This new three-story above, and one story below grade, 470,000-square-foot medical facility is a result of a dual effort to expand an aged, undersized facility and to comply with Senate Bill 1953, which requires hospitals that have Structural Performance Category 1 (SPC-1) buildings (those that are considered hazardous and at risk of collapse or significant loss of life in the event of an earthquake) must be replaced or retrofitted to higher seismic safety standards by 2013.

Central to their design was a large skylight that allows natural light to vertically flow into the atrium area and other light wells throughout the building. However, they also wanted to let light flow horizontally into the adjacent hallways, rooms, etc. Because the walls in the atrium and light wells have to meet a 2-hour rating, Stantec Architects approached SAFTI FIRST for a solution.

To maximize as much natural light as possible, large portions of the 2-hour atrium and light well walls were made “transparent” with the use of SuperLite II-XL 120 in GPX Framing by SAFTI FIRST. In addition, the doors were made with SuperLite II-XL 90 in GPX Framing by SAFTI FIRST to match the transparency of the walls. This way, the architect was able to keep his design while still meeting the fire and safety requirements of the code. Using fire rated glass instead of opaque fire rated materials such gypsum and brick walls played a major role in achieving that.

Daiichi Sankyo Acquires First U.S.-Based Facility

Daiichi Sankyo, Inc. (DSI) announced the acquisition of a 140,000 square foot facility in Bethlehem Township, Pennsylvania from global packaging manufacturer Amcor. The acquisition, worth $10.25 million, enables DSI to leverage existing resources to more cost-effectively supplement its operations rather than build a new facility.

The total cost of the project--which includes the facility’s purchase and renovation, new equipment acquisition, and employee training--is $19.6 million.

The facility is expected to be operational in the summer or early fall of 2011 and is expected to package some of company's portfolio of marketed products, such as Benicar, Welchol, and Azor. Once the facility is operating at full capacity, it is expected to assume an increasing responsibility for packaging the entire line of marketed products in the U.S., as well as perform compounding operations for select products.

Upon completing the initial phase of the renovation, DSI plans to hire approximately 80 new employees and will create a positive economic impact through related purchasing of goods and services from local businesses.

DSI, headquartered in Parsippany, NJ, is the US subsidiary of Daiichi Sankyo Co. Ltd.

"This acquisition diversifies our company's capabilities and allows us to streamline our operations and minimize commercialization risk by exerting greater control over the life cycle of our products, from research and development through packaging and distribution," said Jeff Lane, Vice President of Operations, Daiichi Sankyo.

Chattanooga Research Institute Project in Chattanooga, TN

Biomedical researchers using powerful computers to analyze data from hospitals, drug companies and others in a search for new medications and better patient treatment have a new workplace.

Founders of the new Chattanooga Research Institute hope to harness the power of computational biology to analyze huge stores of existing medical and genetic data that could lead to more cost-efficient and effective drug development.

The institute co-founder, Boston neuroscientist Justin Boyd, said about 200 ongoing clinical trials at the University of Tennessee, College of Medicine in Chattanooga could be a source of both raw data and researchers.

More than a decade ago, researchers first assembled the human genome sequence, developing a blueprint of human beings from more than 3 billion letters in the human DNA code. Research is just now beginning to tap the potential of that development.

Computational biology, or bioinformatics, involves using computers to describe and analyze biological data for work in drug discovery, public health and other research.

A co-founder of the new, nonprofit institute told the Chattanooga Times Free Press that much of its work will be focused on "cleaning up" and storing existing data such as patient medical records, genetic information from blood tests and results from clinical trials to help answer medical questions.

Supporters of the institute hope to raise $6.25 million to fund its first three years. They say Chattanooga has the technology, expertise and medical resources to be a hub for computational biology-based research.

With a super computer at Oak Ridge National Laboratory and UTC's SimCenter, support from researchers and city leaders, Chattanooga could be a leader in the field, said Cony D'Cruz, chief business officer for biotech company Proteros Biostructures and one of the event speakers.

"People don't quite understand how important it is," D'Cruz said. Chattanooga could be at the "forefront of the convergence between the information, the infrastructure, and being able to do something useful with it. That's a beautiful thing."

Regeneration Medicine Building Opened

The University of California, San Francisco, opened its $123 million Ray and Dagmar Dolby Regeneration Medicine Building. The new facility houses the Eli and Edythe Broad Center for Regeneration Medicine and Stem Cell Research at UCSF. No federal funds were used in constructing the facility or purchasing equipment for it, meaning the research conducted there is immune to variations in federal funding policy regarding human embryonic stem cell research, UCSF said in a statement.

Merck Serono Opens Centre in Massachusetts.

EMD Serono Inc., an affiliate of pharma giant Merck, has announced the opening of a new research centre in Massachusetts, U.S.

The state-of-the-art centre, which represents a $65 million investment for the German company, is located in Billerica and will act as a 'hub' within Merck's research organization.

The 140,000 square foot Billerica facility accommodates over 115,000 sq. ft. of lab and office space, consisting of: 25,000 sq. ft. of chemistry and screening labs; 25,000 sq. ft. biology and cell culture labs; 22,000 sq. ft. of general lab support space; 20,000 sq. ft. of office and conference rooms and 23,000 sq. ft. of mechanical space.

The new 140,000-square-foot facility was built on a site that EMD Serono owns, and there is another research building adjacent to it. The older building has 60,000 square feet of space. With the opening of the new facility, EMD Serono said it will have a total of 200,000 square feet of research space in Billerica. When nearly 100 new employees are hired, EMD Serono's Billerica research facility will have a head count of about 350.

According to Serono the facility will create 100 new jobs, accommodating around 200 scientists in total, as well as helping “support the company's commitment to developing and discovering innovative treatments in oncology, neurodegenerative diseases and infertility.”

Fereydoun Firouz, president and CEO of EMD Serono, said the expansion represented the company's “clear purpose of scientific and medical innovation, and solidifies our presence in Massachusetts as a leading, global organization in the life sciences industry.

He went on to say: “We are focused on retaining and attracting the best scientists to develop therapies that provide value and breakthrough solutions to people living with serious medical conditions.”

The company claim the new site's proximity to Boston will help it reinforce existing networks and provide opportunities for scientific collaborations with academic institutions, research organizations and healthcare institutions.

The new facility is a beneficiary of Massachusetts' Life Sciences Initiative, a scheme designed to encourage biotech companies to set up research, development and manufacturing plants in Massachusetts by offering a raft of tax incentives.

Last year, Merck acquired Millipore Corp., a Billerica company that provides equipment and services to the life sciences industry. Merck's EMD Serono division has 1,169 Massachusetts employees, and EMD Millipore has 1,559 Massachusetts employees, EMD Serono said.

The Billerica facility is one of four R&D 'hubs' within Merck Serono – a division of Merck, Germany - with other centers located in Germany, Switzerland and China. Bernhard Kirschbaum, executive VP of research and development for Merck Serono, said: “The research institute in Billerica will bring together EMD Serono scientists, researchers and stakeholders in our research network which allows for greater synergy, collaboration and development of innovative science.”

“In addition, the establishment of EMD Serono's research facility centre of excellence in Massachusetts provides an opportunity to tap into world-renowned academic and research institutions that are located in close proximity to our facility in order to further collaborate with a common objective to drive science forward.”

Genesis Plastics Expands Class 7 Cleanroom

Genesis Plastics Welding, one of the industry’s leading contract manufacturing companies, is investing $500,000 to expand its Class 7 cleanroom to increase production capacity of radio frequency (RF) plastics welding of medical devices, supplies and equipment.

The company is doubling the size of its current medical cleanroom, a controlled environment that meets the medical device cleanroom requirements of an ISO Class 7 Standard 14644 clean zone for particle count testing. The cleanroom features a number of heat sealing processes including impulse welding, sonic welding and RF welding of both polar materials and non-polar materials. Thermoplastics heat sealing of non-polar materials is achieved using ecoGenesis™, the company’s proprietary technology. The cleanroom also features a gown room that meets the requirements of an ISO Class 8 cleanroom.

“The expansion of our medical clean room is an important milestone in our growth initiatives,” said Tom Ryder, president and chief executive officer of Genesis Plastics Welding. “The medical industry is a key vertical market where Genesis can bring significant value. Our heat sealing services paired with an ISO Standard 14644 medical cleanroom enables us to provide high quality, FDA-compliant contract manufacturing services to medical device, supply and equipment companies around the globe.”

Genesis has a large and fast-growing customer roster of medical device, supply and equipment manufacturers. The heat sealing specialist has experience welding medical products such as surgical instrument covers, medical device inflatable components, oxygen hoods, compression therapy and DVT sleeves, cooling caps, disposable warming blankets, cooling therapy products, fluid bladders and drainage bags.

Atek Plastics Adds Portable Cleanrooms

ATEK Plastics, an ISO 13485 and 9001 certified manufacturer, adds portable clean rooms to their list of facility capabilities.

The company recently constructed multiple portable Class 100,000 cleanrooms around their existing presses at the Kerrville, Texas facility due to new medical growth. The cleanroom units will be used to make surgical components and stem cell therapy devices. More cleanroom units and additional presses are to be added in 2011.

Molding presses at their facility are also equipped with individual eDART System monitors and full servo robotics supported by product specific vision systems, box loaders, and automated work cells. With real-time production monitoring through IQMS, ATEK’s Master Molder certified technicians are able to develop repeatable processes that are based on collected data.

ATEK Plastics started manufacturing medical device components in 2001 and today medical products manufactured at their facility amount to 89 percent of their business. Molded components manufactured at the facility are predominately for cardiac surgery, stem cell therapy and pre-surgical skin preparation.

US Oncology Research Phase I

US Oncology Research has added a site in Dayton, OH, U.S. to its network of Phase I cancer research centers.

Expansion of the translational oncology initiative into Dayton continues efforts to increase access to cancer clinical trials in the community setting. Independent community-based oncologists can join the network to bring first-in-man clinical trials of cancer therapeutics to their hometowns.

“This unique research program will provide patients and physicians in our community access to advanced clinical trials that are not otherwise available locally”, said Robert Raju, US Oncology Research, a unit of McKesson Corporation, and Kettering Medical Center medical oncologist.

Raju is a founding member of the translational oncology initiative and has now brought the sponsor- and investigator-initiated clinical trials program to Kettering Medical Center, Dayton. Joining the network gives oncologists access to clinical trials and a centralized support system.

US Oncology Research established the translational program, which has enrolled more than 1,000 patients, “to address the special challenges of Phase I clinical trials, including increased safety concerns and more complex trial designs”.

Oncologists in the network benefit from: biostatistics and medical writing services; centralized regulatory processes; a dedicated institutional review board IRB); a centralized investigational pharmacy; and tissue banking and analysis.

Phase I trials are also supported by a personalized research unit, offering trial design and diagnostic biomarker analysis, and a technological division. The technological unit operates electronic data capture (EDC) and clinical trial management systems (CTMS).

US Oncology Research now supports 14 Phase I sites, and many more Phase II and III centers, that run cancer clinical trials in 11 US states. Many of the Texas-based organization’s sites are in its home state but the network has spread across the US, from Washington to Florida.

Pharmacy School at Fairleigh Dickinson University

Medco made a $5 million commitment to open a new school of pharmacy at New Jersey-based Fairleigh Dickinson University. The school, which will focus heavily on educating pharmacists about personalized medicine, is slated to open its doors in fall 2012

Indiana University to Launch Personalized Medicine Institute

Indiana University plans to use $11.3 million to start the Indiana Institute for Personalized Medicine, which will pursue genome-based and pharmacogenomics studies in cardiology, obstetrics, pediatrics, cancer, and other areas, IU said.

The institute will conduct research, train new specialists in personalized medicine, and work to translate its discoveries into more precise therapeutics. The training program will be funded and supported through the new Brater Scholarship in Personalized Medicine, which will select three scholars this summer.

A panel of IU scientists will form an advisory panel that will aid other researches moving their research beyond the lab stages. The panel will have 21 members initially. In addition, an external advisory board with five members will provide input for the new institute.

"To identify more precisely which drugs are likely to be more effective — or less effective and more toxic — will have a substantial impact on optimizing health care delivery and rationally curbing costs," Patrick Loehrer, director of the IU Simon Cancer Center, said in a statement.

David Flockhart, a professor of epidemiology and genetics at IU who will direct the institute, said that starting a focused institute "allows you to really jump start research and raise the level of participation of an institution in both the laboratory and in the clinic, in a broad range of research interests.

"Much of the future of health care is in personalized medicine, meaning more precise targeting of the right medication to the right patient at the right time," he added.

The new institute will also will receive funding and support from the IU School of Medicine and its Department of Medicine, The Indiana University-Purdue University Indianapolis, the Indiana Physician Scientist Initiative, and the Indiana University Melvin and Bren Simon Cancer Center.

GSK to Move

GSK has unveiled plans to move its operations in Philadelphia to a purpose built facility due to be constructed at a former US Navy shipyard.

The new $81m (€59m) building, work on which is scheduled to start later this month, will be a replacement for GlaxoSmithKline’s (GSK) current Philadelphia base in the city centre.

The building is intended to provide an open-plan environment to boost cross departmental interaction. It is also designed achieve LEED Platinum certification, which is an internationally recognized standard for building sustainability.

The project's "open plan" design, which is consistent with other GSK facilities, is designed to bring employees together to foster better communication and idea sharing. A variety of work spaces will be available, including shared work stations, team tables, meeting areas, social areas and quiet rooms. The facility will also offer a wide variety of amenities, such as a fitness center, restaurant, retail services, and free parking for employees and visitors. The Navy Yard Corporate Center, in which it is based, provides park space with walking paths, fields for sports leagues and even a putting green.

A GSK spokeswoman said that the facility will house the firm’s pharmaceuticals, consumer healthcare businesses and support functions and will employ around 1,300 people.

She explained that: “GSK is slowly transitioning all its facilities to an open plan. In the facilities where GSK has adopted open plan space, employee collaboration, access to decision makers, communication, and group effectiveness have improved significantly.

The UK-based drugmaker also said the 205,000 sq. ft. open plan facility could save it as much as $26m a year when fully operational in late 2012 or early 2013.

Almac Opens North American Headquarters

Almac’s new 240,000 sq. ft. North American Headquarters, built on 40 acres in Souderton, PA, north of Philadelphia is part of the Almac Group’s integrated services solutions strategy. The new facility delivers full-service, integrated clinical packaging, drug supply management and technology solutions to pharmaceutical and biotech clients.

The facility has state of the art analytical labs, complementing existing facilities in the UK.

The lab provides support for clinical packaging operations as well as stand-alone analytical services. The labs are equipped with the latest equipment, including HPLC, UPLC, GC, UV, IR, DSC, KF and others. The new group will also offer Polymorph and Salt Screening and Solid Form Development.

Clinical packaging projects often require a range of analytical support, from simple ‘ID testing’ to full method development and validation. Over-encapsulation (OE) is now a widely accepted process for ‘blinding’ during clinical trials. The investigational product, a potential comparator and/or placebo are blinded in hard gelatin capsules, providing visually identical products, thus removing potential bias during a trial.

Having ‘modified’ the products through OE, it is critical to confirm that quality and activity have not been adversely affected. Good manufacturing practice (GMP) requires that it be shown that the OE products will behave identically to the original products. This requires comparative dissolution and stability testing of the OE product. As these products now contain a hard gel capsule and sometimes filler, assay method development and validation is often required. The US group draws on the many years of method development and GMP experience that resides in the UK group.

Almac has installed the latest bathless dissolution apparatus for rapid and efficient comparative dissolution studies. Installation of the newest Waters H-Class HPLC/UPLC systems provides maximum flexibility for developing, validating and running assay, dissolution and stability methods. Large capacity Stability chambers provide all the required ICH stability conditions in the new labs.

Now that the analytical labs and stability chambers are in-house at Souderton, Almac offers a ‘one stop shop’, and provides an efficient and comprehensive service to our customers.

Almac’s location in the Northeast US pharmaceutical corridor has allowed for the recruitment of top pharmaceutical technical talent. Dr. Aeri Park, Operations Director for the new facility commented: ‘We have built a professional team of skilled scientists, each with extensive pharmaceutical industry experience. We look forward to supporting the clinical packaging operations and growing our stand-alone Analytical and Solid Form business‘.

The new analytical facility complements Almac’s specialty capabilities, including Biocatalysis, Radiolabeling, and peptide and protein synthesis. These services are all part of Almac’s comprehensive Drug Development Services, including API and drug product development and GMP manufacture.

GateWay Community College Plans Phoenix Construction

GateWay Community College, using money comes from voter-approved bonds, the federal government and private contributions, is moving forward with construction of two new buildings, GateWay officials said.

The Emerging Technologies Incubator will house small technology and bioscience startups to help them grow their companies. The other project, the Integrated Education Building, has classrooms, science labs and student services.

The campus at Washington and 40th streets has reported an increase in full-time enrollment, from 4,346 students in the 2005-06 school year to 4,962 students in the 2009-10 school year. Per semester, the college averages about 7,800 students, full and part time.

BUILDING: Emerging Technologies Incubator.

With about 17,000 square feet of space, the building includes labs, such as a "wet lab" for chemical study. Office space will be leased to technology and bioscience businesses. Businesses that align with the college's career-training programs can partner with faculty and the academic programs to train workers and to provide opportunities for student internships. College officials aim to help the businesses expand within three years.

Construction costs for this project total about $6 million, with $3 million of the cost covered by a grant from the U.S. Economic Development Administration, $2 million from the 2004 voter-approved bond offering, and $800,000 from a grant from Phoenix. The remaining funds were covered by a donation from Blue Cross Blue Shield of Arizona. Construction is projected to be finished by September.

BUILDING: Integrated Education Building.

The three-story 120,000-square-foot building will house classrooms, science labs, staff offices, indoor and outdoor art studios, and student services. The building will house a library that will be open to the public, and an amphitheater for outdoor performances.

The project costs about $51 million and is paid from 2004 voter-approved bond funds. Construction is expected to be finished by July 2012.

Brooks Instrument's New Cleanroom Facility

Brooks Instrument, a world-leading provider of advanced flow, pressure and level solutions opened the doors to its new cleanroom manufacturing facility at a ribbon-cutting ceremony at its headquarters in Hatfield, Pa. The new Class 100 cleanroom will serve primarily as the production area for Brooks' GF Series ultra high-purity mass flow controllers for the high tech and electronics industry.

"This is the largest investment Brooks Instrument has ever made in its manufacturing facilities worldwide," said Clark Hale, chief executive officer of Brooks Instrument. "It signifies us taking major strides into the electronics industry and our commitment to the future growth of Brooks."

Brooks' 2009 acquisition of Celerity's Instrumentation Division led to the need for larger cleanroom manufacturing operations of the GF Series and other devices for the electronics market. The increased demand for consumer products requiring semiconductors such as high-brightness LEDs, smartphones and tablet computers is also driving Brooks' foray into the industry.

To help support its new cleanroom operations, Brooks added close to 100 jobs at its Hatfield offices in 2010.

Nano-tech Grant Helps UNM Study Cancer

The University of New Mexico Cancer Center has received a $1.8 million grant to use nanotechnology in cancer research.

The grant from the National Cancer Institute will finance a training program for students in the health and chemical sciences at UNM, the Cancer Center said in a news release. It was one of six such grants awarded by the NCI.

“As nanotechnology has proven to be a vital part in cancer prevention, diagnosis and treatment, we are thrilled to receive the Cancer Nanotechnology Training Center grant,” said Cancer Center CEO Cheryl Willman. “The use of nanotechnology will ultimately provide physicians with a more customized and targeted approach to treating various types of cancer, yielding a much higher survival rate for New Mexicans and cancer patients throughout the country.”

Nonotechnology involves manipulating and building substances at the molecular level. In cancer research, nanoparticles can be covered with antibodies that selectively bind to cancer cells. That allows the cells to be visible in Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) scans. It also allows medicines to be delivered directly to cancer cells, which improves the drug’s effectiveness and reduces negative side effects.

The UNM Cancer Center is one of 66 national cancer centers in the U.S. It employs 85 board-certified oncology doctors and 120 research scientists.

Pfizer to Add Jobs in MA

Drug giant Pfizer Inc. said it will add about 350 jobs in the Boston area and look for a new site to house a pair of research operations it will move from southeastern Connecticut.

The news came as Pfizer, the world's largest pharmaceutical company, unveiled a broad restructuring plan that will slash its global research and development spending by $1.5 billion, shedding thousands of jobs around the world. It was the second big research cutback since New York-based Pfizer acquired Wyeth Pharmaceuticals in 2009.

But even as Pfizer will be shrinking its research profile globally, it will grow in Massachusetts, where it currently employs about 2,300 workers at two research labs in Cambridge and a former Wyeth biotechnology plant in Andover.

"We have recognized that we want to have a very significant footprint in Massachusetts," sad J.C. Gutierrez Ramos, the Cambridge-based Pfizer senior vice president of biotherapeutics research and development. "This emphasizes Pfizer's commitment to increase our interactions with the academic medical centers, our interactions with the biotechnology companies and entrepreneurs, with all of the stakeholders in biomedical research."

Pfizer's move to expand research in the Boston area follows similar recent moves by global drugmakers such as Novartis AG of Switzerland and Sanofi-Aventis SA of France, which want to tap into the area's life sciences ecosystem at a time when drug discovery has slowed worldwide.

Even as it eliminates 1,100 jobs in Groton, Conn., about a quarter of its workforce there, Pfizer said it will be consolidating its neuroscience and cardiovascular metabolic research operations in the Boston area.

Together, they are expected to bring about 450 jobs to Massachusetts, Gutierrez said. But Pfizer will also cut about 100 other jobs in the Boston area, mostly at a lab it will close on Memorial Drive in Cambridge. That lab does regenerative medicine and oligonuceotide therapeutics research, areas Pfizer will continue to be involved in collaboration with other partners.

Life Sciences Center Backs UMass Boston Cancer Center

The Massachusetts Life Sciences Center today awarded a $2 million grant to help launch a joint Center for Personalized Cancer Therapy on the University of Massachusetts Boston campus.

That center is a joint project involving UMass Boston and the Dana-Farber/Harvard Cancer Center, and it’s intended to address the racial, ethnic and socioeconomic disparities in cancer incidence, morbidity and mortality.

The institutional partners have been working together for five years on joint research, training and community outreach activities targeted to addressing cancer disparities among low-income, non-majority and other inadequately served, diverse populations. The center will work to develop reliable and cost-effective tests to determine different sub-types of all common cancers, and to commercialize antibody-based assays that will distinguish different subtypes of human cancer.

The new center will seek collaborations with pharmaceutical and biotechnology companies in order to develop and commercialize affordable clinical test kits for detailed sub-type analysis of individual patient tumors.

The Life Sciences Center grant will supplement $18 million in previously committed federal grant funding for the project. The center will begin operations in UMass Boston’s Venture Development Center.

Construction of UMass Boston’s Integrated Sciences Complex, which will be the permanent home of CPCT, is slated to begin in the spring, with an anticipated opening in fall 2013.

“We are pleased to support an initiative that will address the long-standing racial, ethnic and economic disparities that exist in cancer care as well as improve the quality of care for all cancer patients,” said Susan Windham-Bannister, president and CEO of the Massachusetts Life Sciences Center in a press release. “This is an exciting collaboration between Massachusetts’ outstanding public university system and our world-leading Dana-Farber/Harvard Cancer Center. This project will provide training for the next generation of life sciences workers, foster the growth of new companies, advance scientific knowledge about cancer prevention and treatment and create jobs.”

Edward J. Benz Jr., director of the Dana-Farber/Harvard Cancer Center said, “If there is one thing that we’ve learned about cancer during the past quarter century, it is that cancer is not one disease but instead hundreds, and each cancer is often unique to each patient. This grant will further our efforts to develop more effective treatments that are tailored to the characteristics of a person’s cancer.”

The Waisman Clinical BioManufacturing Facility

The Waisman Clinical BioManufacturing Facility (WCBF) at the University of Wisconsin-Madison is a state-of-the-art cleanroom facility that conducts GMP manufacturing of cell therapeutics, gene therapy vectors, and biologics for phase I/II human clinical trials.

The WCBF serves researchers as they enter early development of novel biological therapies and catalyzes the advancement of therapies into human clinical trials. With broad and comprehensive capabilities, the WCBF specializes in assisting researchers and companies with the entire process of developing a manufacturing process and producing and testing materials for human clinical trials.

The WCBF knows how important it is to maintain strict cleanroom cleanliness and sterility in their Class 7 (Class 10,000) and Class 8 cleanrooms. That is because, if contaminated with microorganisms, the products the WCBF manufactures can adversely harm patients. In addition, the steep price of product rejects and recalls makes it crucial to ensure high product yields.

“We are committed to ensuring that our operations are performed to the highest quality principles, in compliance with the FDA and other regulatory requirements,” says Chuck Valliere, Quality Control Specialist (Gowning Training), WCBF, noting that a failed batch of cell-based products can cost upwards of $100,000.

The bane of cleanroom operators like the WCBF is microorganisms. Microorganisms introduced into a cleanroom environment need only three things to grow: moisture, food and temperature – all of which exist in a cleanroom. Consequently, all incoming air, water, chemicals, and materials must be filtered or sterilized to meet high standards of purity and microbiological control, so as not to contaminate processes or products in production. Also to be “filtered,” in a sense, is the cleanroom operator, who, most will agree, is the dirtiest thing to enter a cleanroom.

Keeping the operator’s dirt and germs out of the sterile cleanroom environment and away from sensitive products and processes is the main objective of the sterile cleanroom suit. The suit needs to protect the environment from viable particles such as bacteria and yeasts, and non-viable particles such as hair, dead skin cells, and dandruff. To that end, it is critical for cleanroom operators to select cleanroom suits that provide not only the highest levels of inherent sterility, but also the greatest chances of maintaining that sterility through the gowning process.

Boehringer Ingelheim to Purchase Amgen's Facility

Amgen Inc. and Boehringer Ingelheim announced they have signed an agreement under which Boehringer Ingelheim will acquire Amgen's rights in and substantially all assets at Amgen's Fremont, California development and manufacturing facility.

The transaction has been approved by the board of directors of each company and is expected to close in March of this year. The Amgen Fremont facility currently employs approximately 360 employees and is a state-of-the-art, 100,000-square-foot manufacturing facility with pilot plant and process development labs.

"With great enthusiasm, we look forward to welcoming the Amgen Fremont employees into the Boehringer Ingelheim family of companies," said Prof. Dr. Wolfram Carius, Boehringer Ingelheim Board of Managing Directors. "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. We greatly value our relationship with Amgen and are enthusiastic about joining the San Francisco Bay Area biotechnology community and for the opportunity to better serve our current and future contract manufacturing customers."

Boehringer Ingelheim has been a contract manufacturer for Amgen for more than ten years.

"We are pleased to be able to build upon a successful contract manufacturing relationship with Boehringer Ingelheim," said Fabrizio Bonanni, Dr. Chem., Amgen executive vice president of Operations. "We look forward to continuing to work closely with them to support Amgen's delivery of safe and effective medicines to patients around the world."

Amgen obtained the Fremont facility through its 2006 acquisition of Abgenix. Amgen will continue to have a key presence in the San Francisco Bay Area biotechnology community through its South San Francisco facility, one of the company's key research centers.

Covance Genomics Lab Gets CLIA Certification

Covance’s genomics lab in Seattle, WA received Clinical Laboratory Improvement Amendment (CLIA) certification from the State of Washington Department of Health. The lab was licensed in May 2010 and completed the initial CLIA inspection, with no findings, in December 2010. Inspections of CLIA labs is mandated by the Code of Federal Regulations (CFR 42 Part 493.2), and was enacted to ensure consistent, accurate, and reliable clinical test result reporting from laboratories across the country.

The lab supports genomics-based drug development with services including: next generation sequencing, gene expression profiling, genome-wide genotyping, qPCR biomarker assays, microRNA profiling, targeted genotyping, tissue homogenization and nucleic acid extraction, scalable amplification protocols and computational biology & bioinformatics.

In addition to performing CLIA-regulated services, the genomics laboratory meets GLP requirements, having performed multiple GLP protocols and undergone subsequent GLP audits from pharmaceutical clients.

“Obtaining CLIA certification demonstrates to our clients that our laboratory is consistently performing at a very high standard in a regulated environment,” said John Gransee, vice president and general manager, Covance Genomics Laboratory. “This is particularly important when a researcher wants to use the data in discovery to develop a clinical assay. In addition, since every test performed in our laboratory is under the CLIA umbrella, our clients can be confident that they are receiving high quality execution of their experiments regardless of analysis platform

Ameridose Opens Sterile Facility

Ameridose, a provider of sterile admixing preparations and pre-filled syringes to hospital pharmacies, has opened its third manufacturing facility in Westborough, MA.

The new 70,000 sq. ft. facility contains state-of-the-art cleanroom equipment, including an HVAC system with energy efficient condensing boilers and ultrasonic humidification.

In addition, more than 400 fan-powered HEPA filter units rated at 99.9% efficiency and featuring motion sensor controls have been installed in the shipping, receiving and warehouse areas.

Now operational, the facility complies with Ameridose’s corporate sustainability policy which requires the recycling of all paper, glass, metal, plastic, corrugated cardboard, wood, and computer/electronic waste.

The company said more than 90 percent of the construction-related waste was recycled.

“This is the largest, state-of-the-art sterile admixing and repackaging facility in the nation,” said Sophia Pasedis, VP of regulatory affairs and compliance at Ameridose. “The new facility expands our capacity to accommodate new business and to offer current customers the security of back-up facility.”

Ameridose provides high-quality sterile, admixed and repackaged preparations and oral repackaging services. An FDA-registered manufacturer, the company exceeds USP 797 standards and meets cGMP requirements.

Cambridge Draws Vertex to Fan Pier

Vertex Pharmaceuticals would occupy about 1.1 million square feet, filling a pair of 18-story buildings at Fan Pier.

In one of the largest office deals in recent Boston history, drug maker Vertex Pharmaceuticals Inc. will move into two new buildings in the Seaport District, catapulting the city’s effort to transform the waterfront into a neighborhood of technology companies, academic institutions, and medical firms.

Vertex signed a letter of intent to relocate its headquarters from Cambridge to the Fan Pier complex in late 2013. The 23-acre development has just one tower now, but is slated to have eight buildings of offices, residences, stores, and hotel rooms, as well as parks and a marina.

The deal is a watershed in Boston’s campaign to court a biotechnology industry that has largely eluded it, with most drug companies preferring to be closer to Cambridge’s prestigious universities or out in massive suburban office parks that offer cheaper rents and room for expansion.

Vertex’s relocation is also a huge boost for Fan Pier developer Joseph Fallon, who will soon be able to resume construction after a recession that dried up funding for large-scale projects in Boston and across the country.

“This is a jump-start for the entire waterfront,’’ said Mayor Thomas M. Menino, who has been trying to remake the area into an “Innovation District’’ by offering incentives to companies to locate there. “Vertex has made the decision to be on the forefront of the Innovation District, and that decision will lead other companies to follow suit.’’

Terms of the deal have not been disclosed, and the company has not yet signed the lease. The lease is contingent on an unusual clause: Vertex must receive federal approval of its first major in-house commercial drug, telaprevir, a treatment for hepatitis C. US regulators are expected to act on the company’s application by June.

Vertex would occupy about 1.1 million square feet, filling a pair of 18-story buildings at Fan Pier, with an option to expand into a third to be built there. Vertex’s portion of the $2 billion Fan Pier complex is estimated at $800 million, according to state officials.

State and city leaders are providing Vertex with a substantial tax break and other inducements to help close the deal. Vertex’s lease will require it to pay real estate taxes on the new buildings. Boston will provide Vertex with an $11.8 million reduction in property taxes through 2018.

But even with that reduction, the new buildings will result in $58.1 million in additional tax revenues for the city over that period, Boston officials said.

The state, meanwhile, will provide $10 million in tax breaks in exchange for Vertex creating 500 additional full-time jobs by 2015. Massachusetts will also borrow $50 million for roads, water and sewer, and other necessary infrastructure, to be repaid with tax revenues generated from Vertex’s buildings. Any shortfall in revenue needed to pay off the state’s bonds would come from the City of Boston or from the developer.

Graphic Fan Pier development plan “This will help to launch one of the largest construction projects in the country at a time when a lot of people in that industry still need work,’’ said Gregory Bialecki, Governor Deval Patrick’s economic development chief. “It will also help ensure that the many people who work at Vertex will continue to work in Massachusetts for many years to come and will be joined by many hundreds of new colleagues.’’

The offer from Massachusetts comes on the heels of the debacle with Evergreen Solar Inc., which earlier this month said it is closing a factory in Devens that was built with the help of millions in state incentives, resulting in the layoffs of 800 workers.

Bialecki said Vertex’s incentives would be subject to rigorous clawback provisions: If the firm did not meet its job creation targets, it would forfeit the tax breaks.

The buildings will be the second and third major structures at Fan Pier, and would be between the existing 18-story tower at One Marina Park Drive and the John Joseph Moakley United States Courthouse. Fan Pier has been in the making for some 30 years, with several previous owners unable to get it underway. Even today the site is mostly covered by parking lots.

“When a company occupies 1 million square feet in one location, it’s an immediate game-changer,’’ Fallon, the chief executive of the Fallon Co., said. “There is no question we will see more demand for retail stores and residences in this area.’’

The relocation will allow Vertex to consolidate its 1,300 workers, now divided among 10 buildings across Cambridge, into a single location.

The decision to relocate comes at a critical juncture for the biotech, which has recently hired 300 employees in anticipation of selling telaprevir, a drug it has been developing for 15 years. If it gets a regulatory nod this spring, Vertex will be the first approved, commercially available treatment for hepatitis C, a disease that has become an epidemic among baby boomers that were infected decades ago, either by a blood transfusions or injecting drugs.

The market to treat hepatitis C is expected to be worth billions of dollars annually over the next decade. Vertex is trying to beat out New Jersey-based Merck & Co., which is seeking approval of a similar drug.

Real estate specialists said the firm’s relocation stands to have a huge impact on the future development of the South Boston Waterfront. Until now, the area has lacked a major tenant to give credibility to the city’s effort to transform it into an Innovation District.

Federal Center Hopes to Spur Drug Research

Federal officials concerned about the slowing pace of new drugs coming out of the pharmaceutical industry have decided to start a billion-dollar government drug development center to help create medicines.

The New York Times reported on the new effort that comes as many large drug makers, unable to find enough new drugs, are trimming back research. Promising discoveries in illnesses like depression and Parkinson's that once would have led to clinical trials are instead going unexplored because companies are not inclined and do not have the money to undertake the effort.

The paper reports that initial financing of the government's new drug center is relatively small compared with the $45.8 billion that the industry estimates it invested in research in 2009. The cost of bringing a single drug to market can exceed $1 billion, according to some estimates.

The drug industry's research productivity has been declining for 15 years and shows few signs of reversing that trend, said Dr. Francis S. Collins, director of the National Institutes of Health.

The new center, to be called the National Center for Advancing Translational Sciences, will do as much research as it needs to so that it can attract drug company investment.

Chester County PA Biotech Company Building Plant

Biotechnology company, Morphotek, is serious about growing in Chester County; $40 million serious.

In April 2010 Morphotek broke ground to build a 60,000-square-foot manufacturing pilot plant for its drugs in clinical trials. The project is currently at the halfway point with completion expected in October.

Morphotek President Philip Sass is committed to Chester County because "this is a great place to hire with all the pharmaceutical companies and universities."

The new pilot drug plant is a true Chester County project. It was designed by Arcus Design Group of Uwchlan and is being built by HCS Builders of West Whiteland, a construction company that did Morphotek's corporate headquarters at 210 Welsh Pool Road in 2008.

The new manufacturing space is going up across the street at what used to be 213, 215 and 217 Welsh Pool Road. The buildings that once occupied those address are now gone to make way for more Morphotek.

Morphotek will use the new space to produce experimental cancer-fighting drugs used in early stage clinical trials. As the company adds space, the payroll will grow, too.

Morphotek, which has 200 employees now, expects to add 30 to 50 more in 2012, Sass said.

Once the company gets its first drug to market, it hopes to build another manufacturing building in the area, Sass said. That could happen in the next three to five years.

Morphotek is not just building big on the outside; inside it is attempting something huge on a molecular level in cancer therapy research.

The company was founded in 2000 by Sass, Luigi Grasso and Nicholas Nicolaides.

The technology, which Nicolaides helped invent while he was still a postdoctoral fellow at Johns Hopkins Medical School, is called morphogenics. It involves manipulating the process of DNA repair that occurs during cell division to accelerate the rate of genetic evolution.

Morphotek's other founders, Grasso and Sass, have helped to refine the company's technology and apply it to the development of biopharmaceuticals.

Morphotek has focused its efforts on applying morphogenics to cells producing antibodies that are able to bind to single molecules found in disease cells and not in normal cells.

That means, instead of targeting all of a cancer patient's cells — as is the case in chemotherapy — morphogenics aids in the development of molecules that will target only diseased areas.

Morphotek's developing treatment of ovarian cancer is at the most advanced stage of all the drugs in the pipeline, Sass said. If all goes well in the pivotal trial, the company could be prepared to submit a request to the FDA for approval in the first quarter of 2013.

Morphotek is a U.S. subsidiary of Eisai Co., a global research-based human health care company.

Like Morphotek, builder HCS is growing with the region's biotechnology industry.

"This is our fourth project for Morphotek," said Jay Heim, who founded HSC in 1988 with three employees. Today, HSC has 80.

HSC has handled the construction of such projects as Cephalon Inc.'s East Whiteland headquarters and the construction of four new buildings in Delaware Technology Park in Newark.

HSC also builds for health care, pharmaceutical and high education clients, including completing the new patient pavilion at Paoli Hospital.

Heim said scrap from the demolished buildings on Welsh Pool Road was recycled to make way for the new plant that will be built to LEED standards.

Developed by the U.S. Green Building Council, LEED — Leadership in Energy and Environmental Design — is intended to provide building owners and operators a framework for implementing green building design, construction, operations and maintenance

"It is a very technical building; HVAC, temperature control, FDA certified, clean room," Heim said, naming a few of the specifications needed in a drug manufacturing plant. "The story for us is that Morphotek is a great long-term client."

REST OF WORLD

La Trobe Institute of Molecular Science Contract Awarded to Watpac

Watpac’s Construction division has been awarded the $66 million construction contract for the prestigious La Trobe Institute of Molecular Science (LIMS) project in Victoria.

Watpac has earned a reputation for successfully delivering a range of highly complex and technically challenging science-based facilities in recent years, with many of the facilities focused on life-saving medical research

The LIMS project, which has an overall value of $93 million, will be an iconic new building creating a world-class facility for molecular science, biotechnology and nanotechnology research, teaching and learning.

Located at the La Trobe University Melbourne campus, the building will form the nucleus of the Faculty of Science and will provide research environments that will both attract and support mid-career scientists.

The project comprises approximately 11,000 sq. meters (118,360 sq. ft.) of new teaching and research laboratories over six levels, plus associated connection works to adjacent buildings, external landscaping and civil works and campus service connection works.

The three levels of teaching laboratories will include associated support spaces, and a ground level lecture theatre and ‘equipment barn’. The upper three levels will comprise research laboratories and associated academic and general staff office spaces.

LIMS has been designed by leading university architects Lyons, and is designed to have a high level of transparency allowing users and visitors to view the teaching and research spaces.

Construction will begin in February 2011, with the project anticipated to be delivered in late 2012.

The project adds to the Company’s impressive portfolio of science and medical research projects, which includes the $360 million Knowledge Based Research and Business Project—Ecosciences and Health and Food Sciences Precincts in Brisbane, the $134 million Queensland Institute of Medical Research Smart State Medical Research Centre, the $80 million Cochlear Global Headquarters facility at Macquarie University in Sydney, and the $56 million Queensland Brain Institute.

AstraZeneca Russian Plant

AstraZeneca has become the latest drug firm to invest in Russian manufacturing capacity with the announcement of plans for a $150m facility in the country’s Kaluga region.

The facility, located at the Vorsino industrial park, will undertake everything from formulation to packaging and, according to the Anglo-Swedish drugmaker, will produce 16 million packs a year for the local drug market.

AstraZeneca joins Big Pharma peer GlaxoSmithKline (GSK) and generic drugmaker Teva Pharmaceutical industries as the third major manufacturer to unveil a Russian investment in as many months.

The wave of investment follows hot on the heels of the Russian government’s call for drugmakers to expand production capacity in the country or risk facing what Prime Minister Vladimir Putin described as “restrictions.”

“Our investment decisions are supportive of Russian policy to modernize and develop the Russian pharmaceutical industry to make it innovative. Our main goal is to make high-quality medicines that will make a meaningful difference in the health and quality of life of Russian patients.”

The Kaluga plant’s focus on the Russian market was also stressed by regional governor Anatoliy Artamonov, who predicted “the new manufacturing facility will develop steadily to produce variety of affordable innovative GMP medicines for Russian patients.

Artamonov added that: “For our part, Kaluga government will strive to provide AstraZeneca with conditions for efficient operating in our region”.

The facility, work on which is scheduled to begin next month, will produce drugs for cancer, cardiovascular disease, neurological disorders, respiratory conditions and infections and will employ a staff of 145 people when fully operations in Spring 2013.

Canterbury Scientific's New Research and Development Facilities

Growing international demand for biotech company Canterbury Scientific's products has prompted it to invest $1.2 million in new research and development facilities in Addington.

The company manufactures controls for monitoring and managing diabetes, and diagnostic instrument calibration.

The company's new site – three times larger than its old premises – is designed with room to increase production even further, as demand for its products is expected to increase.

Founded in 1985, it now has 12 full-time employees and additional contractors.

It has grown its customer base from one large customer to four or five large customers, as well as several smaller ones. They include some of the world's top medical and diagnostics companies and sales of its HbA1c controls have escalated.

Canterbury Scientific estimates it has now captured almost 40 per cent of the US diabetic control market and at least 10 per cent of the European market. Its $3 million revenue comes purely from export sales. New contracts are being signed and sales are predicted to grow to $5 million by 2013.

Company founder Robin Carrell said the new facilities were the starting point from which Canterbury Scientific would start to develop new bio-medical products.

The company believes demand for its HbA1c controls will continue to grow as more than 200,000 people have been diagnosed with diabetes in New Zealand, and the World Health Organization predicts diabetes will rise by epidemic proportions within 20 years.

Tetra Pak Invests in Indian Factory

Tetra Pak has invested €100m in the construction of a new factory in India that is to serve the local market as well as South and Southeast Asia and the Middle East.

Kandarp Singh, the Managing Director of Tetra Pak India

Economic development and urbanization in India are driving big increases in demand for packaged food and milk is no exception.

India is both the biggest producer and consumer of milk worldwide and although around two-thirds of milk consumed is unpackaged, the packaged proportion is expanding fast.

By building a new packaging material facility in Chakan, India near Pune, Tetra Pak intends to take full advantage of this trend.

According to its June 2009 Dairy Index report, consumption of milk sold in cartons has grown at a rate of 24.6 per cent in recent years. Tetra Pak is therefore keen to increase its annual production capacity in India and allow for anticipated future growth.

The market for carton packaged dairy and fruit-based drinks is expected to grow from 757 million liters in 2010 to 1.3 billion liters by 2013 in India, Bangladesh and Sri Lanka.

Tetra Pak already has a manufacturing site in Pune but it has been in operation for nearly 14 years and is reaching its full capacity of 5 billion packages.

The new Pune plant will have an initial annual production capacity of 8.5 billion packages, with the potential of increasing to 16 billion packages.

As well as serving the local Indian milk market, Tetra Pak said the factory will serve the fruit-based drinks market and manufacture for foreign markets in South and Southeast Asia and the Middle East.

Among the carton packaging materials to be produced at the site are the Tetra Brik Aseptic, Tetra Fino Aseptic, and Tetra Classic Aseptic.

In addition to producing these materials, the new Indian plant will have a Machine Rebuilding Centre offering technical services such as start-up support and machine renovation to customers.

There will also be a Product Development and Innovation Center (PDIC), which will have a laboratory, a pilot processing plant and a pilot packaging plant. It is being built to help customers with their product formulations and development.

Shamla Announces Deal to Build Saudi Facility

Shamla Pharmaceutical Industries has announced it will build a manufacturing facility in King Abdullah Economic City (KAEC), Saudi Arabia.

The company - a partnership between Saudi-based Zimmo Trading, Egypt-based Global Napi Pharmaceuticals and Syria-based Unipharma Pharmaceutical Industries – made the announcement after agreeing a deal with developers, Emaar, The Economic City (EEC), to build a pharmaceutical factory in KAEC's Industrial Valley.

Saudi Arabia has been keen to encourage pharmaceutical companies to build in KAEC due to the belief that high-quality jobs and training, along with the manufacture of beneficial products will “contribute to the well being of Saudi citizens.”

According to EEC, the KAEC aims to be a “social and economic enabler” for Saudi Arabia, encouraging local and international manufacturers to open large facilities and providing them with a whole host of “business-friendly” regulatory benefits as sweeteners.

But Hussam Mitwally, Shamla's board secretary, pointed out that the benefits and advantageous infrastructure offered by KAEC are only part of the reason behind Shamla's decision to build.

“Local pharmaceuticals represent only 21 per cent of the Saudi market share,” he said, “This alongside a competitive market climate have been key drivers to direct investment in this prominent sector.”

Microbix Plans Facilities

Microbix Biosystems Inc. specializes in the development of the most advanced vaccine production technology and markets virology and biological products worldwide. Microbix, in partner with the Hunan government in China, is building Asia's largest and most advanced vaccine facility. In addition, the company has intellectual property in large market biotherapeutic drugs, vaccine technologies and animal reproduction technologies. Microbix supplies customers in the U.S., Europe, and Asia. Established in 1988, Microbix is headquartered in Toronto.

Microbix CEO, William J. Gastle, said: "The effects of a reduced burn rate on our three pipeline technologies is beginning to show in our results, as our focus shifts from pure product development activities, to the creation of operating partnerships designed to produce revenue streams for LumiSortTM, the Hunan joint venture in China, and Urokinase."

In December Microbix announced it had formed Crucible International Biotechnologies Corp., which is being capitalized through an initial private offering of at least $2,800,000. Following this financing Microbix will own approximately 80% of Crucible, which will own all of the influenza vaccine assets of Microbix, including its VIRUSMAXTM technology and the company's 50% ownership interest in the Hunan joint venture. Microbix also announced a new partnership agreement on Lumisort, its proprietary semen sexing technology, in late fiscal 2010.

QPS in Taiwan

QPS Holdings has acquired Taiwan’s Center of Toxicology and Preclinical Sciences (CTPS), continuing its expansion in the region’s rapidly expanding drug development sector.

The deal, terms of which were not disclosed, will see CTPS’ 60,000 sq. ft. laboratory, quality assurance and animal housing complex in Taipei City operate as a unit of the US contract research firm’s QPS-Taiwan subsidiary.

QPS CEO Vincent Yen set the acquisition in a wider market context, explaining that: "The biotech industry in the Asia Pacific region is expanding rapidly.”

"With the addition of a well known toxicology unit to our established bioanalytical and pharmacokinetic expertise, QPS can now provide a one-stop solution to the increasing local and international demand for high quality preclinical services.”

The CTPS was set up by Taiwan’s Development Center for Biotechnology (DCB) in the late 90’s to provide preclinical testing services for government, academic and industrial groups working in the country’s drug sector.

The facility has conducted over 890 studies for local and international developers, including 17 projects for US submissions, 18 for Taiwan IND submissions or clinical trials and 2 products seeking Taiwan NDA approval.

QPS established a partnership with the DCB in July 2009 focused on preclinical testing services as part of the Taiwan Government’s bid to double the value of the country’s NT$150bn (€3.3bn) a year biotechnology sector.

The acquisition is the latest in a series of expansions QPS has made in Asia in the last few years that began with the opening of its Taipei bioanalysis laboratory facility in 2004.

But, while Taiwan has certainly been a focus, QPS has also been building in other countries in the region, as evidenced by its acquisition of a majority stake in Indian CRO Bioserve Clinical Research last month.

Bayer Healthcare Cell Biology Centre

Bayer Healthcare broke ground for a new biopharmaceutical manufacturing facility in Wuppertal, Germany on 13 December 2010. Located at Bayer's Wuppertal Pharmaceutical and Chemical Park, the new facility will be dedicated towards biotechnological production of pharmaceuticals for use in clinical trials. It is scheduled to be operational by late 2012.

The project requires an estimated investment of €35m and will operate with 20 highly skilled employees.

The Wuppertal site provides the ideal framework conditions for the new facility. Established over 130 years ago, the site is the company's oldest location.

The multipurpose facility will occupy 1,000m² (10,760 sq. ft.) across five stories. Two stories will be dedicated for production. The remaining three stories will be used for technology suites, administrative offices and social rooms. The building will measure 20m in height.

There will be approximately 1,370m² (14,741 sq. ft.) of cleanrooms. Bayer has faced multiple cleaning validation problems at its biologics manufacturing division in the Clayton, North Carolina facility. With this experience, Bayer is installing exclusive airlock systems to provide access to the clean rooms at the new Wuppertal facility. The air lock systems will prohibit airborne germs and particles from exceeding specific limits.

Equipment required for all phases of the biotechnological procedure will be installed.

The facility will be used for the development of small molecular weight compounds as well as biologically active ingredients. The focus will be on producing antibodies, coagulation factors and other therapeutic proteins. It will enable the company to rapidly develop new drugs for the treatment of serious illnesses including cancer.

The facility will also develop large quantities of material for the later stages of clinical development for a number of potential active ingredients.

The facility will use mammalian cell culture technology based on serum-free cultivation. Recombinant proteins derived from microbial cells will be produced as batch or fed-batch cultures including high cell density cultures.

To produce the desired active agent, the requisite human genes will be first inserted into the appropriate host cells. The genetically modified cells will be stored in cell banks. The cells will be transferred from the deep frozen cell banks and cultivated in suspension culture in order to produce the biopharmaceuticals. As the cell culture grows, it will be transferred to fermenters.

During fermentation, the cultured cells will secrete the product into the surrounding medium. During this phase, fresh medium will continuously replace the removed culture fluid containing the released protein. In order to maintain high cell density, the cells will be separated from the harvest fluid in an external cell retention device and recycled back to the fermenters.

Following fermentation, the cells will be separated from the culture medium through centrifugation or filtration. A series of purification steps will allow the molecules of the active agents to be isolated from the culture medium.

Each batch will be tested for purity and other vital properties to ensure constant quality.

The Wuppertal site operates two independent fully equipped state-of-the art microbial and mammalian biotech facilities. The site offers a range of services from R&D development to the production of chemical and biological API.

"Bayer is installing exclusive airlock systems to provide access to the clean rooms."The cGMP mammalian cell culture facility is integrated into a lab building and can perform batch and fed-batch fermentation with up to 200l of fermenters.

The microbiology facility operates with a flexible range of fermenters starting from 10l to 3,000l and can undertake both batch and fed batch fermentation.

The site has 16 chemical laboratories including 14 for process R&D and automation and two for scale up.

Two GMP laboratories are equipped to handle active compounds and perform GMP batch chromatography. There are seven analytical laboratories.

SCM Gets Ketesin Contract

Contract manufacturing organization (CMO) SCM Pharma has won a production and analysis contract with fellow UK-based firm ProStrakan.

The five-year deal will see SCM fill test vials of Ketensin, which is a drug that is used to treat hypertensive crisis during and after surgical procedures that ProStrakan sells to hospitals in the Netherlands.

Based in Galashiels in Scotland, ProStrakan develops and commercializes medicines for the treatment of unmet therapeutic needs, which fits well with SCM Pharma’s expertise of delivering novel, difficult and dangerous finished drug products. ProStrakan recently received FDA approval in the US for both its breakthrough cancer pain product Abstral and testosterone gel FORTESTA.

SCM’s focus on niche and low-volume production runs makes it an ideal fit for the contract according to ProStrakan’s senior VP of manufacturing and pharmaceutical sciences David Traynor.

“With regular demand for Ketensin in the Netherlands, we required a manufacturing partner that could not only sterile fill into various sizes of vials and test the finished products, but that could reliably deal with smaller commercial quantities.

This was echoed by SCM managing director Dianne Sharp, who said: “This type of product not only complements our core capability of filling and sterilizing small batches of glass vials but also makes optimum use of the in-house microbiology, chemistry and sterility testing services that our facility offers clients.”

Production will take place at the CMO's facility in Northumberland, with the manufacture of process qualification batches scheduled to begin in the near future.

Dalton Signs API Production Deal with Oncovir

Canadian CMO Dalton Pharma Services will provide active pharmaceutical ingredient (API) production and aseptic fill/finish services for nucleic acid-based drug developer Oncovir under a contract announced recently.

While details were not provided, Dalton’s work is part of a collaboration with the Cancer Vaccine Acceleration Fund (CVAF) that is focused on Oncovir’s Hiltonol (Poly-ICLC) “immune activator” vaccine platform.

The CMO’s CEO, Peter Pekos, explained that: “Our expert capabilities in the enzymatic manufacture and analysis of complex biopolymers combined with our strength in aseptic filling solidified the manufacturing agreement.”

Helix to Build in Costa Rico

Contract medical device manufacturer Helix Medical will build a new facility in Costa Rica under a new plan designed to bring it closer to its customer base.

The firm, which signed a leasing agreement for a site at the Coyol free trade zone and Business Park in Alajuela just outside of San Jose, will invest more than $4m to build the new plant.

The facility, which is expected to employ around 100 people when operational next year, will provide a variety of device manufacturing services ranging from silicone extrusion and molding to thermoplastic molding and assembly

General manager Andy Becker explained that: "We chose Costa Rica to be close to our customers in Latin America," adding that "the country offers a large medical device community with a skilled workforce as well as a good reputation for security and infrastructure."

Carbogen Adds Stability Chambers

Contract active pharmaceutical ingredient (API) maker Carbogen Amicus has expanded stability testing capacity at its facility in Hunzenschwil, Switzerland citing growing customer demand.

The expansion, which consists of validated stability chambers that comply with current International Conference on Harmonisation (ICH) guidelines, brings capacity at the facility to around 92sq.meters (990 sq. ft.).

Carbogen sales manager Brian O’Neill said: "We are facing an increasing customer demand for stability studies, as a stand-alone service or tied to our API development and production efforts.

Containment at A5’s Lab OKed

A5 Laboratories has moved a step closer to being able to offer pathogen analysis and development services following its receipt of a letter from Canada’s office Biohazard and Containment Safety.

The document deemed that a checklist A5 submitted in a bid to gain animal pathogen containment level 2 accreditation for its laboratory facility in Lachine has been deemed acceptable for in vitro studies.

Richard Azazi, the contract research organizations (CRO) CEO, said: “This is important news for us toward our capacity of performing tests and analysis in-house.”

A5 said it is now waiting for another approval from the authorities before being able to begin working with pathogen agents on analysis and development projects

PRA Opens Offices in Israel and Ukraine

Global clinical research organization (CRO), PRA International, has opened two new offices in Israel and the Ukraine.

The North Carolina, U.S.-based company said the offices, in Tel Aviv and Kiev, demonstrate its commitment to meet an “increased demand for services in the Middle East and Europe.”

Susan Stansfield, executive VP of product registration for Europe, Asia Pacific and Africa, said the expansion reflects the “rapid and significant [market] growth in these countries over the past three years,” as well as the desire to provide customers with a tangible point of contact.

“Continued delivery of high quality services to our customers and employees is best provided through having our staff benefit from physical offices versus home-working,” she said.

“These offices offer a physical location for our teams to work from and provide face-to-face contact and interaction, plus logistics support.”

PRA now has 17 full-time employees in Israel after initially establishing its presence in the region in 2007. The Ukraine office, located in the business district of Podil, employs another 15 staff, including 10 clinical research associates.

With a population of 50m, Ukraine has emerged as an attractive location for global studies. Stansfield believes that both Israel and Ukraine provide PRA with “all of the key ingredients” with which to conduct meaningful research.

“For global clinical trials to be completed within reasonable timelines to preserve patent life, access to high quality data from suitable patient populations is critical,” she said.

“Each of these countries provides regulatory framework, healthcare system, enthusiastic and well educated and trained investigator staff, and enthusiastic and well trained monitoring and support staff.

“In addition, both provide a safe environment for both local and visiting personnel,” she added.

The new facilities serve to further strengthen PRA global presence, which currently extends to more than 80 countries

Commenting on the openings, Ludger Langer, PRA's vice president of clinical operations in Europe, Asia-Pacific and Africa, said: “We are pleased to be able to provide an increased level of staffing through new offices in these two countries. These facilities bolster our offerings by providing centralized support for local teams to serve our clients in these regions.”

NextPharma Technologies Expands Capabilities

NextPharma, the leading European provider of product development, contract manufacturing and cold chain and logistics outsourcing services to the pharmaceutical and biotechnology industries, is pleased to announce that it is adding a prefilled syringe capability at its Sterile Product Development Center (SPDC) in Braine-l'Alleud, near Brussels in Belgium.

The Sterile Product Development Center will be equipped with semi-automatic syringe fillers with automatic stoppering units under vacuum in both the cytotoxic and non-cyto toxic units of the SPDC. This addition to our already substantial capabilities has been driven by customer demand for formulation development and manufacturing of pre-filled syringes containing both cytotoxic and non cytotoxic products. The new syringe fillers are being configured to fill product aseptically for quantities typically used in Phase I and Phase II clinical trials and the first syringe filler is planned to be in operation in the first quarter of 2011.

Sean Marett, managing director, NextPharma Technologies, product development services, commented: "Sterile syringe filling is a great addition to our sterile vial filling, sterile bottle filling and lyophilization services and we have already been approached by a number of customers for this service. It not only complements our manufacturing, but also our clinical trials packaging and storage capabilities where we can label and then hold finished product in a temperature-controlled environment until our customers request us to ship it directly to clinical trial centers."

NextPharma PDS operates globally with seven centers of excellence in Europe and North America. PDS services include pre-formulation studies, formulation development, including new chemical entities (NCEs), peptides and new biological entities (NBEs), design, development and optimization of lyophilization cycles, manufacturing of investigational medicinal products, analytical and microbiological testing, clinical trial labeling and kitting and stability testing according to ICH guidelines, scale-up services and regulatory support, including product dossier development and registration.

The Sterile Product Development Center supports customers' pharmaceutical development projects from pre-formulation and formulation development through to investigational medicinal product manufacturing with lyophilization for Phase I to Phase II clinical trials with scale-up capability to Phase III and commercial scale in our commercial manufacturing facility on the same site, in accordance with the highest regulatory requirements.

The SPDC has segregated investigational medicinal product manufacturing suites allowing manufacturing of cytotoxics and separately high potency (to OEL4) or conventional products in water or solvent based solutions, emulsions and lyophilized formulations. The Sterile Product Development Center has the capability to provide products filled into glass and plastic vials and pre-filled syringes. All clinical materials are manufactured and supplied in accordance with cGMP requirements of FDA, EMEA and other regulatory agencies.

The facility's analytical laboratories provide a full range of biological and small molecules drug testing, analytical development, lyophilization cycle development and validation services. Stability programs are conducted according to International Conference on Harmonization (ICH) guidelines.

The site can manufacture investigational medicinal products for early phase clinical programs of a few hundred vials rising to 110,000 vials of product for a Phase III clinical program.

NextPharma develops, manufactures, packages, and distributes a broad range of products and formulations for its customers, including solids, liquids and semi-solid dosage forms, antibiotics, hormones and controlled release medicines. It has an established leadership position in the high technology area of injectables manufacturing (lyophilized and liquid fill), with particular expertise in product development and manufacture of oncology medicines.

ScinoPharm Expansions

Global API service provider, ScinoPharm, is to begin the commercial manufacture of vilazodone hydrochloride, the active pharmaceutical ingredient (API) in Clinical Data Inc.'s new antidepressant, Viibryd.

Dr Jo Shen, President and CEO of ScinoPharm expressed the Taiwanese company's pride at its “fruitful partnership” with Clinical Data.

“Beginning from process research through timely development and optimization of long and complicated synthetic processes, we have established a win-win partnership,” he said.

ScinoPharm are also set to expand their contract research and manufacturing (CRAM) services through a new facility in Changshu, China.

The company expects the plant to become operational in the third quarter of 2011 in the hope it will increase R&D and production capabilities, thus boosting their business prospects in the burgeoning Asian pharmaceuticals market.

Carbogen Adds Stability Chambers

Contract active pharmaceutical ingredient (API) maker Carbogen Amicus has expanded stability testing capacity at its facility in Hunzenschwil, Switzerland citing growing customer demand.

Carbogen sales manager Brian O’Neill said: "We are facing an increasing customer demand for stability studies, as a stand-alone service or tied to our API development and production efforts.

Royal Jubilee Hospital (RJH) Expands

The legacy of commitment to exceptional care extends back more than 120 years at the Vancouver Island Health Authority's Royal Jubilee Hospital (RJH), located in Victoria, British

Columbia. This century-and-half legacy guides the thinking and serves as a foundation for the hospital's new, state-of-the-art Patient Care Centre (PCC), which was scheduled for completion

in December, 2010. The first patients are expected to occupy the 500-room, eight-story centre in February 2011.

When it's open and operating, the PCC will be: The first “Pacific Green” hospital in Canada, which means that energy efficiency and environmental sustainability will be incorporated in the building; The first “Elder Friendly” acute care hospital in North America – designed to create a safer and more therapeutic environment by responding to the natural changes that occur when people age; and An “Irresistible Workplace” for health care providers, such as nurses and physicians, who will be drawn to the facility to enjoy a high level of job satisfaction and safe work environment, which should contribute to excellent patient outcomes.

The 400,000-square-foot PCC is a “Pebble Project,” which means that it has been designed to make a difference in improving patient and staff outcomes, as well as operating efficiency.

The Pebble Project is a research initiative of The Center for Health Design and selected healthcare providers across Canada and the United States. The Center, based in California, promotes research in the areas of clinical improvement, patient and family satisfaction, organizational change and financial performance.

By adhering to the latest health care and energy efficiency standards, the PCC is expected to achieve a LEED (Leadership in Energy and Environmental Design) Gold standard. It will have larger, mostly single-patient rooms that provide better privacy for patients and families.

With up-to-date space and equipment, the hospital's improved working conditions for health professionals will enhance the staff's ability to control infections and provide better care to patients. “Protecting our patients and staff from hospital-acquired infections is critical to delivering safe, high quality care,” said Dr. Lynn Stevenson, Vice President, People, Organizational Development, Practice and Chief Nurse at RJH. “The seamless surfaced hand washing sinks in the new Patient Care Centre will make a significant contribution to our commitment to safety.”

Lonza cGMP Manufacturing Facility, Slough, United Kingdom

Lonza operates a cGMP manufacturing facility in Slough, UK. Located close to Heathrow Airport in London in the Thames Valley technology corridor, the facility develops therapeutic grade monoclonal antibodies and recombinant proteins.

The facility was granted the original establishment license for the production of monoclonal antibodies in 1985. It became the first licensed multi-product contract manufacturing facility when it received FDA-approval in 2002.

Since then the facility has established itself as a successful protein manufacturer and successfully passed inspections by all the major regulatory bodies including MHRA, PMDA and FDA, the most recent of which was in 2009.

The site originally belonged to Celltech Biologics and was acquired by Lonza in 1996. It currently operates with approximately 650 employees.

"The site originally belonged to Celltech Biologics and was acquired by Lonza in 1996."

The Slough site spans 76,000ft² and includes extensive research and development laboratories next to a cGMP manufacturing facility.

The cGMP facility occupies 65,000ft² and contains all the required laboratories, utilities infrastructure and process equipment for the production of antibodies and recombinant proteins using mammalian cell culture.

Within the upstream production facility there are four inoculum suites and three fermenter halls. The fermentation halls are equipped with seven production bioreactor systems that utilize a variety of stainless steel and disposable inoculum and production bioreactor technologies.

The reactors used include stainless steel stirred tank reactors, stainless steel air-lift reactors and single use stirred tank bioreactors. There is a flexible range of production reactors with capacities including 200l, 500l, 800l, 1,000l and 2,000l. During the inoculum reactor stages, single use Wave bioreactors that range in volume from 20l to 200l are primarily used.

A variety of primary recovery equipment is available within the fermentation facility to clarify the production reactor contents during harvest. Single use disposable filtration (for example, Millipore POD filtration) and traditional cassette filtration are used for the smaller volumes (≤1,000l) while centrifugation, depth filtration, concentration and 0.2μm filtration are typically used for the larger volumes (≥1,000l).

Following harvest, purification is performed within one of the three well equipped clean rooms. Each of these clean rooms is installed with highly flexible purification equipment that allows execution of virus reduction steps, concentration/buffer exchange steps and a range of chromatography steps. The formulation and bulk fill steps are performed in an additional clean room facility that is specifically designed for material filtered using virus removal filters.

The facility is also equipped with several disposable elements that are utilized during the purification processes for buffer preparation, mixing of process intermediates and storage of process intermediates and final product.

The quality control laboratories operate under cGMP standards and oversee a comprehensive regime of in-process and final product testing. They also undertake environmental monitoring and raw material testing programs.

There is a 12,000ft² administrative space with separate departments for quality assurance, regulation, engineering, sales and marketing.

The facility develops biopharmaceutical products and undertakes a range of activities including cell line construction, process development, process transfer, pre-clinical supply, clinical supply, process validation, regulatory support and commercial production.

Processes at the facility are performed based on mammalian cell culture. It involves suspension culture of mammalian cell cultures at a small to medium scale.

Therapeutic recombinant proteins and monoclonal antibodies are produced using the company's proprietary Glutamine Synthetase (GS) Gene Expression System to create a cell line, a recombinant gene with the necessary transcriptional regulatory element is transferred to Chinese hamster ovary cells, which act as the host cells.

To confer a selective advantage to the recipient cells, a second gene is transferred. A few days following the gene transfer methionine sulphoximine, a selective agent, is applied, in presence of which the GS gene survives at a selection pressure of 50IM MSX.

The selection occurs in the absence of glutamine, preventing the growth of non-transformed cells. After selection, the GS genes are transferred as single cells to a second cultivation vessel where the cultures are fermented to produce clonal populations in glutamine free medium. For recombinant protein expression, the individual clones are eventually evaluated and the highest producers are retained for further cultivation and analysis.

One cell line with the appropriate growth and productivity characteristics is chosen from among the candidates for recombinant protein production. The cell line then advances to purification, pilot and then finally the production phase. The cultivation process is established depending on the production requirements.

Uganda’s QCI to Invest in Drug Capacity

Ugandan drugmaker Quality Chemicals Industries (QCI) will invest $80m in manufacturing operations to boost capacity for the production of generic AIDS and malaria drugs.

The investment, which will take place over the next two years according to a report, will begin with a $30m expansion of its facility in the capital Kampala with funding provided by shareholders and the sale of new stock.

The second phase of the project, which will also be funded by shareholders, will see the addition of a brand new line for the production of pharmaceutical ingredients according to QCI marketing manager George Baguma.

One of QCI’s biggest shareholders is Indian drugmaker Cipla, for which the Ugandan firm produces the combination antiretroviral drug Duovir-N.

Rosendin Electric Begins Work on UCSF Medical Center

Rosendin Electric has started construction on the new University of California, San Francisco Medical Center at Mission Bay. The $80 million contract to wire the new 878,000-square-foot hospital complex includes an energy center, helipad, and support services.

The first phase of the $1.6 billion project, scheduled for delivery in 2014, is construction of a 289-bed hospital specializing in care for women, children and cancer patients. The new UCSF Medical Center has been designed to meet LEED Gold certification standards.

The medical center will incorporate the latest "smart" hospital technology, including wireless distributed antenna systems to provide electronic medical record access via touch-screen patient information systems located at each bed. San Jose-based Rosendin Electric’s contract includes installation of the hospital’s IT infrastructure and antenna system to support the medical records system, as well as a new patient profile system that lists food, lighting, television channel and other patient preferences.

Rosendin Electric was one of the initial developers to work on preconstruction of the project as a member of the Integrated Center for Design & Construction, which included more than 100 architects, engineers, construction managers, and subcontractors. The team was able to reduce the cost of the overall project by $100 million prior to the start of construction. DPR Construction of Northern California is the project's general.

Pfizer R&D Site Closure

Pfizer's decision to close its R&D facilities in Kent, UK, is "not about science", UK Science Minister David Willetts has said.

The decision, which puts 2,400 jobs at jeopardy, has been met with criticism from Business Secretary Vince Cable and trade union Unite, who said that the roles were "exactly the sort of jobs we need to keep in this country".

Speaking to the BBC, Willetts said that the decision was not made because of concern over the strength of British science, and that the company will be communicating with the government over alternative uses for the research centre.

Pfizer confirmed that the majority of staff will be made redundant over the next two years, but hoped to transfer several hundred to other sites.

START to Open Unit in China

START is opening an oncology-focused Phase I unit in China to meet demand for early-stage cancer trials in the growth market.

Establishing the 5,000 sq. ft. oncology unit in Shanghai, China expands South Texas Accelerated Research Therapeutics’ (START) Phase I network into Asia. The site allows multinational sponsors to tap into China, supports local research and improves access to experimental drugs.

START is opening the unit, a joint venture with China-based Cenova Ventures, on the fourth floor of the Fudan University Shanghai Cancer Center (FUSCC). An estimated 600,000 patients visit FUSCC each year, giving sponsors access to a significant number of potential trial participants.

“We expect to enroll our first patient in July”, said Gina Mangold, chief operating officer at START. Before then START will train staff, renovate clinical space, purchase equipment and secure sponsors. START hopes to have a 50/50 split between local and multinational pharma sponsors.

When operational the site will house 10 transfusion chairs for use in conducting Phase I trials. Initially 11 people will work at the unit but START plans to hire a further 18 employees within two years of opening.

The Shanghai site follows the launch of START Phase I units in San Antonio, Texas and Madrid, Spain. START plans to open more Phase I units, said Anthony Tolcher, clinical director at company, but a specific timeline or target geographies are yet to be decided.

Phase I in China

The site will boost Phase I oncology capabilities, an underdeveloped area at FUSCC and throughout China, to further its drug development aspirations in an important, expanding therapeutic area.

“It is important for us to upgrade our capabilities in conducting early phase and first-time-in-human (FTIH) clinical studies”, said Jin Li, director of the oncology unit at FUSCC. Most previous trials at FUSCC have been Phase II and III.

FUSCC has limited Phase I experience but has a heritage in clinical trials and is keen to expand capabilities. It was among the first sites to receive a Chinese State Food and Drug Administration (SFDA) experimental drug test license and is now moving to the forefront of Phase I oncology.

“For us, we can learn the American experience in drug development, improve our system in drug tests and increase our center’s impact in the world. We are excited about this collaboration”, said Guoliang Jiang, president of FUSCC.

Tristel Expands

Infection control group Tristel plc said completion of its Newmarket clean room allowed the manufacture of sterile packed disinfectants as part of its new Crystel branded range.

The company announced plans in June to expand its Newmarket production facility to double capacity and establish cleanroom manufacturing.

The products enabled the company to expand into the pharmaceutical, cosmetics and toiletries market, having recruited a sales team focused on this market in 2010. The first sale of Crystel products had been achieved.

NextPharma Adding at Belgian Plant

UK-Based CMO NextPharma is adding prefilled syringe capabilities at its facility in Braine-L’Alleud in Belgium to meet growing drug industry demand.

The expansion, which will provide aseptic filling capacity for the production of both cytotoxic and non-cytotoxic drugs for Phase I and II clinical trials, is expected to be fully completed and operational in the next few months.

Earlier this month the European arm of US investment group Sun Capital Partners announced plans to buy the contract manufacturing organization (CMO), citing its significant growth potential as a key driver for the move.

NextPharma CEO Bill Wedlake said that the firm’s new owners would support both existing capacity expansion plans and help it grow through acquisitions.

Pharmsynthez Buys Kevelt

Russian drug maker Pharmsynthez has bought Estonian manufacturer Kevelt in a bid to expand its international business.

Kevelt, which is based at the Technopol technology park in Tallinn, makes own brand dermatological drugs and provides contract manufacturing services for liquid and semisolid preparations for clinical trials.

These capabilities are key to Pharmaynthez’ expansion efforts according to company chairman Dmitry Genkin, who said the acquisition will open up direct access to European pharmaceutical markets.

Pharmsynthez, which aims to increase its revenue from the RUB271.5m (€6.6m) it recorded in 2010 to RUB403m by 2013, said that it expects Kevelt to be making €8m worth of its Phase II cancer drug Virexxa by 2015.

The Russian drug maker’s investment in production capacity in Estonia comes just a few weeks after Prime Minister Vladimir Putin set out plans to expand the country’s manufacturing base.

And, while the primary focus of the plan was to encourage investment in Russian manufacturing capacity to cut reliance on international drug makers, Putin also called on home-grown drug makers to boost exports.

The Kevelt acquisition also fits with comments made by Erik Haavamae, a member of majority Pharmsynthez’ shareholder AS Ephag when the Russian firm first listed on the MICEX Moscow Stock Exchange earlier this year. He said that Pharmsynthez will use the RUB528m it raised though the initial public offering “to expand its sales network, buy bio-pharmaceutical companies abroad, increase production capacity and develop innovative drugs.”

China's Clearance for BMP Sunstone and Sanofi-aventis Subsidiary

BMP Sunstone Corporation announced that China's Ministry of Commerce granted clearance for the transaction in which Sanofi-aventis will acquire all outstanding shares of BMP Sunstone Corporation. The acquisition is structured as a merger of BMP Sunstone and a wholly-owned subsidiary of Sanofi-aventis.

As previously announced, Sanofi-aventis offered to purchase BMP Sunstone for cash consideration of USD 10.00 per share, or a total of approximately USD 520.6 million, on a fully diluted basis. BMP Sunstone's board of directors has unanimously approved the transaction.

Under the terms of the merger agreement, completion of the transaction is subject to approval of the merger by BMP Sunstone's stockholders. Stockholders controlling approximately twenty-two percent of BMP Sunstone's shares on a fully diluted basis and seventeen percent on an undiluted basis have committed to vote in favor of the transaction. The transaction is expected to close during the first quarter of 2011.

BMP Sunstone Corporation is a specialty pharmaceutical company that is building a proprietary portfolio of branded pharmaceutical and healthcare products in China. Through Sunstone the company manufactures leading pediatric and women's health products sold in pharmacies throughout the country. The company also markets a portfolio of products under exclusive multi-year licenses into China, primarily focused on women's health and pediatrics, as well as provides pharmaceutical distribution services through subsidiaries in Beijing and Shanghai. BMP Sunstone's main office is in Beijing, with a U.S. office in Plymouth Meeting, PA.

Teva Buying Peruvian Pharma

Teva Pharmaceutical Industries Ltd. said it is expanding its business in Latin America by buying Peruvian drugmaker Corporación Infarmasa.

Corporación Infarmasa is owned by The Rohatyn Group and Altra Investments. Teva did not disclose the price of the acquisition.

Teva is based in Israel, and it is the world's largest maker of generic drugs. The company gets almost two-thirds of its revenue from sales in North America. In the third quarter, it got 12 percent of its revenue from sales in regions excluding North America and Europe. It said that when Corporación Infarmasa is combined with Teva's own Peruvian unit, Corporación Medco, the resulting company will be one of the two largest drug makers in Peru.

Corporación Infarmasa makes and sells brand-name and generic drugs, including corticosteroids, allergy and pain drugs, and antibiotics. It has more than 500 products on the market and operates two manufacturing facilities in Lima.

Teva said Peru is an attractive market because health care coverage in the country has increased significantly in the last five years. On a per-capita basis, Peruvians spend less money on pharmaceuticals than people in most other Latin American countries.

QPS Acquires Bioserve

QPS, LLC has acquired of a majority stake in Bioserve Clinical Research. Bioserve, a full service phase I CRO headquartered in Hyderabad, India, will be known as QPS-Bioserve India. QPS is a global CRO supporting drug discovery and development, with expertise in preclinical DMPK/toxicology, bioanalytical, translational medicine, and early- and late-stage clinical research.

Bioserve has a 92-bed clinical unit for conducting phase I studies and a bioanalytical lab equipped with multiple LC/MS/MS systems for small molecule bioanalysis. In the past six years, it has conducted more than 500 studies, with numerous product approvals, and has been inspected by the USFDA, UK MHRA, WHO and Indian DCGI.

"This new partnership further expands QPS' global range of linearly integrated services," said Ben Chien, Ph.D., chairman, president and chief executive officer of QPS. "With access to Bioserve's additional resources, our customers will have the heightened benefits of a third more phase I beds, bringing our total to 400, greater bioanalytical capacity, and access to another facility, located in India, with a reputation for outstanding performance and a record of timely approvals. Furthermore, current customers will be reassured to learn that Mr. Suneil Reddy will remain as managing director."

Quintiles Expands in India & London

Contract Research Organization (CRO) Quintiles has opened a Phase I facility in Hyderabad, India, citing increasing demand for efficiency in early-phase drug research in the country.

The INR400m (€6m) facility, which was set up in a 60/40 partnership with the Apollo Hospitals Group under a 2009 deal, houses 86 beds and will offer a range of bioavailability, bioequivalence and Thorough QT (TQT) services.

Quintiles had expected the unit to open in 2010 as a 50-bed facility but the extended time line reflected efforts to ensure operations were consistent with other Phase I units.

“Our initial projections were based on our experience with construction projects in US and Europe. Wherever we work, we do so to the same high standards. In this case, our priority was to complete the building to our global standards, rather than pursuing an aggressive construction timeline.”

She went on to explain that demand from pharmaceutical developers for efficiency in early clinical research was the primary motivation for development of the new site.

“We have seen greater demand for Phase I studies in patient populations, as customers look to establish proof of concept as early as possible in the development process to help them make go/no go decisions sooner.”

The new Hyderabad facility, located on Apollo’s “Health City” campus, is one of five Phase I centers that Quintiles operates at sites in the UK, Kansas in the US and in Lulea and Uppsala in Sweden.

Shobana Kamineni, executive director of Apollo Hospitals Group, said “We are excited to be working with Quintiles to deliver high quality Phase I studies for international customers in India. Apollo has pioneered the provision of many medical and surgical procedures in India and our mission is to bring healthcare of international standards to within the reach of every individual.”

The 86-bed unit will evaluate compounds developed both in India and in other countries. Data capture will be linked electronically to Quintiles other Phase I units in UK, US, and Sweden. Thirty-two beds are equipped with diagnostic cardiology equipment for TQT studies.

It is also Quintiles’ second at a hospital behind its recently expanded research unit at Guy’s in London, UK which, according to the firm’s spokeswoman is scheduled for its grand opening later this year.

“The [Guy’s] unit is positioned alongside leading-edge Clinical Research Facilities, a Good Manufacturing Practice (GMP) Pharmacy, and the home of one of five Comprehensive Biomedical Research centers in the UK.”

Quintiles is not the only CRO to have set up a Phase I unit at a hospital in recent times. In December both Celerion and early-phase specialist Dedicated Phase I set up units at hospitals in the US.

Celerion's VP of clinical research said that, while hospital based Phase I units are common in Europe, increasing US Food and Drug Administration (FDA) pressure for certain types of medicine to be tested in a hospital environment is driving demand stateside.

ShangPharma Features Cleanroom

ShangPharma Corporation a China-based pharmaceutical and biotechnology research and development outsourcing company, has commenced operations on the initial phase of production at the company's Fengxian facility. This new multi-purpose pharmaceutical development and cGMP manufacturing facility is located in Fengxian in the suburbs of Shanghai, China. The state-of-the-art facility will operate as a wholly owned subsidiary of the company under the name of China Gateway Pharmaceutical Development Co. Ltd., and will allow the company to expand its service offering to process research and development, formulation research and development, analytical method development and validation, and cGMP manufacturing of intermediates and APIs.

This project represents ShangPharma's growing capabilities in cGMP manufacturing. To date, ShangPharma has successfully developed client projects from the early discovery phase to the provision of materials for GLP Toxicology and Phase I Clinical trials. 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, depending on scale. The company may further expand its manufacturing facilities if it experiences strong demand for commercial manufacturing of FDA- or EMEA-approved drugs.

The Fengxian facility includes a pilot plant that has six separate bays with reactor capacities ranging from 200 to 3,000 liters and other specialty bays with reactor capacities ranging from 50 to 2000 liters for high temperature, cryogenics, highly toxic and pressurized reactions, including hydrogenation. There are also two cleanroom suites rated at Class 100,000 (ISO Class 8) for isolation, 10 kilo-labs suites for both non-cGMP and cGMP manufacturing as well as a large research and development laboratory for analytical, formulation and process development activities. 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.

Part of the new facility is dedicated to analytical support. Testing of raw materials, intermediates and final products will be carried out at the site. An independent quality assurance department ensures that materials are manufactured in accordance with cGMP requirements and that established standard operating procedures are followed.

Big Pharma Reacts to Putin’s Warning

GSK and Teva will invest in Russian drug manufacturing in response to PM Vladimir Putin’s warning that Pharmas will face restrictions if they fail to boost local production and transfer technology.

Last month the Russian government unveiled plans to invest RUB120bn ($3.8bn) to expand the pharmaceutical manufacturing sector, which Putin sees as a priority sector for increasing the county’s industrial strength.

In a statement on the government’s website, Putin made clear he wanted pharma firms to play a part in this and move production to Russia, warning that: “There will be restrictions for [global drug companies] in the Russian market if they do not launch production and transfer technology.”

In reaction several pharma giants, who already have facilities in Russia, have announced plans to ramp up manufacturing in the country and earn the status of local producers.

Teva Plans Investment

Teva Pharmaceuticals is one big player in the Russian drug production field, claiming it has “an extensive product portfolio in Russia” that ranks it among the top 10 pharmaceutical companies in the country.

Tamara Sušanj Šulentić, a Teva spokesperson said, “Teva firmly intends to address the healthcare needs of Russia by providing affordable healthcare products and services.

“Having in mind the importance and the size of the Russian market, Teva is currently exploring different local supply options in order to meet the growing needs of patients and healthcare providers.”

Putin, meanwhile, has accused international companies of exaggerating the health benefits of their imported drugs, claiming: “foreign producers - with the help of some of our celebrities - are pushing their products, saying that without them everyone will die. We just need to get over it.”

Šulentić said Israel’s Teva plans to invest up to $100m in a Russian drug production plant as part of its strategy to triple sales in the country by 2015.

She maintained that additional investments “will enable it to provide a higher quality support to the Russian healthcare system and thus meet the growing needs of Russian patients.”

GSK Joined Russian Binnopharm

UK-drug major, GlaxoSmithKline (GSK), has also plunged cash into the fast-growing emerging market.

This year the drugmaker struck a deal with Moscow-based vaccine firm, Binnopharm, which will make and sell GSK’s cervical cancer, rotavirus and pneumococcal vaccines for Russia.

Knowing that the Russian government favors local partnerships and aims to boost domestic pharma’s portion of the market by 30 per cent, GSK said it expects the local manufacture of these vaccines to “help Russia to modernize its National Immunization Calendar in the future.”

Other drug majors planning to break into the Russian drug manufacturing industry include Novo Nordisk, Sanofi-Aventis, AstraZeneca, Novartis, Pfizer and Nycomed.

Genzyme to Expand Bio-Manufacturing Capacity

Genzyme Corp. will build an additional manufacturing plant in Geel, Belgium, to support the long-term growth of Myozyme and Lumizyme for Pompe disease. Construction of the new $336 million plant will include 8,000 liters of production capacity and a complete purification installation, as well as room for additional future capacity expansions. Commercial approvals for the new site are expected to start late 2014.

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. Genzyme is also continuing its 160-liter 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 with the expansion, bringing the total workforce at the site to approximately 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.”

“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.

McIlvaine Company

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