Crohn’s disease treatment Cimzia, which is timely given that the firm announced a $250m plan to expand manufacturing capacity for the product late last month.
Speaking a few weeks ago Michele Antonelli, Executive Vice President for Technical Operations and QA said: “We want to be able to meet our projected future demand for 2015…by adding internal capacity to our existing capacities with our productions partners.”
He went on to say that the site in Bulle, Switzerland “is the right place and most cost effective location to build our own biotech manufacturing unit which enables us to further improve our productivity at attractive terms.
“The new unit together with the bio-pilot-plant under construction in Braine l'Alleud, Belgium will also strengthen our ability to deliver our future biological products."
Merck KGaA has opened a new centre in India to showcase its range of technology solutions to the country’s rapidly expanding pharmaceutical and cosmetics industries.
The centre, a 1,700sq.meter (18,292 sq. ft.) complex consisting of eight laboratories in Nerul, Navi Mumbai, will provide contract development services for applications ranging from chromatography for drug discovery to shade matching for cosmetic pigments .
Inauguration of the unit follows just six months after Germany-based Merck bought processing technology specialist Millipore and is part of an ongoing expansion of the combined firm’s chemistry business according to laboratory head Klaus Bischoff.
"Following the acquisition of Millipore, a leading life sciences company, earlier last year; Merck Chemicals consolidated its position by covering the entire value chain for our pharma and biopharma customers.”
He also suggested the centre “will be an ideal platform to showcase Merck's capabilities in the high growth fields of Biopharmaceutical Process Solutions, Laboratory Essentials as well as Pigments and Cosmetics for our customers in India.”
Prantik Mukherjee, head of Merck Millipore, predicted demand from both multinational drugmakers operating in India and the increasing number of home-grown manufacturers.
"The facility is equipped with state-of-the-art application, demonstration and quality control laboratories that meet stringent international standards.”
Mukherjee went on to say that: “We will also offer resources for sales force training, for Merck as well as our customers. The aim is to anticipate and not just meet customer needs; thereby verifying our claim of being a true partner in their business.
The Nerul centre is the second application technology unit Merck has established in the last twelve months after the unit it set up in Sao Paulo, Brazil and is a further indication of the firm's efforts to grow in emerging markets.
India-based CRO Ecron Acunova has agreed a clinical research partnership with the UK’s Newcastle University.
Building on initial discussions, both parties recently signed a memorandum of understanding to work together on clinical trials.
To launch the new working relationships Ecron Acunova has contracted a first clinical research study at Newcastle University.
The company plans to expand its operations in the UK and reports that it views the new partnership as a good launch-pad to achieve this goal.
With European headquarters in Frankfurt, Ecron Acunova provides services for phase I - IV clinical research, including clinical trial management, clinical data management, PK/PD services and central lab for pharmaceutical, biotech, nutritional, medical diagnostic and device sponsors.
Newcastle University is a member of the Russell Group, an association of research-intensive UK universities.
Meanwhile last month, Ecron Acunova forged a partnership with Chulalongkorn University, Thailand to undertake contract research.
“The partnership will expand medical research work in Thailand while creating new knowledge and academic work and developing the university's personnel and Thai research work system,” said Prof Kua Wongbunsin, the rector for research operations.
The newly Chula Clinical Research Centre will take on research work assigned to it by Ecron Acunova. A particular focus will be research in Southeast Asian countries.
Indian drugmaker Dr Reddy’s Laboratories has formed a manufacturing partnership with R-Pharma in a bid to strengthen its position in Russia’s fast-growing drug market.
The deal, announced late last month, will see Hyderabad -based Dr Reddy’s share manufacturing expertise and collaborate with Moscow-headquartered R-Pharm on the development of new, as yet unspecified, drug products.
Dr Reddy’s, which has operated in Russia since 1992, said the partnership deepens its engagement in the market and shifts its focus away from the importation of finish products towards local manufacture.
And, while details are yet to be disclosed, the focus on technology-transfer will be welcomed by the Russian Government which made development of the local manufacturing sector a core aim of the Pharma 2020 policy it announced last month.
Advanced Cell Technology and Roslin Cells, a non-profit organization established by the Roslin Institute, said that they have signed a memorandum of understanding to collaborate on developing a stem cell bank.
The partners said that they intend to establish a bank of Good Manufacturing Practice-grade human embryonic stem cell lines using Advanced cell's "single-ceblastomere" technique for deriving embryonic stem cells without damage to the embryo. The cell lines will be created and stored using protocols that meet regulations of both the European Medicines Agency and the US Food and Drug Administration, according to Marlborough, Mass.-based Advanced Cell.
Scotland-based Roslin Cells will be responsible for maintaining the banked hESC lines, which will be made available for both research and commercial purposes. In addition, it will promote access to the hESC lines from the bank as research reagents to both academic and commercial entities.
The partners plan to publish a commercialization license "so that third parties will have a reasonable and predictable path to commercialization of products using the same hESC lines that they may use in animal model studies for preclinical data," the firms said in a statement.
Any proceeds from licenses will be shared by Advanced Cell and Roslin Cells. Financial details of the agreement were not disclosed.
"Through the creation of hESC lines derived using our proprietary 'embryo-safe' technique, we fully expect Roslin Cells to quickly become a leading hESC bank for Europe, North America, and Asia," Advanced Cell Interim Chairman and CEO Gary Rabin said in a statement. "We foresee major demand for these embryonic stem cells from both researchers and commercial interests across the globe."
ProJect Pharmaceutics has opened its Munich headquarters and laboratory facilities in Martinsreid, Germany, beginning business operations to transform proteins, peptides and small molecules into novel drugs.
The new pharmaceutical service provider said its aims is to help client’s successfully transfer products from the pilot lab into large scale GMP manufacturing without the risk of defective batches thorough its service offerings.
Based on its ‘Advaceutics’ concept, ProJect Pharmaceutics (PJP) claims it can add value to clients’ bio-therapeutic products using state-of-the-art analytical methods, science-based formulation design and tailor-made drug delivery systems.
“Advaceutics ensures that customers receive tailor-made solutions for their recombinant and synthetic polypeptides,” said managing director and founder of PJP Andreas Schütz.
Explaining that the service is targeted towards small and mid-sized biotech companies looking to outsource responsibility for the pharmaceutical and technical aspects of their projects, Schütz said Advaceutics comprises of several services which will be offered out of the new facility.
As part of the package, the firm promises it will design safe and convenient formulations and drug delivery systems as well as identifying packaging systems and delivery devices and developing reliable and cost-effective manufacturing processes.
Furthermore, the firm offers to select and qualify suitable contract manufacturing organizations (CMOs) for the pharmaceutical system, leading to the eventual “smooth transfer” of the technology into large scale GMP manufacturing.
Schütz claimed PJP’s Advaceutics provides “a holistic approach, which integrates the marketing aspect of a safe and convenient drug presentation, science based stabilization technologies for long term stability of therapeutic proteins and economic aspects for the optimized and cost-effective manufacturing of the drug.”
The new facility, located in the biotech cluster in Martinsried, comprises of analytical labs, equipped with analytical instrumentation used to characterize therapeutic proteins and protein drug products, such as chromatography, spectroscopy, and electrophoresis, as well as a pilot lab, equipped with process technologies used in commercial aseptic manufacturing of drug products.
Bayer HealthCare is building a new facility in Wuppertal for the biotechnological production of pharmaceuticals to be used in clinical trials. The €35m investment will enable Bayer to expand its competences in the area of biological products.
On the laying of the foundation stone for the facility on December 13, 2010, in the pharmaceutical and chemical park, Dr Wolfgang Plischke, who is on the Board of Management at Bayer AG and responsible for Innovation, Technology and Environment, said: 'For a research-oriented pharmaceutical and chemical company like Bayer, innovation is the key to future growth. The new cell biology facility centre represents an investment in our long-term success. To this end, Wuppertal is able offer the ideal framework conditions.' The new facility should be operational by late 2012.
The main focus of Bayer HealthCare is on antibodies, coagulation factors and other therapeutic proteins. 'In this way, we can increase the prospects of being able to offer new drugs in the fight against serious diseases such as cancer,' said Professor Dr Andreas Busch, member of the Executive Committee at Bayer HealthCare.
'The new facility centre will enable us to increase our production capacities in order to manufacture enough material for the late phases in clinical development for an increased number of potential active ingredients,' he added.
The 20m high building will be equipped for all stages of a biotechnological procedure. Production will take place across two stories with a total of 1,370 m2 (14,741 sq. ft.) for cleanrooms. These will be accessible exclusively via air lock systems.
Technology areas, offices and social rooms are spread across another three stories. The multipurpose facility will accommodate 20 members of staff who will manufacture a variety of products.
PX’Therapeutics is opening a cGMP mammalian cell culture facility to produce materials for preclinical, clinical and niche markets.
At the current good manufacturing practice (cGMP) compliant facility, France-based PX’Therapeutics, formerly known as Protein’eXpert, will perform cell banking and small scale production.
Expanding production capabilities furthers the company’s development and is a step towards its ambition of supporting therapeutic antibody development. PX’Therapeutics has been authorized by AFSSAPS, the French regulator, to manufacture biotech, immunology and extracted products.
“Today, PX’Therapeutics can indeed provide an integrated service offer including generation of murine monoclonal antibody, humanization of therapeutic antibody, development of stable recombinant cell lines and clinical manufacturing”, said the company.
Aesica has bought three manufacturing sites from UCB, making its first foray into continental Europe and more than doubling its production capacity.
The acquisition, terms of which were not disclosed, is accompanied by the creation of a strategic partnership between the UK-based contract active pharmaceutical ingredient maker (API) and the Belgian biotech.
The three plants, in Monheim and Zwickau in Germany and Pianezza, Italy, also provide, according to Aesica, a “strong platform” from which to seek more business in Europe when the deal is completed early next year.
The facility deal is the latest in a number of expansions the contract manufacturing organization (CMO) has made in recent months, beginning in June when it acquired fellow UK-based API maker R5 pharmaceuticals.
The following month Aesica unveiled plans to build a “high containment” manufacturing plant to expand its high potency drug formulation capabilities.
The £3m ($4.6m) facility, at the UK contract manufacturing organization’s (CMO ) site in Queenborough, Kent, will produce, package and ship both liquid and solid dosage forms when fully operational in summer 2011.
The UCB acquisition also fits with Aesica’s wider global expansion plan and effort to position itself as a leading global supplier, particularly in the US market.
Adam Sims, Aesica commercial director, said the firm’s aim was to generate some 50 per cent of its revenue in the US in the next few years, up from the 30 per cent it made there at the time
Aesica subsequently set up units in New Jersey and San Diego, boosting the proportion of revenue it generates in the country.
Novartis has confirmed its intention to build a full-scale pharmaceutical manufacturing plant in St. Petersburg, Russia. The investment forms part of a $500 million commitment by Novartis in local infrastructure and collaborative initiatives over the next five years. The overall partnership with the Russian government will target local manufacturing, R&D partnerships, and public health development.
Construction of the St. Petersburg plant is expected to start in 2011. Novartis says it will represent one of the largest investments by the firm in local manufacturing and serve both the Russian market and other territories. Once fully completed it is expected to produce about 1.5 billion units of branded generics and pharmaceuticals every year.
Additional investments in R&D and public health collaborations will include alliances with academia and with the emerging Russian private sector in a range of medical science fields. Novartis hopes its efforts will lead to agreements for the outlicensing of its own compounds to Russian companies and the in-licensing of promising drug candidates from Russian academia. The Swiss drugs giant also aims to double its investment in Russian clinical trials and hopes to have 4,000 Russian individuals involved in clinical studies by 2013.
“This collaboration shows our commitment to contributing to the ambitious healthcare goals of the Russian government,” remarks Joseph Jimenez, Novartis CEO. “The ongoing partnership with Russia enables us to expand our commercial presence in a key emerging market. The scientific development and public health efforts have been prioritized to focus on the most beneficial programs for the Russian people.”
The new medical centre for the private healthcare provider Mehiläinen Group in Pori is one of the first healthcare facilities in Finland to capitalize on the antimicrobial properties of copper. Opened in early September, the newly renovated facility introduces copper floor drains and covers.
The unit manager at the medical centre and ear, nose and throat specialist Harri Reunanen were already familiar with the electrical and thermal conductivity and recyclability of copper, as well as its natural antimicrobial properties, and wanted to exploit this characteristic further in the renovation of the new facility.
The centre sourced its antimicrobial copper locally from the Luvata facility in Pori, which is an international metals supplier for manufacturing and construction, while floor drain manufacturer Vemta joined the efforts to produce the copper floor drains and covers from this material.
“The tests results of the antimicrobial effectiveness of copper are very convincing,” said Reunanen.
“We chose copper specifically for floor drains, because the moist environment is conducive to growing bacteria.”
In the medical centre the copper drains are in the toilet and equipment maintenance facilities. Infection prevention efforts have been escalated by adding antimicrobial nano coating to door handles and call buttons and silver treatments to the microfibre clothes used by the cleaning service SOL.
International scientific communities have studied the antimicrobial properties of copper extensively and the results are very positive.
A study performed at the West Finland Deacony Rehabilitation Centre in Pori, for example, tested the use of copper on door handles, support rails and floor drain grating and compared it with stainless steel.
“The results showed copper acting quickly and effectively. The copper and brass items were microbiologically cleaner compared with the other material surfaces,” said head of laboratory Kirsi Laitinen from the Hjelt Institute laboratory of hygiene and microbiology, which analyzed the samples.
UK hygiene company Tristel is to build a £950,000 cleanroom operation at its premises in Snailwell, near Newmarket, to enable it to manufacture sterile packed disinfectants and cleaning products in the new Crystel product range. These products are deployed in pharmaceutical, cosmetics and toiletries manufacturing plants.
A sales team of five has been recruited for the project and the cleanroom investment is due to be completed by the end of the current financial year. The cleanroom manufacturing operation, designed by Clean Room Construction Ltd, is expected to create a total of eight jobs, expanding the workforce to more than 60.
Chief executive Paul Swinney revealed the plans as Tristel reported annual profits up by more than a third.
The company posted a pre-tax profit of £1.72m for the 12 months to 30 June, up 34.2% on the previous year’s figure of £1.3m.
Turnover rose 28 percent to £8.8m, reflecting the firm’s 2009 acquisition of the Medichem animal healthcare range and increased sales, particularly overseas, of its chlorine dioxide-based hospital infection control products.
Swinney said the company is now in the process of rolling out its Wipes System and the Stella disinfection system globally.
“Tristel has had another successful year, increasing turnover and profit for the fifth consecutive year,” said Swinney.
“We continue to expand internationally, obtaining our first regulatory approval in China and achieving our first sales, and we have now also entered the German market. We look forward to the future with confidence.”
McIlvaine Company
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