PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY
UPDATE
October 2010
McIlvaine Company
TABLE OF CONTENTS
Upstate Medical University Plans Construction
Althea Expands Prefilled Capacity
Almac Moves into New North American Headquarters
Shrink Nanotechnologies Works with Corning
Ontario Genomics Institute Supports InDanio Bioscience
The BloodCenter of Wisconsin's Diagnostic Laboratories
Bunge Opens Illinois Innovation Center
Miami Life Science Center Preleases Space to Daya Medicals
Nexcore Breaks Ground on Medical Office
Southern Research Gains Bioanalytical Lab in BioCryst Acquisition
Roche Solidifies Arizona Presence
HB Fuller Company Willow Lake Laboratory wins Award
La Jolla Institute Gets Money from NIH
Eli Lilly Has New State-of-the-Art Lab
Laureate to Expand and Upgrade
Novo Nordisk and Nypro Inc. will Expand Plants
Govt. Awards Fort Hood Hospital Project
Woman’s Hospital in Baton Rouge to Grow
Pharmatek Expands Manufacturing Capabilities
Medicago Holds Groundbreaking for Vaccine Facility
Kansas Biodiversity Center Gets NSF Funding for Renovations
Dana-Farber Raises Money for Cancer Institute
DaVita Opens Central Lab Facility
University of California at Santa Barbara to Receive $2 Million
Covance Expands Biotech Services to North America
Porsolt Opens New U.S. Research Center
Xcelience Expands Dry Granulation Expertise
Biomedical Firm Expands Textile Engineering Facility
Arkansas Wins Funding for Protein Center
Vermillion OKed for European Union
University of Colorado Hospital Expansion
ShangPharma Plans Fengxian Facility
Pfizer to Acquire Brazilian Generics Stake
Herbalife Launches Botanical Extraction Facility in China
Pfizer Opens UK Biotech Packaging Expansion
BioStorage Adds Sample Prep Services
PPD Opens New Office in Beijing
Emergent BioSolutions Launches Singapore Operations
Retina Implant AG Opens Manufacturing Plant
FrieslandCampina to Open New R&D Centre in 2012
Bosch to Build Indian Packaging Plant
Syngenta Opens Singapore R&D Lab
Recipharm Acquires Abbott Mfg. Site in Spain
SAFC Completes Facility Expansion
Johnson & Johnson Buying Dutch Biotech Firm
High Tech Research in Portugal
Rostock Group Opens Genomics Research Center
Zydus Nycomed API Site to Start Production
Eurofins Has New Indian Food Testing Lab
Pharmaceutical Packaging Plant to be Built in India
IDT Biologika Plans Viral Vaccine Expansion
Diabetes Research Unit to Help China’s Diabetes Problem
PharmaZell Continues API Expansion in India
Sanofi to Build Plant in Algeria
Takeda Plans Production at New Plant
Alliance Medical Adds High-Volume Vial Filling Line
Upstate Medical University has about $225 million worth of construction projects in the pipeline as part of an aggressive effort to enlarge its Syracuse campus.
Those projects include a cancer center, an expansion of research space in the Institute for Human Performance building at 505 Irving Ave., renovation of two downtown apartment buildings and a new nursing school. Some of them will begin in the next few months.
Dr. David Smith, Upstate’s president, said the academic medical center needs the additional space to accommodate increases in student enrollment, patient volume and research activity.
Upstate will break ground on the cancer center next month. It will go up along East Adams Street just west of the Upstate University Hospital entrance. The Institute for Human Performance expansion will begin early next year. Renovations of the Harrison House and Townsend Tower apartment buildings downtown will begin later this year. Upstate will convert them into student housing. Construction will begin in 2012 on a new college of nursing west of Upstate’s Weiskotten Hall. That college now occupies space on the Hutchings Psychiatric Center campus.
Smith said the academic medical center is growing so it can provide more doctors, nurses and other health care professionals to upstate communities struggling with shortages of health care workers. It is also growing so it can generate more revenue to offset decreases in state funding, he said.
Upstate, which has about 8,100 people on its payroll, is the area’s largest employer.
The academic medical center, which has a $1.1 billion budget, is part of the State University of New York. It gets less than 10 percent of its revenue from New York. That percentage is expected to continue shrinking because of state budget cuts, according to Smith. The dwindling state support prompted this crack from Smith:
“We’re right now a private university with a noble public mission regulated like a state agency.”
Smith said he never wants to see Upstate privatized, but he would like to see the state give it more flexibility to do business with private companies.
Last year Upstate took over the former Kennedy Square housing complex between East Fayette and East Water streets where it and SUNY College of Environmental Science and Forestry are building a biotechnology research center on a portion of the property. Efforts to get the rest of the property redeveloped have been delayed because Upstate cannot solicit proposals from developers until it gets the OK from the state Legislature. Smith said there are five developers interested in the site. He called Kennedy Square “the poster child for the lack of flexibility.”
Smith said Upstate’s 409-bed hospital is running at nearly 100 percent occupancy.
To increase its capacity Upstate is trying to buy 306-bed Community General Hospital on Onondaga Hill. Smith said preliminary discussions with Community are going well. Upstate has reviewed credit reports on Community and “... we’re not seeing anything that is a show stopper,” he said.
Nutritional ingredients supplier Kemin Industries has unveiled a 5-year global expansion program that includes plans for new manufacturing and research facilities in Iowa.
As the family owned company approaches its 50-year anniversary in 2011, it is looking to expand, starting at home with the building of new headquarters in Des Moines, Iowa.
Still in the town where the business began, the building project will include 5 manufacturing facilities, 3 research labs and a corporate headquarters building.
To be built on a 20-acre site in the south east of Des Moines along the new SE Connector roadway, the new facilities will cost over $30m.
In addition to the new infrastructure, Kemin expect to be able to create 98 jobs in the areas of research, marketing, information technology and support functions, as a result of the investment.
In addition to the Des Moines expansion, Kemin also has plans to grow its global footprint that now includes operations in 60 countries and manufacturing facilities in 8 counties. In a statement, the company said it is actively evaluating expansion opportunities in Brazil, Russia, India and China.
Founded in 1961, Kemin produces of nutritional ingredients for all levels of the feed and food supply chains as well as health, nutrition and beauty markets. In the functional food market it is best known for its FloraGLO Lutein ingredient, which is marketed for its eye and skin health benefits.
Althea Technologies, Inc. has completed the installation of a new INOVA H3-5 high-speed syringe filling line at its large scale and commercial manufacturing facility in San Diego, CA. The expanded capacity allows the company to provide drug product in prefilled syringes from early development through commercial supply. The line will be available for production of GMP batches in 1Q11.
The INOVA H3-5 syringe line operates within a Restricted Access Barrier System (RABS) and has the ability to fill under vacuum, which facilitates handling of viscous products and products that require minimal head space. According to the company, the line accommodates nested syringes from a variety of suppliers and can produce batch sizes of more than 100,000 units. The system also incorporates non-destructive, in-process weight checks designed to minimize product loss.
Rick Hancock, president of Contract Manufacturing Services at Althea, said, "We've been filling syringes for clinical use for over eight years, and the addition of this new line allows us to continue to meet client requirements as they progress from late stage development through commercialization."
Almac announced that its Clinical Technologies division has successfully moved into the Almac Group’s new North American Headquarters. After groundbreaking of the 40-acre site in Souderton, PA on 23 July 2008, the drug development firm has now completed the first phase of relocating employees from three Almac business units to the new 240,000 square feet integrated drug development facility.
On 11 October, Almac’s technology business unit joined employees from Almac’s analytical testing and clinical supplies units as occupants at the North American Headquarters. Over the course of the next two months, Almac will transition the remainder of its clinical supplies operations currently located in Audubon, PA, into the integrated drug development facility in Souderton, PA.
The transition of the technologies business into Almac’s new North American Headquarters was carefully planned and executed. Over the course of the past few months, Almac successfully relocated and tested all of its new and existing technologies and systems in the new locale to make certain that there were no disruptions to client studies during the transition into the North American Headquarters.
Jim Murphy, President of Almac’s clinical technologies business unit, comments on the flawless move of the business from Yardley, PA, to its new location in Souderton, PA. Murphy: “Our IT, Quality Assurance, senior management team, and other key personnel worked in unison to ensure that all of our systems were tested and met the highest standards before we moved into the new facility. The transition team’s meticulous planning enabled us to avoid any downtime on client studies outside of our normal maintenance windows. I am delighted to announce that everything went as planned with this perfectly executed transition.”
The move of three Almac business units to a new North American Headquarters is part of the Almac Group’s integrated services solutions strategy. The new facility was planned to deliver a full-service, integrated drug supply management and technology solution to biopharmaceutical clients.
Joseph Bedford, Ph.D., Director of Marketing at Almac’s Clinical Technologies business unit comments: “The biopharmaceutical industry is making great strides to streamline drug development and bring efficiencies to clinical trials. Our new North American Headquarters allows Almac to deliver an integrated clinical supplies, analytical testing, and clinical technologies offering to sponsors that is unparalleled in our industry. Working with integrated teams of drug supply management and technology specialists at Almac, our clients will benefit from the combined insights of experienced professionals who deliver efficiencies in the clinical supplies chain that no other firm can match.”
Shrink Nanotechnologies has entered into a licensing agreement for Corning's modular microfluidic system, which Shrink said is the world's first fully functional plug-and-play system that allows for integrated high PSI connectors, electronics, and pumps. The deal is for eight years. In exchange for commercial royalty, Shrink, based in Carlsbad, Calif., retains the exclusive right to use and sublicense the technology, which is applicable to biomedical, cell-based drug discovery work, and biochemical work.
St. Louis, biotech firm Mediomics has been awarded a $185,000 Phase 1 SBIR grant from the National Cancer Institute to develop a hand-held biosensor and protein assay reagents for in-process analysis of biologics production. The reagents are based on its Pincer technology. The project will culminate with beta testing by a third-party manufacturer collaborator.
The Ontario Genomics Institute has made an investment of an undisclosed amount into start-up InDanio Bioscience, which is developing a novel screening system for the complete human nuclear hormone receptor family. InDanio's technology uses fluorescent tags attached to copies of human genes in living zebrafish embryos to identify and localize functioning individual NRs.
The BloodCenter of Wisconsin's Diagnostic Laboratories said it has built one of the largest genotype databases in the nation. Using its high-throughput technology, it was able to screen more than 25,000 donors in nine weeks and is screening repeat blood donors to create a database of rare and uncommon donors. It also announced a donor screening service designed to reduce costs associated with identifying red blood cell antigens is available.
Madison, Wis-based Biosystem Development has completed a financing round that raised $978,000, which will be used to expand manufacturing infrastructure and to launch new products into the biopharmaceutical development market, including new products based on the company's AssayMap high-throughput micro-chromatography platform.
Canadian technology commercialization agent Mars Innovation has provided C$500,000 ($494,000) to start-up chip-based molecular diagnostics firm Xagenic. The company also has a C$300,000 loan from the Health Technology Exchange; C$200,000 from the Ontario Institute for Cancer Research; and C$40,000 from the Ontario Centre of Excellence Centre for Commercialization of Research, bringing the amount in new working capital to C$1.04 million.
Bunge North America has opened a new ingredient innovation center for edible oils and carbohydrates in Bradley, Illinois to allow faster commercialization of new products, the company said.
The new center brings together the company’s ingredient innovation and pilot plant facilities, and includes a scaled-down edible oils production facility to produce shortenings and oils on site, as well as an extrusion pilot plant to test cereal and snack food applications made with milled grain products. Currently, there is particular interest in developing foods that include whole grains and snacks that are free from trans fats, the company said.
President and CEO of Bunge North America Soren Schroder said: "This state-of-the-art facility ensures we can quickly take our ingredient solutions from concept through commercialization."
The company said that food manufacturers can work directly with Bunge staff at the center, known as the Bunge Ingredient Innovation Center (BIIC), in the development of new products.
Director of innovation and technical services at Bunge Milling Brian Anderson said: "The BIIC puts us in position to provide our customers with a collaborative innovation environment. We now have the ability to configure customer-specific extruded snack, cereal and ingredient applications on site."
The BIIC also covers development of bakery applications, and analytical and sensory laboratories to help meet nutritional, sensory and functional demands.
Director of research and development at Bunge Oils Roger Daniels said that the company’s team of 25 scientists and support staff has created a portfolio of ingredients to supply trans-fat free shortenings and whole grain products.
He said: "With the BIIC, our customers will be able to test how these solutions improve the nutritional profile and performance of their existing products or work with our experts to develop new products."
On the back of growing concern, the Food and Drug Administration issued a regulation that was implemented in 2006 requiring manufacturers to list trans fatty acids on the nutrition panel of foods, providing further motivation for manufacturers to cut trans fats from their products. In addition, there are now trans fat bans in place in many parts of the United States, in areas that encompass about 20 percent of the population.
Meanwhile, manufacturers have flocked to include whole grains in new product offerings following the introduction in 2005 of the Whole Grain Stamp, which indicates high whole grain content. According to the market research organization Mintel, ‘whole grain’ has consistently been among the top 20 new product claims since 2005, and has increased each year. It appeared on 2.3 percent of products launched in 2005 – rising to 5.6 percent in 2010, Mintel said
Medical device company Daya Medicals, Inc. has become the newest tenant to sign a lease at the University of Miami Life Science & Technology Park, where Wexford Science & Technology, LLC is building a 252,000-square-foot life science facility scheduled for delivery in mid-2011.
Daya Medicals, Inc. will relocate its corporate office from the Palm Beach County area to the park. News of DayaMed’s lease follows the recent announcement that the University of Miami will occupy 80,000 square feet in the park’s first building. The 15,000-square-foot lease brings the total amount of square footage leased in the tech park to roughly 40%. The Life Science & Technology Park will house wet and dry labs, offices, and lab-ready development suites.
Wexford hopes to position the area, already home to one of the nation’s largest concentrations of health care facilities and the University of Miami Miller School of Medicine, as a global center for the development and commercialization of new life science products and technologies.
The project’s master plan includes five buildings totaling between 1.6 and 2 million square feet of lab and office space, plus restaurants and retail to serve employees and residents. Wexford is drawing on success building similar research parks in association with universities in Baltimore, Philadelphia, Chicago, and other U.S. cities.
NexCore Group broke ground on a new 182,000-square-foot medical services building, a part of Silver Cross Hospital Center in New Lenox, IL. Delivery is scheduled for the fourth quarter of next year.
The hospital is a part of a $400 million, 76-acre replacement of the old campus. The new building will be six levels, and provide 70,000 square feet of new outpatient facility space.
This is the first project to be financed in part by the Denver-based healthcare real estate firm’s newly obtained company, NexCore-Heitman. Heitman LLC partnered with NexCore to provide the financing for the project, which brings the NexCore-Heitman joint venture portfolio to $136 million.
Beta-Pro is addressing rising demands from drug discovery and research institutes in the hepatocyte market by expanding its site at the University of Virginia Research Park, US, with a new GLP facility.
The human cellular sciences firm has opened its facility to gain new business opportunities in the lucrative hepatocyte and drug discovery markets. Additionally, Beta-Pro will focus on other human cell applications, including tissue assays, custom drug discovery, and toxicology testing services using human cells for potential pharmacological applications.
Joe Shields, a spokesperson for Beta-Pro, said the expansion is important for the company as performing human tissue-based drug discovery research “can yield significantly more efficacious results” compared to when using animal cells.
“If human cells provide just one per cent greater accuracy or breadth in results, the increased efficacy can save pharma companies anywhere from a couple to several hundred million dollars as products come through the pipeline,” he claimed.
According to Shields, the new laboratory is more expansive than the clinical transplant GMP (good manufacturing practice) facility Beta-Pro currently manages for the University of Virginia.
He said the laboratory will be used to investigate islet cell cryopreservation, so the company can offer one of the first islet cell banks to researchers. The laboratory is fully equipped with a controlled-rate freezer and a long-term cyostorage system, as well as a Cobe 2911 cell processor used for research isolations on cells.
The company says it will perform assays on site to produce quicker, cheaper, and more accurate results by eliminating the degradation, timing and costs that come with shipping cells and tissue to other screening facilities.
“Many pharmaceutical companies and research institutes are not large enough to have their own in-house screening facilities, so clients may now outsource to us,” said Shields.
So far Beta-Pro has invested around $3m (€2.2m) in the facilities and expansion initiatives to break into the $2-3bn hepatocyte drug market. “The size may seem small in the pharmaceutical world,” said Shields, “but drug screening results play a critical role in the entire drug process and impact decisions downstream that are worth billions of dollars.”
In recent years, new developments in stem cell research, driven by the discovery of induced pluripotent stem cells (iPSC), have increased the availability and consistency of human cells available for clinical research. These changes “have enabled drug discovery teams to use human cells to a greater extent in their research, to improve their results and decision-making,” he said.
Along with the new facility, Beta-Pro will continue to run its GMP facility at the University of Virginia to supply diabetes researchers and transplant centers with clinical and transplantable human islets and other pancreatic biomaterials.
Shields said “Beta-Pro expects to become a $100m company within the next few years.” Saying that pharma companies need to test products in vitro on human cells as a primary toxicology screen before making billion-dollar investments, he believes this will secure long-term business prospects for Beta-Pro in the human cell service field.
Southern Research Institute is acquiring BioCryst Pharmaceuticals’ bioanalytical laboratory assets and personnel in a move towards expanding its bioanalytical service offerings.
In what Dr Andrew Penman, vice president of Drug Development at Southern Research described as “a win-win situation for both companies,” the non-profit Scientific Research Organization (SRO) will acquire BioCryst’s bioanalytical lab to enhance the existing Bioanalytical Sciences unit at its Southside Birmingham, Alabama, US, campus.
Furthermore, Penman said, “It greatly enhances our capability in providing small molecule clinical trials with bioanalytical support because of the experience of the new employees who will be joining us.”
The firm will initially gain five bioanalytical lab personnel who will continue to work in BioCryst’s research facility in Birmingham until early next year when they will be relocated early to Southern Research’s Southside Birmingham campus, where most of the firm’s life sciences work is conducted.
The new staff members will work with Southern Research to support the liquid chromatography-mass spectrometry (LC-MS/MS) component of clinical studies in all phases of research, as well as performing clinical and statistical analysis through in-house and partnered relationships.
Penman mentioned that for over five years, the SRO has supported clinical trials by analyzing serum for influenza specific antibodies using the Hemagglutination Inhibition Assay (HAI) and Microneutralisation (MN) assays under GLP conditions.
According to Penman, the infectious disease group at Southern Research has “a multitude of clinical isolates” from recent influenza seasons along with various clades of H5N1 viruses, all of which he says are available for use in assays.
“We strongly believe this area will be growing as the number of biological therapeutics in development increases,” said Penman who added that Southern Research’s experience in toxicology, infectious diseases, and cancer research makes the company a firm candidate for outsourcing all aspects of a bioanalytical program.
Believing there to be “significant opportunities within the bioanalytical arena,” Southern Research aim to bring new drugs therapies and vaccines to the market, with a particular onus resting on small molecule therapeutics.
Already successful in securing a place in the market for seven of its anti-cancer drugs, Southern Research has a further seven in various stages of preclinical and early clinical development, though Penman says, “more rewarding is working with our clients to help make crucial decisions about drugs in their development pipelines.”
Swiss drug giant Roche has further cemented its commitment to the Tucson area, unveiling a $180 million expansion plan for Ventana Medical Systems' Oro Valley campus. The growth plan will bring up to 500 new jobs as Ventana, a University of Arizona spinoff acquired by Roche in 2008, boosts its work force by up to 50 percent over the next five years.
"We are poised to keep growing to meet the demand, both national and international, for our products and services in the cancer-diagnostics arena," Ventana President Hany Massarany said during an announcement event held at Ventana's main building at 1910 E. Innovation Park Drive.
But despite the fact that Roche has accelerated Ventana's already steep growth curve since buying the company -- boosting its payroll and buying up property for expansion -- its decision to expand here was no slam dunk. State and local economic-development officials said they spent nearly a year courting Ventana for the major expansion. The effort included officials of Tucson Regional Economic Opportunities Inc. (TREO), the Arizona Commerce Authority, Pima County and the town of Oro Valley. The local area competed for the expansion against at least three other markets -- Indianapolis, home to Roche Diagnostics' U.S. headquarters and some 3,000 employees; and proposed sites in Southern California and northern New Jersey, TREO President and CEO Joe Snell said.
The Ventana chief said a variety of other factors contributed to the decision, including the availability of skilled workers and scientists. He also cited Ventana's ties to the University of Arizona, noting that Ventana was founded in 1985 by UA pathologist and Arizona Cancer Center member Dr. Thomas Grogan, who still serves as chief scientific adviser to the company. Massarany also pointed to critical research links with the UA's Bio5 Institute, the university's genomics research arm; and the Critical Path Institute, a Tucson-based partnership of the UA and the U.S. Food and Drug Administration researching ways to improve new-drug development and safety.
The company's development plans, which call for $180 million in capital investment, have not yet been finalized, but Massarany said the company plans to build on its 60-acre campus. "We have some capacity to add more people ... but there's no question we'll have to expand facilities," Massarany said.
Ventana expects to add workers across the board in the coming years, including scientists, sales, manufacturing and administrative positions, as the company expands its sales and enters new global markets. While there are no plans to move jobs from elsewhere to Oro Valley, some jobs may be moved here from future acquisitions, he added.
Massarany said Ventana's growth is being driven by advances in so-called "personalized" medicine that uses genetics to match patients to therapies for the best results. One example is a Ventana test for a certain type of breast cancer that is identified through a genetic trait and responds to a specific drug, marketed by Roche subsidiary Genentech. Another factor is Roche's reach into international markets, including Russia, that Ventana would have had difficulty reaching as a stand-alone company, Massarany said.
Industrial adhesives manufacturer HB Fuller Company’s Willow Lake Laboratory in Vadnais Heights, Minnesota, designed by HGA Architects & Engineers, has scooped the 2010 American Institute of Architects (AIA) Minnesota 25-Year Award.
In 1979, extensive planning for the site and building began with final construction completing in 1985. Since the site consists of several acres of wetland habitat and sixty-acre lake, the goal was to create minimal impact upon the site. Upon completion, 97% of the site was preserved as unmodified wetland and wildlife habitat. The façade is oriented to the south-southeast for solar gain, day-lighting and views, allowing scientists to be exposed to natural light from workspaces throughout the building.
The laboratory backs into a hillside, consisting of a cascading three-level atrium with the entry/reception on the top level, dining commons in the middle, and a research library on the lower level with each of the elements opening up to roof terraces.
HGA Architects & Engineers designed the building in a way to address society’s responsible use of natural resources and integration of the site, building and systems. About 50% of the building’s envelope is earth-sheltered and not exposed to the north wind. The primary heating and cooling system was based on geothermal heat exchange and the environment systems, and laboratory exhaust systems to reheat makeup air. The project has been awarded numerous national conservation and innovation awards for its 92% energy independent structure.
The HB Fuller Company Willow Lake Laboratory represents the mid-century efforts of the profession to address responsible building and energy conservation. The building was the result of the energy crisis of 1979 and its founder, former Governor Elmer Anderson, who was a strong advocate of environmental sustainability.
Willow Lake Laboratory is HB Fuller Company’s world headquarters building. Established by AIA Minnesota in 1981, the 25-Year Award recognizes exemplary architectural projects that have withstood the test of time.
Jurors for this year’s 25-Year Award were John Cuningham, FAIA, founder of Cuningham Group Architecture; Nathan Johnson, AIA, 2009 Young Architect recipient and founder of 4RM+ULA; and Blaine Brownell, AIA, Assistant Professor at the University of Minnesota College of Design and founder of the design/research firm Transstudio.
The La Jolla Institute for Allergy & Immunology has won a $12.6 million stimulus grant from NIH toward developing San Diego's first Center for RNAi screening, with the intent of hosting projects by researchers from throughout the region.
The center — one of five to be created nationally with NIH funding — will be housed at the La Jolla Institute's new Division of Signaling and Gene Expression. Mitchell Kronenberg, the institute's president and chief scientific officer, said in a statement that the center will be launched with four initial immunology-focused research projects examining how genes affect immune system function.
Kronenberg is co-lead investigator on the center grant along with Anjana Rao, whom the institute recruited from Harvard Medical School last year to lead the signaling and gene expression division. Three of the projects will be led by Kronenberg and Rao, along with scientists Sonia Sharma and Matthew Pipkin, who work with Rao.
The fourth project will be led by David Nemazee and Changchun Xiao, both from the Scripps Research Institute. Nemazee and Xiao will analyze how microRNAs regulate B lymphocytes, with an eye to better understanding diseases such as lupus and rheumatoid arthritis
According to the institute, the center will offer researchers help and advice about high-throughput screen design, tapping into Rao's expertise in the technology, in addition to molecular libraries and instrumentation.
"We recognize the power and groundbreaking capabilities of this technology and will use it to advance scientific knowledge toward new and more effective vaccines as well as potential new therapies for autoimmune diseases ranging from type 1 diabetes to rheumatoid arthritis," Kronenberg said in the statement.
Eli Lilly and Company announced that approximately 140 of its scientists have begun working at its new state-of-the-art cancer research facility in New York City that is focused on speeding to market a new generation of potentially breakthrough cancer medicines to improve outcomes for individual patients. Occupying 90,000 square feet of office/laboratory space, Lilly is the anchor tenant at the new Alexandria Center for Life Science - New York City, located along Manhattan's East Side Medical Corridor just north of Bellevue Hospital and adjacent to New York University's Langone Medical Center.
Given its size and proximity to leading academic and medical institutions, the site will be a hub of life science activity. The Alexandria Center now houses the research activities of ImClone Systems, a wholly-owned subsidiary of Lilly. Lilly acquired ImClone in 2008, along with certain rights to already marketed Erbitux® and ImClone's pipeline of oncology biologics. At the site, ImClone scientists will conduct the preclinical discovery efforts for potential new biotechnology medicines for patients with cancer.
"We are driven by our goal of improving outcomes for individual patients, and our strong biotechnology research capability working with several therapeutic areas is one of the key ways we are executing this innovation strategy," said Jan M. Lundberg, Ph.D., executive vice president of science and technology, Eli Lilly and Company, and president, Lilly Research Laboratories. "The ImClone research move to the Alexandria Center will provide state-of-the-art laboratory facilities and help us foster both internal and external innovation, and promote collaboration."
Lilly has two other biotechnology centers in the United States, one in San Diego and the other at its corporate headquarters in Indianapolis. Of these, the biotechnology center in New York is the only one specifically dedicated to discovering potential new cancer medicines.
Lilly has a long history in biotechnology research and development, beginning with the introduction of the first commercially produced biologic -- insulin -- in 1923. Sixty years later, Lilly, in collaboration with a partner, ushered in the modern era of biotechnology by producing the first recombinant DNA-based biologic: human insulin. Biotechnology Drives Lilly's Search for New Cancer Treatments because they can be genetically engineered, biologics are more easily tailored to individual patient subgroups, which is a key element of improving cancer treatment. Tailored therapies can significantly increase value for patients and their doctors because their use can be focused in the subgroup of patients where the benefit-risk ratio is most favorable.
"My colleagues and I are excited about being part of the Alexandria Center, where we will continue our discovery efforts for new breakthrough biotech treatments that have the potential to truly change cancer care for patients around the world," said John H. Johnson, president, Lilly Oncology, and senior vice president at Lilly. "We are using biomarkers and applying new tools and technologies to tailor our potential medicines during the earliest stages of development, including the preclinical work that our researchers are conducting right here at this new world class facility."
Banyan Biomarkers won a $26.3 million contract from the U.S. Department of Defense to develop a point-of-care test for diagnosing traumatic brain injury (TBI). The firm claims the award will fund research to develop a test with applications for civilian use as well as military.
Florida-based Banyan was established in 2002 to develop the first point-of-care test for diagnosing TBI. The firm says it has identified biomarkers that are specifically present in a patient’s blood after injury to the brain, and has developed ELISA assays to quantify the markers. There is currently no blood test that clinicians can use to detect the presence or severity of brain trauma, Banyon points out.
The firm is complementing its diagnostics development by offering a range of core biomarkers for research applications along with service offerings based on its panel of neurological, psychiatric, neurodegenerative disease, and organ toxicity biomarker assays. Additional analytical services use the firm’s animal models and primary neuronal culture models of neuroinjury or neurotoxicity.
Banyan also operates a Center of Innovative Research (CoIR) to promote relevant research by both the academic and industrial communities. The CoIR promotes basic and applied human disease research that is focused on brain disorders, but it also includes other organ systems such as liver damage.
Banyan cites estimates suggesting that over 1.4 million people annually suffer a TBI in the U.S., resulting in more than 230,000 hospitalizations, 50,000 deaths, and 80,000–90,0000 people experiencing permanent disability from their injury. Currently, 5.3 million Americans live with TBI-related disabilities, compared with 4 million who are disabled by Alzheimer disease, the firm notes. In the military, it is estimated that up to 20% of combat veterans have suffered some degree of traumatic brain injury due to bomb blasts while in Iraq or Afghanistan.
Laureate Pharma, Inc. has secured $20 million to finance five investment initiatives over the course of three years. "This marks a significant milestone in our efforts to relaunch Laureate Pharma," said Michael A. Griffith, chief executive officer. "Our strategically planned improvements coupled with our solid financial footing will position us for exceptional growth. As we transform Laureate, care will be taken to maintain continuity of client services. Quality Assurance will oversee investment activities to ensure our offerings comply with the strict demands of global regulatory agencies."
Laureate has recently added 10 new jobs and plans to fill 50 more positions when working at capacity.
The company’s investments included:
Upgrading aseptic fill capabilities through the construction of a new segregated fill suite and the installation of a new fully-automated fill line incorporating vial washing, depyrogenation, filling, and capping. All product contact pathways of the new line will be single-use disposable. Commissioning is planned for early 2012.
Upgrading protein production services to increase bioreactor (2000L) and purification (10L chromatography skid) capacity, new gowning rooms, renovated purification suites and additional support utilities.
Launching a contract analytical testing business to serve a broader client base including clients who do not require other Laureate services. Laureate will enhance sample management procedures, upgrade and add new instrumentation to offer a full range of testing required to characterize protein products.
Expanding mammalian cell line creation services; in 2011, Laureate will offer access to a variety of protein expression systems that can be selected based on the specific characteristics and requirements of the protein product. Additionally, the Company plans to add cGMP cell banking services.
Adopting new quality systems technologies including new systems to manage inventory, deviations, and calibration and validation. In addition, the Company will acquire a new software solution that will enable it to assemble documentation for clients in an eCTD format.
Finally, Laureate will expand its regulatory affairs unit to assist clients in the preparation of data summaries, batch reports and regulatory submissions.
Laureate Pharma has added 10 new jobs since bringing on a new CEO and a new Vice President of Business Development and plans to fill 50 more positions when working at capacity.
For Four Oaks Mayor Linwood Parker and other Johnston County leaders, Friday's groundbreaking for Becton, Dickinson and Company was a milestone in a years-long job-creation effort.
Parker and County Commissioner Wade Stewart said they remembered rabbit hunting as boys in the field where the medical-device maker will build a distribution center. The Guin field, as it was known then, is now well on its way to becoming Four Oaks Business Park.
Stewart noted that BD won't be the first business conducted in the field. "There's been a lot of things done in the Guin field -- from bootlegging to unmentionables," he said.
Parker told the crowd of about 100 that he knew early on the property had potential. "I have always believed that this land was the cornerstone to the future of our town," he said.
Parker traced the roots of Four Oaks Business Park back several decades, when town leaders lobbied the state to build an interchange on Interstate 95. Once that effort was successful, Parker said, Four Oaks residents agreed to give up the immediate benefits of what he called a "plastic interchange" -- gas stations and fast food restaurants -- in the hopes of something better.
That something centered on the Guin field, and the five families that owned the land agreed to sell. More recently, Parker said, a neighboring family made its land available for future expansion of the business park.
At Friday's groundbreaking, Charlotte-based developer The Keith Corp. displayed updated drawings of the park, with BD's distribution center shown at the back of the park. Up to seven other companies could eventually line the entrance road, which will run from Hockaday Road just east of its I-95 crossover to the BD distribution center. BD's building will back up to N.C. 96, and the company is leaving room for a future expansion in that direction.
With a 720,000-square-foot building, BD is expected to be the park's largest tenant. Plans show the second-largest tenant topping out at 420,000 square feet.
"It actually is the equivalent of 15 football fields under one roof," said Larry Smith, vice president of global-supply-chain operations for BD. The center will be the hub for shipping BD products up and down the East Coast and overseas, he said. The company will build using environmentally-friendly standards, with the goal of earning certification through the U.S. Green Building Council's Leadership in Environmental Energy and Design (LEED) program.
The distribution center is scheduled to open in 2012, with employment reaching 187 within three years. The average wage will be $28,771 a year, just under the Johnston County average.
The state and county lured BD in part with $2.3 million in incentives, including $1.7 million that Johnston County will pay out over seven years if the company delivers on its planned $38.4 million investment. Also, the company will get a $600,000 grant from the One North Carolina Fund, a state program that provides incentives for companies to grow.
Two companies plan to create 241 jobs over the next four years in North Carolina as they expand production of a new insulin device for people with diabetes.
Novo Nordisk A/S and Nypro Inc. will expand plant employment in Johnston and Buncombe counties through a $161 million investment. Novo Nordisk will add 85 jobs at its Clayton plant to increase production of an insulin delivery device. Nypro will hire more people in Asheville to make plastic and assemble the device.
Novo Nordisk also can receive an additional $840,000 if they follow through with the extra jobs and investment.
The U.S. Army Corps of Engineers selected the joint venture of Balfour Beatty Construction and McCarthy Building Cos., and HKS Architects and Wingler & Sharp as design partners, as design-builder for the replacement of the 45-year-old Carl R. Darnall Army Medical Center at Fort Hood, TX.
The 944,000-square-foot, $503 million project will include a hospital, outpatient clinics, ambulance garage, logistics building, central utility plant and three parking structures.
American Recovery and Reinvestment Act of 2009 stimulus money is funding $351 million of the design and construction budget. Construction is scheduled to start next April and be complete May 2014. The facility will be designed and constructed to achieve LEED Gold certification.
The project team will maximize the use of building information modeling (BIM) tools to help facilitate collaboration and coordination of all project aspects during design and construction. Altogether, Balfour Beatty Construction and McCarthy Building Cos. have designed and/or built over 2,000 healthcare projects nationwide with a combined value exceeding $25 billion.
Ventas, Inc. announced that wholly owned subsidiary Lillibridge Healthcare Services, Inc. will begin construction on a $40 million, 250,000 square foot medical office building on the campus of the new $350 million Woman’s Hospital campus in Baton Rouge, LA.
The nonprofit Woman’s Hospital will own the entire campus, including the MOB, as part of a plan to replace the facility. Lillibridge will serve as developer, architect, space planner and construction manager of the new medical office building, said Todd W. Lillibridge, chairman and CEO of Lillibridge and executive vice president/medical property operations for Ventas.
The MOB, which will consist of two buildings of four and five stories, will be physically connected to Woman’s Hospital and will house a comprehensive breast care center, a maternal-fetal medicine center, infrastructure for an ambulatory surgery center, retail space and other potential outpatient services. It's expected to be ready in late 2012.
The replacement campus is being built at Airline Highway and Pecue Lane in Baton Rouge, about five miles from the current Woman’s Hospital campus, which will be vacated when the new hospital and MOB are completed.
Pharmatek Laboratories, Inc., a premier contract development and manufacturing organization supporting the pharmaceutical industry, announced that it has added roller compaction to its solid oral dosage form manufacturing capabilities. The company has purchased two roller compactors, a pilot-scale Vector TFC-220 roller compactor with a rate of 20 kg/hour, and a Vector TFC-LAB Micro lab-scale roller compactor with a rate of 1 kg/hour. Both machines have been integrated into Pharmatek’s GMP facility and are ready for GMP manufacturing.
“The addition of roller compaction expands our granulation capability, especially in the area of moisture sensitive and density-challenged API’s. When used in conjunction with our microdose capsule filling technology (Xcelodose 600S and Symyx Powdernium MTM2005), roller compaction also provides an option for larger fill weights in powder-in-capsule dosage forms,” said Kevin Rosenthal, Director of Manufacturing. “Additionally, with the purchase of two roller compactors we now have dry granulation capability in our highly-potent and non-highly-potent manufacturing facilities.”
Pharmatek has also complemented existing manufacturing capacities by expanding single-batch blending size capabilities three-fold (up to 36kg) with the acquisition of a 3 cu. ft. V-blender, and increasing capsule and tablet production by purchasing a Bosch GKF400 automated encapsulator with a rate of 23,000 capsules/hour and a Korsch PH-106 instrumented tablet press with rate of 32,400 tablets/hour.
“With the roller compactors, Pharmatek can now support a broad range of solid oral formulations that previously were not optimal or feasible using our existing wet granulation equipment due to moisture sensitivity. The 3 cu. ft. V-blender and Bosch encapsulator have positioned us well for large-scale Phase II clinical trial manufacturing,” stated Jeff Bibbs, CEO and CSO of Pharmatek. “Also, by expanding our existing encapsulation and tablet manufacturing capabilities, we can better serve our clients' clinical drug supply needs as they move beyond small-scale development and transition to GMP manufacture of drug product for clinical trials.”
Medicago U.S.A. Inc., a wholly owned subsidiary of Medicago Inc. a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), announced that company executives, held an official groundbreaking ceremony this morning for its U.S. plant-based commercial grade vaccine facility in Research Triangle Park, North Carolina. Medicago U.S.A. also announced the appointment of Mike Wanner as Vice President of U.S. Operations.
Recently, Medicago U.S.A. officially commenced the construction of its cGMP facility in Research Triangle Park (RTP), North Carolina. This VLP plant-based vaccine facility will include a fully automated greenhouse and a state of the art extraction and purification unit. The facility is targeted to produce 10 million doses of pandemic influenza vaccine per month. On an annual basis, the facility would have production capacity of 40 million doses of seasonal Influenza vaccine or 120 million doses of pandemic influenza vaccine.
"Thanks to the efforts and experience of our partners Alexandria Real Estate Equities and BE&K Building Group as well as our employees at Medicago, we are confident that this fast-track project will be delivered on time," said Andy Sheldon, President and CEO of Medicago. "North Carolina and RTP is a great place to build our business due to the excellent workforce, training programs and quality of life."
"We are very pleased to be working with Alexandria Real Estate Equities and with Medicago who is bringing this unique, rapid and cost-effective vaccine technology to North Carolina and to the Research Triangle Park," stated Joseph M. Raimondi, Project Executive of BE&K Building Group.
Using federal stimulus funds as well as its own money, the University of Kansas over the next three years will renovate the century-old home of its Biodiversity Center, modernize its facilities and equipment, as well as step up its training of graduate students.
KU has won a five-year, $1.5 million grant from the National Science Foundation toward repair and renovation costs at Dyche Hall directly related to research, including architectural and engineering plans and fees, demolition and removal, construction, and fixed lab equipment such as benches, cabinets, and fume hoods. NSF awarded its grant through its Academic Research Infrastructure: Repair and Renovation program, funded by the $814 billion American Recovery and Reinvestment Act of 2009.
The university will use other funds to purchase equipment and upgrade the building's infrastructure, including $1.3 million of its own money for new electrical, cyber, and heating and air conditioning systems.
Construction is set to start in November and conclude by 2013.
Leonard Krishtalka, director of the Biodiversity Institute, said the renovations will include a revamping of the Genomics Complex that will add to its capabilities. A second sequencing lab will complement the institute's current amplification lab, while a set of freezers will be replaced with a new liquid nitrogen cryogenic facility that KU says will improve its ability to preserve its collection of 80,000 tissues.
The NSF grant will fund construction of the space, with the institute paying for the cryogenic facility's new dewars, racks, and other equipment through other funds.
NSF is also funding construction and fixed lab equipment of:
A cloning lab for research into ancient DNA; the instruments will be paid for from other funds.
New biotic and morphology analysis laboratories for research into the body and skeletal attributes of organisms.
A geographic information systems (GIS) laboratory for analyzing and forecasting the potential spread of diseases and pests.
A new data server room five times the size of the current 94 nsf server room, which archives and feeds terabytes of biotic and other environmental research data to the institute and global community networks.
"All other renovations involve major improvements for enhanced capacity and capability to biocomputation, morphology, GIS, tissue preparation, and biotic analysis labs, all but two of which will also involve relocation from their current spaces. For all intents and purposes, these labs will be 'new,'" Krishtalka said.
The new data server room will contain 368 nsf for equipment, and another 120 nsf for mechanical systems. The current server room, originally designed for an office, "is too small for current and anticipated data storage and server needs, and has limited network capacity with only 12 100mb network jacks. It lacks sufficient electrical service and backup power to support the HVAC system, which, in turn, lacks humidity controls, redundancy, or fail-safe mechanisms that are standard for cooling server facilities," KU said in its application for the NSF grant.
"As a result, repeated electrical overloads have caused system failures and threatened the loss of mission-critical data," KU concluded.
Krishtalka said the extra server space is needed not only because of the explosion of sequencing data, but of "other kinds of data from biotic surveys, inventories of animals and plants, phylogenetic and morphological analyses, and GIS analyses combining biodiversity occurrence data with multiple layers of environmental data."
Setting aside space for servers was never envisioned when Dyche Hall was opened in 1903. The building – which houses the Natural History Museum as well as the biodiversity institute – is the second oldest building on KU's main campus in Lawrence, Kan., and is listed on the National Register of Historic Places. Despite additions in 1964 and 1996, Dyche Hall suffers from antiquated infrastructure and years of deferred maintenance, according to KU.
The institute now consists of 30 faculty/scientists, about 55 graduate students in residence conducting research on masters and doctoral projects, five and a half full-time equivalent administrative support staffers, and 15 scientific support staffers. The scientific support staffers manage labs, research facilities, biotic research collections of 8.8 million animals and plants, 1.2 million archaeological specimens, and associated biotic data.
Krishtalka said the institute has no immediate plans for increasing faculty/scientist positions.
"We do have a strategic plan to expand our biodiversity expertise in areas of undiscovered or poorly known animals and plants — essentially a genomic & nano/micro biological world — while maintaining critical mass in our areas of established excellence," said Krishtalka. "Depending on the university's economic climate, we hope to grow our numbers perhaps by as many as four faculty/scientists in the next five years."
Dana-Farber Cancer Institute said that it has raised about $1.2 billion to conclude the largest capital campaign in its history — a seven-year drive whose proceeds helped establish several centers focused on developing personalized cancer care.
According to Dana-Farber, gifts raised during Mission Possible: The Dana-Farber Campaign to Conquer Cancer helped establish the Center for Cancer Genome Discovery, Blais Proteomics Center, Lurie Family Imaging Center, Linde Program in Chemical Biology, Belfer Institute for Applied Cancer Science, and the Center for Novel Experimental Therapeutics.
"The investments made in Dana-Farber during the past seven years have generated unprecedented insights into the causes and underlying mechanisms of cancer, giving us the knowledge and tools needed to provide care that is personalized to each person's cancer," Dana-Farber President Edward Benz Jr. said in a statement.
Research and care was one of four priorities for which Dana-Farber said it raised funds during the campaign. The other three include new technologies; the Jimmy Fund and unrestricted funds; and construction of the Yawkey Center for Cancer Care, a 14-story, 275,000-square-foot clinical care and research facility set for completion in January 2011.
The Yawkey Center is designed to help the cancer institute better accommodate growth in its volumes of patients and clinical trials. Between 2001 and last year, outpatient visits and infusions at Dana-Farber more than doubled from nearly 128,000 to more than 292,000, while the number of clinical trials available to Dana-Farber patients nearly doubled from 409 to 736.
To date, Dana-Farber has received more than 2 million gifts of all sizes — including 121 gifts of $1 million or more, and 820 gifts of $100,000 or more. Every member of the Board of Trustees made a gift during the campaign period, and 96 percent of senior faculty contributed very early on, the institute said.
Dana-Farber accomplished its financial mission of raising a billion dollars a year ahead of schedule in September 2009, and continued raising funds through the Sept. 30 conclusion of the effort.
"Dana-Farber has the resources to expand on its leadership role in translational, bench-to-bedside research, which will mean more cancer patients will be given a much better chance to become cancer survivors," Larry Lucchino, president and CEO of the Boston Red Sox, and co-chair of the Mission Possible campaign, said in the statement.
DaVita Clinical Research (DCR), Minneapolis, MN, has announced the launch of its clinical Central Lab facility. The over 47,000 square foot facility allows technicians to dedicate themselves to conduct each project with precision, using the latest methodology and technology generating approximately 114,000 tests on 60,000 samples daily.
Exceptional project management and customer service are what we provide at the DCR Central Lab. Each and every clinical project has a project manager assigned to ensure that client-specific requirements are met and communication to the operational team is maintained. We also feature a convenient Web-enabled data access system that allows fully compliant order entry and reporting anytime, anywhere. This will help you save time while maintaining strict quality assurance (QA).
At the DCR Central Lab, we’ve invested in the latest equipment to provide rapid, accurate results. With our advanced instrumentation for chemistry, hematology, and microbiology tests, you are assured to have quick turnaround with quality and precision.
DCR continues to strive for innovation, and our latest breakthrough at the Central Lab is green packaging for samples. It features a unique IATA-compliant, storage-friendly design that results in significant shipping cost reductions. The shipping process is further enhanced through our worldwide partnership with FedEx, which delivers samples to the lab three times daily. The DCR Central Lab uses industry-leading scientific expertise, allowing us to continually work with over 1,400 assays with additional assays being validated constantly.
The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH) is awarding $2 million to UC Santa Barbara as part of the renewal of its Programs for Nanotechnology Research. The program is focused on helping researchers develop tools based on materials designed at the molecular level to detect and deliver treatments for heart, lung, and blood diseases.
"The Program of Excellence in Nanotechnology grant from the National Heart, Lung and Blood Institute of the NIH will allow UCSB researchers to exploit recent discoveries in functional polymers and develop nanotechnology-based tools and devices for use in the diagnosis and treatment of heart, lung, and blood diseases," said Craig Hawker, professor of materials, chemistry, and director of the Materials Research Laboratory. "Through collaborations with some of the best medical schools in the U.S., our long-term goal is to apply these nanotechnology systems to clinical diagnosis and therapeutics for major unmet U.S. medical issues."
The UCSB funding is part of a $17.2 million collaboration with Washington University, Texas A&M University, UC Berkeley, and the University of Texas-Southwestern Medical Center. There are three additional nanotechnology research collaborations funded by NHLBI as part of the same package. Together, they total grants of $65 million.
"Nanotechnology has enormous potential for faster and more sensitive detection of disease and for targeted disease treatments," said Susan B. Shurin, M.D., acting director of the NHLBI. "We are committed to harnessing these new technologies for heart, lung, and blood diseases, and moving them towards application in the real world."
The California NanoSystems Institute at UCLA has opened its new Integrated Systems Nanofabrication Cleanroom (ISNC), more than doubling the amount of cleanroom space available on the Westwood campus and extending research capabilities to researchers in biology and medicine.
The facility, which houses more than $8 million of state-of-the-art equipment, features 9,700 square feet of highly purified and regulated cleanroom and support space, kept free of bacteria, viruses and other contaminants.
As a shared resource facility, the ISNC is available to all researchers at UCLA, as well as those from other universities, industry and government. Like all the CNSI's core labs, the ISNC is open 24 hours a day, seven days a week. After setting up an account and undergoing training, researchers can book equipment using an online reservation system.
Equipped with tools like an electron-beam writer capable of fabricating nanoscale structures with device geometries as low as 10 nanometers and an ASML optical stepper capable of 0.3-micron resolution, the ISNC will also serve as a valuable resource for startup companies. Early-stage companies like those at UCLA's on-campus technology incubator at the CNSI don't have the resources to purchase millions of dollars worth of cleanroom equipment, though such equipment can be vital for their proof-of-concept work.
For researchers working on medical devices that must operate in biological environments, the ISNC provides a unique opportunity to do all the patterning and biological processes in a cleanroom environment, avoiding the problems of contamination encountered when moving devices between laboratories.
To maximize the cleanroom services offered on campus, the ISNC was developed as a complementary facility to the Nanoelectronics Research Facility (NRF) at UCLA's Henry Samueli School of Engineering and Applied Science. Each of these cleanrooms has its unique strengths—the ISNC with biological processes and patterning smaller features, and the NRF with electronics research. The partnership also provides ISNC staff with a valuable resource, as they are able to tap into the NRF staff's 20 years of experience.
Covance Inc. expands its biotechnology offerings into North America with the opening of a biotechnology services facility on its Greenfield campus in Indiana. This facility will use the expertise developed and offered by Covance in the United Kingdom for more than 20 years.
Earlier this year, Eli Lilly and Co. and Covance expanded their relationship with a three-year biotechnology services agreement, in which Lilly transferred bioproduct analytical testing to Covance. The Greenfield biotechnology services facility includes state-of-the-art analytical laboratories for protein chemistry, immunocharacterization, bioassay, stability studies, and release testing services. This facility has more than doubled Covance’s global biotechnology services footprint and it continues to expand. Covance is currently providing biotechnology services to Lilly as well as second major pharmaceutical client at the Greenfield site and is now accepting work from other clients.
Covance has provided biotechnology services at for the past 20 years at its Harrogate U.K. site. Over the last year alone, its industry-leading scientific and regulatory experts have supported more than 250 different biomolecules. This experience, coupled with the addition of top scientific, regulatory and operational talent, enabled Covance to quickly begin operations at the Greenfield facility. Covance has worked with more than 100 biopharmaceutical clients globally.
“The expansion of our high-quality biotechnology services from Europe to North America is a critical milestone for Covance to meet the growing biopharmaceutical development needs from our clients,” says Carl Martin, VP, Biotechnology, Covance. “With a dedicated team of experts in biological development and commercialization, and an unwavering commitment to operational and service excellence, Covance strives to provide clients with optimal solutions to bring their biotherapeutics to market.”
Porsolt Opens New U.S. Research Center
Porsolt has opened a new preclinical contract research facility in San Antonio, TX. The facility will be operational in October 2010 under full AAALAC accreditation, and will provide non-GLP and GLP specialist pharmacology services to the global pharma and biotech industries. Services will initially focus on abuse liability assessment of new Chemical and Biological Entities (NCEs and NBEs) in non-human primates, as well as will include those provided by the parent company headquartered in France.
Dr. Roger D. Porsolt, president and founder of Porsolt, said, “Possessing our own Research Centre in the U.S. fulfils a longstanding ambition to provide services to our expanding list of US sponsors. Since our inception over 25 years ago, we have sought to establish ourselves as internationally recognized scientific experts in pharmacology and have already had considerable success in attracting North American clients. Possessing our own research site on the North American continent will reinforce this and should open the way for U.S. public bodies and private U.S. research foundations to benefit from our services. Although our initial thrust will be in the area of drug abuse/dependence, we intend to expand rapidly to cover other major medical areas including cognitive, pain, inflammatory, schizophrenia, respiratory and cardiovascular pharmacology.”
Xcelience has expanded its solid oral dosage form development and manufacturing capabilities to include a Vector TFC-220 Roller Compactor in its GMP manufacturing area. The new equipment allows for faster transition from development in the experimental area to GMP production of clinical supplies. Dry granulation technology provides an option for clients with development challenges related to moisture sensitive APIs.
The company currently has a Vector TFC-Lab Micro Roller Compactor in the experimental area. The TFC-220 allows for scale-up to the GMP manufacturing area and expands the company’s processing capacity for dry granulation. The TFC-220 is capable of processing blends at a rate of up to 20 kg/hour.
“Taking a cross-functional approach to dry granulation ensures effective technical transfer and supports improved manufacturing outcomes,” said Ted Koontz, director of operations at Xcelience.
Biomedical Structures, a provider of biomedical textiles for medical devices, recently completed the construction of a new purpose-built cleanroom.
The new facility will be used for high-density weaving and advanced braiding infrastructure for polymer and wire materials, the company said.
With the growth, BMS said it intends to hire additional technical workers.
The facility addition is purpose-built for handling finer PET fibers, DSM Dyneema Purity, and other mono- and multi-filament fibers. The clean room also supports high-density weaving and knitting for biomedical textile production, and houses state-of-the-art warping and twisting equipment for an increased range of precise solutions for orthopedic, cardiovascular, and general surgery device applications.
BMS said it has also expanded its braiding capabilities with new braiding machines. To meet the additional capabilities, the company added textile technicians, and plans to add more sales engineering and project management expertise in the near future.
"Our textile solutions are helping orthopedic and cardiovascular device manufacturers bring the next generation of more lifelike, high performance implantables and instruments to market," said John Gray, BMS president. "These expanded capabilities for more advanced engineering and production of our biomaterials will allow us to further innovate and deliver at the level our customers have come to expect."
The University of Arkansas has landed a $5.4 million grant from the National Institutes of Health to expand and fund new research projects in its Center for Protein Structure and Function, the University said.
The protein center conducts research into the structure and function of proteins that may be involved in, or could help lead to treatments for, cancer, heart disease, osteoporosis, influenza, and other diseases and conditions.
The center is comprised of five core facilities that support this range of research efforts including a mass spectrometry facility; a large-scale protein production facility; a nuclear magnetic resonance spectroscopy facility; a chemical synthesis facility; and an X-ray crystallography facility.
The funding came from the National Center for Research Resources' Centers of Biomedical Research Excellence program.
The grant is funded by the Centers of Biomedical Research Excellence program of the National Center for Research Resources, a part of the National Institutes of Health.
One of the major aims behind expanding the facilities at Arkansas is to create an environment that researchers can use to expand their studies and to reel in more funding.
"These grants will allow researchers to get some experimental evidence for their ideas so that they can write a major grant proposal," Frank Millett, who directs the center and is a distinguished professor of chemistry and biochemistry at the school, said in a statement. "These facilities have helped everyone involved in biomedical research on campus become competitive in getting research grants."
Qiagen broke ground on a 117,000-square-foot, $52 million expansion of its operations in Maryland. The firm is consolidating many of its Maryland manufacturing operations and offices and intends to add more than 90 jobs there within the next five years. The German firm had opened its US headquarters in Germantown, Md., in 2002, and significantly expanded its footprint in the state through its acquisitions over the past few years of Gaithersburg-based Digene and Frederick-based SABiosciences.
GATC Biotech will be the first European service provider to offer sequencing on Pacific Biosciences' RS platform. The German firm has agreed to purchase the single-molecule, real-time sequencer and expects to have it installed in early 2011.
Vermillion said that its OVA1 test now has the CE Mark required for marketing the test in the European Union. The OVA1 is a multiplex, proteomic biomarker test used to help physicians assess, prior to surgery, the likelihood that a woman's ovarian mass is malignant. The test was cleared for marketing in the US a year ago.
Numerate recently received a grant from the US Department of Defense's Defense Threat Reduction Agency to adapt its small-molecule drug design platform to the rapid design and optimization of drugs against biowarfare agents. The San Bruno, Calif.-based firm said that the contract could bring in $6.75 million to the firm. It will apply its platform, which uses biological assay data to develop predictive models of activity, to first focusing on drugs for the Ebola virus and other anti-bacterial drug leads with broad-spectrum activity.
University of Colorado Hospital (UCH) has announced ambitious plans to add a second inpatient tower to meet what has become an enormous demand for its services. At a cost of about $400 million, the project brings more patient beds, more emergency care and more jobs to the Anschutz Medical Campus and the state.
"As the only academic medical center in the Rocky Mountains, our team of specialists and sub-specialists provide unique care for patients with complex health care needs," said Bruce Schroffel, President and CEO of University of Colorado Hospital. "Expanding the hospital will allow us to provide that care to more people in Colorado and the entire Rocky Mountain region.
"University of Colorado Hospital has been working near or above capacity since moving our inpatient facilities to the Anschutz Medical Campus in 2007," Schroffel added. "The demand for our services only promises to grow, and expanding the hospital will help us continue to serve a growing patient population."
The UCH expansion project will consist of a second building dedicated to inpatient and emergency care. The first inpatient building, the Anschutz Inpatient Pavilion, opened in 2004. UCH moved its remaining inpatient practices from its old site at 9th Avenue and Colorado Boulevard in Denver to the new Aurora campus in June 2007.
The newest building, slated to open in 2013, will immediately add 144 staffed inpatient beds to the hospital's current capacity of 407, and will include space to add another 120 to 144 beds to meet future demand.
As the only academic medical center in the Rocky Mountain region, our teams of specialists and sub-specialists provide unique care for patients with complex health care needs. This project will put us in an even more solid position to continue providing world-class care while expanding the quality and depth of our care and meeting the growing needs of our expanding patient population. The expansion will not only mean more care, but also more jobs on the Anschutz Medical Campus.
The expansion will include:
Will cost about $400 million
An additional 264-288 beds
Emergency Department will double in size
Expansion will also mean more operating rooms and diagnostic and treatment facilities (i.e: expanded cardiac and vascular services)
The 12-story building will be about 660,000 square feet
Increased parking, better access for patients and visitors at Anschutz Medical Campus
Brings 1,400 high paying, full-time jobs to Anschutz Medical Campus, also creates 600-650 construction jobs.
The UCH expansion project brings an economic stimulus plan to the Anschutz Medical Campus and the region. The project will bring hundreds of new jobs and millions of dollars in material costs and tax revenue to Aurora, the Metro Area and the state of Colorado.
"This is a multi-million dollar project and while UCH and its patients will benefit from the expansion, the entire state of Colorado also will see the positive effects. We also will be bringing over a thousand jobs to our community," said Schroffel. "And we will be able to do this without any funding from the state or federal governments."
When it is finished, the addition will mean another 1,400 jobs at UCH with an average salary of $81,000 a year including benefits. The project also will create 600-650 jobs for those involved in the construction.
Other initiatives underway:
UCH also is in the midst of a $67 million project to implement an integrated, patient-centered electronic medical record across all clinical areas. That project ultimately will bring another 150 jobs to the Anschutz Medical Campus during its three-year implementation period.
Finally, a capital campaign is underway to raise $20 million for a much-needed expansion of the hospital's Anschutz Cancer Pavilion. The hospital's cancer services have seen a patient increase of nearly 100 percent since opening in 2001. The University of Colorado Cancer Center, in fact, is the only National Cancer Institute designated comprehensive cancer center in the region, and one of only 40 in the United States. UCH hopes to start construction on the cancer center expansion before the end of 2010.
"Patient outcomes at the University of Colorado Cancer Center are all significantly above state and national averages, and are another reason why demand for our services has grown so dramatically," Schroffel said.
The selection of the architect and general contractor is underway. The UCH board of directors approved the project last month.
The University of Colorado Hospital is the Rocky Mountain region's leading academic medical center, and has been recognized as one of the United States' best hospitals, according to U.S. News & World Report. It is best known as an innovator in patient care and often as one of the first hospitals to bring new medicine to patients' bedsides. Located at the Anschutz Medical Campus in Aurora, Colo., the hospital's physicians are all affiliated with the University of Colorado School of Medicine, part of the University of Colorado system.
Alliance Medical Products (AMP) has completed its high volume vial filling line at its Irvine, CA facility. The eight-head Conquest line has a capacity of 150,000 vials per shift and is supported by an inline vial washer, depyrogenation tunnel and 12-spindle capper. The line supports nitrogen purge or blanket and vial sizes ranging from 2mL to 150mL.
“We are very excited to announce the completion of a high volume vial filling line located at our 54,000 square foot filling facility,” said Juan Valdes, AMP's president and chief executive officer. “The addition of this line further extends our ability to provide a complete range of developmental, clinical and commercial contract manufacturing services to large and small organizations.”
ShangPharma has raised $87m through an IPO on the New York Stock Exchange according to a Bloomberg report, beating the $46m to $53m the Chinese CRO forecast.
In a US Securities and Exchange Commission (SEC) filing the Shanghai firm said it will spend some $15m of the proceeds on construction of a new facility in neighboring Fengxian.
The contract research organization (CRO) added that the 460,000 sq.ft. building will produce drug intermediates and active pharmaceutical ingredients (APIs) for both preclinical development and clinical trials
The project is expected to take two years with, according to ShangPharma, the first 200,000 sq. ft. of manufacturing space due to be operational sometime in 2011.
ShangPharma, which lists Wuxi PharmaTech, Albany Molecular Research, Cerep and Covance as key rivals in its IPO prospectus, also predicted that competition in the contracting sector will increase.
“We face competition based on several factors, including the quality and scope of services, the ability to protect confidential information and intellectual property, the ability to be responsive and efficient with respect to customers’ requests, depth of customer relationship and pricing.”
ShangPharma also suggested that, in China, it is likely to compete more directly with pharmaceutical firms that have invested significant capital in building R&D capacity in the country.
“These in-house investments may result in increased competition for qualified personnel. Some of our larger competitors may have greater financial, research and other resources, broader scope of services, greater pricing flexibility, more extensive technical capabilities and greater name recognition than we do.
“Furthermore, consolidation within the global pharmaceutical and biotechnology R&D outsourcing markets may create stronger competitors than those we are facing today.
Pfizer has entered into a partnership with Laboratorio Teuto Brasileiro S.A., a Brazilian generics company, to develop and commercialize generic medicines. Pfizer will acquire a 40% stake in Teuto, expanding its presence in Brazil with access to Teuto's portfolio of approximately 250 products. Pfizer will have access to distribution networks in Brazil and the opportunity to register and commercialize Teuto's products in markets outside Brazil. Additionally, Pfizer will have two representatives on Teuto's board of directors.
Pfizer will make an upfront payment of $240 million and Teuto will be eligible to receive a success-based milestone payment. Pfizer has an option to acquire the remaining 60% of Teuto's shares beginning in 2014.
Pfizer will have the opportunity to register and commercialize Teuto products in Brazil and other markets under its own brands, covering therapeutic areas such as pain and inflammation, cardiovascular, anti-infectives, central nervous system and respiratory, and others. Teuto will have access to select Pfizer products for distribution and the right to commercialize them under Teuto's own brand in Brazil.
"We believe this partnership will enable both companies to effectively build upon one another's core capabilities and areas of expertise to help address the needs of more patients than ever before," said Jean-Michel Halfon, president of Pfizer's Emerging Markets Business Unit. "This agreement demonstrates Pfizer's commitment to pursue focused investments in key emerging markets to accelerate our growth and increase patient access to high-quality medicines."
"Teuto's partnership with Pfizer is very complementary to our business goals. It will expand our product portfolio and address the needs of the changing customer base," said Marcelo Henriques, chief executive officer of Teuto Laboratories. The transaction, subject to customary closing conditions, is expected to close in 4Q10.
Work has started in China on a state-of-the-art extraction facility for botanical extracts, powders and pure compounds for use in nutrition products, according to dietary supplements supplier, Herbalife.
John DeSimone, the company’s chief financial officer, said: “The new extraction plant will produce botanical extracts including teas, guarana, chamomile, broccoli and bilberry, among others, for use in many of our products.”
The facility is a joint venture with NatSource Chemicals.
The facility will buy botanicals directly from farms in Hunan province and other regions, he added. “The plant will perform extraction and other conversion processes and then send these processed raw materials directly to our manufacturing facilities in Suzhou, China and Lake Forest, California or to our third party manufacturers throughout the world.”
The company uses botanicals in many of its nutrition products, including Herbal Tea Concentrate, Liftoff energy drink; Best Defense and Garden 7.
Expected to open in the second half of next year, Herbalife says the new plant is part of its seed-to-feed strategy designed to ensure the quality, purity, and traceability on all ingredients throughout its supply chain.
The 80,000 sq. ft. facility at Changsha in Hunan Province is expected to have the capacity to process 8,000t annually and to create about 120 jobs.
Changsha is in southern central China and was chosen because of its strategic location on the banks of the Yangtze River; close to the home of many of the China’s nutritional herbs and botanicals.
The project is receiving funding from the Hunan provincial and Changsha City governments.
Herbalife is also planning strategic supply agreements with farmers in Hunan and other provinces to guarantee further the traceability for its health ingredients.
The company received its first direct-selling license in China in March 2007 and is now licensed to sell direct in 16 provinces.
In addition it operates 75 retail stores in 30 provinces in China. It operates in 72 other countries through a network of about 2.1m independent distributors.
Pfizer has invested £26.3m ($41.7m) into a new facility at its biotech packaging and distribution site in Havant, UK.
Opening of the new facility is a boost for the site which has seen its workforce reduced in recent years, first by Wyeth and then, post-acquisition, by Pfizer. Further investment in the site to install new packaging lines and additional cold storage capacity is planned for 2011.
“This investment in the new packaging hall at Havant demonstrates our aim to ensure this state-of-the-art facility remains a centre of expertise for cold chain distribution and packaging”, said Richard Blackburn, managing director of Pfizer UK.
In 2006 Wyeth reorganized the Havant site to focus on the packaging and distribution of its biologics and vaccines, such as Prevnar (pneumococcal conjugate vaccine). Pfizer, having in May detailed plans to cut 90 jobs from Havant, has now bolstered packaging capabilities.
Investment from Pfizer has been welcomed by the UK government which is keen to see the country’s life sciences and manufacturing sectors prosper despite global competition and the economic downturn.
David Willetts, science minister in the UK, said: “I’m hugely encouraged that even in these tough economic times the world’s largest research-based biopharmaceutical company has chosen the UK to make this significant investment.”
A high quality science base, strong innovation and research and development, and a well-established intellectual property rights system make the UK attractive to inward life sciences investment, says the government.
Furthermore, the UK National Health Service (NHS) is open to collaboration with industry and researchers. Examples of this collaboration include translational medicine sites Icon and Quintiles have established in the UK in collaboration with the NHS.
The UK government says the reputation for effective collaboration between the NHS, industry and researchers is growing, both nationally and internationally and this attracts inward investment.
BioStorage Technologies has expanded its sample management services to include laboratory sample preparation services. The company’s U.S. and European facilities will now offer nucleic acid extraction and verification services in addition to sample aliquoting and PBMC (Peripheral Blood Mononuclear Cells) processing. All services, according to the company, will be supported by automated liquid handling technology to ensure the accuracy and precision needed for high-throughput testing and screening.
The integration of these services allows the company to provide customers with a sample renewal and extension process designed to maximize their samples for comprehensive R&D activities. Once samples are processed, aliquots of blood and/or DNA products can be allocated for future testing by using sample prioritization through the company’s tracking and inventory management system, ISISS. According to the company, this process ensures samples are removed, transported, processed and replaced to storage in a compliant, consistent and efficient fashion.
“Many times, errors that can affect the results of laboratory tests occur in the pre-analytical phase,” said Cathy Michael, global head of sample management operations, BioStorage Technologies. “By extending our technical expertise to include sample preparation services, we can help to mitigate the risk of variables that have a negative impact on sample integrity.”
PPD, Inc. has consolidated its clinical development operations in Beijing, China, into a new, larger office to support its growth in the region. The new location better equips the company to provide a full range of clinical research and development services in China.
Last year, the company expanded its Phase II-IV clinical development services in Asia Pacific and added more than 300 employees through its acquisition of Excel PharmaStudies. The new office combines PPD and Excel employees in one facility.
"The opening of our new office further demonstrates our commitment to investing in China, which continues to be an increasingly important, high-growth area for clinical research," said Simon Britton, vice president of clinical development in Asia Pacific. "The new facility provides us a solid foundation for continued growth in this country and across Asia Pacific to meet the growing needs of our clients."
Emergent BioSolutions, Inc., a U.S.-based developer and manufacturer of vaccines and antibody therapies, has launched Singapore operations through EPIC Bio Ltd., a recently formed Singapore-based joint venture with Temasek Life Sciences Ventures Ltd. (TLV), to develop, manufacture, and commercialize pandemic influenza vaccines and therapeutics.
Emergent’s Singapore office will provide support to EPIC Bio as the joint venture expands its operations. EPIC Bio plans to begin clinical manufacturing of a broad-spectrum influenza vaccine candidate in 2011 and to initiate a clinical trial in 2012.
“Emergent is pleased to enhance its presence in Asia-Pacific with initiatives that help carry out our corporate mission, to protect life,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “First, by broadening the scope of Emergent’s Singapore operations, not only will it continue to make our present and future biodefense products available, but it will also provide support to the company’s ongoing tuberculosis program as well as explore manufacturing and business development opportunities in the region. Second, by forming EPIC Bio with TLV, Emergent leverages important technology and product development know how to complement TLL’s research and development efforts in pandemic influenza.”
Retina Implant AG, a leading developer of subretinal implants for the visually impaired, announced the opening of a new manufacturing plant to meet anticipated demand for their implants. The company’s second human clinical trial will be expanding outside of Germany in early 2011 to European countries including the U.K. and Italy and discussions are underway for potential clinical trials in the United States and Asia. Also looking ahead, the new facility meets manufacturing capabilities required for CE mark approval.
The new manufacturing plant is 312 m², (3,357 sq. ft.) more than 25 times larger than the former plant, and is located in Technology Park, Tübingen-Reutlingen, Germany. Of this space, 100 m² (1,076 sq. ft.) is dedicated as a cleanroom, with the capability to increase its size to 250 m² (2,690 sq. ft.). A cleanroom denotes an atmosphere with low particle numbers to guarantee foreign biological substances will not contaminate product. Manufacturing capacity is estimated to be 1500 units per year.
Retina Implant AG is planning to invest another 1.3 Mio.EUR to stock the facility with specialized equipment to produce their state-of-the-art retinal implants. Four trained employees will begin working in the plant with the capacity to grow to 15 employees.
Today marks an exciting milestone in Retina Implant’s journey to restore vision to the blind, said Walter-G. Wrobel, CEO of Retina Implant AG. Pending positive results of the second human clinical trial currently underway, our new manufacturing facility will position us well to make our implants available quickly to patients in need. We’re encouraged by the first few implanted patients in our second clinical trial, specifically with how they have been able to function in their home without assistance.
Retina Implant AG is the leading developer of subretinal implants for partially sighted and blind patients. After extensive research with German university hospitals and institutes which began with a large grant from the German Federal Ministry of Research and Education in 1996, Retina Implant AG was founded by Dr. Eberhart Zrenner and his colleagues in 2003 with private investors with the goal of developing the first fully-functioning electronic retinal implant to restore useful vision to the blind. Retina Implant began implanting in human patients in 2005, and has started a second clinical trial this year.
Dutch dairy co-operative Royal FrieslandCampina is building a new €16m research and development (R&D) center to target innovation in consumer products and ingredients.
Due to open in the second half of 2012, the new 15,000m2 (161,400 sq. ft.) center, based on the campus of Wageningen University & Research Centre, will comprise research facilities, laboratories, a pilot plant and offices.
It will provide the dairy giant with 3,300m2 (35,508 sq. ft.) of laboratory space, while the pilot plant will occupy 1,800m2 (19,368 sq. ft.); there will also be a test bakery and a 5,000m2 (53,800 sq. ft.) office complex.
FrieslandCampina manufactures products for sale in over 100 countries: everything from dairy-based ingredients to baby food, milk-based drinks, cheese, fruit-based beverages and yoghurt.
A new onsite ‘experience centre’ will allow products developed in these areas to be tasted, smelt and touched, whilst the new building will also generate sustainable energy via a heat exchanger and (potentially) solar panels.
Royal FrieslandCampina spokeswoman Ria van der Peet told FoodNavigator.com: “The building has still to be realized, but the experience centre will allow both our customers and the public to realize the wonderful natural power of milk.
“We’re concentrating all our knowledge of food ingredients in one place – and in The Netherlands the region is known as ‘food valley’ – to bring all our research specialties together in one place.”
Van der Peet said the new centre had been driven less by the company’s stated desire to innovate than the aim of consolidating its R&D operations; current research is also undertaken at sites in Tilburg and Wageningen, from where staff will relocate when the centre opens.
Active in the hotel and catering, bakery and foodservice industries, FrieslandCampina aims to grow its specialist ingredients business by 5 per cent a year, which reflects a shift away from its traditional bulk products such as milk- or whey powder.
The co-operative is also targeting sales of more branded consumer products in more European, Asian and African countries, by catering for strong worldwide growth in dairy-based beverages, branded cheeses and infant/toddler nutrition ingredients.
Cees ’t Hart, Royal FrieslandCampina’s CEO said: “Achieving breakthrough innovations in consumer products, ingredients and processes is vital to help consumers and customers further and to better valorise the milk of our members."
With a turnover of 8.2bn in 2009, FrieslandCampina employs 20,000 staff across 24 countries.
Bosch has unveiled plans to build a new €4m packaging machinery plant in India to meet burgeoning demand growth from the country’s food, beverage and pharmaceutical sectors.
The company said the new 33,000 square meter (355,080 sq. ft.) site in the Verna area of Goa should be fully operational by the end of 2012. It will become Bosch’s packaging hub in the sub-continent. The firm said it will be integrating all of its packaging production at the plant.
Ashok Gourish, business head at Bosch Packaging India, said the investment would realize a major increase in its production capacity.
“Our current output is around 150 machines a year but we are catering for an increase in demand of around 45 to 50 per cent,” he said. “We are also expecting to see the number of employees jump by around 40 per cent to more than 150.”
He said that sustained and strong growth from the food industry, particularly in confectionery, was fuelling climbing demand for the company’s machinery.
"In India the demand for packaging machines is expected to grow by 10 per cent per year," he added. "The development of food parks in India, increased hygiene standards in the food and beverage industry, adoption of Western-style medicines in the pharmaceutical sector and attracting global players of the confectionery industry to India – all these are factors which have acted as key catalysts for this growth."
The company was seeing greatest demand for horizontal flow wrapping systems, said Gourish.
“There is very strong demand for this type of packaging from India’s fast-growing retail sectors –particularly in supermarkets and hypermarkets,” he said. “This is because consumers want to be able pick up and see what they are buying prior to purchase. Flow wrapped products allow customers to do this but they also maintain product freshness and hygiene.”
Friedbert Klefenz, company president, underlined the growing importance of expanding its Indian base said, "We have a strong market position in the emerging markets, and to cater to the rising demands we are looking into expanding our existing portfolio”. “This approach has not only brought us closer to our customers but has also helped us strengthen their confidence in us. Today, India is the hub for SAARC (South Asian Association for Regional Cooperation) countries as well as the Middle East and Africa."
Danone is poised to establish a new international R&D centre for baby and medical nutrition in The Netherlands after signing an agreement to purchase land on Utrecht Science Park.
Since entering the market with the acquisition of Numico in 2007, Danone has seen turnover from its baby nutrition and medical nutrition activities grow. In 2009 they accounted for 20 per cent and 6 per cent of the group’s almost €15bn turnover, growing 8 per cent and 11 per cent on the previous year.
The global food firm’s plan to build a new centre as a base for international research and innovation is billed as the next step in its evolving specialized nutrition strategy. R&D in this area is currently split between locations in The Netherlands, Germany and the UK, but when the new centre is complete in 2012 at least 400 employees will transfer there.
The new site is said to have room for these activities to grow. The agreement for the land purchase was signed.
The company has not unveiled the budget for the new centre, nor details of the facilities and equipment it will house. It has determined that it will be constructed in adherence with sustainability principles, however. It has teamed up with sustainable property development OVG.
“OVG considers Danone’s new centre on the Utrecht Science Park to represent a powerful combination, because of the shared vision regarding innovation and sustainability,” the company said.
At the time of its Numico acquisition Danone said its focus would remain on dairy, but that nutrition would become the business’ new ‘third pillar’, alongside beverages. The brands that came along with the purchase include brand names Nutricia, Milupa, Cow & Gate and Dumex.
Prior to buying Numico Danone sold its biscuit business to Kraft for €5.3bn. This maneuver is a further indication of its commitment to a healthy future.
The new Kendall Laboratory in Singapore will focus on identifying molecular markers that are associated with desirable traits and for use in molecular-associated plant breeding, which compresses the development cycle by half compared to traditional breeding methods, the company said. Specifically, the lab will support development of new tools for use in agriculture around the Asia-Pacific region.
"The Asia Pacific region is expected to have an additional billion mouths to feed by 2030 and with limited natural resources, new technology in agriculture is necessary to help farmers grow more with less," Peter Pickering, the regional head of Syngenta's Asia Pacific Seeds business, said in a statement.
Syngenta is based in Basel, Switzerland and has R&D facilities there as well as in the US, UK, China, and India.
“Syngenta’s Kendall R&D laboratories will support our research network around the region and allow us to bring better technology to Asian farmers as they work to provide greater food security across the region," Pickering said.
Pickering added that incorporating the molecular biology approach into its established platforms enables the company to "leverage both biology and chemistry of plant science… to develop effective solutions to meet the challenges of growing food and feed today and into the future."
ICON’s hospital-based Clinical Pharmacology Unit in Manchester, UK has achieved Supplementary Accreditation from the Medicines and Healthcare products Regulatory Agency (MHRA). The unit is part of the ICON Development Solutions division. The designation allows the company to carry out all Phase I trials, including First in Human (FIH) trials requiring review from the EAG (Expert Advisory Group).
Thomas Frey, president of ICON Development Solutions, commented, “Our Clinical Pharmacology team in Manchester worked closely with the MHRA during their routine inspection to demonstrate our active commitment to safety and quality. This accreditation award, combined with our experience conducting more than 1,500 early phase studies, reinforces to trial volunteers and sponsors alike that ICON is an industry-leader in Phase I clinical research. We are pleased to have participated in this voluntary accreditation process that ensures continuous safety improvements are realized in early clinical development.”
The MHRA established this accreditation in 2006 to formalize routine, rigorous inspections, raising the level of clinical safety standards. The accreditation was granted following a successful MHRA GCP inspection of personnel and facilities, as well as the ability to manage medical emergencies.
Recipharm AB has acquired Abbott’s (formerly Solvay Pharmaceuticals) manufacturing site in Parets, close to Barcelona, Spain. Parets produces solid dose, sterile ointments, oral liquids, aerosols and topical products. The newly acquired business will be called Recipharm Parets SL. Financial details were not disclosed.
The acquisition adds to Recipharm’s capabilities and provides entry into the Spanish market. Recipharm will continue to produce all Abbott products currently manufactured at the site. Recipharm also plans to retain all existing employees.
Thomas Eldered, chief executive officer of Recipharm, said, “We are extremely pleased to be entering into another transaction with Abbott and to be building on the successful integration of the Fontaine les Dijon facility which we acquired last year from former Solvay Pharmaceuticals. Both the facilities and staff are first class and we look forward to nurturing and developing current and new business in the important Spanish market.”
SAFC, a member of the Sigma-Aldrich Group, has completed the expansion of its facility in Jerusalem, Israel, adding manufacturing capabilities in large molecule recombinant proteins and small molecule Active Pharmaceutical Ingredients (APIs) through fermentation, including High Potent APIs (HPAPIs) and secondary metabolites.
The 50,000 sq. ft. cGMP fermentation expansion will focus on niche fermentation of APIs and bulk drugs, producing secondary metabolites (antibiotic-like molecules), cytotoxins and large-molecule proteins. A 30,000 sq. ft. area has been designed to be Biosafety Level 2 compliant, enabling manipulation of human pathogens. Capabilities include 1,000-liter and 4,000-liter tank capacities for bacterial and fungal fermentation, as well as explosion-proof suites.
"Fermentation is a long-standing technology, yet new applications have been recently discovered, including the synthesis of high potency compounds, which is a major growth area currently driving contract manufacturers such as SAFC to look beyond traditional active pharmaceutical ingredient (APIs)," said SAFC president, Gilles Cottier.
Johnson & Johnson is buying Crucell N.V. for about $2.41 billion boosting the company's vaccine business. The move had been expected since September, when the companies announced they were in advanced talks. Johnson & Johnson already owns a 17.9 percent stake in the company. The current offer is worth 1.75 billion euros. That marks a 58 percent premium to Crucell's closing price the day before the companies announced a potential deal. Johnson & Johnson said it will retain Crucell's existing facilities and senior management, along with current staffing levels. It will use Crucell as the center of its vaccines business and maintain headquarters in Leiden, Netherlands. Crucell's board supports the deal. The companies have been working together since 2009 to develop a universal flu vaccine and vaccines directed against infectious and noninfectious diseases.
Portugal has opened a new cancer and neuroscience research center in Lisbon. The facility was built by the Champalimaud Foundation, which began work four years ago. Portuguese businessman Antonio Champalimaud gave the foundation $688 million to complete the work and make the facility one of the best in the world, AP says. The foundation is now looking to recruit researchers from all over the world to work in the new center.
Kraft said its new innovation centre in Switzerland, inaugurated today, will ensure innovations in chewing gum and sugar confectionery have regional appeal.
The US group said that the team at the new €10.4m gum and confectionery R&D facility at Eysins will work closely with researchers at its gum and candy centre of excellence in New Jersey to determine how to develop gum and confectionery products and packaging that adhere to taste and other preferences of consumers throughout Europe.
Laurie Guzzinati, a spokesperson for Kraft, said that this was the culmination of a two-year project kickstarted by Cadbury management prior to the acquisition of the confectionery group by the US giant in February this year, and the move represents another stage in the integration of the Cadbury business into the global group.
And the Kraft spokesperson said that the growing consumer demand for gum that can deliver ingredients that aid oral healthcare and hygiene as well as interesting new flavor profiles were the primary triggers for the development of the regional centre in Switzerland.
Indeed, resurgence in gum product innovation within the EU is likely given the approval last week by the European Food Safety Authority (EFSA) for a health claim related to sugar-free chewing gum and a reduction in tooth decay.
Guzzinati said that the Swiss R&D facility is the latest addition in Kraft’s global network of innovation centers, which now total 15 sites globally, and she added that collaboration with research institutes based in Switzerland is on the cards.
According to Guzzinati, innovation focused on chocolate confectionery will remain the remit of the Bourneville R&D centre in the UK but that alliances between it and the Eysins centre will naturally form as “often technology developed at one centre will have obvious applications for other food categories.”
Kraft has a number of gum brands with leading positions in markets across Europe, such as Hollywood in France, Trident in Spain, Greece and Portugal, and Stimorol in Denmark and Switzerland, and has recently launched a new chewing gum brand Fresh&Clean across its European markets.
Worth $23bn annually, the global gum market has grown by almost a quarter since 2005.
Moscow-based global investment firm Rostock Group said it has opened a new genomics research center that will carry out wide-scale genetic research in the area of neurodegenerative human diseases.
"The immediate objective of the center is to search for new diagnostics and treatments for Alzheimer's disease, schizophrenia, and other ailments with a significant genetic component in pathogenesis. In particular, the research team will reveal respective gene mutations and develop target-specific pharmaceuticals for the diseases," Rostock said in a statement.
The center's research will be led by Evgeny Rogaev, a Russian State Prize winner, and a developer of methods for individual genomic identifications and discoverer of Alzheimer's disease variants. Last year, he and his team published research that identified a gene as the cause of the Royal Disease, a form of hemophilia transmitted from Queen Victoria to European royal families.
According to Rostock, the genomics center has the only Illumina HiSeq 2000 DNA sequencer in Russia, and will closely collaborate with the N. I. Vavilov Institute of General Genetics of the Russian Academy of Sciences.
The genomics center is an entity of Rostock Biotech Research, a subsidiary of Rostock Group.
Semler Research Centre has inaugurated a 25,000 sq. ft. centre for drug evaluation and pharmacology research in Bangalore, India.
Housed at the 25,000 sq. ft. site are three clinical pharmacology units. An 80 bed facility has been built to support clients’ development, from early through to late stage, and lifecycle management.
Semler also operates two other facilities in India, a formulation development centre in Bangalore and a 48 bed clinical research unit in Salem. Both facilities are housed on sites covering 18,000 sq. ft.
Further investment is planned for the coming years, which is predicted to increase headcount from 150 to 500.
Zydus Nycomed expects commercial production at its newly commissioned API plant in Navi Mumbai, India to begin in December 2010.
Expansion of active pharmaceutical ingredients (API) capabilities at Zydus Nycomed, a 50:50 joint venture between Zydus Cadila and Nycomed, advances the plant the beyond its original purpose as a provider of key starting materials.
The site was established to provide starting materials used in production of pantoprazole, an API used in a gastrointestinal treatment marketed by Nycomed. Now, with the addition of pantoprazole API production capabilities, the site has end-to-end manufacturing capabilities.
Initially production will be limited to pantoprazole, urapidil and lornoxicam but Zydus Nycomed plans to start manufacturing an additional eight API by 2011.
Pankaj Patel, chairman and managing director at Zydus Cadila, said: “This milestone marks a new beginning in the partnership that has been evolving and growing from strength to strength over the years.”
Expanding production capabilities builds on work done at the joint venture since it formed in 1998 to give Nycomed another API supply source for its portfolio of branded generic products.
Zydus Nycomed intends to have the site audited by the European Medicines Agency (EMA) and other international regulatory agencies. Completion of this process will make the Navi Mumbai site a global hub for supplying APIs to Nycomed for its branded generic portfolio.
“Having a time-tested and solid partnership in place, like we have with Zydus Cadila, gives me confidence we will continue to achieve our goal of getting medicines that matter to those who need them”, said Håkan Björklund, CEO of Nycomed.
The significant and rapid growth in demand for food safety and quality checks in India has been the driver behind the opening of a new state-of-the-art testing laboratory in the country, said Eurofins Scientific.
The facility, based in Bangalore, is an extension to the existing genomic testing site and will serve to strengthen its position in a key emerging market, said Florian Heupel, group marketing director.
“We believe growth potential for food safety, food quality and food authentication services in India and China is huge as expectations rise in line with wealth – both from industry and consumers,” he added. “A number of our existing Indian clients that operate in Europe expressed a desire for such a facility in India – and we responded to this.”
The laboratory specializes in a raft of analytical services relating to food safety and composition testing – such as microbiology, mycotoxins, vitamins, heavy metals, minerals, and proximate analysis. The company also unveiled plans to increase the service portfolio further in future to analysis of fatty acids and sugar profiles, as well as the detection of pesticides and antibiotic residues.
“It’s not just about food safety but also food quality and testing the authenticity of products”, said the marketing director. “Many of the requests we receive relate to verification of basmati rice because people want to be sure that the product is authentic - especially if they are paying a premium for it.”
A local presence, fast turnaround leading to time savings in logistics and the ability to pay in local currency, were all benefits India-based clients would gain from the new facility, said Eurofins.
The company expects most demand for the lab’s services will initially come from companies exporting products from India into the European Union. But Heupel forecasted that rising domestic standards in the Indian food sector would likely fuel internal demand for the types of analysis its experts could provide. The Indian Government has made expansion of the domestic food processing sector one of its major economic priorities.
“The market for food testing in India is set to grow at a rapid pace due to a new food law, requirements for nutritional labeling and growing exports of agricultural commodities and food products,” said Dr Gilles M. Martin, CEO Eurofins Group. “This new laboratory is another sign of Eurofins’ commitment to provide testing at the highest technical standards in an increasing number of countries around the world.”
The latest expansion is part of an overall company strategy to expand into emerging markets in Asia and Latin America. The company has recently opened three Chinese facilities - two in Shanghai and a laboratory in Shenzhen.
Helvoet Pharma recently broke ground on its new modern production facility in India. This new plant will begin operation in 2012 and will supply the local pharmaceutical industry and global operating pharmaceutical customers with components for primary packaging for parenteral pharmaceutical and diagnostic drugs. Helvoet Pharma's decision to build its own manufacturing plant in India has been made to leverage the country's position as the center of excellence for generic and branded pharmaceutical products. India has the highest number of U.S. FDA-approved plants outside the U.S.A. and is expected to become a significant healthcare consumer market. This brand-new plant fully equipped with state-of-the-art facilities will be operational early 2012. The new plant will be located near Pune (Maharashtra state) in a newly developed MIDC Special Economic zone with a secure energy supply, good transport connections and access to trained personnel.
Holvoet said it will invest a further €14m ($19m) in the facility in next two years, and suggested that its location at the heart of Maharashtra state’s MIDC Special Economic Zone (SEZ) will help it find both customers and highly trained personnel.
The Belgian drug packaging maker, which is part of the Daetwyler Group, currently generates around €2m a year in India but, as CEO Guido Wallraff suggested, sees significant potential to expand in the country.
He predicted that, while already established as a manufacturing centre, the country will become a “significant healthcare consumer market” over the next few years as public demand for effective drugs continues to increase.
”Our confidence in the Indian market is reflected in our long association with the country. Our engagement dates back to 1991 when we started collaboration in India for distribution of our products.”
IDT Biologika unveils plans to expand viral vaccine contract manufacturing operations and says global capacity failing to keep pace with resurgence in drug industry demand.
IDT will add high-containment formulation, fill and finish capacity at its facility in Dessau-Tornau Pharmapark, Germany in a project that Andreas Neubert, VP of the firm’s vaccines business, should be completed in 2013.
Dr. Neubert said the expansion, which will also house cleanroom, containment and lyophilisation capacity, followed market analysis that uncovered an “urgent need for such capacities.”
He explained that: “Our investigations revealed that there is an apparent worldwide lack of contract manufacturing capacities for [viral vaccine production],” citing progress of clients’ candidates into late-stage trials as a specific motivation.
Neubert also echoed recent comments by CEO Ralf Pfirmann relating that scientific breakthroughs were driving a considerable upswing in pharmaceutical industry interest in the development and production.
“Recent developments for therapeutic vaccines based on better understanding of immunological aspects of chronic diseases, including cancer. Some other very exiting aspects are the use of viral vectors for cure of oncological diseases.”
He predicted that such progress, coupled with “new technologies [that] allow development of vaccines for prevention of diseases where traditional vaccines showed insufficient efficacy and safety profiles,” would further increase demand for manufacturing capacity.
Further support for this idea comes from recent headlines which show that, while in clinical development firms like PPD and Encorium are building capacity, in the contract manufacturing space such investments are few and far between.
Danish biopharma giant, Novo Nordisk is expanding its R&D Centre in China by introducing a new Diabetes Research unit and doubling its quota of employees from 100 to 200 by 2015.
China now has the second largest diabetes population after India, with nearly 40m sufferers of the chronic condition; a number expected to rise to 59m, say the Ministry of Health. “It is very important that [Novo Nordisk] works together with the government to help find a way to rectify the problem,” said Matt Thompson, a spokesperson from Novo Nordisk.
Novo Nordisk said it will strive to help overcome this problem by conducting local research and studying the Chinese population for differences in the genes of westerners and easterners, in addition to developing new technologies for global applications.
In 1997, Novo Nordisk became the first international biopharmaceutical company to establish R&D in China, and is now about to swipe another 100 employees from the country’s huge and inexpensive talent pool. The new additions to the R&D Centre at Zhongguancun Life Science Park in Beijing will develop drug candidates for clinical studies.
Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk, commented that “By doubling the current staff at our R&D Centre, we demonstrate our long term commitment to take part in the scientific and technological development of China,” as wells as gaining “access to the tremendous resource of talents, ideas and innovation in China.”
China’s Ministry of Commerce say the number of foreign R&D centers in the country has rocketed from 200 four years ago, to 750 today, with multinational drug giants such as Pfizer, Roche, Merck and Sanofi all having capitalized in building R&D capacities in China in recent years.
The company plan to broaden its horizons in biopharmaceutical research by developing new treatments and conducting pharmaceutical trials to meet demand in its fastest-growing market and contribute solutions to China’s increasing problem with diabetes.
Annual sales growth for Novo Nordisk in China met 30 per cent and its sales in the country are predicted to top $700m this year; a figure which contributes to 7 per cent of its global business.
PharmaZell GmbH has expanded its manufacturing capabilities in India. The company has completed construction of a cGMP kilo-lab at its R&D center in Vizag, India. This follows two other recent expansions in India. In 2007, PharmaZell built a commercial production plant in Vizag, India to produce the API, Mesalamine. In 2008, PharmaZell continued expanding in Vizag by building an R&D facility that now employs approximately 35 chemists focused on chemical route and process development, analytical R&D and small scale synthesis.
The company also expanded its European base in 2007 by acquiring a fully integrated development and commercial production site from Sandoz in Copenhagen. The site in Denmark has a focus on controlled substances, and its scientists have expertise in lab development, pilot plant and commercial manufacturing under cGMP.
“In the past three years PharmaZell has had three expansions in India while growing by acquisition in Europe. We have continued to grow our manufacturing capacity and expand our services to the pharmaceutical and biotechnology industries. We believe that our strong revenue growth and diverse customer base is positioning our company as a significant API manufacturer and service provider,” said Wolfgang Burger, Ph.D., managing partner of PharmaZell.
French drug major Sanofi Aventis will build a production plant in Algeria after receiving clearance from the country’s government.
According to a report on El Khabar the new manufacturing facility will make a range of pharmaceutical for distribution and sale across Algeria where Sanofi already has an 18 per cent share of the market.
Sanofi will operate the facility in partnership with Algerian state owned drug manufacturing firm Saidal.
The investment fits with Sanofi’s recent strategy of expansion in emerging pharmaceutical markets which, after India, has most recently seen it invest in a new production plant in Saudi Arabia .
Takeda says new Y14bn ($163m) Japan plant will offer round-the-clock drug manufacturing capacity when operational in April 2012.
The facility, construction of which is scheduled to begin next month, will be adjacent to Takeda’s existing manufacturing complex in Hikari City, Yamaguchi Prefecture and is intended make oral solid dose drugs in large volumes.
Osaka-headquartered Takeda said the additional capacity will enable it to “achieve economical cost structure and also to fully respond to the required level of quality control that is becoming more and more sophisticated.”
The firm also stressed the “24 hour a day production capacity” as a key benefit, explaining that such operations give it the flexibility to respond to changes in the business environment.
US CMO Alliance Medical Products has installed a new high-volume drug vial filling line at its facility in Irvine, California
The new line, which has the capacity to produce up to 150,000 vials in a single production shift, is supported by an inline vial washer, depyrogenation tunnel and 12 spindle capper. The line also features nitrogen purge or blanket and vial sizes ranging from 2mL to 150mL.
Juan Valdes, CEO of the contract manufacturing organization (CMO) said: “The addition of this line further extends our ability to provide a complete range of developmental, clinical and commercial contract manufacturing services to large and small organizations."
Swiss contract manufacturer Cerbios Pharma has opened a new high potency active pharmaceutical ingredient (API) manufacturing plant in Lugano.
The new plant, which can produce APS for low-dose drugs, houses separate synthesis, drying and isolation capacity as well as a floor dedicated to chromatography, warehousing and repackaging space.
The plant is the latest part of a decade long strategy that has seen Cerbios build capacity in HPAPI production in response to increased pharmaceutical industry focus on oncology and cytotoxics.
IDT Biologika unveils plans to expand viral vaccine contract manufacturing operations and says global capacity failing to keep pace with resurgence in drug industry demand.
IDT will add high-containment formulation, fill and finish capacity at its facility in Dessau-Tornau Pharmapark, Germany in a project that Andreas Neubert, VP of the firm’s vaccines business, should be completed in 2013.
Dr. Neubert said the expansion, which will also house cleanroom, containment and lyophilisation capacity, followed market analysis that uncovered an “urgent need for such capacities.”
He explained that: “Our investigations revealed that there is an apparent worldwide lack of contract manufacturing capacities for [viral vaccine production],” citing progress of clients’ candidates into late-stage trials as a specific motivation.
Neubert also echoed recent comments by CEO Ralf Pfirmann telling Outsourcing-pharma that scientific breakthroughs were driving a considerable upswing in pharmaceutical industry interest in the development and production.
“Recent developments for therapeutic vaccines based on better understanding of immunological aspects of chronic diseases, including cancer. Some other very exiting aspects are the use of viral vectors for cure of oncological diseases.”
He predicted that such progress, coupled with “new technologies [that] allow development of vaccines for prevention of diseases where traditional vaccines showed insufficient efficacy and safety profiles,” would further increase demand for manufacturing capacity.
Further support for this idea comes from recent headlines which show that, while in clinical development firms like PPD and Encorium are building capacity, in the contract manufacturing space such investments are few and far between.
In related news, IDT said it has hired an additional 80 employees, expanding its total manufacturing workforce by some 11 per cent.
Dr. Pfirmann predicted that additional capacity "will accommodate increased demand in [the area of biologics production], and ensure the highest levels of efficiency and quality for our customers."
Almac's Clinical Technologies division announced that it had successfully passed one of the UK's first joint routine GCP/GMP Medicines and Healthcare Products Regulatory Agency (MHRA) inspections at its Craigavon, UK site. This involved senior MHRA inspectors from both its GCP and GMP areas assessing compliance with UK and European legislation.
The MHRA inspection was conducted on the GMP side to determine whether Almac's IXRS integrated phone and web response system was able to adequately ensure that expired products were not shipped to sites or dispensed to patients at clinical trial sites. Additionally the system was reviewed in general terms for its compliance with Good Clinical Practices (GCP). Almac Clinical Technologies received notice from MHRA that no serious findings were found in any of these areas or others investigated by the regulatory agency.
This was the first time in its history that Almac's Clinical Technologies division has been inspected by a regulatory authority. The inspection was conducted as part of a routine inspection plan and process of MHRA and was not triggered by any particular events, issues, or potential violations at Almac. MHRA routinely conducts inspections of both pharmaceutical companies and associated vendors who are involved in clinical trials. The results of the MHRA inspection were reported to Almac on 3 September 2010 after the company was inspected from 23-25 August 2010.
Jim Murphy, President of Almac's Clinical Technology division comments on this significant milestone: "The highly successful results of our first-ever regulatory inspection validate the efforts of all Almac employees to deliver the highest quality GCP and GMP systems and services to our clients. We take great pride in Almac's specialized full supply chain solution involving patient, site and drug management services, which are delivered using our IXRS technology. As patient safety is a key concern for Almac, we employ every effort to assure that patients in clinical trials are provided with products that are managed carefully to prevent expiration and meet all the requirements defined and monitored by regulatory agencies."
Bill Kane, Director of Quality Assurance for Almac's Clinical Technologies division, notes that Almac was not surprised by the results, given the company's long history of delivering quality systems and services to biopharmaceutical clients. "Almac has very stringent quality SOPs that clearly define and guide the way we build systems for our clients and manage the drugs that patients take during clinical trials. The MHRA inspection validates the quality procedures that Almac has put in place and offers another testimony to our focus on providing high quality technologies and services to biopharmaceutical companies worldwide. We typically excel at client audits and now have passed another key test - an MHRA inspection."
McIlvaine Company
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