PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY UPDATE
June 2012
McIlvaine Company
TABLE OF CONTENTS
Sentry BioPharma Services Invests in Expansion
Proposed Kansas Biocontainment Lab Still Inadequate, Risky
Batavia Opens Massachusetts Facility
Rollprint Announces New Cleanroom
Smith & Nephew Spins off N.C. Biologics Unit into Joint Venture Bioventus
Particle Sciences Expands cGMP Capabilities
Catalent Increases Sterile Fill-Finish Capacity
NIMH to Fund Center for Genomic Studies of Mental Disorders
University of Miami Breaks Ground on Marine Life Sciences Lab
Progenika Gets CAP Accreditation for Lab
Silicon Biosystems has Opened Lab Facilities in San Diego
Sorenson Molecular Biotechnology Building Opens in Utah
Clinilabs Opens New Phase I Unit
Haberberger Completes Project on UMSL Campus
Massachusetts Accelerator for Biotechnology Planned
Construction of Nursing, Natural Sciences and Biotechnology Building
Buck Institute Regenerative Medicine Research Center, California
Jennie Smoly Caruthers Biotechnology Building, Colorado
James L. Sorenson Molecular Biotechnology Building, Utah
North Dakota Funds Life Sciences Center
U.S. FDA Approves Bristol-Myers Squibb Devens Biologics Manufacturing Facility
Quintiles Deepens Investment in China
Ubichem boosts Fine Chemical Output with Hungary Plant
Eli Lilly Expands Manufacturing Base in China
Vetter Expands Its Capacities and Services for Prefilled Syringes
UBC Pharmaceutical Sciences Building, Vancouver, Canada
Sanofi Gains Regulatory Approval for Expansion at Site in Ireland
A New Cytotoxic Plant will be a Dedicated Facility at Helsinn
ShangPharma Builds Capacity for Lilly
Quintiles Launches China CRO, Kun Tuo
SGS Opens Second Facility in Mumbai
Life Technologies Establishes Manufacturing Facility in Singapore
Covance and BML Expand Lab Space
SAFC Launches Integrated Chiral Offering
Suzhou Pharma Opens U.S. Corporate Offices
Nestlé Centralizes Clinical Research in New Centre
Terumo BCT Invests in Vietnam Plant
Boehringer Ingelheim to Establish European Pilot Plant
Eli Lilly Opens Center in Shanghai
SafeBridge Certifies Baxter Facilities in Germany
Takeda to Acquire Multilab of Brazil
NSF-DBA, Semler Research Center in India Pact
Novozymes Begins Commercial Supply from China Facility
Randox Opens New Manufacturing Facility in Bangalore, India
Sentry BioPharma Services, a provider of global biopharmaceutical cGMP storage, supply chain management, prescription drug distribution and clinical packaging services, announced the addition of a -45C environmental room to its cGMP facility in order to accommodate clients in need of clinical trial depot services and bulk cGMP storage. The expansion increases Sentry's capacity to warehouse and distribute temperature-sensitive pharmaceutical products including APIs, intermediates, clinical trial materials and commercial drug products.
Tim J. Mitchell, Sentry's president, notes, "The highly customized -45C freezer enhances Sentry's ability to serve global biopharmaceutical clients' clinical sites through a single depot location centrally located in North America. Recently, a large, publicly held biotechnology company selected Sentry based upon our proven track record of success, our robust quality management system, pristine regulatory compliance record and expertise as the premier provider of clinical supply depot services. Further, Sentry identified a strong need within its European client base for clinical trial depot and API management services at this crucial temperature setting."
Mitchell continues, "By further building Sentry's risk management approach to the specialized handling of temperature-sensitive biopharmaceutical products, we are better able to assist our clinical trial clients in devising and implementing custom secondary labeling, packaging configurations, and depot service solutions at Sentry's headquarters. This investment strengthens Sentry's position as a leader in the biopharmaceutical industry and contributes to new market expansion."
"Sentry will complete validation of the -45C freezer next month," says Dwayne Marcum, Sentry's chief operations officer. Marcum adds, "Upon completion, the 1,200 square foot chamber will complement Sentry's existing ambient (15C to 25C); refrigerated (2C to 8C); frozen (-15C to -25C) and ultra low (-70C to -90C) environments. The -45C environmental room is unique in that it was specially designed and built to continuously operate with triple redundancy, using state-of-the art refrigeration, temperature monitoring and controlling systems to provide optimal product safety and efficacy."
Since incorporating in 2005, Sentry has always embraced an innovative approach to solving technical challenges by offering tailored, high-quality services among the most stringent international regulations. Sentry's on-demand services continue to reliably offer pharmaceutical and biotechnology companies with superior service, immediate regulatory compliance, speed to market and a high probability for a successful project outcome.
Sentry BioPharma Services maintains cGMP temperature-controlled storage for vaccines and other biopharmaceutical product, controlled substances III - V, FDA labeling capability, drug distribution licenses and an active Foreign Trade Zone status to exclusively serve the global pharmaceutical, biotechnology and healthcare industries. Its facilities, infrastructure and services are specifically designed to meet the cGMP warehousing, labeling, packaging, cold chain logistics and contract service needs of pharmaceutical and biotech firms, health care providers and suppliers, contract research organizations (CROs), contract manufacturing organizations (CMOs), wholesalers, distributors and governmental entities.
Sentry's management team offers expertise in pharmaceutical cold chain storage and logistics, quality assurance, biopharmaceutical packaging and kitting development. Sentry also offers strategic solutions for global transportation and logistics, as well as end-to-end import and export management.
The company's validated processes and inventory tracking systems are FDA compliant, adhere to current Good Manufacturing Practices (cGMPs) and comply with the stringent standard operating procedures (SOPs) outlined in Sentry's Validation Master Plan. Sentry is VAWD® accredited, which ensures its storage, handling and distribution methods meet the recognized guidelines of the National Association of Boards of Pharmacy®. The company is privately held and strategically headquartered in Indianapolis.
A new National Research Council report requested by Congress finds the U.S. Department of Homeland Security's updated site-specific risk assessment for the proposed National Bio- and Agro-Defense Facility (NBAF) in Manhattan, Kan., a "substantial improvement" over the original 2010 version, but it has a number of deficiencies and inadequately characterizes the risks associated with operating the facility.
The NBAF would be the world's fourth Biosafety Level 4 laboratory capable of large animal research, replacing the aging Plum Island Animal Disease Center located off Long Island. It would study dangerous foreign animal diseases- including highly contagious foot-and-mouth disease (FMD), which affects cattle, pigs, deer, and other cloven-hoofed animals- as well as emerging and new infectious diseases that can be transmitted between animals and people. In 2010 the Research Council reviewed the original site-specific risk assessment by DHS and found that it was inadequate due to flawed methods and assumptions. In response, Congress mandated that DHS revise its assessment to address shortcomings and directed the Research Council to evaluate the updated assessment, which is the focus of this report. Another Research Council committee, whose work is separate from this report, is examining the needs and possible scientific alternatives for a foreign animal and zoonotic disease research laboratory in the U.S.
The committee that reviewed the updated risk assessment found that many of the shortcomings identified in the 2010 report have been addressed and that the new version uses more conventional risk assessment methods and conceptual models, presents clearer descriptions of the approaches, and complies better with standard practices than the previous version. However, some of the risk analysis methods were misinterpreted and misapplied when executed. The assessment also contains questionable and inappropriate assumptions that led to artificially lower estimates of the probability of an accidental pathogen release from the facility, the committee says.
Information from the 2010 risk assessment implies that for the two greatest release scenarios there is nearly a 70 percent chance that a release of FMD could result in an infection outside the laboratory over the 50-year lifetime of the facility. In contrast, the updated assessment concludes that for 142 possible release events, the cumulative probability of a release leading to an infection is 0.11 percent, or a 1 in 46,000 chance per year.
The committee noted that some of the risk reduction may be explained by improvements to the latest design plans for the facility, but despite improvements, the updated assessment underestimates the risk of an accidental pathogen release and inadequately characterizes the uncertainties in those risks. Moreover, the committee found that the updated probabilities of releases are based on overly optimistic and unsupported estimates of human-error rates; low estimates of infectious material available for release; and inappropriate treatment of dependencies, uncertainties, and sensitivities in calculating release probabilities. For instance, the 2010 assessment concludes that human error would be the most likely cause of release, and the previous Research Council report agrees. However, the updated assessment concludes that natural hazards, specifically earthquakes and tornadoes, would be 20 times more likely to cause a pathogen release than operational activities at the facility. The committee questioned whether natural hazards posed the greatest risk for accidental release of FMD and believed the updated assessment overestimated the release probabilities due to both kinds of natural disasters versus other pathways.
In addition, the low estimates of risk found throughout the updated assessment are not in agreement with most modern, complex industrial systems, and in many instances the committee could not verify results because methods and data were unevenly or poorly presented. The updated assessment also contains inconsistent information, which made it difficult to determine the degree to which risks were underestimated.
"A risk assessment of this nature carries significant complexities, yet the practice of completing such assessments is mature enough that the committee's expectations are attainable," says Gregory Baecher, chair of the committee and Glenn Martin Institute Professor of Engineering at the Univ. of Maryland, College Park. "Because a pathogen release from the NBAF could have devastating agricultural, economic, and public health consequences, a risk assessment that reaches inappropriate conclusions could have substantial repercussions."
The committee says the updated assessment addresses many of the issues outlined in the congressional mandate. However, it still does not adequately include overall risks associated with the most dangerous pathogens. Additionally, assumptions about surveillance, detection, response, and mitigation strategies were not adequately comprehensive or science-based.
The latest design plans for the NBAF appear to be sound, the committee says. It reviewed the design documents to understand the assumptions about the release probabilities for the risk assessment and to verify that design concerns raised in the previous Research Council report were addressed. The committee noted that inadequacies in the updated assessment do not imply inadequacies in the facility's design. It was beyond the committee's task to formally review or pass judgment on the actual engineering or safety of the facility.
The study was sponsored by the U.S. Department of Homeland Security. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies. They are independent, nonprofit institutions that provide science, technology, and health policy advice under an 1863 congressional charter. Panel members, who serve pro bono as volunteers, are chosen by the Academies for each study based on their expertise and experience and must satisfy the Academies' conflict-of-interest standards. The resulting consensus reports undergo external peer review before completion.
Canton biotech firm Organogenesis Inc. has opened a 13,000 square-foot research and development wing in the building where it’s been headquartered for the last two years.
Corporate Communications Manager Angelyn Lowe said the new wing, at 85 Dan Road, is part of a $63 million expansion the company began in 2009. The project expands the company from one to four buildings, and the company’s total square footage will grow by 300 percent when completed toward the end of 2013.
The developer of the skin treatment brand Apligraf, which received one of the first FDA approvals for a living, human cell-based product, according to the company, has seen “more than 20 percent growth” in both sales and revenue for the past several years, said Lowe, though she declined to give specific figures.
The expansion is being funded mostly by the company, with a $12 million life sciences grant from the state of the Massachusetts Life Sciences Center.
The new wing will house the R&D center, which has previously been in the company’s manufacturing facility at 150 Dan Road. Five new, large laboratories at 83 Dan Rd. will support ongoing research efforts and include a scanning electron microscope, equipment for time lapse photography, waste water neutralization and centralized cold storage.
Prior to 2009, the entire company was housed in the 79,000 square-foot building at 150 Dan Road, according to Lowe. In 2010, the company opened its new headquarters in a 78,000 square-foot space across the street at 85 Dan Road. The third building, at 65 Dan Road, was purchased last year, and 30 percent of the 78,000 square feet it houses will be storage, with additional space to accommodate growth. A fourth building, a 95,000 square-foot building at 275 Dan Road, is now under construction and will become the main manufacturing facility, leaving the current manufacturing space at 150 Dan Road for development of new products, said Lowe.
The company’s staff has ballooned along with the physical space, said Lowe. In 2009, when the company committed to staying in Massachusetts to get the life sciences grant, it had 325 employees, with 220 in state, and vowed to add another 280 in-state jobs by 2014. Today, Lowe said, the company has 505 employees, with 350 of those in Massachusetts. The company plans to add about 80 new positions by the end of the year.
Tate & Lyle opened its 110,000-square-foot innovation and commercial development global headquarters in Chicago, as part of its strategy to focus on specialty food ingredients and move closer to its customers.
The facility will also become the company’s regional headquarters for specialty ingredients in the US. Tate & Lyle said two years ago that it intended to relocate the divisional headquarters from Decatur, Illinois, and shifted its strategy to make its specialty ingredients business the focus of investment and long term growth. In its recent full-year financial results for the year ended March 31, the company said it saw sales by value in the sector rise 10 percent, while volumes were up 4% during the past year.
Volatile sugar prices and an ongoing interest in healthier ingredients have driven companies toward Tate & Lyle’s cost reduction projects, and the company has also been able to pass high input costs down the supply chain to increase value sales.
The new center, located in Chicago’s Hoffman Estates suburb, has been designed to foster greater collaboration between the company and its customers in new product development, and to accelerate the process of introducing new products onto the market. The facility includes food science research and processing laboratories, applications and technical services laboratories, a demonstration kitchen, consumer insight and testing facilities, a pilot plant, and prototype manufacturing facilities.
Speaking at the official opening ceremony, Tate & Lyle’s president of Specialty Food Ingredients Olivier Rigaud said: “Our new center demonstrates our commitment to develop distinctive, high-quality specialty food ingredients and solutions for our customers across the world.”
The company’s president of Innovation and Commercial Development Karl Kramer said: “The new center will enable us to collaborate more closely with our customers and deliver the creative solutions they need to stay ahead in today’s fast-paced and evolving global marketplace.”
Batavia Bioservices, a service provider aiding its customers in the development of complex biological medicines, has decided to launch a US facility in Woburn, Massachusetts. The company is headquartered in Leiden, The Netherlands.
Menzo Havenga, President and CEO of Batavia, said: “We have been growing more than four hundred percent in the past two years in the Netherlands and to keep up with customer demand we have decided to launch a facility in the Boston area.” Christopher Yallop, COO, adds: “We have chosen the greater Boston area due to its importance as a biotech cluster. Positioning ourselves here allows us to be close to our customers, which we deem extremely important in delivering on time and on budget.” Batavia Bioservices provides a one-stop shop from DNA cloning to Phase 1/2 clinical manufacturing for all major classes of biopharmaceuticals, including antibodies, proteins or vaccines.
The Woburn facility (± 5500 sq. feet), located at Cummings Properties’ TradeCenter 128, contains multiple BSL-2 laboratories dedicated to specific tasks including Molecular Biology, mammalian cell line generation, protein production, protein purification or assay development. The company has already hired six employees for the new facility, with plans to hire four more by the end of this year.
The announcement comes as the state is preparing to host the 2012 BIO International Convention, being held June 18-21 at the Massachusetts Convention & Exhibition Center.
Rollprint Packaging Products, Inc. is announcing the construction of a 6,000 sq. ft. cleanroom for the production of sterile medical packaging pouches. The cleanroom is expected to be fully operational in the second quarter of 2012.
The ISO Class 8 cleanroom will utilize Rollprint’s innovative material offerings. This vertical integration allows Rollprint to cost-effectively control the quality of the material being used in the cleanroom and assures best-in-class status.
“We started preparing for this two years ago with investments in vision systems, web cleaners and other equipment and procedures to minimize particulates in our film converting area. We wanted to properly address upstream criteria before taking the next step,” said Dwane Hahn, vice president of sales and marketing, Rollprint.
By definition, a cleanroom environment has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified size. ISO Class 8 cleanroom certification dictates the following maximum concentration limits for airborne particulate (particles/m3) according to ISO 14644-1: 3,520,000 at 0.5 µm; 832,000 at 1 µm, and 29,300
at 5 µm.
The upgraded capability has been driven by customer demand for domestic supply that has been produced in a clean room environment. Pharmaceutical, medical device and diagnostic/life science manufacturers are constantly looking for ways to reduce the number of contaminants that come in contact with their products.
“There is a big difference between ‘cleanroom environments’ that some manufacturers claim they have, and actual cleanroom certification. In a few months time, we expect to be able to announce to the industry that we have met the rigorous certification criteria and are producing pouches in our cleanroom,” Hahn explained.
The cleanroom will house five production lines capable of producing a variety of pouch structures for which Rollprint is known. This includes header bags, chevron, vented, three-side weld seals, corner peels, etc.
“Many of the packaging structures used today for pharma and medical device applications—such as film and foil header pouches, coextruded, peelable heat-seal films and silicon oxide/aluminum oxide composites—were first introduced to the industry by Rollprint. The new cleanroom capability builds on that legacy,” said Hahn.
Smith & Nephew‘s spinoff of its biologics and clinical therapies operation into a joint venture will keep the business at its present location in Durham, North Carolina.
But the unit, which will be majority owned by life sciences investing firm Essex Woodlands, will operate under the new name Bioventus. London-based medical technology giant Smith & Nephew and Essex Woodlands has invested in more than 120 life science and healthcare companies. They expect to close the deal in coming months.
Essex Woodlands will own 51 percent of Bioventus while London-based Smith & Nephew will retain a 49 percent stake. Smith & Nephew will receive $98 million cash, which will be used to pay down debt as well as a $160 million, five-year note from Bioventus.
Smith & Nephew operates three global divisions: Advanced Surgical Devices, Advanced Wound Management, and Biologics & Clinical Therapies. The Biologics & Clinical Therapies division is focused on less invasive treatments compared to “hardware-based” surgical options. Medical device products include Exogen, a bone healing system that uses ultrasound. Biologics & Clinical Therapies has grown from $52 million in revenue in 2004 to $223 million in 2010; $33 million of those 2010 sales coming from outside of the United States.
“We see tremendous growth potential with this new venture as more patients discover how active products can help heal and treat joint and bone ailments without invasive surgery,” Marty Sutter, founding partner and managing director of Essex Woodlands said in a statement. “Smith & Nephew has built an excellent business and we are excited about the prospect of working with the management team on the next phase of growth as it brings more active therapeutic products to market.”
But Smith & Nephew’s overall sales have disappointed and the company decided to pursue changes to improve performance. After the release of third quarter financial results, CEO Oliver Bohuon said the company needed to adapt faster to meet market challenges. In the conference call to discuss financial results, Bohuon signaled forthcoming changes saying, “I think it’s important for us to reinforce our strengths and reinforce the field where we believe the future will be bright.”
The Smith & Nephew biologics division was helmed by President Mark Augusti. He and his management team will move to Bioventus. Smith & Nephew will retain its research facility located in the United Kingdom. Both Smith & Nephew and Essex Woodlands said they will invest “a significant proportion” of Bioventus’ cash flow into R&D over the next five years.
Ruspak has completed a $1 million upgrade at its Lyons, NY, facility and added a third Bartelt horizontal form-fill-seal pouching machine to handle business growth.
Cleanroom suites are enhanced with reinforced fiber-glass wall panels, and epoxy-coated concrete floors. The contract packager currently has 10 suites, including a documented Class 100,000 cleanroom, with the ability to add three or four more, says Tim Brickle, president.
“We have also added auxiliary equipment like forklifts and powered hand trucks. Our business is up 25% from last year,” Brickle says.
FDA’s rule of 2007 requiring cGMP for dietary supplement manufacturers has driven customers to the contract packager.
“The dietary supplement and herbal markets represent the largest increase in our business. As they have been forced to establish cGMP, in many cases they do not want to invest in the equipment and structures for establishing compliance,” Brickle says.
These companies will often favor sustainable solutions as brand reinforcing. Ruspak helped a customer downsize packaging for a powder supplement by 40 percent. The new packaging provided a more earth-friendly design that reduced package costs. The customer achieved savings from less use of film and shrink wrap, and smaller chip boxes and shippers.
The downsizing was accomplished without a significant reduction in line speed, as the same volume of powder was filled in a smaller pouch.
“If you are filling the smaller pouch too fast, you can lose product or have product coating the seal area. They were expecting a 20 percent reduction in operating speed. We designed and engineered a solution that limits the speed loss to 3 to 5 percent. We are now producing 600,000 to one million of these pouches a month,” Brickle says.
For packaging the launch of very large herbal energy supplement tablets, Ruspak designed a line for an initial order of 300,000 per month. The order grew to 450,000 and is increasing to one million. The hydroscopic 1135-mg chewable tablets are packaged one tab to a pouch, 30 pouches in a carton.
Ruspak often juggles production schedules to accommodate the new business.
“As a contract packager we have to be flexible. We can jump on new business because of the relationships we have with our established customers who are willing to work with us. We can often interrupt a current project for a few days or weeks to take on a new project,” he says.
When a manufacturer of a major dietary product last year lost their production source, Ruspak was dropped in as a second source with another packager to get production up and running. The solid dose product is bottled, shrink-sealed, and cartonned with lot and expiry printed on the bottle and carton. Cartons are shrink-banded in groups of six before being packed in a shipper.
“We got the go ahead on Monday, began running on Thursday, and worked through the weekend. We worked around the clock for eight weeks to help them make a successful launch,” he says.
Particle Sciences, Bethlehem, PA, has added new coating capabilities for preparing polymer film-based drug products from liquid formulations, under cGMPs. The company focuses on advanced drug delivery solutions and is FDA registered and licensed for all schedules of controlled substances.
Garry Gwozdz, director of Formulation Services, said, “Particle Sciences’ purpose is to provide our clients with the most efficient drug product. Increasingly, we are seeing a demand for thin film-based products, particularly with respect to transdermal drug-eluting patch products, and rapidly-dissolving strips. While we have been working in this area for some time, the acquisition of semi-automated coating equipment will allow us to screen more formulation approaches, and get our clients into the clinic faster with a commercially representative film-based product.”
Mr. Gwozdz added, “Particle Sciences already had cGMP hot-melt film extrusion capability and now with the addition of coating and drying capabilities for liquid-based formulations, our clients have access to a complete array of viable and scalable film-manufacturing technologies.”
Cincinnati-based Q Laboratories, Inc. has completed renovation of a new Analytical Research and Development Laboratory, which will perform method development, method validation and method transfer of analytical methods, along with a wide range of other R&D projects.
Analytical Research and Development Laboratory Supervisor Sara Goetz stated, “We had previously performed Analytical R&D projects in our general Analytical Chemistry laboratory, but with the new space, we will be able to handle larger and more numerous projects and serve our clients better in a facility designed specifically to handle this type of work.”
“The opening of this new Analytical R&D laboratory completes the latest step, in a continuing mode of expansion that we have made to our facilities to continue to expand our business in a manner consistent with our client’s needs. I believe our facilities measure up to any laboratory, and allow us to provide cutting-edge, efficient service to companies around the world,” added Q Laboratories, Inc. President David Goins.
Q Laboratories, Inc. is an FDA-Registered, ISO/IEC 17025 Accredited, GMP/GLP compliant laboratory providing comprehensive microbiological, analytical chemistry and research and development laboratory services to companies around the world. In business since 1966, Q Laboratories, Inc. serves the food, pharmaceutical, cosmetic, dietary supplement and personal care product industries.
Catalent Pharma Solutions has completed construction of its newly-renovated 3,300 square foot aseptic fill-finish manufacturing facility at Research Triangle Park, NC, where it offers comprehensive sterile product formulation and development.
The renovation provides a four-fold increase of the sterile fill-finish capacity at the site and adds new complementary technology to Catalent’s existing service offerings.
The state-of-the-art sterile clinical manufacturing suite will provide Class A manufacturing space containing a flexible aseptic vial filling line capable of producing Phase I and Phase II clinical trial materials in compliance with global GMP requirements.
The product development group conducts preformulation, formulation development, process development, and manufacturing support in addition to offering full service analytical development and stability capabilities.
“(This renovation) is part of Catalent’s ongoing investment to provide integrated solutions to meet biologic and biosimilar drug development companies’ growing needs,” says Christine Dolan, vice president and general manager, Catalent Development and Analytical Solutions business.
“Combined with Catalent’s GPEx technology, expert biopharmaceutical lab services capabilities, world leading clinical trial supply services and commercial manufacturing capabilities, we will be able to help our customers bring more products from gene to market.”
The National Institute of Mental Health plans to provide up to $9 million per year for as many as five years to fund a new center that will be a resource for accelerating research into genes that may be involved in mental disorders.
The Center for Genomic Studies on Mental Disorders will expand research resources that support the NIMH Human Genetics Initiative and will make them freely and openly available to the research community.
The center will support research in a range of areas, will provide information from genomic sequencing studies, gene expression experiments, and in silico genomics research, and will share data that can speed up gene discovery for a range of mental disorders, such as Alzheimer's disease, autism-related spectrum disorders, bipolar and related mood disorders, schizophrenia, depression, eating disorders, and others.
It will provide a genomic infrastructure to enable access to distributed data, software, and other information resources supporting studies of genes potentially involved in mental disorders.
The center also will house a team of investigators with expertise in molecular biology, cell culture, computer and information sciences, statistical genetics, and psychiatric genetics, and it will provide banking of primary cultures of source cells used for deriving induced pluripotent stem cells.
NIMH launched the Human Genetics Initiative in the late 1980's with the aim of characterizing the genetic basis of vulnerability to diseases, such as schizophrenia, Alzheimer's, and bipolar disorder by creating a national scientific resource of clinical and genetic information and samples.
In 1997, a working group of the National Advisory Mental Health Council recommended that NIMH continue to fund large-scale data collection efforts and to maintain a DNA repository and clinical data for sharing with the scientific community. In 2000, advisory councils at NIMH and the National Institute of Neurological Disorders and Stroke recommended that the institutes support data sharing for genetic analysis of complex diseases.
The research topics, functions, and services the center will conduct include, but are not limited to, exploration of discrepancies in characterization of DNA markers and statistical methods; receipt of blood samples and cell line immortalization and clinical and genetic data files; development of a genomic cyberinfrastructure that provides tools and web services for data integration, management, modeling, simulation, and visualization; creation of cell lines from fresh whole blood samples and extraction of high-quality DNA; establishment and distribution of pedigree datasets in which genome scans and analyses are used to determine non-Mendelian inheritances; and creation of tools and graphical user interfaces for integrating multiple data sources that connect genetics, genomics, and biological databases with those at the center.
PerkinElmer said this week that it will establish a Personalized Health Innovation Center of Excellence at its facilities in Hopkinton, Mass. The center will focus on creating new technologies for researchers developing diagnostic and therapeutic products. It is expected to be fully operational later this year and eventually have 350 employees.
The University of Miami broke ground on a new marine research complex that will include one building focused on marine life sciences research projects and another that will house oceanographic, meteorological, and marine physics-related studies.
The two buildings in the Marine Technology and Life Sciences Seawater Complex, part of the UM Rosenstiel School of Marine and Atmospheric Science, will consist of two buildings connected through an open atrium that will be located on Virginia Key.
The research center was funded in part through a $15 million American Recovery and Reinvestment Act grant from the National Institute of Standards and Technology, and it is expected to be completed in late 2013.
"These laboratories will help researchers study coastal structures, weather phenomena, and marine life, all of which have a profound effect on the health and well-being of people and the planet," UM President Donna Shalala said in a statement.
The 47,942 square-foot Marine Life Sciences Center building will be a space for studying living marine animals including fish, corals, and sea hares.
The research will involve using genomics to learn how gene expression changes in marine populations that are exposed to pollution, and will study the impacts of environmental toxicants on marine life. The projects also will include studies of the effects of algal blooms, and will seek to assess the effects of climate change on marine ecosystems.
"Few facilities exist in the world where marine research is being conducted on such a wide range of aquatic organisms. The Marine Life Sciences Center will provide a dedicated space for the study of marine animals with special attention on the critical connections between oceans and human health and the impacts of climate change on marine organisms and ecosystems," Michael Schmale, co-principal investigator at the Rosenstiel School and Professor of Marine Biology and Fisheries, said in the statement.
The center also will be home to a National Resource for Aplysia, which will be the only facility in the world that cultures and raises sea hares.
"The relatively simple nervous system of Aplysia offers an ideal model for research on neurophysiology, brain function, memory and learning, and aging, which also have implications for human diseases such as Alzheimer's," added Schmale, who will direct the Aplysia center.
Progenika said that its CLIA laboratory has received accreditation from the College of American Pathologists.
The Medford, Mass.-based firm provides blood group genotyping services to blood banks and hospitals in the US and Canada.
It also provides genetic testing for familial hypercholesterolemia. The firm said this test also is used by pharmaceutical firms in developing cholesterol-lowering drugs.
Japanese drug-maker Astellas Pharma opened its new $150 million headquarters for the Americas in a Chicago suburb.
The facility includes two seven-story glass-covered buildings totaling more than 400,000 square feet, six video conference rooms and green features, like landscape irrigation from retained storm water, company officials said.
Astellas Pharma US Inc.'s headquarters were in suburban Deerfield but relocated nearby to Glenview with the help of about $4 million in incentives from the state of Illinois, mainly corporate tax credits.
Astellas Pharma has added more than 200 jobs since 2011. About 1,000 employees work at the new location for a total of about 2,600 employees nationwide.
Astellas is one of Japan's largest pharmaceutical companies. The Glenview-based site is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Japan's largest drug-maker is Takeda, which also has its North American headquarters in suburban Chicago.
Illinois' corporate tax breaks for other companies recently have come under scrutiny.
The state has more than quadrupled the breaks since 2006 to more than $270 million in 2010. Lawmakers have sent Quinn a bill seeking more oversight, but the Democratic governor has not said whether he'll sign it.
Quinn tied the opening of the new headquarters to efforts to improve the state's trade potential. He traveled to Japan and China last year and formed the Illinois Export Advisory Council. He's slated to travel to Brazil later this year.
Silicon Biosystems has opened lab facilities in San Diego to support its expansion efforts in the US. The Bologna, Italy-based firm said that placing the new facility in a global biotechnology hub will enable it to "showcase the unique benefits of our DEPArray system" and offer services to US customers.
University of Utah's new innovation centre, the James L. Sorenson Molecular Biotechnology Building, was officially dedicated in April 2012. The 208,000 square feet building is located on the north side of the university campus in Salt Lake City in the state of Utah, US. It is the first facility to link the western and eastern portions of the university campus. An investment of $130m has been made in the building.
The facility is part of the Utah Science Technology and Research (USTAR) initiative. USTAR is an economic initiative backed by the state of Utah to support state-of-the-art research facilities and research teams. It is aimed at creating new technologies and their commercialization.
The new biotechnology building will be used to carry out research in various disciplines, such as materials science, engineering and biomedical science.
It is constructed as part of a four building quadrangle being planned by the university to bridge the gap between various disciplines. The Brain Institute, the Nana Institute and the Department of Bioengineering will be part of the facility.
"The facility is part of the Utah Science Technology and Research (USTAR) initiative. USTAR is an economic initiative backed by the state of Utah."The building features a transparent design with floor-to-ceiling glass walls. This enables natural light to enter nearly 75% of the interiors, such as the labs and gathering areas of the building.
The unique design of the facility promotes interaction between researchers and scientists. It will be home to senior and junior researchers, as well as administrative and laboratory personnel.
The laboratories of the building are both flexible and open-bench type. The open lab space is situated next to the closed equipment rooms and office space. The flexible labs have been added to promote collaboration between researchers of various disciplines and feature state-of-the-art equipment.
Built to LEED Gold certification standards, the facility will reduce energy use and costs by nearly 40 percent. Some of the sustainable features included in the building are multistage evaporative cooling systems and low volatile organic compound finishes. Vegetated bioswales in the building help in collecting surface runoff.
Concrete with high fly ash content has been used for the construction of the facility. In addition, renewably sourced materials, such as local stone and copper materials, have been used for construction.
The Sorenson building includes a 23,000 square feet nanofabrication facility, a wet lab and research computing space. It also includes office spaces and meeting and public areas designed to encourage interaction.
"The 208,000 square feet building is located on the north side of the university campus in Salt Lake City in the state of Utah, US."A small animal imaging facility is also part of the building. It will be used for carrying out imaging studies of small animals.
The building also includes an optical imaging facility equipped with high-performance electron and confocal microscopes. The equipment will be used for florescent imaging of cellular processes and is available for use by all the researchers at the campus.
The nanofabrication facility at the building will be used to fabricate electronic devices such as silicon integrated circuits and sensors. It features 18,000 square feet of cleanroom space and a biobay. It also includes a 5,300 square feet microscopy and materials characterization suite, which is equipped with a range of instruments including Scanning Electron Microscopes costing $3m each.
Construction of the facility started in April 2009 and was completed in December 2011. Advanced 'virtual building' software was used during the construction of the facility. A total of 33,000 cubic yards of concrete and 6.8 million pounds of reinforcing steel were used for the construction.
A total of $100m was raised in state bonds and the remaining was raised through private investors. The Sorenson Legacy Foundation provided $15m in funds, to recognize which the building was named after the inventor and entrepreneur, James LeVoy Sorenson. Micron Technology provided another $1.25 million.
Lord, Aeck & Sargent, with Prescott Muir were the architects, while Layton Construction was the general contractor.
Subcontracts include Van Boerum & Frank (civil and mechanical engineering), m+w Zander (cleanroom design), Daw Technologies (cleanroom contractor), Reaveley & Associates (structural engineer), Daw Construction and Cache Valley Electric (electrical engineering), J&S Mechanical (mechanical and plumbing), EDAW (landscaping architecture), Valley Crest (landscaping) and Infinite Scale (Building Identification Standards).
Clinilabs has opened a second Phase I unit in Southern, NJ. The 50-bed, 15,000 sq. ft. Specialty Pharma Unit features semi private rooms, a large PK sampling facility, a bioanalytic laboratory, pharmacy, and exam rooms.
The Phase I Unit expands services currently offered at the company’s 50-bed, Phase I unit in Manhattan, raising total bed capacity to 100.
“I am pleased to announce the opening of our new unit in Eatontown, NJ,” said Dr. Gary Zammit. “This unit allows us to expand our Phase I capacity in two locations, providing first-in-human through end-of-Phase II CRO services to our clients. We are now able to enroll larger samples of normal healthy volunteers and patient populations at our two units and at investigator sites worldwide.”
Affton-based Haberberger Inc., a mechanical contracting company, announced the completion of a $1.65 million project at the Innovative Technology Enterprises building on the University of Missouri - St. Louis campus.
Haberberger was selected by Volk Construction Co. to construct HVAC mechanical upgrades for the 53,200-square-foot facility. The company also installed new chillers, boilers, energy recovery equipment and a new laboratory exhaust system. Scott Loehr at Volk Construction headed the project. Construction started in October of last year and was completed this spring.
The building houses several startup companies in the information technology, life sciences and physical sciences fields, including Achor Anaerobic, a biotech company that focuses on the treatment and disposal process for organic waste; BMA Software, an information technology company that provides resource management and accounting systems; and St. Louis Medical Devices Inc., a company that is commercializing a novel non-invasion glucose monitoring device developed by an UMSL researcher. There are currently 11 startup companies using the facility.
Haberberger has about $25 million in annual revenue. Its sheet metal capabilities include HVAC ductwork fabrication and installation, architectural sheet metal, dust collection and bag houses, clean room and hospital ductwork.
A first-of-its-kind U.S.-based accelerator for biomanufacturing got a rousing start in Fall River last month despite steady spring downpours and muddy footing.
State, local and university representatives gathered under a rain-soaked tent May 16 to officially break ground on the 33,000-square-foot Massachusetts Accelerator for Biotechnology. The $28 million facility will allow startups to test their biomanufacturing methods and products at multiple stages of development while also receiving business and product support.
Construction is expected to finish in the fall of 2013.
Once in operation, the MAB will be staffed by 10 university employees, with as many as 8,000 employees expected once the 300-acre biotech park, officially called the SouthCoast Life Sciences and Technology Park, reaches full capacity.
"How exciting is it to think that life science companies from around the world will partner with UMass to commercialize their life science products (here)," said James Karam, UMass chairman, about the MAB.
Retiring Chancellor Jean F. MacCormack called the accelerator a "game changer." "This is another strategic investment that enables UMass Dartmouth to fulfill its service mission to the Commonwealth and to expand its role as the anchor of the SouthCoast Innovation Triangle," she said.
Susan Windham-Bannister, president and CEO of the Massachusetts Life Science Center, said the accelerator is perfectly placed on the SouthCoast. The SouthCoast already has an active medical device cluster, she said, and that plus the region's deep manufacturing background make it the best Massachusetts site for this kind of facility.
According to university promotional material, the SouthCoast currently has 25 medtech and life science companies employing more than 3,500 people.
The MAB is also a new kind of resource for the biotech industry, Windham-Bannister said, noting that the accelerator is the first of its kind in the nation and only the fourth in the world.
Once operational, the accelerator will help researchers scale up products and methods in the fields of biotherapeutics, biomedicine and green chemistry, the university said, describing potential activities such as growing antibodies to fight disease and generating new tissue from stem cells.
Facility users will also benefit from a statewide network of partners who will analyze and validate products and help companies make the transition to full-scale production.
Funding for the project comes from multiple sources including a $14.6 million MLSC capital grant, $10 million from UMass Dartmouth and an anticipated $3 million from equipment grants and corporate donations.
The construction kick-off comes at a strategic time for the Commonwealth, just one month before the Bio International Convention in Boston. The event is bringing an expected 15,000 life science leaders to Massachusetts from all over the world, according to a university release.
In his comments at the ground-breaking, Gov. Deval Patrick stressed the cooperation and collaboration of so many people that was needed to make the accelerator a reality. Everyone had to "pull in the same direction at more or less the same time," he said.
Patrick urged those present to remember that feeling and keep it somewhere safe.
"We'll have to call on it again and again to lift the SouthCoast and lift the nation," he said.
Southwest Community College hopes to begin construction in September on its $18.2 million Nursing, Natural Sciences and Biotechnology Building, thanks to a confidential agreement the school has struck with Clear Channel Outdoor to remove two billboards on the site.
The school is to be built on 1.28 acres at Union and Myrtle, and construction could be completed by fall 2013. However, the school won’t be able to use the building until the spring semester of 2014, said Ron Parr, vice president of financial and administrative services for Southwest.
The Foundation of Southwest Tennessee Community College purchased the property at the end of September 2011, and almost immediately began negotiating the removal of the billboards with Clear Channel. At the heart of the matter was a disagreement in the language of an easement of the billboards.
The project is three months behind schedule, despite having funding in place. The 61,000-square-foot building was designed by Fleming/Associates Architects and W.G. Yates & Sons Construction will be construction manager. Parr expects the process to now move quickly toward a September construction start date.
One thing he’s sure of is demand for the nursing program, which is still growing.
“We won’t have any problem meeting the demand,” Parr said. “We’ll probably max out the building the first semester it’s open. We may have lost some students to other programs in the city (because of the delays), but we’re waiting for others to come in.”
The New Regenerative Medicine Research Center in California was opened on 14 April 2012. It is a biomedical research facility which focuses on how the regeneration of human cells and tissues can be used for treating fatal diseases and conditions, such as Parkinson's, Alzheimer's, strokes and diabetes in older people. It is located in Novato in California, USA.
The Buck Institute for Research on Aging and the California Institute for Regenerative Medicine (CIRM) sponsored the facility.
The Novato facility is the third research facility of the Buck Institute. Its construction started in March 2010 and took nearly two years to reach completion.
"The Buck Institute for Research on Aging and the California Institute for Regenerative Medicine (CIRM) sponsored the facility."The research facility is spread over a 488-acre campus in Novato at a three-storey building, with more than 65,708 square feet of space. It was constructed at a cost of $36.5m.
The facility has 12 laboratories and has the equipment needed for developing treatments for age-related conditions such as Parkinson's, cardiovascular problems, cancer, macular degeneration, strokes and Alzheimer's disease, by focusing the research on various stem cell technologies.
The facility is primarily engaged in researching and developing regenerative medicines, which include naturally stimulating the damaged organs, cells and tissues in the body for healing, to develop cells, organs and tissues in the laboratory and implant them in to the human body, as well as to eliminate the rejection of transplanted organs in the body.
The other medical research which is currently being conducted at the facility includes Parkinson's disease research at the Andersen laboratory, finding causes of breast cancer at the Benz laboratory, plus stem cell therapies research at the Campisi laboratory.
Research is also being conducted on replacing the brain cells lost from Huntington's disease at the Ellerby laboratory and restoring the functions of the brain following strokes at Greenberg laboratory.
The research facility broke ground in March 2010 and was constructed during three phases. In the first phase of construction, earthworks and site grading were completed. In phase II the building's structural construction was completed, while in the third phase finishing and installation works were completed.
Buckle restrained brace frames (BRBF) were used in the construction to allow the building survive during a seismic event.
Travertine limestone from Italy was used for the construction of the façade of the building. More than 250 precast foot panels with thickness of eight inches were attached to the steel.
Three major contractors and 92 subcontractors were hired for the building's construction.
"The facility has 12 laboratories and has the equipment needed for developing treatments for age-related conditions such as Parkinson's."The design for the building was provided by Perkins+Will architecture. Rutherford & Chekene, a structural engineering company, provided the building frame. IM Pei provided the original master plan for the Buck Institute campus.
Phase I construction was awarded to North Bay Construction. A phase II construction contract worth $17m was awarded to a joint venture consisting of Cahill Contractors and Otto Construction. Kitchell Corporation completed the core and shell work in phase II.
CSW/Stuber-Stroeh and the Miller Pacific Engineering Group provided civil engineering and design consulting services for phase II construction. The pre-construction services were provided by Ghilotti Construction.
Kitchell Corporation was the general contractor for phase III construction. Alfa Tech Cambridge provided a HVAC system design for the building.
Peterson Mechanical provided plumbing and low-flow fixtures installation. The electrical systems were provided by Northern Electric and W Bradley Electric (WBE). Alcal-Arcade supplied roofing, waterproofing, insulation and glazing. Shamrock Materials supplied concrete for foundations and decks. The heating and cooling heat pump and thermal recovery systems were provided by ClimaCool. Clark Pacific provided raw stone cutting, polishing and bonding of rocks to concrete.
The original cost of the project was projected to be $41m in 2008, but due to the effective construction methods adopted by the contractor, the actual cost of the project came down to $36.5m. It was financed by the California Institute of Regenerative Medicine (CIRM) with $20.5m, while Buck Institute contributed $16m.
University of Colorado's Jennie Smoly Caruthers Biotechnology Building (JSCBB) was opened in April 2012. The new research and teaching facility located at the university's Boulder campus in the US has been built with an investment of $160m.
JSCBB will house 60 faculty members and nearly 500 researchers from various fields, including biology, physics, engineering, chemistry, biochemistry, computer science and medicine.
It will help in fostering innovation and discovery, to help find cures or treatments for illnesses such as cancer, inherited diseases and heart disease, along with the creation of biofuels and tissue engineering.
The bioscience industry in Colorado generates nearly $400m in taxes annually for the state. It employs about 36,000 people across more than 375 companies.
JSCBB includes four wings, which house the Department of Chemical and Biological Engineering, the Division of Biochemistry, the University of Colorado Biofrontiers Institute and the Colorado Center for Biorefining and Biofuels (C2B2).
The main areas of research focus include synthetic tissue engineering to regenerate cartilage for human joints, bioengineering of heart valves and the development of liquid membrane technology to capture carbon dioxide.
Some of the most famous scientists of the Colorado University will be working at the new facility, including Tom Cech, who won the Nobel Prize in chemistry in 1989.
The facility will enable collaboration between biotech companies and academia. Biotech companies will be able to run tests using the state-of-the-art equipment available at the facility. They will be able to understand the various biological processes and improve the design of medicines being developed.
The new building is spread over an area of 336,800 square feet and has been designed based around the concept of research neighborhoods. It consists of a 'main street' corridor, around which several clusters of offices are located. This design fosters cooperation among scientists from various disciplines.
Scientists are currently scattered across various buildings of the university. The facility also features spacious lounge areas, aimed at facilitating interaction between scientists.
The specialized temperature controlled labs are modular and can be reconfigured based on the requirements of the scientists and students. They feature high-tech equipment which can be used by scientists and researchers to carry out research in various disciplines.
The labs feature advanced genomic sequencing equipment, which can be used to conduct millions of genetic, chemical and pharmacological tests. X-ray crystallography machines to examine atoms, proteomics machines to analyze protein data and mass spectrometry equipment are also all part of the facility.
The new building has been built to meet LEED Platinum rating standards. The mechanical and electrical systems of the facility incorporate energy saving features.
The project broke ground in September 2009, with the topping out ceremony taking place in November 2010. The building required the use of 975,000 bricks and 10,000 pieces of cut limestone for its construction. The windows of the facility required 3,400 pieces of glass.
The four wings of the facility required 44 miles of piping work. The ductwork running through the building weighs about 338t. The construction phase of the facility created nearly 600 jobs.
The research facility was funded through private donations totaling about $48m. Marvin Caruthers, a professor of the chemistry and biochemistry department at the university, committed $20m towards the project. The facility has been named after his late wife Jennie Smoly Caruthers.
ConocoPhillips provided $1m to the facility and plans to provide another $2.5m in the future. The National Institutes of Health provided $15m through the American Recovery and Reinvestment Act.
Colorado University and the state also provided funds towards the construction of the facility. By 2014, the university plans to raise $75m in funds for the facility.
Robert A.M. Stern Architects and HDR Architects designed the facility. The general contractor for the facility was JE Dunn Rocky Mountain.
University of Utah's new innovation centre, the James L. Sorenson Molecular Biotechnology Building, was officially dedicated in April 2012. The 208,000 square feet building is located on the north side of the university campus in Salt Lake City in the state of Utah, US. It is the first facility to link the western and eastern portions of the university campus. An investment of $130m has been made in the building.
The facility is part of the Utah Science Technology and Research (USTAR) initiative. USTAR is an economic initiative backed by the state of Utah to support state-of-the-art research facilities and research teams. It is aimed at creating new technologies and their commercialization.
The new biotechnology building will be used to carry out research in various disciplines, such as materials science, engineering and biomedical science.
It is constructed as part of a four building quadrangle being planned by the university to bridge the gap between various disciplines. The Brain Institute, the Nana Institute and the Department of Bioengineering will be part of the facility.
"The facility is part of the Utah Science Technology and Research (USTAR) initiative. USTAR is an economic initiative backed by the state of Utah. "The building features a transparent design with floor-to-ceiling glass walls. This enables natural light to enter nearly 75% of the interiors, such as the labs and gathering areas of the building.
The unique design of the facility promotes interaction between researchers and scientists. It will be home to senior and junior researchers, as well as administrative and laboratory personnel.
The laboratories of the building are both flexible and open-bench type. The open lab space is situated next to the closed equipment rooms and office space. The flexible labs have been added to promote collaboration between researchers of various disciplines and feature state-of-the-art equipment.
Built to LEED Gold certification standards, the facility will reduce energy use and costs by nearly 40 percent. Some of the sustainable features included in the building are multistage evaporative cooling systems and low volatile organic compound finishes. Vegetated bioswales in the building help in collecting surface runoff.
Concrete with high fly ash content has been used for the construction of the facility. In addition, renewably sourced materials, such as local stone and copper materials, have been used for construction.
The Sorenson building includes a 23,000 square feet nanofabrication facility, a wet lab and research computing space. It also includes office spaces and meeting and public areas designed to encourage interaction.
"The 208,000 square feet building is located on the north side of the university campus in Salt Lake City in the state of Utah, U.S." A small animal imaging facility is also part of the building. It will be used for carrying out imaging studies of small animals.
The building also includes an optical imaging facility equipped with high-performance electron and confocal microscopes. The equipment will be used for florescent imaging of cellular processes and is available for use by all the researchers at the campus.
The nanofabrication facility at the building will be used to fabricate electronic devices such as silicon integrated circuits and sensors. It features 18,000 square feet of cleanroom space and a biobay. It also includes a 5,300 square feet microscopy and materials characterization suite, which is equipped with a range of instruments including Scanning Electron Microscopes costing $3m each.
Construction of the facility started in April 2009 and was completed in December 2011. Advanced 'virtual building' software was used during the construction of the facility. A total of 33,000 cubic yards of concrete and 6.8 million pounds of reinforcing steel were used for the construction.
A total of $100 million was raised in state bonds and the remaining was raised through private investors. The Sorenson Legacy Foundation provided $15 million in funds, to recognize which the building was named after the inventor and entrepreneur, James LeVoy Sorenson. Micron Technology provided another $1.25 million.
Lord, Aeck & Sargent, with Prescott Muir were the architects, while Layton Construction was the general contractor.
Subcontracts include Van Boerum & Frank (civil and mechanical engineering), m+w Zander (cleanroom design), Daw Technologies (cleanroom contractor), Reaveley & Associates (structural engineer), Daw Construction and Cache Valley Electric (electrical engineering), J&S Mechanical (mechanical and plumbing), EDAW (landscaping architecture), Valley Crest (landscaping) and Infinite Scale (Building Identification Standards).
North Dakota State University said that it will use $1.4 million in funding from a state program and additional support from Sanford Research and the RJ Lee Group to fund the creation of a new Center of Research Excellence in life sciences.
The Center for Life Sciences Research and Applications, to be located at NDSU, Fargo, will receive the $1.4 million from the North Dakota Centers of Excellence Commission. It also will receive $2.7 million in cash and in-kind contributions from non-profit Sanford Research and the RJ Lee Group.
NDSU said it expects the center's initial research efforts will include breast cancer studies and investigation into rare diseases in children. It also will focus on spurring the growth of genomics, bioinformatics, and DNA-based forensics and identification research and applications. Other aims of the center will be to use technologies and discoveries generated by NDSU and private-sector partners and to encourage growth of the life sciences industry in North Dakota.
The center and NDSU's DNA Laboratory also will work with the RJ Lee Group, a supplier of industrial forensic capabilities, to develop next-generation DNA-based identification and forensic tests and methods.
A new research building will include space for startup biotechnology companies, according to officials at the University of Mississippi Medical Center in Jackson.
UMMC officials said construction could start in January 2013 at cost of $35 million for the eight-story shell of the Cancer and Biomedical Science Research Center. They said $20 million in funding comes through the National Institute of Standards and Technology.
UMMC plans to finish the ground-, first- and second-floor interiors of the 220,000-square-foot building.
That work should take about 18 months. Contractors would complete additional floors as funds become available.
UMMC associate vice chancellor for research Dr. John Hall said research space now is limited.
Hall said the new center will help UMMC recruit scientists, expand research centers and institutes and develop the Biotechnology Research Park.
Hall said biotech company incubator space will occupy about 25,000 square feet on one floor. The building will also house laboratory animal facilities and UMMC Cancer Institute labs - both of which need more space.
Astro Pak Corporation, a US supplier of precision cleaning services, has opened newly renovated and expanded Class 100 and 1000 cleanrooms for contract precision cleaning for the medical device, semiconductor, laser, biopharm, aerospace and defense industries.
The Costa Mesa, California-headquartered firm began to update and modernize its cleanroom facilities on the West and East coasts of the US in 2011 so that it could meet increased customer demand for capacity and develop world-class cleanroom services.
The Chesapeake, VA cleanroom was completed in January this year, with the Downey, CA location now completed and fully functional.
The Californian facility has more than 35,000ft2 of space and includes ISO 14644-1: Class 5 and Class 6 cleanrooms.
The large component Class 6 cleanroom measures 40ft x 30ft x 18ft (height) and supports a 2,500psi high-pressure spray system. In addition, a 4,000lb bridge crane has been installed to move heavy hardware and components.
Astro Pak has also constructed a high volume component/hardware processing cleanroom that houses 1,500ft2 of Class 100 space and 2,100ft2 of Class 1000 space, supported by a modern 6,000ft2 preclean area.
This preclean area includes eight workstations, 4,000lb bridge cranes, three large (3ft x 3ft x 8ft) ultrasonic cleaning units and a high purity, high-pressure spray system integrated into the area that houses additional immersion tanks.
A new safety containment pressure test room for pneumatic pressure testing and a new hydrostatic pressure test stand are also included. Pneumatic testing is performed at up to 10,000psi and hydrostatic testing at up to 30,000psi.
Squibb Company announced that the U.S. Food and Drug Administration (FDA) has approved the company’s biologics manufacturing facility in Devens, Massachusetts for commercial
production of ORENCIA (abatacept).
The Devens facility, a state-of-the-art bulk biologics manufacturing facility, employs roughly 300 scientists, engineers, bioprocess operators, quality specialists and other skilled workers.
The approval of our Devens site is an important milestone for Bristol-Myers Squibb as part of our strategic focus on delivering innovative biologic medicines for patients with serious disease, said Lou Schmukler, president, Global Manufacturing & Supply, Bristol-Myers Squibb. The increased manufacturing capacity from the Devens site will support market demand for ORENCIA and positions us well for future production of additional biologic medicines.
Bristol-Myers Squibb currently manufactures its biologic medicines in a company-owned facility in Syracuse, NY and through third party suppliers, and finishes and packages them in Manati, Puerto Rico. The Syracuse site will remain a key component of the company's biologics strategy and will serve as a center of excellence in process development and early product launch for the company's biologic medicines.
In 2010, the company announced the Devens facility received Leadership in Energy and Environmental Design (LEED) Silver certification while the laboratory and office building at the same facility received LEED Gold certification in December 2009. LEED certification, established by U.S. Green Building Council and verified by the Green Building Certification Institute, is the nation’s preeminent program for the design, construction and operation of high
performance green buildings.
In a ceremony underscoring the growing importance of China to the global biopharmaceutical industry, Quintiles executives and local dignitaries announced agreements to establish a Quintiles regional headquarters for China in Shanghai, and to significantly expand lab testing capabilities in China.
Chenggang Zhu, Vice Mayor of the Shanghai Xuhui District People's Government and executives from the Shanghai Clinical Research Centre (SCRC), Quintiles' strategic partner in the China-based lab initiative, joined Quintiles' executives at the ceremony.
“With its burgeoning economy and growing healthcare needs for its 1.3 billion citizens, China exemplifies the opportunities and challenges of the New Health,” said Quintiles Executive Chairman Dennis Gillings, CBE. “By broadening our investment and infrastructure here, Quintiles is ready to partner with our biopharma customers as they look to realize China's potential.”
Under a joint venture agreement, Quintiles will engage SCRC to provide lab testing services to local customers.
To provide the infrastructure essential for its growth strategy in China, Quintiles is investing US$14 million to establish a new 4,000-square-meter (43,000 square feet) headquarters in Shanghai to serve China and nearby Asian countries. The office in Feng Lin Science Park is designed to achieve LEED Gold accreditation; it is expected to accommodate more than 450 employees in the next five years.
“These investments and agreements demonstrate our commitment to this District and to China,” said Ling Zhen, General Manager for Quintiles' operations in China. “Quintiles recognizes the unique needs of our customers in China. By collaborating with SCRC in labs we can help local and international biopharma companies develop new and better medicines to serve China's enormous unmet medical needs.”
Rongxing Gan, President of SCRC, said: “SCRC's Central Laboratory's experienced staff and modern technology will be further enhanced through Quintiles' investments. We are delighted to work closely with Quintiles to further biopharma innovation and improve human health.”
The Quintiles-SCRC collaboration follows last year's launch of Kun Tuo, Quintiles' local contract research organization, built to help local and global biopharma companies achieve successful registration of medicines in China. Quintiles commenced operations in China in 1997 and, today has existing offices in Beijing, Dalian, Hong Kong and Shanghai, with employees and capabilities to serve all major population centers and study sites across China.
Ubichem has expanded its pharmaceutical ingredient capabilities through the opening of a 590,000 sq. ft. plant in Hungary.
The facility will produce industrial quantities of starting materials, intermediates, and other fine chemical products for pharmaceutical and other applications. Having added the facility Ubichem now offers services spanning from process research and development to commercial-scale production.
Ubichem thinks the range gives it an edge. “We believe we have a competitive edge over intermediate manufacturers based in Asia by leveraging the highly skilled talent pool of chemists and by meeting high quality expectations and strict deadlines”, József Répási, CEO of Ubichem said.
Eli Lilly announced an expansion of their manufacturing capabilities in China through an expanded collaboration with Novast Laboratories, a generic and specialty pharmaceutical company based in Nantong, China. The collaboration will enhance Lilly’s efforts to build a portfolio of Lilly branded generic medicines in China, and eventually may be used to provide regional manufacturing support for Lilly’s pipeline of products in development.
Lilly made an initial equity investment in Novast several years ago through the Lilly venture capital unit, Lilly Asian Ventures, and the new agreement increases Lilly’s equity position by $20 million. As part of the agreement, Novast has committed to set up a platform to support Lilly branded generic products and increase the manufacturing capacity at its Nantong site over the next several years, with Lilly providing technical support to enhance quality standards. The additional capacity will support the collaboration, but will not be solely dedicated to Lilly products. The two companies have selected an initial list of medicines across multiple therapeutic areas that will be manufactured by Novast once the facilities are operational.
"In China, Lilly is building for the future by investing across our value chain," said Eric Baclet, president and general manager of Lilly China in the press release. "We have made significant investments in research and development, increased our commercial presence to better serve patients and healthcare providers, and expanded our manufacturing capabilities both at Lilly owned sites and through partner companies such as Novast. We are committed to help meet the medical needs of the Chinese people by providing innovative medicines of the highest quality."
The demand for prefilled syringes is on the rise and Vetter is prepared. The company, a leading contract development and manufacturing organization is building a state-of-the-art, high-performance filling line for syringes at its Ravensburg Vetter South location, the company said.
The line can handle batches of up to 1 million units per day and is particularly well suited for the aseptic filling of high-volume products, like vaccines. The company is also expanding its services for the early clinical phases of new drugs.
At its Vetter Development Service locations in Chicago, Illinois (USA), and Ravensburg (Germany), the company offers a wide range of services including formulation support and customized packaging development. With another new filling line at the Ravensburg facility and further investments planned in Chicago, Vetter continues to increase its capabilities in clinical manufacturing.
Vetter is reinforcing its position as a strategic partner for the development and commercial manufacturing of parenteral drugs. With the expansion in capacity and service portfolio, Vetter is providing efficient answers to the growing demand for prefilled syringes throughout a product lifecycle. Vetter Development Service supports customers in efficiently transferring new drugs from early stage phase to commercial manufacturing including regulatory support.
The company’s comprehensive know-how in process- and packaging development in aseptic filling is used to support a high-professional clinical offering. "Vetter is continuously and strategically investing in its partnerships with international customers," says Peter Soelkner, Vetter Managing Director. "In the area of prefilled syringes we provide our partners a full range of service, from small batches manufacturing and support in early clinical stages to high-volume manufacturing for large scale commercial production."
Vetter is an international contract development and manufacturing organization (CDMO) specializing in the aseptic filling of syringes, cartridges and vials. The company has extensive experience with a broad array of compounds, including monoclonal antibodies, peptides, interferons and vaccines.
An independent firm headquartered in Ravensburg, Germany, Vetter provides support for pharmaceutical and biotech clients from preclinical development through regulatory approval and global market supply. Vetter's new Chicago facility, an expansion of Vetter Development Service, supports early-stage products. The CDMO works with the world’s top 10 pharmaceutical/biotech firms and emerging companies alike, and employs approximately 2,800 staff across Europe and the United States.
The innovator of the Vetter Lyo-Ject dual-chamber syringe and V-LK cartridge, the company holds numerous patents and is a leader in the use of RABS technology in cleanrooms. Approved as a foreign manufacturer by the government of Japan, Vetter’s global regulatory experience includes numerous customer product approvals by the FDA, EMA and other authorities.
Source: Vetter Pharma International GmbH.
The University of British Columbia (UBC) is constructing a new facility for the Faculty of Pharmaceutical Sciences in Vancouver, in the state of British Columbia in Canada. It will bring together all the learning, teaching, community outreach and research activities of the Faculty under one roof. The building will also accommodate the Centre for Drug Research and Development (CDRD).
Construction of the Pharmaceutical Sciences Building started in July 2010. The C$133.3m facility is expected to open in 2012. The Province of British Columbia has announced its commitment to contributing C$86.4m for the new facility, in September 2009. The remaining amount is funded by the UBC. The project will also be a sustainable development and aim to achieve LEED Gold certification from the US Green Building Council.
The new pharmaceutical sciences facility is located adjacent to the UBC Life Sciences Centre (LSC), the largest building on the Vancouver campus, which also won LEED Gold certification in 2006. It is expected to promote collaboration across the health disciplines including life sciences and medical students and researchers.
"The facility was designed by a joint venture between Saucier + Perrotte Architectes and Hughes Condon Marler Architects. "The UBC Pharmaceutical Sciences Building will be a six-storey structure with 22,871 square meters (246,091 sq. ft.) of usable space. It will include educational spaces, 14 small case-based specialized learning laboratories, research spaces, classrooms, a lobby, lecture halls, distance learning educational facilities, informal learning spaces, administration and professor's offices, a student lounge, a cafeteria and conference rooms.
The building will also have a private multimedia recording room, laboratories equipped with portable tablet computers and a multipurpose lab with remote lab access. An exhibition area, called Story of Medicines, will be housed in the public spaces of mezzanine and ground levels. It will feature interactive screens and historical artifacts to allow the visitors to know about various aspects of pharmacy, such as evolution and life of the drugs.
Merck donated about C$250,000 worth of pharmaceutical equipment for use at the current and new facilities, in April 2011.
The new facility will enable the Faculty of Pharmaceutical Sciences to increase the enrolment of students into graduation and under-graduation programs by 47% (72 student spaces) a year. It is expected to have 896 undergraduate students by 2015.
The new building will also support the Doctor of Pharmacy (Pharm.D) and PhD programs. This in turn is expected to cope with the shortage of pharmacists in the British Columbia region.
The UBC pharmaceutical building project is expected to generate about 850 jobs during construction. It is easily accessible through public transportation and has several bicycle parking and showering facilities.
"Merck donated about C$250,000 worth of pharmaceutical equipment for use at the current and new facilities, in April 2011."The project will not add any new car parking spaces but will promote sustainable transport options.
The facility has glazed façade and two full-height atria to allow maximum daylight, passive ventilation and maintain temperature of the interiors throughout the year.
Heat from the data centre in the basement will be recovered to reduce the consumption of energy. An on-site stormwater runoff system, efficient irrigation system and 20% less potable water consumption are also planned.
Recycled, local construction materials, low-emitting materials and FSC-certified wood are being used to reduce environmental impact. The facility is also designed to increase the lifespan of the building and reduce maintenance costs.
The CDRD is an independent not-for-profit organization launched in 2007. It collaborates with institutions and research universities to reduce the gap between academic discoveries and commercialization of the developed new drugs in laboratories.
The faculty in collaboration with CDRD will allow the students to conduct pharmaceutical research and get hands-on experience in an innovative environment.
The organization will provide its expertise in technical, scientific and commercial aspects of drug development. It has so far raised about $75m from the government and pharmaceutical companies.
The Pharmaceutical Sciences Building is being developed by the UBC Properties Trust. The facility was designed by a joint venture between Saucier + Perrotte Architectes and Hughes Condon Marler Architects.
Ledcor is the general contractor. Glotman Simpson is the structural engineer. Stantec is the mechanical contractor, while Applied Engineering Solutions (AES) is the electrical works contractor. Perry + Associates is the landscape architect.
SGS’ has opened a new cell-based assay laboratory in Poitiers, France in its latest European, biopharma-focused investment.
The lab – plans for which were announced last September – features two validated flow cytrometry systems which run software that is 21 CFR Part 11 compliant and hence suitable for a wide variety clinical development projects, including comparative sample analysis for multicentre trials.
As well as investing in new technology SGS has also formed a partnership with the neighboring Poitiers’ blood transfusion centre, which the firm said will give it access to samples for testing and assay development.
“This collaboration allows SGS to validate methods using fresh blood to determine the stability of relevant markers [biomarkers] of blood cells from very early time periods.”
SGS has already started work on two neutralizing antibody projects for an unnamed large pharmaceutical company and said that it has more work in the pipeline.
The addition of cell-based assay testing capacity is the latest stage SGS’ expansion of the Poitiers lab, which began with the installation of mass spectrometry (MS) capabilities in 2010.
The launch of new services at the Poitiers site also fits with SGS’ wider efforts to build in biopharmaceuticals testing, which began with the acquisition of Wokingham, UK-based M-Scan in 2010 and continued with the purchase of Glasgow, Scotland-headquartered Vitrology earlier this year.
And the latest investment is unlikely to be the Swiss testing firm’s last in the continent if comments it made at Interphex last month are any indication.
SGS plans to offer formulation development services similar to those recently launched at its laboratory in Illinois, US at one of its sites in Europe in due course.
Sanofi’s subsidiary Genzyme has received approval from FDA and EMA for a second operation for a fill–finish product at its Waterford, Ireland, manufacturing plant.
With this approval, Genzyme has nearly doubled its ability to fill–finish Myozyme and Lumizyme (alglucosidase alfa) produced at the 4000-L bioreactor scale. Genzyme also will begin the process to secure FDA and EMA approvals to fill–finish additional products in the second suite, with the long-term goal to use the Waterford site as a fill–finish platform across its portfolio of products.
Genzyme’s Waterford facility has been in operation for more than 10 years, and a $150-million expansion was completed earlier this year. The Waterford manufacturing site employs over 500 people and is considered Genzyme’s center of excellence for aseptic manufacturing.
Advanced Synthesis SA Biasca, Switzerland is already moving full steam ahead with the building of a new Cytotoxic Plant. The engineering designs have been drawn up and perfected as space was allocated for this expansion when the facility was originally built. The permitting phase began in August 2010 and has ended with approval given in January 2011.
Therefore, we have broken ground on the project. The groundwork for this plant was laid in 2000 when the new facility at HAS was built, which enables us to cut off 6 months of the construction timeline and reduces the cost of investment. Ultimately, this will be a 20 Million CHF investment. Paolo Guainazzi, HAS’ General Manager, felt that with Helsinn’s expertise in Highly Potent compounds, moving into the Cytotoxic market would be a smooth transition. We will be able to begin commissioning laboratory projects in Q1 2012.
The laboratory will include dedicated areas for R&D and QC: in addition one small scale GMP area will be available for the production of reduced quantities of Cytotoxic APIs for clinical and
registration purposes (grams to hundreds of grams). The layout, personnel, and material flow for the lab and production area are designed to be completely independent from the existing API production plant.
The Cytotoxic Plant will have two different production areas. Both production areas are designed to process one product at a time. The first production area will have three reactor units. This equipment includes:
1 x 250L S.S. glass-lined Reactor;
1 x 250L Hastelloy C2000 Reactor;
1 x 400L Hastelloy C2000 Reactor; and
1 x 0.125 m³ Hastelloy C2000 Filter dryer within a glove box.
This area will be able to produce up to 10KG per batch. The second production area will also
have three reactor units. This equipment includes:
1 x 630L S.S. glasslined Reactor;
1 x 630L Hastelloy C2000 Reactor;
1 x 800L Hastelloy C2000 Reactor; and
1 x 0.25 m³ Hastelloy C2000 Filter dryer within a glove box.
This area will be able to produce up to 20KG per batch (Hundreds of KGs / year). The operative conditions of the production area of the Cytotoxic Plant will range from -80°C to +160°C for temperature and full vacuum up to +6 bars for pressure. In the existing Highly Potent facility, Helsinn Advanced Synthesis has been manufacturing Category 3 molecules (OELs ranging from 30 ng/m³ to 10μg/m³) for over ten years. In the Cytotoxic facility, we will now be able to handle Category 4 molecules (OELs less than 30 ng/m³). As mentioned above, Helsinn will be able to begin commissioning laboratory projects in Q1 2012. We are very excited to become a player in the Cytotoxic market with our expertise, dedicated personnel and topnotch facilities.
ShangPharma, a China-based R&D outsourcing company, has opened a new facility to meet the growing needs of one of its largest customers, Eli Lilly. ShangPharma also announced that it has signed a multi-year extension of its contract with Lilly.
The newly opened facility adds 110,000 sq. ft. of laboratory and office space to the company's overall capacity, and is fully dedicated to supporting Lilly's ongoing and future projects. ShangPharma's services consist of discovery chemistry, discovery biology and preclinical development, pharmaceutical development and biologics services.
"We are delighted to extend and deepen our highly productive relationship with Lilly," said Michael Xin Hui, founder and chief executive officer 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."
Further deepening its commitment to China, Quintiles today announced the launch of Kun Tuo (koon-TOO-ah), a local contract research organization (CRO) built to service the unique needs of the Chinese biopharmaceutical industry and multinational biopharma companies operating in China.
Building on Quintiles’ unmatched success at the global level and experience in conducting clinical trials in China since 1997, Kun Tuo will focus on developing customized solutions to help local and global biopharma companies achieve successful registration of new medicines in China.
Kun Tuo will provide a full range of services, including comprehensive clinical trial management, regulatory submission preparation, biostatistics and data management. Kun Tuo will tap Quintiles’ global resources and expertise to develop customized offerings in key therapeutic areas, along with vaccines, late phase studies, medical devices and diagnostics.
“Kun Tuo will leverage Quintiles’ quality and training systems to offer customized, high-quality solutions best suited for local Chinese biopharma, as well as global biopharma local affiliates,” said Zhen Ling, general manager of Quintiles China. “We have an aggressive growth plan for China and anticipate doubling Quintiles total staff during 2012 as we look to provide our customers with the solutions they need to succeed in one of the world’s most dynamic marketplaces.”
Operating in China since 1997, Quintiles China today has more than 300 staff to cover all population centers and study sites in China. With more than 20,000 employees globally operating from offices in 60 countries, Quintiles is the partner of choice for both global and local biopharmaceutical companies to conduct drug development in China.
Quintiles is a recognized industry leader globally, regionally and locally. The company was awarded Best Asia Pacific by Frost & Sullivan in 2009, 2010 and 2011; Best Central Lab in China by the Shanghai Medical Health Center in 2009; and Best CRO by Biopharma Asia 2011.
SGS has opened a second Life Science Services facility in Mumbai, India. The 15,000-sq.-ft. analytical lab establishes a dedicated GMP lab to provide a wide range of analytical development and quality control testing services. The new lab expands the company's current service portfolio in India by adding 10,600 ft3 of stability storage space. The facility offers the latest generation Q-TOF Quadrupole mass spectrometer for performing Extractables and Leachables studies. Also, in addition to microbiological testing, in-process sample testing and water system validation, the new site will also develop some capabilities to test biopharmaceuticals for mycoplasma and endotoxin.
“We are pleased that the realization of the Mumbai laboratory was done within a short timeframe," said Anne Hays, executive vice president for SGS Life Science Services. "This new analytical lab demonstrates SGS's commitment to serve the growing demand in the India market and to support the development of the top western pharma companies that have operations in Mumbai - many of which are already SGS clients in other regions"
Life Technologies announced it has created a Global Instrument Center of Excellence in Singapore, making it the company's only internal instrument manufacturing facility outside the US.
The design and manufacturing of Life Tech's products — including its next-generation sequencers and molecular diagnostic instruments — for its customers within the region and outside of Asia-Pacific will be conducted at the new center, the Carlsbad, Calif.-based firm said.
The manufacture of Ion Torrent's Personal Genome Machine will also be moved to the Singapore center.
Asia-Pacific is a key growth driver for the life science industry, and Life Tech said that its sales in the area, excluding Japan, grew more than 9 percent in 2011, while the volume of items shipped per day in the region has increased four-fold. The Asia-Pacific region is about 10 percent of Life Tech's total business, the spokesperson said.
Life Tech's presence in Asia has consisted of commercial offices in Singapore as well as India, Korea, and Australia, and dedicated distribution centers in Singapore, India, Australia, New Zealand, and Korea. Life Tech also conducts research in India.
"The scientific community in Asia Pacific is growing at a rapid rate," Mark
Smedley, President of Asia Pacific and Japan for Life Technologies, said in a statement. "By establishing the Instrument Center of Excellence in Singapore we are providing our global customers innovative technologies more efficiently, while helping them advance their research even faster."
Kevin Lai, director of the Biomedical Sciences Group for the Singapore Economic Development Board, added "This new Global Instrument Center of Excellence is an example of how leading life science instrumentation companies are increasingly looking to Singapore as an integrated location for complex analytical instrument manufacturing, research and development of next generation platforms, and Regional Headquarters for Asia."
Covance Inc., a leading provider of drug development services, and BML, Inc., a leading Japanese laboratory testing company, announced the expansion of the Covance-BML Clinical Trial Laboratory (CB Trial Lab) in Kawagoe City, Saitama Prefecture to enhance the capacity and capabilities in the region. The companies, which opened the lab together in 2010 as part of a five-year agreement, will launch several new expansion-related services this month.
“The expansion of the CB Trial Lab speaks to both the success of our affiliation with BML and the growing drug development relationships we have built with our clients in Japan and across the Asia-Pacific region,” said Jonathan Koch, Global General Manager, Covance Central Laboratory Services.
“This investment is an important step in growing our relationship with Covance and allows us to offer clients a wider range of services in an increasingly competitive marketplace,” said Kazuta Fukuda, President, BML.
The lab expansion includes increasing the size of the original facility by 50% , while adding new testing platforms, equipment and additional sample storage space. Specifically, new laboratory testing platforms have been added to enhance the capacity of the CB Trial Lab to manage the growing demand for in-country testing services. These new service offerings in the areas of immunoassay, flow cytometry, and protein chemistry will speed results to physicians conducting clinical trials for these critical testing parameters.
The CB Trial Laboratory is accredited by the College of American Pathologists (CAP), and maintains CDC lipid certification as well as National Glycohemoglobin Standardization Program (NGSP) Level 1 certification.
SAFC, the custom manufacturing and services business unit of Sigma-Aldrich Corp., will consolidate its global chiral chromatography screening and small-scale purification operations and locate them at its Pharmorphix solid State Research Laboratories in Cambridge, UK. The Cambridge facility will now become the hub for SAFC's chiral service offering which ranges from chiral gas chromatography (GC) and liquid chromatography (LC) separations, to large-scale crystallization, simulated moving bed (SMB) separations and production of enantiomerically pure APIs.
The consolidation of SAFC's chiral services will provide customers with a single point of contact from the development stage through scale up. Paul Rodwell, a former senior principal scientist with Pfizer, has been appointed to lead SAFC's chiral chromatography method development team. "SAFC offers a robust, cohesive range of chiral services that are applicable for a wide range of markets, from early stage drug discovery to route optimization and product development, through gram to multi kilo scale-up," said Mr. Rodwell.
Analytical equipment from Sigma-Aldrich subsidiary Supelco Analytical in Bellefonte, PA, where the chiral screening service was previously performed, is currently being installed at the Cambridge site. The chiral screening operation will continue to support the analytical chiral column business and will draw upon Supelco's analytical expertise to complement the solid-form characterization and research services at the Cambridge site. The new labs are expected to be validated and operational in July 2012.
Suzhou Pharma Services, an affiliate of Amerigen Pharmaceuticals, has opened new corporate headquarters in Lyndhurst, NJ. The company’s primary manufacturing facility is located in Suzhou, China and is FDA approved and Chinese SFDA licensed for finished product cGMP manufacturing.
The corporate U.S. office includes the senior management team, R&D, regulatory affairs and quality heads, a U.S.-based product development and project management team, and business development. The management team in China includes western-trained leaders, averaging more than 20 years of experience with multi-national branded and generic pharma companies. The company’s customer service and project teams are local and U.S.-based to facilitate all interactions and communications.
According to a company statement, “We are solely focused on solid oral dosages with a highly skilled and trained workforce. Suzhou Pharma Services can deliver to pharmaceutical manufactures’ not only cost savings and high quality products for western and global markets, but also a local manufacturing solution for access to the growing Chinese pharmaceutical marketplace.”
Bayer CropScience has opened a new vegetable breeding research and development center in Leudal, The Netherlands. The firm pumped €12 million ($15.1 million) into the facility, which will be used by scientists conducting cell biology and molecular breeding research.
Nestlé will centralize the development and management of all of its clinical trials, after the inauguration of its new clinical development unit and metabolic research centre in Lausanne, Switzerland.
The company said its new research centre will help it to more effectively and efficiently evaluate the impact of foods and ingredients on human biology and health – in addition to measuring the effects of products on taste and pleasure.
Speaking at the launch of the new centre Rafael Crabbé, head of the new clinical development unit confirmed the new centre will be responsible for the design and execution of all Nestlé clinical development programs on a global scale.
“Our desire to do more sophisticated studies to understand the physiological effects of nutrition requires an investigational centre that has the capabilities to meet our demands,” said Crabbé.
“In order to do all this, we have a multidisciplinary team of medical directors, clinical project managers, data managers and statisticians.”
Whilst the clinical development unit itself will be responsible for the design and management of Nestlé’s global clinical trial program, the metabolic research unit attached to it will play a growing role in the execution of trials, said the unit leader.
Also speaking at the inauguration, Werner Bauer, Nestlé’s chief technology officer cited the company’s commitment, “to offer our consumers healthy food and beverages” as a key reason for the move to centralize its clinical research activities.
“In the history of mankind we’ve never had so much information about how nutrition affects health. And yet we know surprisingly little,” explained Bauer.
“New technologies are revolutionizing our understanding of how nutrients and foods affect biological mechanisms and influence health...Here at Nestlé, we are contributing to this biological revolution.”
Bauer added that there is a strong focus on producing strong scientific data – something he believes is ‘essential’ both for responsible communication and for the substantiation of health claims.
From fundamental nutrition research and work on new biomarkers, to testing of how products affect energy metabolism, body fat, bone density, or pleasure mechanisms; the new unit will plan and conduct clinical research on a whole range of products and specialist areas.
The unit will employ around 40 specialists, who will manage and plan up to 100 clinical trials – with data from over 20,000 participants – at any one time.
As far as emerging medtech markets go, what comes to mind are usually China, India and Brazil, likely in that order. Terumo BCT, with funding from its parent company Terumo Corporation, will be building a new manufacturing facility in Vietnam. Terumo Corp. is committing $100 million to both this project and a new facility in the United States.
Terumo BCT, a blood component and cellular technologies company, was known as Caridian BCT before being purchased by Tokyo, Japan-based Terumo Corp. Terumo BCT is headquartered in Lakewood, Colo., and is the only subsidiary of Terumo Corp with headquarters outside Japan. Terumo Corp. has regional headquarters in Brussels, Belgium; Buenos Aires, Argentina; Hong Kong, China; and Tokyo.
“This is an exciting time for our organization. In just 12 months, we combined the businesses of CaridianBCT and Terumo Transfusion to emerge as Terumo BCT,” said David Perez. “With Terumo’s investment we are able to expand our global capabilities and footprint to be even more responsive to the demands of the marketplace. This investment demonstrates Terumo's commitment to the industry, to our organization and to better serve our current and future customers.” Perez is president and CEO of Terumo BCT, and serves as chairman of Terumo Corp.’s Blood Management Business Division.
The new U.S. facility will be located in Colorado, and will receive its funding around the same time the Vietnam facility sees the beginning of construction in early 2013. The bulk of the funding will go to the Vietnam facility, with only $6 million being funneled to Colorado. The land on which the Vietnam facility is to be built is approximately 25 acres.
Koji Nakao, Terumo Corp. chairman and representative director, said that this investment is part of the company’s mission to “contribute to society through healthcare.”
Terumo BCT designs and manufactures systems for apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with technologies in therapeutic apheresis and cell processing.
Germany-based pharmaceutical company, Boehringer Ingelheim, will establish a new European pilot plant facility, designed to increase development of new active pharmaceutical ingredients.
The technical centre, expected to cost in excess of €50m, will be located in Biberach, Germany, and represents the company's largest research and development site.
Boehringer has described its research pipeline as "well-stocked" and the facility is expected to ramp up the production of new compounds in order to ensure that sufficient quantities are available for upcoming clinical studies.
Boehringer Ingelheim board of managing director's chairman, Andreas Barner, said: "In order to continue offering new products in therapeutic areas with significant unmet medical needs, such as diabetes, cancer, hepatitis C, idiopathic pulmonary fibrosis and asthma, we need to invest now."
The 2,700m² (29,052 sq. ft.) facility is expected to be completed in early 2014 and will comprise 15 chemical reactors with volumes of 100l to 300l, as well as four manufacturing bays, significantly increasing the company's production capacity.
Boehringer Ingelheim development corporate senior vice president, Dr Wolfgang Baiker, said: "The pilot facility will make it possible to produce sufficient amounts to provide active ingredients from the global group's own research and development for later phases."
Eli Lilly and Company announced it has officially opened the Lilly China Research and Development Center.
According to a release, the goal of the LCRDC is to discover diabetes medicines with novel mechanisms of action that can be tailored specifically for the Chinese population to delay the progression of the disease.
The LCRDC, which employs approximately 150 scientists and staff hired primarily from China, is the latest in a series of significant research and development investments exemplifying Lilly's commitment to diabetes care and improving outcomes for individual patients around the world.
"Conquering a devastating disease like diabetes requires innovation, collaboration and investment. The establishment of the Lilly China Research and Development Center demonstrates we are serious about discovering and developing desperately needed breakthrough medicines for Chinese people with diabetes," said Jan Lundberg, executive vice president, science and technology, and president, Lilly Research Laboratories.
"We will do this by looking at diabetes in new and different ways and through collaborations with local academic research centers and partners that enable us to link Lilly scientists with scientists in China. With an eagerness and optimism to explore new theories about disease development and progression and potentially translate this to tailored diabetes medicines, I believe we will make a difference for people with diabetes, in China and around the world."
"Diabetes has reached epidemic proportions in China there are more people in China with diabetes than in any other country in the world, with as many as three-quarters of them not having adequate control of their disease," said Bei Betty Zhang, vice president, China Research and site head and general manager, LCRDC. "The research community needs to better understand the genetic and environmental factors that underlie this epidemic so that we may discover medicines that address these factors. At the Lilly China Research and Development Center, we will explore innovative ways to address this unmet patient need, such as targeting pathways involved in disease pathophysiology and partnering with the Chinese academic network to investigate unique features of diabetes in Chinese patients, with the goal of discovering breakthrough treatments."
Lilly and Covance announced a new agreement to establish a diabetes discovery partnership in China. Under this agreement, Covance's entity in China will provide the LCRDC with a range of services, including pharmacology studies, pharmacokinetic screening and other preclinical research to test and evaluate potential new diabetes medicines. The partnership in China is aligned with the global strategic alliance between Lilly and Covance, and will focus primarily on diabetes.
SafeBridge Consultants has certified Baxter’s manufacturing facilities in Halle and Bielefeld, Germany to handle potent pharmaceutical compounds.
Baxter now claims to be the only company worldwide with facilities certified by SafeBridge to handle both parenteral drug substance synthesis and parenteral drug product manufacturing and testing.
The German facilities support Baxter's BioPharma Solutions business, a contract manufacturing organization that collaborates with pharmaceutical companies to support their commercialization objectives. BioPharma Solutions provides scientific expertise, sterile manufacturing solutions, parenteral delivery systems and customized support services needed for parenteral products.
‘Baxter is honored to be recognized by SafeBridge for our safe handling of potent pharmaceutical compounds and our abilities to handle and manufacture these materials to industry standards,’ said Dr Burkhard Wichert, vice president of Manufacturing Oncology for Baxter's Halle facility.
‘We take our commitment to our pharmaceutical partners seriously and, ultimately, the patients who rely on the critical medications manufactured at our facilities in Halle and Bielefeld.’
SafeBridge Certification provides an objective and scientific assessment of a company's ability to handle safely and manufacture to industry standards potent compounds such as oncology drugs, steroid and peptide hormones, and new generations of opioids.
The certification also demonstrates that Baxter manufactures these compounds not only to US Food and Drug Administration, European and German laws, but also to international industry occupational health standards. In addition to the SafeBridge certification, the Halle facility is also OHSAS 18001 and ISO14001 certified.
During the assessment SafeBridge noted Baxter's commitment to operating safely; strong collaboration between management, supervision and employees; procedures in place to support potent compound handling operations; a strong preventative maintenance program and effective health surveillance system.
‘Baxter Oncology has established its operations in Halle and Bielefeld with safety and occupational health as cornerstones of its business in recognition of their product mix in the hazardous drug area,’ said John Farris, president and CEO of SafeBridge Consultants.
Takeda Pharmaceutical Co is to purchase Brazilian firm Multilab Indústria e Comércio de Produtos Farmacêuticos (Multilab) for BRL500m (US$246m; €196m) in cash, plus up to BRL40m in future milestone payments.
Under the transaction, the Japanese drugmaker will strengthen its position in Brazil and become one of the top 10 pharmaceutical companies in the country.
Takeda expects the deal to be finalized by the end of Q2. Other financial conditions were not disclosed.
Multilab, based in São Jerônimo/Rio Grande do Sul, employs around 650 people and had annual net revenues of BRL140m in 2011. It sells branded generics and over-the-counter (otc) pharmaceutical products. Retail sales grew by more than 20% a year from 2009–2011.
Takeda has an established presence in Brazil, manufacturing and marketing both prescription drugs as well as otc brands such as Neosaldina (analgesic), Eparema (digestive) and Nebacetin (anti-bacterial).
Multilab’s leading products include Multigrip, Brazil’s best-selling otc product for cold and flu treatments.
Multilab has well-established distribution through regional wholesalers and small-to-mid-sized independent pharmacies, in particular in Brazil’s emerging northeast region, which will complement Takeda’s strong relationships with major wholesalers, key chains and pharmacies in more established cities and state capitals.
‘This acquisition significantly reinforces Takeda’s position in Brazil, which is the world’s sixth-largest economy and the biggest in South America,’ said Jostein Davidsen, corporate officer, head of emerging markets commercial operations for Takeda.
‘Takeda has ambitious plans for growth in emerging markets. Brazil is our second-largest emerging market after Russia/CIS in terms of revenues and the acquisition of Multilab is a clear signal of our intention to become a significant player both in Brazil and other high-growth markets.’
Hilton Cavedon, executive director of Multilab, added: ‘Multilab will benefit from becoming part of the Takeda group, enabling the company to reinforce its market position and reach more patients with its key products in Brazil.’
NSF-DBA, an NSF International Health Sciences Co., has signed a collaborative agreement with Semler Research Center (SRC) of Bangalore to expand pharmaceutical training, auditing, consulting and testing services throughout India. NSF-DBA’s partnership with SRC provides global and India-based pharmaceutical companies with local access to training, consulting, auditing and testing services.
SRC, the Indian subsidiary of U.S.-based Arnold A Semler, Inc., specializes in all aspects of pharmaceutical development, clinical services, bioavailability/bioequivalence testing and GxP2 auditing and consulting. The two companies will work together to harmonize consulting and auditing practices and standards, as well as train SRC staff to deliver NSF-DBA training courses.
NSF-DBA services in India now include: GxP consultancy services, clinical services, bioanalytical services, and formulation, process and analytical development. SRC’s Bangalore facility has pilot scale manufacturing equipment to develop formulations and processes for a range of dosage forms, from oral solids, through semi-solids, to liquid injectables.
“We asked for recommendations from trusted clients and professionals in the region and one name came up time after time – SRC in Bangalore,” said Bob Pietrowski, NSF-DBA managing partner. “This agreement with SRC allows NSF-DBA to better assist companies in Europe and North America who are seeking audits of suppliers and contractors in the region as part of their supply chain assurance program.”
“This collaboration with NSF-DBA brings a host of high quality and competitively priced pharmaceutical services to companies based in India. The consultants of SRC, trained by the reputed Senior Consultants of NSF-DBA, provide a wide range of services that help ensure the safety of pharmaceuticals,” said Gurudatta G.G., chief quality officer, SRC.
Novozymes Biopharma has initiated the first shipment of its Bacillus-derived hyaluroni acid, Hyasis, from its new manufacturing facility in China. The first commercial products using Hyasis as a raw material are expected to reach the market in 2Q12.
“Shipment of the first commercial hyaluronic acid material from our new Q7 GMP facility marks an important milestone on our journey to becoming a leading producer of high quality hyaluronic acid. With our new patented process, based on the safe bacteria Bacillus subtilis, the market will have access to a new improved source of HA which is fully compliant with the highest pharmaceutical standards and developed with customers’ specific needs in mind,” said Thomas Videbæk, executive vice president of Novozymes A/S.
Hyasis has been specifically designed to fill a gap in the market for biomedical and pharmaceutical manufacturers looking for Q7 regulatory compliant ingredients with enhanced performance benefits. The Tianjin, China facility was designed exclusively for Hyasis and employs a patented water-based process to manufacture Hyasis to Q7 cGMP standards.
“Improving how our customers can process and formulate HA for medical applications has been the key driver in the development of Novozymes’ new patented HA production process and facility,” said Hans Ole Klingenberg, global marketing director at Novozymes. “Our unique technology will expand opportunities in the pharmaceutical and biomedical industries across multiple applications for HA, creating improved therapeutic treatments with real benefits for both manufacturers and patients.”
Randox Laboratories (India) Private Limited has opened their brand new manufacturing facility in Bangalore, India.
The opening of this purpose built facility marks a focal point in the company’s 30 year history.
With manufacturing facilities in the UK, Ireland, the United States of America and now India, Randox is a truly global manufacturing company producing revolutionary, innovative diagnostic solutions for the worldwide market.
Starting from humble beginnings in 1982, Randox has grown to become a global market leader; with the opening of another manufacturing facility a strong testament of this fact.
The 30,000 sq. ft. manufacturing plant also includes a 15,000 sq. ft. area for future development.
The impressive facilities include an Adelphi filling machine with an output capacity of 6000 vials per 8 hour shift as well as cold room and room temperature storage facilities with a 24,000 finished kits capacity.
Randox employs the same technology across all of their global manufacturing sites. “We believe consistency is key when manufacturing our world class diagnostic products. This good practice allows us to develop world class diagnostic products with unrivalled quality.
The company states, “Our new Bangalore manufacturing facility will allow us to continue to enhance product quality, ensure on time delivery and generate excellent customer satisfaction.
We are committed to revolutionizing healthcare worldwide, and this new facility based in Bangalore will further aid our ongoing expansion and growth whilst bringing new employment opportunities and industry to the area.
Flamma Italy has expanded its gas production capabilities after buying a facility near Milan, Italy.
The API maker says the plant – which includes drying, R&D (research and development) and analytical capabilities, as well as warehouses – means the firm can now handle large batch quantities of triphosgene and ammonia gas.
The firm says the move is a bid to meet growing customer demand for industrial production.
Gian Paolo Negrisoli, president and CEO, said: “The future at Flamma is very bright and we are delighted to provide our customers with the knowledge that we will grow to support their growth.”
Ropack, a provider of solid dose contract packaging services to the pharmaceutical and consumer health-care industries, announced an expansion of its production campus. The new site, strategically located directly next to its main pharmaceutical manufacturing plant, increases Ropack's total operating space to nearly 250,000 square feet.
The fully licensed site will complement the Montreal, Canada-based company’s broad contract manufacturing and packaging services by providing an additional 36,000 square feet of validated ambient and cold storage warehousing space.
Ropack is adding 5 new Class 100,000 cleanrooms to the existing 31 validated Class 100,000 cleanrooms to accommodate growing pharmaceutical packaging needs of its customers. The site will be fully operational June 1, 2012. Space is available to add an additional 6 rooms Class 100,000 at a later date.
“This facility reflects Ropack's unconditional commitment to providing the capacity and technology that allows our clients to succeed,” says Yves Massicotte, President and CEO. “Pharma (companies) are feeling pressure to bring new products to market, so as they focus more intently on core competencies, they are turning in greater numbers to contract packagers like Ropack. This expansion allows us to accommodate their increased requirements flexibly, agilely, and competitively.”
The expansion is just one component of Ropack's growth. In 2011, Ropack launched a 15,000-square-foot dedicated facility with low RH and controlled temperature for the production of stick-packs.
Quanticate, a leading global data-focused clinical research organization (CRO), announced expansion of its capabilities in India with the opening of a new office in Bangalore, India.
“Expansion of our facility in India is in direct response to the requirements of our customers and the driving force that enabled us to significantly grow in this region,” explained Daniel Chapple, Executive Vice President and Chief Commercial Officer at Quanticate. “Research has shown that customers turn to Quanticate because of our experience, knowledge and the high quality that we offer. Now through this expansion, our customers will also benefit from even more cost effective offerings, particularly with the large-scale FSP’s that we have in place” said Chapple.
India, along with other lower cost locations, have become integral to the greater adoption of outsourcing approaches especially since price remains one key consideration in the decision making process. However, ensuring that the operational structure keeps overall costs at an optimal level when taking into account oversight, communication and quality control at both the CRO and customer side, is a critical element to successfully provide support and solutions to the pharmaceutical, biotechnology, device and nutrition industries.
Karen Oooms, Executive Vice President of Operations (Strategic Delivery) explains, “Quanticate has been careful in its approach to using lower cost regions and does so for more than the purpose of achieving more attractive labor rates. The employees that are working in all our sites are not only highly experienced but also have a focus on teamwork to ensure that the high quality deliverables and communication that Quanticate has a reputation for is not impacted. We anticipate that all our locations will continue to grow based upon our healthy pipeline,” said Ooms. “This is an exciting time at Quanticate as we have recently launched our centralized data solution and we have been adding new expertise and technologies to support both our customers and our growing number of highly skilled statisticians, programmers, data managers, medical writers and pharmacovigilance experts.”
McIlvaine Company
Northfield, IL 60093-2743
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