PHARMACEUTICAL & BIOTECHNOLOGY INDUSTRY
UPDATE
January 2012
McIlvaine Company
TABLE OF CONTENTS
St. Jude Expands Cardio Facility
Catalent to Build Biologics Plant at Former GE Healthcare Facility
Ashland to Boost Capacity at Texas Plant
Novartis to Shutdown Nebraska Facility Temporarily
International Food Safety Training Laboratory
Radford University's New Science Building
Argonne National Laboratory's Advanced Protein Crystallization Facility
Boehringer Ingelheim Expands U.S. Headquarters
Sanford Consortium for Regenerative Medicine's Stem Cell Research Facility Opens
AAIPharma Plans Lab and Manufacturing Expansion
Jackson Lab, Connecticut Finalize Plans for Genomic Center
Teva to Restart Generic Animal Vaccine Production
University of Colorado Biotech Building Open Soon
HistoGenetics to Open White Plains Facility
Nation's Largest Adult Stem Cell Lab Opens
FDA Approves Expansion of BioMarin Plant
Pfizer and MIT Break Ground on New Research Units In Kendall Square
Ipsen Announces Major US R&D Investment and Headquarters Relocation
Belfer Research Building in New York
Skanska to Expand and Renovate St. Francis Hospital in Georgia
Versatile Packagers Provides Contract Packaging Services with Cleanroom
NY State Funds New Genomics, Biotech Projects
Vertex Pharmaceuticals' Boston Campus, United States of America
Argonne National Laboratory's Advanced Protein Crystallization Facility
Sanford Consortium for Regenerative Medicine's Stem Cell Research Facility
Hikal Starts Construction of Multiproduct API Plant
Piramal Completes Grangemouth ADC Expansion
Steris Opens European Headquarters in Bordeaux
UK IAH Opens Lab for Virus Research
Russia Steps Up Investments in Innovative Biotechs.
Wallace Wurth Biomedical Research Centre, Australia
Roche New Research and Development Facility, Switzerland
York University Department of Biology Expands
Julphar to Become First Middle Eastern Insulin Maker
Balda Medical Extends Cleanroom Capacity in Germany
Mozambique to Produce Its Own Antiretrovirals
New Genome Institute Opens in Minsk
Merck Establishes New MSD R&D Asia Headquarters
Lonza Adds Capacity at Nansha Plant
St. Jude Medical Inc. is expanding its facility in Plymouth, MN. The construction project is designed to expand the company’s current facilities and consolidate operations for its cardiovascular division.
St. Jude’s board recently approved plans to add a three-story, 275,000-square-foot addition to its existing Plymouth building, consolidating the company's current cardiovascular division leased locations in Minnetonka and Maple Grove with existing operations at the site. The company expects the construction to be completed in 2013.
"Because many of the future growth opportunities for St. Jude Medical are expected to arise from devices in the cardiovascular division, we're excited to develop a Plymouth Campus that will not only help streamline operations and business activities, but also bring employees together under one roof," said Frank J. Callaghan, president of the St. Jude Medical’s cardiovascular division. "This expansion is viewed as a consolidation and space solution for the company, but also acknowledges a need for adequate space to house our growing business in the years ahead."
Designs for the Plymouth campus capture the look and feel of other St. Jude Medical buildings, including the company's corporate headquarters in St. Paul as well as other new buildings in Brazil and Costa Rica, officials said. In line with those facilities, the expansion is expected to incorporate environmentally responsible and sustainable design. St. Jude Medical also planned for long-term growth at the Plymouth Campus with additional site upgrades that can be added at a later date. The company's headquarters and atrial fibrillation division site in Little Canada are also planned for expansion.
The current building in Plymouth includes 205,000 square feet of space located on 26 acres of land. The site formerly served as the headquarters of AGA Medical, a company acquired by St. Jude Medical in 2010.
St. Jude Medical has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.
US contractor Catalent Pharma Solutions’ new biologics plant will be a facility formerly owned by GE Healthcare.
In December Catalent announced plans to boost biologics production capacity by moving operations from its plant in Middleton, Wisconsin to neighboring Madison to a site which – according to a report in the Wisconsin State Journal – was previously operated by GE’s bone scanning tech unit, Lunar.
Facility general manager told the paper the move will more than double the company's space, from 40,000 square feet to 100,000 square feet, and roughly quadruple manufacturing capacity.
Jenkins added that the remodeling work and additional construction required to convert the plant will be completed later this year with the aim of brining the facility online early in 2013.
Ashland says it will ramp up production of the tablet disintegrant and dissolution aid polyvinylpyrrolidone (PVPP) to meet growing drug industry demand.
Ashland will add production capacity at its site in Texas City, Texas, US with the aim of bringing it online late in 2013. The US Specialty chemicals firm operates a second PVPP production plant in Calvert City, Kentucky.
Jeff Wolff, VP Pharma and Nutrition Specialties, said: "Over the next few years, Ashland expects steady growth in PVPP driven by an industry need for formulation ingredients that improve the dissolution of poorly soluble drugs and growth in emerging markets.”
He attributed this to the expanding global population and increasing demand - in both established and emerging markets - for non-branded pharmaceutical products.
The announcement is the first major development at Ashland since it purchased International Specialty Products (ISP) in August last year.
At the time observers predicted that the $3.2bn (EUR2.5bn) acquisition – and the subsequent combination of the firms’ large industrial customer bases - would accelerate Ashland's growth in the pharmaceutical sector.
This point was referenced by Ashland Specialty Ingredients president John Panicella in light of the PVPP expansion.
"We acquired International Specialty Products because of its growth potential and this major capacity expansion demonstrates our positive outlook and our commitment to growing this business.”
Ashland's pharma grade PVPP brand is Polyplasdone, however, it also produces Polyclar for beer and wine producers, which use it a filter aid during production to improve the clarity and stability of their products during shipping and storage.
Packaging inconsistencies as well as broken or chipped tablets have prompted Novartis Consumer Health Inc. (NCH) to conduct a sweeping recall. NCH is voluntarily recalling all lots of select bottle packaging configurations from retailers of Excedrin and NoDoz products with expiry dates of December 20, 2014, or earlier as well as Bufferin and Gas-X Prevention products with expiry dates of December 20, 2013, or earlier, in the United States, the company reported on its Web site. These products "may contain stray tablets, capsules, or caplets from other Novartis products," it reported.
While consumers did complain of chipped and broken pills, NCH is not aware of adverse events related to the issues leading to the recall.
Just before the recall, NCH ceased operations at and shipments from its Lincoln, NE facility. "These actions were taken to accelerate maintenance and other improvement activities at the site," the company reported on its site. It plans to "gradually resume operations at its Lincoln, NE site following implementation of planned improvements and in agreement with the FDA."
"We are committed to a single quality standard for the entire Novartis Group and we are making the necessary investments and committing the right resources to ensure these are implemented across our entire network," said Joseph Jimenez, CEO of Novartis, on the company's Web site. "The high quality of our products and operations has been critical to building the Novartis reputation over the past 15 years. We are committed to ensuring the highest standard for patients who rely on our products and medicines."
University of Maryland's Joint Institute for Food Safety and Applied Nutrition, supported by Waters, has opened a new International Food Safety Training Laboratory, to give technicians who test imports to the US intensive, hands-on lab training in US government methods, standards and technology, as well as acceptable alternatives.
"The more we can get foreign food facilities to harmonize their procedures and their work with US requirements, the greater the likelihood of safe imported foods reaching American consumers," says the University of Maryland's Janie Dubois, who directs the new laboratory.
Dubois continued, "The FDA can only inspect a tiny fraction of all imports, so food should enter the country safe, well-tested and up to our standards."
According to the university, food laboratory workers will learn US-recommended microbiological and chemical analysis methods directly from regulators at the Food and Drug Administration, Department of Agriculture, Environmental Protection Agency and other federal agencies.
Also, the training will give students a chance to discuss acceptable, alternate analytical methods that regulators call "fit-for-purpose."
"We've gotten enthusiastic responses from a number of developing countries because they see the potential benefits for both their export and domestic markets," Dubois says.
Dubois continued, "JIFSAN is already actively training overseas, and this facility gives us the chance to further contribute to the harmonization of international food-handling and testing standards."
Waters has provided liquid chromatography and mass spectrometry equipment for the measurement of the presence of multiple pesticide residues simultaneously.
"Waters Corporation is committed to bridging the gap between governments and industry to ensure the best science and most innovative technologies are used to make our food safe," says the company’s corporation chairman, president and CEO Douglas A. Berthiaume.
Berthiaume continued, "We are proud to join with the University of Maryland to create this laboratory that will bolster the capabilities of both the FDA and our global partners as we work together to improve food safety."
An international biotechnology company has donated $50,000 to Radford University for a laboratory in the school's new Center for the Sciences building.
The Novozymes Biology Lab will be a teaching laboratory for introductory biology courses for undergraduate students.
Construction of the $49 million, 115,000-square-foot Center for Sciences is expected to begin in fall 2012 with a tentative completion date of fall 2014.
Novozymes Biologicals is based in Denmark and has facilities around the world, including Salem, Va.
Argonne National Laboratory is building a new advanced protein crystallization facility (APCF) in Illinois, US. The $34.5 million facility will help scientists across the world study the structure and function of different types of proteins. It will also help accelerate the development of new medicines based on this research to fight various diseases.
The project is being funded by the State of Illinois. Groundbreaking for the construction of the facility was held in August 2011. The construction is slated for completion in 2014.
The project is expected to generate 825 jobs during construction and another 550 indirect jobs upon opening. It will help in expanding research activities at the University of Illinois and also support genomics studies at the US Department of Energy's Structural Biology Center and the Midwest Center for Structural Genomics.
"Argonne National Laboratory is building a new advanced protein crystallization facility (APCF) in Illinois.”Protein crystallography in a key technology used by researchers for developing drugs. It provides researchers with three-dimensional (3-D) structures of proteins which are involved in diseases.
Using these structures, researchers identify the sites on the protein where the drug needs to attach and cause reaction. The technology enables researchers to understand the interaction between a new drug and a protein.
Computational methods can be used to predict the interaction of the drug and the protein, but the action needs to be proved experimentally. Existing technologies are very time-consuming and produce just one or two usable crystals for every 100 attempts.
The APCF will address this problem and aid in the development of drugs which can be marketed by pharmaceutical firms. It will use robotics to produce, purify and crystallize proteins five times faster. The proteins to be analyzed by researchers can be produced more accurately.
The insights provided by the APCF about proteins will also help in developing new strategies for environmental management, which can be applied in fields such as energy production, agriculture and remediation.
The APCF is a single-storey circular steel structure spread over an area of 50,000 sq. ft. It is split into two areas - office space and laboratory space. The laboratory space can accommodate 76 researchers and will have a flexible and modular layout enabling re-arrangement of space at no extra cost. It will include open labs, lab support, shared core lab facilities and a highly specialized crystallization suite.
The open labs will provide large flexible spaces for researchers to carry out their activities. It will also promote collaboration and discussion between the researchers. The open labs will feature height adjustable, movable tables with adjustable shelves.
"Protein crystallography is a key technology used by researchers for developing drugs."The lab support areas include lab equipment and feature fume hood and chemical storage alcoves to improve safety. Placing the equipment in the lab support areas also helps in reducing noise levels in open labs.
The state-of-the-art laboratory space will be used for determining the 3-D structures of proteins. It will be connected to the Argonne National Laboratory's Advanced Photon Source, enabling access and exchange of research between the two centers.
The APCF will use microfluidics and robotics technologies to promote research. Microfluidics includes the use of extremely small droplets of protein solution of 10 to 20 nano liters. Researchers can examine these droplets and choose the best ones that are capable of promoting crystal growth.
The robotics technology will automate the process of crystallography. It includes the use of a crystal mounting robot which will automatically calculate and analyze the protein structures.
The office space of the APCF will include workstations, offices, administrative areas, four conference rooms and a lobby. The conference rooms will feature audio visual equipment and can accommodate medium size gatherings of people.
The office space also includes common areas to promote collaborative discussion. The exteriors of the office space will be clad with glass and metal. Glass will provide views of the surroundings and also cut down energy costs by allowing natural light into the building.
SmithGroup provided conceptual and preliminary designs for the facility. Cotter Consulting provided commissioning services for the project.
Germany-based privately held pharmaceutical company Boehringer Ingelheim is involved in drug discovery, development and manufacturing. The company has invested more than $350m in 2011 to boost its operations in the US. It announced a number of projects to expand its US headquarters campus.
The planned expansions include construction of a new research and development building, a safety assessment building, a potent compound facility, cogeneration system and new administrative building, plus IT infrastructure.
The US headquarters of Boehringer Ingelheim is located on a 294-acre site, on Ridgebury road on the border of Ridgefield and Danbury, in the state Connecticut. It features a number of buildings for office, research and development (R&D) and safety assessment.
The existing research and development centre in Ridgefield was originally designed by Flad & Associates. It was built in four phases with 40,050 sq. ft. of R&D space, 109,800 sq. ft. of laboratory space and an 88,690 sq. ft. safety assessment building.
"The company has invested more than $350m in 2011 to boost its operations in the US."Ground was broken for a new safety assessment building within the headquarters campus in August 2011.
The new building will be used for conducting non-clinical safety studies on the drugs being researched or developed by the company. It will have a footprint of 63,000 sq. ft.
The construction is expected to be completed by 2013 at an estimated investment of $42.5m.
The company announced $65m investment on an R&D facility at its headquarters in November 2011. The facility is being built as an extension to the existing R&D facility at the campus.
The existing facility has become old and unsuitable for the latest technologies. The new facility will help the company overcome this problem.
The $65m facility will have 72,000 sq. ft. space for R&D and production activities. The pilot plant at the facility will produce active pharmaceutical ingredients (API) for use in drugs which are in the early stages of development. It will provide a chemical processing environment to transform the new chemical entities discovered in the company's R&D facilities to APIs in sufficient quantities to support the development of life saving drugs
The new $65m R&D facility will be suitable only for drugs in the first two phases of development.
"As part of expansion of operations, Boehringer announced a number of projects in the US in 2011."The third stage of development needs testing on a large scale population, which requires higher quantities of the drug.
The products that are developed and approved at the facility will, therefore, be sent for further research and development to the company's full scale R&D facilities in Ohio and Virginia in the US, as well as those in Germany and Italy.
CDA agreed to provide a $5m Sales & Use tax rebate to Boehringer Ingelheim for creating jobs through the expansion of the headquarters at Ridgefield.
The project is expected to create about 400 jobs. The CDA approved the exemption based on Boehringer Ingelheim's proposal to invest $84m in the headquarters expansion.
As part of expansion of operations, Boehringer announced a number of projects in the U.S. Investments made by the company in 2011, other than those at the headquarters, included an $89m investment on expanding a biological manufacturing facility of the company in St. Joseph's Missouri, investment in a new animal vaccine research facility in Sioux Center, Iowa, and a $50m investment in a High Containment Operations Facility in Columbus, Ohio.
The investments made by Boehringer are expected to significantly benefit the local economy. The company expects to develop innovative and new drugs and attain more patents through the new facilities.
The Sanford Consortium for Regenerative Medicine (SCRM) inaugurated a new stem cell research facility in La Jolla in the state of California, US, in November 2011. The project broke ground in March 2010 and required an investment of $127m. The facility will carry out stem cell research to develop new medicines for various diseases.
SCRM is a non-profit consortium formed by five research institutions including the Sanford Burnham Medical Research Institute, the Salk Institute, the Scripps Research Institute, the University of California, San Diego (UCSD), and La Jolla Institute for Allergy and Immunology.
The research institutions in the consortium are known for their scientific excellence and supported by 14 Nobel Prize winning scientists.
Basic research carried out by these institutions has created more than 200 spin-off companies and brought 24 new products to the market.
The new facility, also termed Collaboratory, will enable these five institutions to share their research work and enhance stem cell knowledge. It will help in developing new therapies to fight various diseases, repair damaged organs and fix spinal cord injuries.
SCRM was originally founded in 2006 as the San Diego Consortium for Regenerative Medicine. In September 2008, T Denny Sanford, a businessman and philanthropist, donated $30m to the consortium.
In the honor of this donation, the San Diego Consortium for Regenerative Medicine was renamed as the Sanford Consortium for Regenerative Medicine.
The main goal of the consortium is to invent research tools which will aid in stem cell research and lead to discovery of new diagnostics, therapies and cures for chronic diseases and injuries.
The consortium will focus on different research areas such as stem cell growth and differentiation neuroscience, cardiovascular biology, hematopoiesis and vision science.
"The Sanford Consortium for Regenerative Medicine (SCRM) inaugurated a new stem cell research facility in La Jolla."The new research facility has been built on a 7.5 acre site located next to the Salk Institute and UCSD. It is spread over four-stories and has a total area of 150,000 sq. ft.
The facility has space to house 335 scientists, research labs featuring movable equipment, administrative areas, a 16,000 sq. ft. vivarium, office space and two two-storey break rooms.
It also has conference rooms, a 150-seat auditorium and an enclosed space for observing plant and animal life. The facility provides access to animal models of disease, advanced imaging and robotics equipment, as well as protein and nucleic acid analysis.
The design of the facility encourages interaction among the scientists and helps in knowledge sharing. The research areas face each other, creating opportunities for scientists to meet and exchange ideas.
The shared two-storey break room at each end of the building also assists in idea sharing. The stairway of the facility has also been designed to encourage interaction. They connect the research labs on various levels, enabling scientists to meet and interact.
Financing the Sanford Consortium for Regenerative Medicine's stem cell research facility
Construction of the facility was financed through state and private funds. The project was awarded $43m facilities grant award from the California Institute for Regenerative Medicine. It also received $65m from the sale of tax-exempt bonds.
Private funding came in the form of the $30m donation made by T. Denny Sanford.
Sustainable features of the SCRM's complex and contractors involved
The facility has incorporated several sustainable features into its design which conform to the LEED Gold certification standards.
"SCRM was originally founded in 2006 as the San Diego Consortium for Regenerative Medicine."The design allows natural daylight into the facility improving the energy efficiency. It also features shading devices, displacement ventilation and low-flow plumbing fixtures.
Certified wood has been used in the construction of the facility. Use of potable water has been eliminated for irrigation, increasing efficiency of water-usage by 40 percent.
Alternative transportation and public transit are encouraged by incorporating changing rooms and facilities in bikes parking area.
The facility was designed by Fentress Architects in collaboration with Davis Architects. The development was handled by a consortium of Lankford and Associates and Phelps Development.
HOPE Engineering provided structural engineering services for the project and Hensel Phelps Construction was the general contractor. Jacobs' Consultancy-GPR was the lab programmer.
AAIPharma Services says it will expand its contract analytics and manufacturing capacity to meet increasing customer demand.
The North Carolina, US-headquartered services firm has begun work on the construction of a new 40,000 sq. ft. laboratory and technology centre at its base in Wilmington.
When completed, the lab will provide microbiology, physical chemistry services, raw pharmaceutical materials testing and stability management services to AAIPharma's clients in the drug industry.
Additionally, AAIPharma plans to add a second production shift at its contract parenteral manufacturing facility in Charleston, South Carolina in the next few months again citing increasing customer demand for its services as the key driver.
CEO Patrick Walsh, said the investments are designed to ‘increase capacity and efficiency’ and are in keeping with the development of the wider outsourcing market.
“Pharmaceutical and biotech companies are expected to maintain or increase their level of outsourcing, we continue to see growth for a range of contract services in the pharmaceutical drug development industry and believe AAIPharma is well positioned to continue growing and increasing its market share."
Walsh’s contention fits with AAIPharma’s performance in the third quarter during which, the private-equity owned firm reported revenue increased around nine per cent.
“The excellent business results reflect our significant progress and investment in our people and facilities, along with AAI’s world-class scientific team’s ability to serve our clients development and manufacturing needs,” Walsh said.
“AAIPharma achieved record revenue in the third quarter of 2011, surpassing any previous quarterly performance since the company’s 2009 acquisition by Water Street Healthcare Partners.”
The Wilmington expansion follows just a few months after the launch of AAIPharma’s online testing services portal which, at the time, the firm predicted would generate additional business and streamline operations for customers.
Jackson Laboratory and the State of Connecticut have finalized the details of a $1.1 billion, 20-year plan to build a genomics research center on the campus of the University of Connecticut Health Center (UCHC) and will include UConn and Yale University as collaborators.
Under the final agreement for the Jackson Laboratory for Genomic Medicine, the state will provide $290.7 billion for the new facility and Jackson will raise the balance of $860 million through federal research grants, philanthropy, and service income. The state's $291 million commitment includes $192 million in a secured, forgivable construction loan to fund the building of the facility and $99 million in grants for research and related activities.
When the 250,000-square-foot lab is completed, in an estimated 20 years, it will employ 600 scientists and technicians.
Signed by Gov. Dannel Malloy at a ceremony at UCHC, the agreement requires a commitment from Jackson to create at least 300 positions within 10 years, with at least 90 of those employees (or 30 percent) to be senior scientists. The annual average wage at the center will be required to be 125 percent of the average wage in the state, and preference must be given to state residents and vendors if they are qualified.
Jackson and the state also struck an intellectual property sharing agreement that will give Connecticut Innovations (CI), a quasi-public organization, 10 percent of any net royalty proceeds from IP up to $3 million and 50 percent of net royalty proceeds above $3 million starting in the 10th year and running over 15 years. During the first 10 years, if Jackson monetizes any IP through transfer, CI will have the same sharing arrangement described above.
When the state's legislature passed the plan to issue the bonds to fund the new lab in October, dissenting lawmakers had questioned whether the deal offered enough protections for the state, or could create enough jobs over time to justify the nearly $300 million taxpayers were being asked to provide.
"The state's investment in the Jackson Laboratory project is important for several reasons," Catherine Smith, commissioner of the Connecticut Department of Economic and Community Development and chair of the CI board of directors, said in a statement from the governor's office today. "It helps to grow an industry sector – bioscience – that holds great promise in terms of job creation, innovation, and capital investment for our state. It also helps build the critical mass of scientists and other top-flight workforce talent that will give Connecticut a competitive edge as we continue to attract organizations like this to our state."
"We've been working hard over these weeks of negotiations, and the process has helped us build strong working relationships with our new colleagues," added Jackson Laboratory President and CEO Edison Liu. "With this agreement in place, and with great partners across Connecticut,
we're looking forward to building the bioscience industry here and doing great science that will improve medicine and health care."
In 2009, Teva Animal Health Incorporated (Petah Tikva, Israel), the largest U.S. manufacturer of generic animal drugs, was ordered by the U.S. Food and Drug Administration (FDA) to cease operations at its facility in St. Joseph, Missouri. The subsidiary of Israel-based Teva Pharmaceuticals had failed to comply with current Good Manufacturing Practice (cGMP) regulations in its quality control, employee training and manufacturing practices.
Teva's plant was ordered to remain closed until the company was able to comply with cGMP regulations and obtain authorization to reopen from the FDA. However, since then, the company has been working diligently to reassess, upgrade and improve its facility, as well as retrain its personnel.
Teva Animal Health manufactures a range of products in a wide variety of dosage forms and therapeutic categories, including antimicrobials, parasiticides, hormones, anesthetics, analgesics, and veterinary specialties for companion and food animal species. The crux of the FDA warning letters centered on Teva's failure to test each lot of a component with potential for microbiological contamination that is objectionable in view of its intended use; failure to investigate discrepancies in the batches to meet specifications; failure to demonstrate that the equipment used in the manufacture, processing, packing or holding of drug products was of appropriate design to facilitate operations for their intended use; failure to clean and sanitize equipment and utensils at appropriate intervals; failure of quality control unit to appropriately approve or reject manufacturing procedures; failure to define the responsibilities and procedures applicable to the quality control unit; failure to implement systems for maintaining equipment used to control aseptic conditions in aseptic processing areas; failure to maintain records for cleaning and sanitizing equipment; failure to maintain an adequate system for monitoring environmental conditions of the aseptic processing areas; and failure to establish written procedures for design to prevent microbiological contamination of drug products purporting to be sterile.
It has been a long road for Teva to get back in to FDA-ordered compliance of cGMP. Teva responded to these deficiencies by engaging Whiting-Turner Contacting Company (Baltimore, Maryland) to handle the plant upgrades, which are winding down. The FDA is on site at the facility and is working with the facility's team and Whiting-Turner to ramp up operations by the end of the first quarter of this year.
The University of Colorado's new $194 million biotechnology building, which will be a hub for some of Boulder's geniuses, is set to open this spring. The building will house the Biofrontiers Institute, the Department of Chemical and Biological Engineering and the Division of Biochemistry. Research space is designed to allow researchers, including Nobel Prize-winning scientist Tom Cech, to collaborate on complex biomedical problems.
The biotechnology company HistoGenetics purchased 104 Corporate Park Drive in White Plains in a cash deal finalized Dec. 28. HistoGenetics, currently based in Ossining, will build a research and development facility in the 118,000-square-foot building. The company provides rapid DNA sequence-based tissue typing to hospitals and transplant centers.
The building was the former headquarters of the environmental consulting firm Malcolm Pirnie and was vacant for two years before the deal. Marissa Brett, executive director of economic development for the Westchester County Association, announced the deal, which was the largest office sale in 2011 for a relocation or expansion in Westchester County.
"HistoGenetics ... is not only committed to furthering state-of-the-art biotechnology, it is committed to Westchester County's future as well," said Brett in a press release. "We anticipate that the project will add more jobs in biotech, as well as hundreds in construction. This is a feather in Westchester's cap."
Celltex Therapeutics, a biomedical company headed by Stanley Jones, the doctor behind Rick Perry’s recent experimental stem cell procedure, recently unveiled its new Sugar Land laboratory. The massive 15,000-square-foot facility will be the largest adult stem cell lab and bank in North America, offering clients an advanced culturing process licensed from Korean firm RNL Bio to reproduce mass quantities of healthy cells that can be stored for potential future use.
Fees start with an introductory charge of $4,873 plus an annual fee of $150. Clients can withdraw 50 million stem cells for $1,759.
“The Houston area has an international reputation for its willingness to test and develop new ways to help those who are ill,” Celltex chairman and CEO David Eller told a crowd of about 30 guests at the ceremony in mid-December. “The adult stem cell treatment used at Celltex will prove enormously beneficial to many, many people.”
Celltex was careful to highlight its political and ethical standing at its ribbon-cutting event which involved a flag-raising ceremony, the reading of a congratulatory letter from Rick Perry, a Bible story and a group prayer.
A typical adult stem cell treatment involves extracting stem cells from a patient's fat tissue. The cells are cultured at a lab like Celltex and then reinjected back into the patient. Treatments are thought to allow stem cells to replace damaged tissue, potentially helping conditions like Alzheimer's disease, diabetes, Parkinson's and multiple sclerosis.
Research is still very much in its infancy. As of yet, the U.S. Food and Drug Administration has not licensed any type of treatments involving cultured stem cells.
Since the 1990s, the debate over stem cell use has split into two camps roughly along political party lines.
On one side are those who champion research using embryonic cells — the biological building blocks drawn from human embryos that can develop into any type of cell. Embryonic stem cell research struggles with rejection issues when cells are introduced into a patient’s system.
On the other side of the debate are those who favor research using adult stem cells, which are extracted from fully-grown consenting patients. Adult stem cells have a more limited use, but face virtually no patient rejection problems, a fact Celltex officials mentioned on several occasions throughout the opening ceremony and subsequent facility tour.
Both adult and embryonic methods have potential. Federal funding restrictions, however, have limited embryonic studies, which opponents question from a moral standpoint based on their use of discarded embryos from private fertility clinics.
Texas emerged as a battleground for stem cell research this summer, with Rick Perry promoting millions of Texas dollars in adult stem cell research initiatives as the FDA attempts to regulate a growing number of unapproved stem-cell treatments.
Perry, who opposes embryonic research on moral grounds, sees economic and biomedical opportunities for his state through adult stem cell research. Though excited about the funding possibilities, scientists and physicians have voiced patient safety concerns about approving stem cell treatments too quickly.
BioMarin Pharmaceutical Inc. said that the Food and Drug Administration has given it the green light to begin manufacturing in an expanded facility in Novato.
BioMarin finished a 21,800-square-foot internal expansion of its building at 46 Galli Drive in April 2010. The $60 million project nearly tripled BioMarin's manufacturing capacity, all of which is based in Novato, to 40,000 square feet of cleanroom space.
"We are now approved to manufacture Naglazyme, basically our biggest enzyme replacement therapy product, in this facility," said Bob Purcell, a BioMairn spokesman.
Purcell said the newly licensed facility gives BioMarin the capacity to produce $1 billion in products, twice its previous capacity.
BioMarin is one of only a handful of companies focused on the orphan drug market. It was already making Naglazyme and another drug, Aldurazyme, in pre-existing facilities at the Novato site that were licensed by the FDA in 2003 and 2005. Both drugs treat an inherited metabolic disease that can cause tissue damage and mental retardation; and both drugs are produced by engineering hamster cells to make human proteins.
Purcell said BioMarin has two more products in the late stages of the approval process.
"Should they be approved in late 2012 we'll need to start ramping up," Purcell said. "We need to make sure that we have manufacturing capacity ready."
One of the new drug candidates is designed to treat Morquio Syndrome -- a genetic disease that causes skeletal and joint problems and shortness, and can also cause hearing loss, clouded vision and heart valve disease.
Earlier this year, BioMarin moved to further expand its manufacturing capacity by buying a Pfizer Inc. facility in Cork, Ireland.
Pfizer Inc. and the Massachusetts Institute of Technology (MIT) held the official groundbreaking of the new location of Pfizer's Cardiovascular, Metabolic and Endocrine Diseases (CVMED) and Neuroscience research units at 610 Main Street, Cambridge, MA.
In September, Pfizer announced it had entered into a 10-year lease agreement with MIT for more than 180,000 square feet.
In February Pfizer announced a strategic shift in research and development, to focus the company’s efforts on a smaller number of research areas where the potential for impact is greatest, including its CVMED and Neuroscience research units. As part of this shift, Pfizer announced it would substantially boost its presence in Cambridge by moving these two important research units there. This relocation makes Pfizer the second largest biopharmaceutical company in Massachusetts in terms of number of employees.
“We deliberately chose to move to Cambridge, MA, as a key part of our research and development strategy, in order to foster productive collaborations between our drug discovery experts and the outstanding scientists of Cambridge’s world-class institutions,” said Pfizer Worldwide R&D President Mikael Dolsten.
“This is a very exciting period in Pfizer research and development during a time of great change while we strengthen our innovative core with the goal of delivering the best medicines to patients,” said Dr. Dolsten.
Pfizer plans to bring around 400 new research jobs to Cambridge. In addition to relocating key Pfizer scientists to the area, the company anticipates hiring a significant number of scientists for the two research units, including biologists, chemists and individuals with other areas of research expertise.
“Physical proximity to the medical R&D community in Massachusetts is designed to encourage frequent and meaningful relationships with leading biomedical research institutions,” said Rod MacKenzie, senior vice president of Pfizer PharmaTherapeutics R&D.
“By bringing together our drug discovery scientists with the best contemporary biologists and scientific minds in Cambridge, we aim to provide the most stimulating environment for our researchers to invent the next generation of medicines. Tackling the symptoms of diabetes and moving to prevention; reducing the symptoms and slowing disease progression of Alzheimer’s disease; taking the control of lipids and cardiovascular risk reduction to unprecedented new levels - the opportunities to positively impact human health are endless,” said Mr. MacKenzie.
“Kendall Square’s thriving innovation cluster makes a strong case for the creative power of proximity. Pfizer has supported MIT research for more than a decade, and we are convinced that establishing their new research facility right next door will accelerate the cycle of discovery and innovation. Connecting MIT’s pioneering research with Pfizer’s commitment to delivering real-world solutions for patients is a potent formula for impact,” said MIT President Susan Hockfield.
Also based in the Cambridge/Boston area are Pfizer’s BioTherapeutics Research & Development group and the Boston Center for Therapeutic Innovation.
While the new facility is being built, the CVMED research unit will be based in an interim space at Pfizer’s location at 620 Memorial Drive in Cambridge, MA. The Neuroscience unit also will relocate to interim space in Cambridge in the second quarter of 2012. Pfizer will move into the new space when it is completed, which is anticipated to occur in the fourth quarter of 2013.
Ipsen's (a Paris-based pharmaceutical company) U.S.-based subsidiary, Biomeasure Inc., and its North American Operations group announced that the Group will further expand its commitment, investment and commercial presence in the U.S. market. Ipsen will make a multi-million dollar capital investment in its Milford, MA research and development (R&D) and technical operations facility, and will relocate U.S. Operations headquarters from Brisbane, CA, to Bridgewater, NJ, in order to enhance the North American commercial organization. Enhancing Ipsen's U.S.-based R&D and Technical Operations Capabilities The existing 77,000 square-foot Milford facility serves as a center for Ipsen's US-based peptide and toxin R&D platforms, as well as a cGMP manufacturing facility focused on production of recombinant proteins for the treatment of hemophilia.
The expansion and renovation capital investment project, currently in the design phases, will deliver a new three-story, 62,000 square-foot building while completely renovating one of the site's two existing buildings. Ground breaking is anticipated for mid-2012, with construction of the new building targeted for completion in early 2014. The new facility will house R&D and Process Sciences laboratories that support Ipsen's strategic objectives to deliver five New Molecular Entities (NMEs) and three Proofs of Concept (POCs) by 2015.
"Ipsen's Milford-based facility is at the cutting edge of innovative, impactful and high-performing research, development and manufacturing capabilities focused on delivering new treatments for serious and life-threatening diseases to patients," said Cynthia Sylvestre, President, Biomeasure Inc. and Vice President, Milford Site Head. "We are confident that investing $45 million in this unique site, in such close proximity to the impressive concentration of scientific skills and talent in Massachusetts, will enable Ipsen to expand its bio-therapeutic technological platforms and pipeline."
With a staff of 150 employees, the Milford site is home not only to chemists, biologists and translational science experts but also a full technical operations team specializing in the manufacture of OBI-1, a breakthrough B-domain depleted, recombinant porcine factor VIII in late stage development with Inspiration Biopharmaceuticals Inc., Ipsen's strategic partner in hemophilia. Currently recruiting patients in two Phase III clinical trials, OBI-1 presents a unique approach to address the needs of individuals who have developed autoimmune inhibitory antibodies to human factor VIII.
The Company expects to hire more than 100 employees, including many members of its developing executive team, who will work from the Bridgewater, NJ location. The Company expects to begin operation from the Bridgewater location by April 2012.
Principals of owner Weill Cornell Medical College, professionals from AECOM’s Tishman Construction Corporation construction-management practice, and hundreds of construction trades people celebrated the “topping out” of the Belfer Research Building recently, as the final bucket of concrete was lifted to the highest levels of the building’s structure.
The project is a new, $650-million, 19-story building comprising 480,000 sq. ft.—equivalent to 10 football fields—which will become home to significantly expanded bench-to-bedside translational, medical research initiatives.
Located on E. 69th Street between First and York Avenues on Manhattan’s Upper East Side, the world-class facility will include 16 program areas, dozens of state-of-the-art laboratories and principal investigator office suites, and three below-street levels, and will allow Weill Cornell Medical College to recruit 30 or more additional top scientists. Its open design will promote collaboration with Cornell University faculty in Ithaca and with other researchers across the country and the world.
When it opens in 2014, the research center’s core facilities will house leading-edge scientific equipment in a shared space that will reduce technology costs. Its design and construction team is pursuing a LEED (Leadership in Energy & Environmental Design) Silver rating for the building. The project’s architect is Ennead Architects LLP.
Tishman is utilizing Building Information Modeling (BIM) on this project to increase efficiency and reduce costs. Because it is a laboratory building, it has many more mechanical and laboratory process systems than a typical medical building. The application of BIM to the building-design process assisted the team in minimizing the space used for mechanical systems and maximizing the research spaces. Tishman also utilized BIM during pre-construction reviews to perform logistical and safety analyses, and resolve conflicts between the mechanical/electrical/plumbing and structural steel designs prior to award of contracts.
Skanska has secured the assignment to expand and renovate St. Francis Hospital in Columbus, Georgia. The total contract amounts to $115 million, out of which $103 million, will be included in the bookings for USA Building in the fourth quarter of 2011.
The expansion includes a four-story, 17,500 square meters clinical services building and a five-story, 15,700 square meters, medical office building. Skanska will also renovate the main hospital.
The new clinical services building will house a dedicated cardiovascular surgical unit with four labs, a special procedures room, a nuclear medicine suite and 30 prep and recovery bays. It will offer spacious an expanded number of spacious private rooms.
The medical office building will house the Cardiac and Women’s Centers of Excellence and include a new 324-seat auditorium. Renovation of the main hospital will result in an expanded emergency room, including 20 new patient treatment rooms and an expanded surgical suite.
Work has started and is expected to be completed in August 2013.
Florida-based contract packaging company, Versatile Packagers, has been working with alcohol and tobacco distributors and retailers, to provide contract packaging services.
A representative of Versatile Packagers, explains, "We receive cigars in bulk packaging and convert them in to multipacks for our clients. We typically package varieties of cigars into 5-packs, 10-packs, 16-packs, and 20-packs. Many times we will package the products into humidors or other types of special packaging for the holidays."
Packaging or repackaging alcoholic beverages and tobacco products, which requires special licensing from Department of Business and Professional Regulation, is just one of the many services Versatile Packagers offers companies within these industries. Versatile Packagers utilizes its warehouse space for product storage, fulfillment and distribution.
The company Representative adds, "Redoing or undoing an existing type of packaging to reflect new standards is increasingly popular with alcohol distributors as well. Since 2005 we have repackaged and put together promotional packaging for Bacardi and Coke, Alize and Cognac, Buy One Get One Free Wine Bottles and more."
Outsourcing alcohol and tobacco product fulfillment activities to one location not only decreases freight time, but reduces the costs associated with inventory movement and storage space. Outsourcing additionally eliminates companies' peak staffing problems, avoids the cost of chasing the latest technologies and relieves executive teams from day-to-day process managing.
In addition, Versatile Packagers announced the finished construction of a new cleanroom at their 150,000 square foot facility last month. The new room is utilized for packaging when the process requires a high level of product safety and quality. Cleanrooms offer contamination control and protection against external influences following production. The finished products retain the purity in which the client has invested, right up until they are in the hands of the customer.
Cornell University has been chosen to develop a science graduate school in the city, reports The New York Times. Cornell's proposed campus includes 2.1 million square feet — at a cost of more than $2 billion — with space for classrooms, a conference center, housing, and labs. Further, Cornell recently announced a gift of $350 million to help fund the project, while the city is to put up $100 million for infrastructure improvements, the Times adds. The campus is to be located on Roosevelt Island.
New York State plans to invest $49.7 million in a wide range biotechnology-focused economic development projects with funding going to research institutes, incubators, and businesses throughout the state.
Funded through New York's Regional Economic Development Council Initiative, the awards largely support biomedical research, but also will fund agricultural biotech and bioenergy projects, the New York Biotechnology Association said today.
The Roswell Park Cancer Institute Genome project is one of the recipients of funding and will receive $5.1 million. Other awards will provide $4 million to develop the Jacobs Institute Center for Innovation in Medicine, a medical device prototyping facility at the Buffalo Niagara, Medical Campus; $2 million to fund construction of a new cancer drug testing facility at the Cold Spring Harbor Laboratory on Long Island; and $5 million to expand a partnership between the University of Rochester and IBM and a new Health Sciences Center for Computational Innovation in the Finger Lakes region.
In the capital region, the state funding will include $2 million for an RNA Institute for Biomedical and Translational Research; $1 million for the Biotechnology Training Center and the Capital Region Biotechnology Corridor; and $950,000 to create the New York Capital Research Alliance.
The central New York area will receive $2 million to complete the Central New York Biotechnology Research Center, and $3.6 million for the BioTech Park at Kennedy Square in Onondaga County. The Finger Lakes region will receive $7 million to support the Seneca AgBio Green Energy Park for renewable energy, enhanced agriculture, and environmental sustainability. The mid-Hudson Valley area was awarded $5 million to develop the Biotech Incubator Center for Advanced Research at New York Medical College.
Other grants were awarded for pharmaceutical research projects, a bioenergy plant, and materials research.
"These investments will enable further growth in a field that supports some 250,000 direct, indirect and induced jobs, and contributes over $32 billion a year to the state's economic output," NYBA Director Nathan Tinker said in a statement.
"NYBA worked closely with Regional Councils across the state to identify and support projects that would create jobs and continue to nurture New York's growing bioscience industry, and we actively advocated for this funding. We encourage the State to continue to invest in the biosciences, a sector that creates jobs; develops important products in bio-pharmaceuticals, agriculture, and industry; and drives economic development."
Massachusetts-based biotechnology company Vertex Pharmaceuticals (Vertex) is planning to move its headquarters from Cambridge to Fan Pier, on the Boston Waterfront. The company has its current headquarters at 130 Waverly Street and operates about ten different facilities in and around Cambridge.
Vertex Pharmaceuticals signed agreements in May 2011 to lease two buildings at Fan Pier for a period of 15-years. It is the largest commercial lease in Boston, amounting to $1.1bn. The move will consolidate the company's headquarters and entire operations at Fan Pier.
Vertex Pharmaceuticals was founded by Joshua Boger in Massachusetts in 1989. The company is focused on discovering, developing and commercializing new medicines through research.
It is engaged in the development of medicines for life threatening diseases such as hepatitis C, epilepsy and cystic fibrosis through worldwide research programs.
Vertex currently has a workforce of 1,300 employees in the state. About 500 more employees are expected to be hired by 2015, to support the continuous growth of the company. Other office locations are in San Diego and Coralvillein the US, Abingdon in the UK and Laval in Canada, with a total workforce of about 1,800.
The first drug of the company INCIVEK (telaprevir) was approved by the US Food and Drug Administration (FDA) in May 2011 for the treatment of hepatitis C. Vertex is also developing VX-770 for the treatment of cystic fibrosis. Several other medicines are in the mid-stages of development.
Fan Pier, also called Innovative District, is a 21-acre mixed-use waterfront development spanning about nine blocks along the edge of the Boston Harbor. It has about three million square feet of commercial, hotel, retail, residential and public green space. It includes a six-acre marina, harbor walk and a public park and has a well connected transportation infrastructure.
Fan Pier is home to the Institute of Contemporary Art, Salon Mario Russo, LOUIS and other commercial tenants. ONE Marina Park Drive is the first and LEED Gold certified development at the Innovative District.
The relocation of Vertex Pharmaceuticals to Fan Pier is expected to promote establishment of other academic institutes and technology companies.
The project includes construction of two 16-storey buildings for Vertex headquarters. The biomedical research laboratories and offices in the two buildings will occupy a total area of 1.1 million ft2. The ground floor development will include retail and restaurant spaces in an area of 60,000ft2. It will also have underground parking garage for 725 vehicles.
The two buildings will be distinctive and differ in design. A contemporary design building, 50 Northern Avenue is designed by the architectural firm Tsoi/Kobus & Associates of Cambridge. It will have floor to ceiling glass exteriors.
The light blue façade will have sloped floor heights along the Northern Avenue. It will offer panoramic views of the Boston skyline and the waterfront.
Elkus Manfredi Architects of Boston designed the other building, 11 Fan Pier Boulevard. The building will have a metallic framework façade with floor to ceiling green glasses. The facade will be curved in the east.
All the building corners facing the city will feature glass. Both the buildings are designed to achieve LEED Gold certification.
Construction of the new headquarters was started in June 2011 and is scheduled for completion in December 2013. The total cost of construction of the project is estimated at $800m, making it one of the largest private-sector projects in the US. The project is expected to create about 2,000 construction jobs. Turner Construction is the general contractor of the project.
Public-private funds will support the construction of the pharmaceutical buildings and refurbishment of the public accessibility, landscaping, utilities, sidewalks and construction of a new water public transpiration dock.
The Fallon Company is the owner and developer of the Fan Pier facility. Cornerstone Real Estate Advisers and Massachusetts Mutual Life Insurance are the financial advisors for the project.
A loan of $355m was secured in July 2011 by HFF towards the construction of the Vertex Pharmaceuticals Campus on behalf of the Fallon Company and investors. In October 2011, the state-run public-private program, Innovative Infrastructure Investment (I-Cubed), committed to fund $50m towards the development of the Fan Pier facility.
Argonne National Laboratory is building a new advanced protein crystallization facility (APCF) in Illinois, US. The $34.5m facility will help scientists across the world study the structure and function of different types of proteins. It will also help accelerate the development of new medicines based on this research to fight various diseases.
The project is being funded by the State of Illinois. Groundbreaking for the construction of the facility was held in August 2011. The construction is slated for completion in 2014.
The project is expected to generate 825 jobs during construction and another 550 indirect jobs upon opening. It will help in expanding research activities at the University of Illinois and also support genomics studies at the US Department of Energy's Structural Biology Center and the Midwest Center for Structural Genomics.
"Argonne National Laboratory is building a new advanced protein crystallization facility (APCF) in Illinois.”Protein crystallography in a key technology used by researchers for developing drugs. It provides researchers with three-dimensional (3-D) structures of proteins which are involved in diseases.
Using these structures, researchers identify the sites on the protein where the drug needs to attach and cause reaction. The technology enables researchers to understand the interaction between a new drug and a protein.
Computational methods can be used to predict the interaction of the drug and the protein, but the action needs to be proved experimentally. Existing technologies are very time-consuming and produce just one or two usable crystals for every 100 attempts.
The APCF will address this problem and aid in the development of drugs which can be marketed by pharmaceutical firms. It will use robotics to produce, purify and crystallize proteins five times faster. The proteins to be analyzed by researchers can be produced more accurately.
The insights provided by the APCF about proteins will also help in developing new strategies for environmental management, which can be applied in fields such as energy production, agriculture and remediation.
The APCF is a single-storey circular steel structure spread over an area of 50,000 sq. ft. It is split into two areas - office space and laboratory space. The laboratory space can accommodate 76 researchers and will have a flexible and modular layout enabling re-arrangement of space at no extra cost. It will include open labs, lab support, shared core lab facilities and a highly specialized crystallization suite.
The open labs will provide large flexible spaces for researchers to carry out their activities. It will also promote collaboration and discussion between the researchers. The open labs will feature height adjustable, movable tables with adjustable shelves.
"Protein crystallography in a key technology used by researchers for developing drugs. "The lab support areas include lab equipment and feature fume hood and chemical storage alcoves to improve safety. Placing the equipment in the lab support areas also helps in reducing noise levels in open labs.
The state-of-the-art laboratory space will be used for determining the 3-D structures of proteins. It will be connected to the Argonne National Laboratory's Advanced Photon Source, enabling access and exchange of research between the two centers.
The APCF will use microfluidics and robotics technologies to promote research. Microfluidics includes the use of extremely small droplets of protein solution of 10 to 20 nano liters. Researchers can examine these droplets and choose the best ones that are capable of promoting crystal growth.
The robotics technology will automate the process of crystallography. It includes the use of a crystal mounting robot which will automatically calculate and analyze the protein structures.
The office space of the APCF will include workstations, offices, administrative areas, four conference rooms and a lobby. The conference rooms will feature audio visual equipment and can accommodate medium size gatherings of people.
The office space also includes common areas to promote collaborative discussion. The exteriors of the office space will be clad with glass and metal. Glass will provide views of the surroundings and also cut down energy costs by allowing natural light into the building.
SmithGroup provided conceptual and preliminary designs for the facility. Cotter Consulting provided commissioning services for the project.
The Sanford Consortium for Regenerative Medicine (SCRM) inaugurated a new stem cell research facility in La Jolla in the state of California, US, in November 2011. The project broke ground in March 2010 and required an investment of $127m. The facility will carry out stem cell research to develop new medicines for various diseases.
SCRM is a non-profit consortium formed by five research institutions including the Sanford Burnham Medical Research Institute, the Salk Institute, the Scripps Research Institute, the University of California, San Diego (UCSD), and La Jolla Institute for Allergy and Immunology.
The research institutions in the consortium are known for their scientific excellence and supported by 14 Nobel Prize winning scientists.
Basic research carried out by these institutions has created more than 200 spin-off companies and brought 24 new products to the market.
The new facility, also termed Collaboratory, will enable these five institutions to share their research work and enhance stem cell knowledge. It will help in developing new therapies to fight various diseases, repair damaged organs and fix spinal cord injuries.
SCRM was originally founded in 2006 as the San Diego Consortium for Regenerative Medicine. In September 2008, T Denny Sanford, a businessman and philanthropist, donated $30m to the consortium.
In the honor of this donation, the San Diego Consortium for Regenerative Medicine was renamed as the Sanford Consortium for Regenerative Medicine.
The main goal of the consortium is to invent research tools which will aid in stem cell research and lead to discovery of new diagnostics, therapies and cures for chronic diseases and injuries.
The consortium will focus on different research areas such as stem cell growth and differentiation neuroscience, cardiovascular biology, hematopoiesis and vision science.
The new research facility has been built on a 7.5 acre site located next to the Salk Institute and UCSD. It is spread over four-stories and has a total area of 150,000 sq. ft.
The facility has space to house 335 scientists, research labs featuring movable equipment, administrative areas, a 16,000 sq. ft. vivarium, office space and two two-storey break rooms.
It also has conference rooms, a 150-seat auditorium and an enclosed space for observing plant and animal life. The facility provides access to animal models of disease, advanced imaging and robotics equipment, as well as protein and nucleic acid analysis.
The design of the facility encourages interaction among the scientists and helps in knowledge sharing. The research areas face each other, creating opportunities for scientists to meet and exchange ideas.
The shared two-storey break room at each end of the building also assists in idea sharing. The stairway of the facility has also been designed to encourage interaction. They connect the research labs on various levels, enabling scientists to meet and interact.
Financing the Sanford Consortium for Regenerative Medicine's stem cell research facility
Construction of the facility was financed through state and private funds. The project was awarded $43m facilities grant award from the California Institute for Regenerative Medicine. It also received $65m from the sale of tax-exempt bonds.
Private funding came in the form of the $30m donation made by T. Denny Sanford.
The facility has incorporated several sustainable features into its design which conform to the LEED Gold certification standards.
"SCRM was originally founded in 2006 as the San Diego Consortium for Regenerative Medicine."The design allows natural daylight into the facility improving the energy efficiency. It also features shading devices, displacement ventilation and low-flow plumbing fixtures.
Certified wood has been used in the construction of the facility. Use of potable water has been eliminated for irrigation, increasing efficiency of water-usage by 40%.
Alternative transportation and public transit are encouraged by incorporating changing rooms and facilities in bikes parking area.
The facility was designed by Fentress Architects in collaboration with Davis Architects. The development was handled by a consortium of Lankford and Associates and Phelps Development.
HOPE Engineering provided structural engineering services for the project and Hensel Phelps Construction was the general contractor. Jacobs' Consultancy-GPR was the lab programmer.
Belgian biopharmaceutical firm Ablynx has been granted an extended Certificate of Good Manufacturing Practice (GMP) from the Federal Agency for Medicines and Health Products (FAMHP) in Belgium for its new GMP unit at its headquarters in Ghent, which was inspected in November 2011.
Ablynx’s GMP unit will now perform release-testing on drug substance and drug product batches and independently perform all stability studies on these batches. The large scale GMP manufacturing of nanobodies will continue to be outsourced to contract manufacturing organizations (CMO).
Dr Edwin Moses, chief executive of Ablynx, said the GMP certification is a testament to the firm’s commitment consistently to perform at a high standard in its internal and partnered development programs.
‘This is an important step forward as we continue to transform into a product-based company,’ he added.
Ablynx currently has more than 25 programs in its pipeline and seven nanobodies in clinical development. The firm has ongoing research collaborations and partnerships with Boehringer Ingelheim, Merck Serono and Novartis.
BioCity Scotland, a joint venture between BioCity Nottingham and Roslin BioCentre in Midlothian, has acquired the former MSD research facility at Newhouse, Lanarkshire. The plan is to turn the site into a dedicated base in central Scotland for bioscience, pharmaceutical, medical technology and healthcare companies.
MSD closed the site in 2010 with the loss of 250 jobs following its £30m takeover of Schering-Plough.
The site includes 130,000 sq. ft. of purpose-built laboratories on the 23-acre site, which are capable of supporting pre-clinical drug discovery and development by a range of independent companies. It will complement the existing provision of space for life science firms in Scotland by catering to start-up and growing companies wanting a central base on the M8 just 15 miles from Glasgow and 33 miles from Edinburgh city centers.
In addition to the laboratory and office space, BioCity Scotland provides access to state-of-the-art equipment, including high-throughput screening, nuclear magnetic resonance machines, mass spectrometers, HPLCs, electrophysiology and cell culture suites, centrifuges and freezers, which will be available to rent at competitive rates.
A compound management system and a library of 100,000 compounds is also part of the offering.
BioCity Scotland Chairman Louis Nisbet said: ‘BioCity Scotland is much more than a property proposition – it will be a unique, vibrant community of scientific companies. Just a short drive from Scotland’s two largest cities, it is ideally situated to attract the cream of life science talent. BioCity Nottingham’s success in nurturing and growing more than 70 new companies since 2003, and Roslin’s expertise in life sciences innovation and facilities management makes this team the perfect commercial partnership. The work starts now, the prospects are boundless.’
Hikal, an Indian supplier of active ingredients and intermediates to the pharmaceutical industry, has started construction of a new multipurpose, multi-product API plant, which will be operational by June 2012.
The flexible plant will be able to manufacture four APIs simultaneously under GMP and consists of two parallel streams running simultaneously with quick changeover capability.
The plant will also be able to accommodate 32 reactors with capacities ranging from 6m3 to 10m3, resulting in a total reactor volume of approximately 300m3.
A wide range of reactions will be carried out in the new plant, including nitration, liquid phase Oppenauer oxidation, Swern oxidation, Suzuki reaction, chiral synthesis, Mannich reaction, Friedel Craft reactions and more.
The firm says the reactors will be a combination of stainless steel and glass lined. Equipment for isolation and drying such as agitated nutsch filters, centrifuges and various types of dryers will also be installed.
Hikal has five manufacturing facilities in India at Maharashtra (Taloja and Mahad), Gujarat (Panoli) and Bangalore (Jigani), including an R&D centre and a dedicated contract research facility, Acoris Research, in Pune.
Piramal Healthcare says expanded antibody drug conjugate (ADC) capacity will support the launch of new cancer drug by US biotech partner.
The expansion, at Piramal’s plant in Grangemouth, Scotland, added extra manufacturing and quality control (QC) laboratory space.
Piramal also unveiled plans to add commercial scale manufacturing suites which, spokeswoman Nicole Tingley, described as a significant step forward for an increasingly important part of the firm’s manufacturing business.
“By adding production capacity of launched products to our proven development and clinical trial phase expertise the new investment offers long-term benefits to customers developing ADC products.”
ShangPharma has revealed its newly opened 100,000 sq. foot facility will serve the growing capacity needs of pharma giant Eli Lilly.
In November, Outsourcing-Pharma broke the news that the China-based contract research organization (CRO) will use the plant for an un-named major customer’s operations as part of its plans to strengthen relations to its top clients.
After this month opening the facility – which includes laboratory and office space – the firm announced it would be dedicated to supporting Lilly’s on-going and future projects. The ribbon-cutting coincides with a multi-year extension of ShangPharm’s contract with Lilly.
“We are delighted to extend and deepen our highly productive relationship with Lilly,” said Michael Xin Hui, founder and CEO of ShangPharma.
“Renewing our agreement to serve as a key support partner for Lilly's discovery services is a clear indication that international pharmaceutical companies appreciate the high quality of ShangPharma's team and the excellence of our R&D capability.”
Neither firm gave any hint towards which projects Lilly will carry out in the new lab.
However in November, Hui said the site will accommodate continued fast growth for in-vivo pharmacology, with oncology and metabolic disease work particularly in demand.
The news backs Lilly’s recent announcement that it will increase R&D (research and development) spending in 2012 despite a steep projected drop in profits.
Commenters attribute the decline in large part to the firm’s Zyprexa schizophrenia treatment’s patent expiry – a gem which has earned $4.5 billion-a-year for the company.
CFO Derica Rice said that Lilly had been preparing for Zyprexa’s generic competition with a streamlining plan that has seen it cut more than 7,000 jobs since 2004.
“Having substantially reduced our infrastructure, we are positioned to fund the R&D that will drive our future growth” Rice said.
Steris Corporation, a US provider of infection prevention and surgical products and services, has opened a new Centre of Excellence and European headquarters in Bordeaux, France.
The state-of-the-art facility brings together marketing, R&D, manufacturing, and sales and customer services under the same roof, which the firm says will ensure closer ties between technical and application specialists and the R&D team and allow more rapid development of new products.
The 8,000m2 (86,080 sq. ft.) building currently houses more than 150 staff relocated from Steris facilities in France, Switzerland and the UK. More than 100 additional posts will be created in the next few years, the firm says.
This expansion and centralization of resources will allow Steris to offer locally designed global solutions for infection prevention and contamination control, as well as surgical and critical care technologies.
The Centre of Excellence includes technical training facilities and a large showroom alongside the R&D, manufacturing and customer support functions. Together with a new Centre of Excellence for Sterility Assurance in Leicester, UK, the Bordeaux facility will provide comprehensive services to better serve medical professionals and improve patient outcomes across Europe, Middle East and Africa.
More new laboratories are under construction at Pirbright which they hope to be opened in 2014.
The Institute for Animal Health (IAH) in Pirbright, Surrey, UK has completed a £10m hi-tech IS4L interim laboratory, which is packed with cutting-edge equipment to allow staff to deal safely with deadly animal viruses.
Dr Michael Johnson, Head of Estates at the IAH, says: ‘We need high containment-level laboratories that are fit for purpose. We work with the most dangerous animal pathogens and need the right facilities to do the work effectively.’
Funded by BBSRC and Defra, the Interim SAPO (Specified Animal Pathogens Order 1998) 4 Laboratory (IS4L) is central to IAH's strategic priorities to enhance and protect animal health and ensure food security for the UK and the wider world.
‘The IAH runs a number of strategic programs that are all involved with looking at exotic diseases one way or the other,’ says Johnson. ‘The programs deal with the most economically important agents to the UK.’
IS4L will work on high containment viruses, such as FMD. The work in IS4L will primarily focus on animal virus diseases such as foot-and-mouth disease (FMD), African swine fever (ASF) and African horse sickness (AHS).
IS4L has been built to replace the main laboratory at IAH, which was closed down in 2007 following the foot-and-mouth disease outbreak at Pirbright that was contained.
‘This facility will ensure work on AHS, ASF and FMD can continue under the best conditions possible,’ says Johnson.
Diseases such as ASF and AHS – both of which have more than 90% mortality rate – show signs of changing distribution patterns, possibly due to climate change, and would be devastating to rural communities and the UK economy at large if outbreaks occurred on British soil.
The IS4L building has the best engineering standards applied to it to ensure that no pathogen can escape to the environment.
‘This is critically important to our work,’ says Johnson. ‘We want to make sure we are operating safely within the laboratory and so we have a number of layers of protection between ourselves and the environment.’
The new building, for example, features a unique secondary monitoring system that interrogates the primary building management system with real-time information on every single critical control, such as the air pressure and filtering systems.
The IS4L is part of a wider £100m+ development program at IAH that will eventually see another bigger, better laboratory replace the one that has only recently gone live.
‘It's currently in construction, on time and on budget, and we hope it will be ready by 2014,’ says Johnson.
The avian diseases division based at the IAH labs in Compton, Berkshire will also move to the new site in 2014 when IAH's operations are consolidated on one site.
‘By 2014 we should have the world's best high containment facilities,’ Johnson explains. ‘We are working to ensure that everything that goes in there is the world's best.’
An agreement struck between a Russian fund and two U.S.-based biotech startups is the latest example of Russia's desire to court Western biotech innovators. On October 27, the Moscow-based Russian Corporation of Nanotechnologies (Rusnano) fund invested $25 million each in BIND Biosciences, of Cambridge, Massachusetts, and Selecta Biosciences of Watertown, Massachusetts. As part of the deal, the two US nanobiotech firms will invest $22.25 million from new and current investors, and establish subsidiary facilities in Russia.
The agreements enable BIND and Selecta to conduct drug development in Russia as well as gain a foothold in the Russian market. “I completely saw the double opportunity,” says Selecta CEO Werner Cautreels. Lack of experience in taking products to market and bureaucratic holdups have kept foreign firms from engaging with Russia. But some organizational reforms geared towards helping the sector prosper are starting to build confidence, at a time when access to the Russian clinic trial network is proving attractive to both Western biotechs and big pharma.
The Wallace Wurth Building is the most recognizable building at the Kensington Campus in the premises of the University of New South Wales (UNSW) in Sydney, Australia. The building is home to the teaching and research staff of the Faculty of Medicine at the UNSW.
It has been named after the first Chancellor of UNSW Wallace Wurth, for his contribution towards the establishment of the Faculty of Medicine at the UNSW.
The five-storey Wallace Wurth building is situated in the wing 'M' of the UNSW Campus. It is located in the corner of the campus and runs in the north and south directions along Botany Street and High Street.
The biomedical research building is being expanded to create additional space for the academicians and students of the Faculty for Medicine to focus on research practices. Biomedical research at UNSW is focused and more practiced in the fields of neuroscience, molecular biology and pharmacy, epidemics, cardiovascular and cancer.
The new building will also house the National Centre in HIV Epidemiology and Clinical Research (NCHECR) which will be shifted from the Darlinghurst Campus.
The project was approved by the New South Wales Government in January 2011 and is currently underway construction. The project work commenced in August 2011 and is scheduled to be completed in March 2014.
The existing building is 12,800m2 (137,728 sq. ft.0in size. The expansion project will witness the addition of 10,000m2 (107,600 sq. ft.) to make way for a single building size of more than 22,800m2 (245,328 sq. ft.).
The facility's design will meet Green Star Education v1 star certification requirements. The existing facilities will be retained wherever possible and the ones that need to be changed will be refurbished.
The redeveloped building will have six levels with a roof plant excluding the lower ground floor and the floor above it.
The completed facility will accommodate 1,400 research staff and 700 students of the Faculty of Medicine's School and the Kirby Institute.
The redeveloped Wallace Wurth Building will complement the new Lowy Cancer Research Centre and the Biological Sciences Building that was completed recently at the UNSW Campus. It will facilitate sharing of knowledge and resources within the UNSW campus.
The facility houses wet and dry research areas for undergraduate and postgraduate medical teaching and research staff.
The ground floor and level one will be dedicated to the undergraduate medical teaching staff. It will comprise of the lecture and seminar rooms with audiovisual facilities, small group spaces, clinical teaching rooms and wet research area.
The lower ground floor has already been refurbished. It now has a new morgue with walk-in stainless steel cold rooms equipped with -20°C freezers. Special laboratory services and back-up generators will be stationed at this level.
Levels two to six will comprise of wet and dry research areas and also house a laboratory, write-up space and research equipments for use by the postgraduate students and academicians.
Other facilities at the renovated building will include special purpose areas such as animal facilities and administration and infrastructure support.
The building's footprint will be expanded to the north and south of the 'M' wing. An atrium running through the full length and height of the building will connect all the floors in the east and west side of the wing.
The new building has been designed by LahzNimmo Architects and Wilson Architects. Lend Lease was awarded the A$122.5m ($122.1m) project management contract for the expansion in June 2011.
Taylor Thomson Whitting and AECOM are the structural and mechanical engineers respectively. The morgue in the lower ground floor was refurbished by the Buildplan Group.
Other contractors signed for the project are Aurecon as electrical engineer, Design Coalition as lighting specialist, LHO Group as hydraulic engineer, Meinhardt as fire engineer, The ENTS as arborist and Spackman Mossop Micheals performing as landscape architect.
Roche's new R&D facility is located in Wettsteinallee near Basel, Switzerland. It was officially inaugurated in November 2011. Roche made an investment of $271m in the Wettsteinallee site.
"Roche's new R&D facility is located in Wettsteinallee near Basel, Switzerland. It was officially inaugurated in November 2011."Designated as Building 97, the new facility replaces one of Roche's older buildings - Building 60. The facility will be used for producing pharmaceutical formulations and also manufacturing samples for clinical trials.
The plant will employ 100 people who will be moved from Roche's plants at other locations. It strengthens Roche's presence in Basel where the company employs nearly 9,000 people.
Various functions of the pharmaceutical value chain already exist in Basel. The new plant will be an important addition to Roche's facilities and establish Basel as a global research and development center.
The new plant will also help in increasing Roche's workforce in Basel. Several big pharmaceutical companies including Roche have been on a cost cutting spree due to increasing competition. Roche cut sales and manufacturing jobs especially in the US in 2010.
Roche's R&D activities are centered on developing a new medicine which is safe, tolerable and stable. Once a medicine is discovered, further research is carried out to market the drug in the form of a tablet, capsule, liquid or a pre-filled syringe.
Formulation is an important step in the development of a medicine as it enables it to be administered to patients. It also enables the active ingredient in the medicine to reach its target and optimizes the amount of time it stays in the patient's body.
The new facility will specialize in this research and help bring innovative drugs to the market. It will carry out R&D to transform new active substances into various solid and liquid dosage forms. The plant will also produce samples of new investigational drugs to be used in global clinical trials.
The new R&D facility was designed to blend in with the existing buildings in Wettsteinallee. A glass facade similar to Roche's other buildings was, therefore, not chosen for the plant.
The design of the facility is clear and compact featuring ribbon windows and white parapets. Its architecture is based on the Bauhaus tradition.
The northern part of the facility is spread over four stories and is 20m high. The southern part includes nine stories and is 40m high. Gross floor area of the building is 22,705m2 (244,305 sq. ft.).
The main structure of the R&D plant was constructed out of steel and reinforced concrete. It is capable of supporting heavy loads of up to 35t.
The plant includes 670 rooms including 239 cleanrooms and features 42km of piping and 676km of cabling. It also includes three basement stories. The facility has been designed to be energy efficient and earthquake resistant.
Construction activities at the Wettsteinallee site commenced in August 2008 with the demolition of Building 60. In January 2009, Roche laid the foundation stone for the plant.
The plant required pouring of 32,500t of concrete, use of 1,750t of steel reinforcement and 530t of steel girders. For the construction of the basement, 25,000m3 of material was excavated. A major part of the supporting structure was prefabricated enabling construction to be completed quickly.
The main engineering contractor for the facility was M+W Process Industries. The company was also responsible for HVAC, process and mechanical engineering and clean room engineering.
"The facility will be used for producing pharmaceutical formulations and also manufacturing samples for clinical trials. "Herzog & de Meuron was the architect for the project. The company also provided planning and construction development services.
Structural engineer for the facility was ZPF Ingenieure. Proplaning Architekten was the quantity surveyor.
Dr. Heinekamp Labor und Institutsplanung was responsible for laboratory engineering. IB Albrecht was responsible for plumbing engineering services. KIWI Systemingenieure & Berater, Dübendorf was responsible for providing electrical engineering services.
Emmer Pfenninger Partner was the facade consultant for the project and Zimmermann + Leuthe was responsible for the building physics.
Fire protection and safety consulting services were provided by Sicherheitsinstitut. Martin Lienhard was responsible for designing the building acoustics.
York University will shortly be taking delivery of a number of priorclaves for use in the biology department's teaching laboratories and associated central wash-up and sterilizing facilities, the third contract to be awarded to Priorclave by the university in the past 12 months. The operations manager at York University specified the Priorclave brand of autoclaves because of their inherent and proven energy efficiency, enabling the department to reduce significantly its day-to-day operational costs. This was a key factor in changing to priorclaves since all utility supplies along with media disposal costs are levied direct to the university.
The department of biology is internationally renowned for the strength and quality of its research, teaching and state-of-the-art facilities, and is consistently ranked as one of the top biology departments in the country. The spacious modern teaching laboratories provide an outstanding research environment for studying cancer, immunology and tissue engineering, to novel agricultural products, environmental studies and bio-archaeology.
For the ultra-modern teaching laboratories, Priorclave is supplying a 350l autoclave featuring a 'square' chamber, providing sufficient capacity to sterilize everything from small and medium-sized containers to large canisters and other plastic items. Despite its large chamber the 350 autoclave has a small footprint ensuring that York University can maximize the teaching area. Effortless access to the front-loading chamber is gained by the two hand-wheel door closure system.
It is the combination of standard functions such as delayed start and media warming for ready to pour media at the start of the day plus automatic timed freesteaming for improving air removal and sterilizing performance that contributes to the speed at which the priorclaves can move from an off status into a full on-start for steam sterilization. It proved a major factor in winning the contract for the biology department.
As part of this contact, Priorclave is to supply a high-capacity steam sterilizer, a 700l autoclave for the central wash-up and sterilizing facility to ensure complete sterilization of all medium and other waste by-products generated by more than 30 research groups located in the department of biology. This large, front-loading rectangular chambered autoclave also has an easy-open/close door locking system activated by three hand-wheels.
The addition of Priorclave autoclaves at York University ensures that the biology department, which is recognized as one of the leading biological science departments in the UK, maintains the highest of standards in sterilization in the laboratory to prevent cross contaminations, as well as in the central wash-up facility for the safe disposal of deactivated waste material from research experiments in-line with legal requirements.
Gulf Pharmaceutical Industries is set to become the first insulin maker in the Middle East with its new $136m plant in Ras Al Khaimah, UAE.
The firm – otherwise known as Julphar – hopes the factory, which is capable of producing up to 50 million vials of the raw material for insulin per year, will fill a gap in the local market, where over 90 per cent of pharmaceuticals are imported.
With obesity related diabetes on the rise in the region – the World Health Organization (WHO) estimates almost a fifth of the population are affected by the disease – insulin is one of the most sought after medications.
The International Diabetes Federation (IDF), who has partnered with Julphar over the deal, also believes that the number diabetics in the UAE – 32.6 million – will soar by 80 per cent by 2030.
The plant will begin production within the next few weeks. The company says that producing the drug locally will help lower costs to patients.
Through its partnership with IDF, Julphar CEO Ayman Sahli hopes to become a serious contender in the market.
He said the alliance will help the business diversify its business and become a “real investor in healthcare.”
“We will work very closely with the IDF in the coming months to begin various tailored regional campaigns in order to raise awareness of the epidemic as we look to take up the role of not only as producers of medicine, but also providers of care,” he said
Delphine Sartiaux, account manager for IDF, said that the partnership extends the organization’s reach in the Middle East. It is already working with Kuwait Finance House in the finance sector, and Landmark Group, who is a retail arm.
Julphar, who recently reported its highest ever sales figures of $272.2m (€212m) in 2011 – a revenue boost of 11.3 per cent – has set its sights on further growth in the Middle East this year.
And in the wake of recent turbulence for the country, the firm plans to cash in on the increase in demand for medication in Libya by expanding production capacity at its RAK plant by as much as 30 per cent this year.
Chief financial controller Krishna Gopa told Gulf News: “There has been turbulence in the Middle East but the pharmaceutical industry was not really affected significantly because it is immune from these crises. Sometimes it brings us opportunities.”
Furthermore after receiving some government tenders from the Iraq government, the firm also plans to enter the private market in the country. Gopa added: “More people are consuming drugs and we are enhancing our marketing there.”
Due to new project orders for production of diagnostic and pharmaceutical consumables, Balda Medical has recently enlarged its cleanroom capacity by 50% to 2,500 square meters (26,900 sq. ft.). These products have to fulfill, among other requirements, the highest standards regarding particle load, so the clean room production areas are in line with the requirements of ISO Class 8 according to EN ISO 14644.
In total, Balda Medical uses an area of 14,100 square meters (151,716 sq. ft.) at the site in Germany. A share of 6,200 square meters (66,712 sq. ft.) of this area is used for production. Space for further extension of the production capacity is available at Balda Technology Park.
Mozambique health minister Alexandre Manguele has confirmed that the country will begin producing its own antiretrovirals to combat high HIV rates, becoming the first African country to do so outside of the private sector.
The minister added that the first antiretrovirals, produced in partnership with Brazil, will be ready by July 2012.
Antiretrovirals have been proven to prolong the lives of HIV sufferers significantly, but a lack of production in Africa and high import prices have slowed their distribution.
According to an interview with Maputo-based Noticias, a deal has been struck between the Southern African country and Brazilian ambassador Antonia Silva to co-produce the drugs in a factory in the southern city of Matola.
Brazil will provide training as well as technical oversight.
The National Academy of Sciences of Belarus (NASB) launched a new institute to provide genetic testing and research services in Minsk.
The new National Center of Genome Biotechnology will provide services for determining the presence of genetically modified ingredients in food raw materials and agricultural products, to identify DNA markers for certification of crop varieties, and to identify the genes responsible for valuable characteristics and diseases in animals and individual human traits.
According to the state-run Belarusian Telegraph Agency, the center opened at the Institute of Genetics and Cytology at the NASB. It will support government agencies including the Ministry of Agriculture and Food, the Sport and Tourism Ministry, and the Ministry of Natural Resources and Environment.
The National Center of Genome Biotechnology, which has received certification for ISO quality management standards, will reach its full testing capabilities in about a year, when it will provide at least 6,944 tests per year.
Syntagon will implement a restructuring program designed to improve its offering to customers in the field of drug substance development.
The company's Sweden-based operations, Syntagon AB, will focus and strengthen its customer-oriented expertise within drug substance development, quality assurance and regulatory support, while the Latvian site, SIA Syntagon Baltic, will ramp up capacity and know-how within the field of preclinical and clinical deliveries of drug substances. The moves will result in the relocation of several positions from Syntagon’s Sweden base, south of the Swedish capital Stockholm, to the company’s Latvian site.
“The reorganization will enable Syntagon to build more dedicated core competence areas, while maintaining the high quality of service Syntagon has been delivering to its customers worldwide for the past 13 years,” says Syntagon's chief executive officer, Andis Slaitas.
Merck & Co., Inc., known as MSD outside the United States and Canada, announced the establishment of an Asia Research & Development (R&D) headquarters for innovative drug discovery and development located in Beijing, China. The new facility is part of a $1.5 billion commitment the company has made to invest in R&D in China over the next five years.
"The establishment of the MSD Asia R&D headquarters represents an important milestone as we implement our strategy of building capabilities, and relationships to succeed in fast growing geographic regions," said Peter S. Kim, Ph.D., president, Merck Research Laboratories. "By strategically locating in China, we are able to complement our existing R&D capabilities, and facilitate new collaborations with scientists in the region and across emerging markets."
Located in Wangjing Park, one of Beijing's rapidly expanding science and technology parks, the facility will consist of 47,000 square meters (505,720 sq. ft.) of office and laboratory space. The first phase of construction, scheduled to be completed by 2014, will provide capacity for approximately 600 employees working in the areas of drug discovery, translational research, clinical development, regulatory affairs and external scientific research programs.
"Merck/MSD has a proud legacy of translating scientific breakthroughs into novel medicines and vaccines with proven ability to impact global human health," said Michel Vounatsos, chairman and president, MSD in China. "We are immensely proud of the impact that MSD's medicines and vaccines have had on improving health for the people of China as we have grown our business here, and we are eager to build on this legacy by directly investing in R&D here in China to bring forward more innovations that can help people in China and around the world."
Merck conducts research in a broad range of therapeutic categories including cardiovascular disease and diabetes, which are becoming increasingly prevalent in China. The company's global scientific strategy is focused on retaining deep internal therapeutic area and functional expertise in core therapeutic areas while strategically collaborating to access external innovation.
Merck also maintains its commercial headquarters for MSD in China in Shanghai and has manufacturing capabilities at other locations throughout China.
Lonza has expanded small molecule production capacity at its plant in Nansha, China to meet demand for clinical trial materials.
Spokeswoman Melanie Disa said that Lonza has added a new cGMP (current good manufacturing practice) standard kilo-lab and a small scale active pharmaceutical ingredient (API) production line.
She added that “The motivation for the expansion was to provide increased flexibility for our customers to be able to more quickly respond to customer needs for clinical material.
The investment is in keeping with comments the Switzerland-based supplier made when it reported that strong demand for APIs and chemical intermediates produced at the Nansha facility was the key growth driver for its custom manufacturing business.
In other manufacturing news Lonza has launched a new microbial-based development and production platform for plasmid DNA vaccines and therapeutics.
The technology – available at the firm’s facilities in Hopkinton in the US and Visp in Switzerland – combines fermentation, primary recovery and purification to produce plasmid DNA in an approach that, Lonza claims, is faster than other methods.
Lonza also claims that the strain of Escherichia coli used for production – which was created by Scarab Genomics LLC – has a genome that is 15 per cent smaller than the K-12 strain from which it was developed.
The significance of this is that the ‘Clean Genome’ organism lacks the insertion sequences that can – by switching position in the genome during fermentation – impact on the quality of the pDNA that is produced.
Marken has expanded its services in Latin America with its new, purpose-built Buenos Aires facility. The move is part of Marken's plan to build "the most advanced, fit-for-purpose clinical distribution network to serve the pharmaceutical community," according to a company statement.
"The expansion of our services in Latin America enables our clients to better recruit in treatment naive populations and work with previously unreachable investigator sites, assuring quality and regulatory documentation through the entire supply chain." said Wes Wheeler, Marken's chief executive officer. "Our goal is to be the premier provider of life sciences supply chain services."
The new Argentina depot builds on Marken's current Latin America business, which serves more than 1,200 clinical research investigator sites in the region. Marken is developing additional depot facilities in Europe, Asia and the Americas.
The Argentina depot joins Marken's already operational Mexico and Singapore depots offering the full range of temperature-controlled storage capabilities, including controlled ambient, refrigerated (2° to 8° C), frozen (-20° C), as well as a secured area for controlled substances. Each of Marken's depots provides drug and equipment distribution solutions, including Pick & Pack, relabeling services, reverse logistics, reconciliation and certified destruction. Additionally the network manages specimen kit distribution, interim specimen storage and management.
AstraZeneca entered into an agreement to acquire Guangdong BeiKang Pharmaceutical, a privately owned generic-drug manufacturing company based in Guangdong province, China, for an undisclosed amount. Guangdong BeiKang Pharmaceutical’s portfolio includes injectable medicines used to treat infections. Upon completion of the acquisition, AstraZeneca will be responsible for the manufacture and commercialization of these medicines. The deal is contingent upon approval from the Ministry of Commerce in China and is expected to close in the first quarter of 2012.
AstraZeneca first established a presence in China in 1993 and has invested around $500 million in China since that time, according to a company press release. In October 2011, AstraZeneca invested $200 million in a new manufacturing facility located in the Jiangsu province that will produce intravenous and oral solid medicines for the company’s growing business in China. The acquisition of Guangdong BeiKang Pharmacuetical accelerates AstraZeneca’s strategy, which aims to increase the accessibility and affordability of medicines for wider patient populations that are currently underserved.
“AstraZeneca continues to invest in the key emerging markets such as China where the combination of growing populations, elevated levels of chronic diseases, and increasing income are driving demand and expectations for better healthcare treatment,” said Mark Mallon, president of AstraZeneca’s Asia-Pacific region, in the press release. “Our new acquisition further underscores our intention to serve the health needs of Chinese patients through our innovative medicines and, increasingly, high-quality branded generic treatments that are locally produced to global standards.”
The Lowy Cancer Research Institute, located in the premises of University of New South Wales (UNSW), Sydney, is the largest dedicated cancer research centre in southern Australia. It is also Australia's first combined and dedicated adult and children cancer research institute. The A$100m ($127m) facility was completed in November 2009 and officially opened in May 2010.
The facility is shared by 400 researchers of the University's Faculty of Medicine and Children's Cancer Institute of Australia (CCIA).
"The Lowy Cancer Research Institute project was also financially supported by both the government and private organizations." Sharing of the facility's equipment by the adult and children cancer research institutes is expected to provide cost saving on the heavy equipment.
The building was constructed from the sale proceeds of Little Bay facility located on the outskirts of Sydney. The Little Bay site was previously occupied by the Prince Henry Hospital, constructed in the late 1800s and early 1900s for the treatment of epidemics. The site was made available for residential use in 2001 after the transfer of the hospital services to Prince of Wales Hospital.
The Lowy Cancer Research Institute project was also financially supported by both the government and private organizations. The institute is named after Frank Lowy, a leading businessman and philanthropist who donated $10m towards the construction of the new building. It is the largest amount ever received by the university in the form of a donation.
The NSW Government and the Federal Government supported the project through a grant of $18.3m and $13.3m respectively given to the CCIA. The Australian Cancer Research Foundation (ACRF) donated about $3.1m to make space for the Drug Discovery Centre for Childhood Cancer.
The facility is built alongside three teaching hospitals, including the Wallace Wurth teaching facility to facilitate the knowledge transfer of research discoveries into actual patient care.
The Lowy Cancer Research Institute has a floor area of 16,800m2 (180,768 sq. ft.) and is an eight-storey building.
The two in-ground basements house specialist equipment. The next four floors (level 1 to level 4) comprise wet laboratories with write-up space. The movement between these levels is facilitated by an internal lift. Equipments are placed to the north side of the laboratories with write-up space created in the south side.
Keeping this classification in mind, the northern façade of the building is mostly concrete-built to avoid sunlight falling on the equipment. In contrast to this, the southern façade is attractive and has a combination of glazed and vertically shaped green aluminum bands. The ceiling on the south of the building is stepped-up and provided with a large size window to provide garden views.
The seventh and the eighth floors of the facility provide room for administration services, dry research, seminars and staff entertainment.
The wide corridors at each level provide space for informal associations and semi-open plan work areas for the researchers. The upper levels of the new building and the Wallace Wurth Medical Faculty building are bridged by the corridor's core. A diagonal path between these two buildings serves as a pedestrian entrance to the building as well as the garden.
The foyer is built vertically and spans all the six floors as an atrium.
The building is powered by a 770KW gas-fired co-generation electric plant connected parallel to the main grid. The power is distributed throughout the campus via an on-site high voltage ring main. This unit is estimated to save up to 1,600 tons of carbon dioxide a year.
The institute will carry out clinical trials on an anti-mitochondrial cancer drug to be used in patients suffering from bowel cancer.
Clinical trials were carried out on the earlier version of this drug in the UK. The new trials will however be carried out on Australian patients.
"The Lowy Cancer Research Institute has a floor area of 16,800m2 (180,768 sq. ft.) and is an eight-storey building."It is constructed on the northern end of the UNSW campus. The floor area increased by 30% during the design phase and as a result the northern façade could not be built further back from the street. The project is still not 100% complete as the adjacent Faculty of Medicine building is under renovation, which is scheduled to be completed by 2013. This will include a new north façade.
The construction had to be carried with the university staying open. The site required remediation as the ground water was contaminated. For this purpose, the land was excavated and layered with pieces of rock to control the incoming ground water.
As the facility was being constructed adjacent to the Wallace Wurth teaching facility, vibrations and sound resulting from the building construction were controlled and monitored to the lowest level.
The building design and landscape was provided by Lahz Nimmo Architects and Wilson Architects. They won the bid through a competition.
Lend Lease of Australia provided the construction and project management services.
The main engineers involved in the project were Taylor Thomson Whitting for structural and façade engineering, Knox Advanced Engineering for mechanical engineering, Warren Smith and Partners for the hydraulic and fire services, Aurecon for electrical and lighting engineering and Arup for fire engineering.
SC Medical Gases was the medical gases consultant. Steve Watson and Partners provided consulting and approval services. Acoustic Studio was the acoustic consultant.
The co-generation electric power unit was provided by Cogent Energy.
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