PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY
UPDATE
May 2011
McIlvaine Company
TABLE OF CONTENTS
Ropack Launches Stickpack Facility
Lonza Expands Production Capacity
Advion Opens Midwest Center of Excellence
Pfizer to Invest $21m in U.S. Injectables Plant
Cretex Buys Pacific Plastics & Engineering
BioCritica to Establish Headquarters in Indiana
Texas A&M University System Seeks to Establish National Biosecurity Center
Syngenta Biotechnology to Expand NC Research Facility
North Carolina Announces AG-Tech Center
PacBio, Mt. Sinai Partner on Clinical Research
Biovest Expands Vaccine Production
Translational Research Institute Creates Calorimeter Lab
Organogenesis, Life Sciences Center Break Ground on Cell Manufacturing Plant
Creganna-Tactx Opens Facility at the Cleveland Clinic
Jabil Investing in New Molding Facility in China
Biomedical Structures Buys Concordia Medical
Medicine Lake Extrusions Bought by Optinov
Pathfinder and SyntheMed Merge
InVivo Therapeutics Opens Facility
Hamner Institutes for Health Sciences Expands with China
Genesis Opens Expanded Clean Room
Precis Engineering Supporting Morphotek Construction
Noble Life Sciences Opens Facility in Gaithersburg, MD
Glatt Adds cGMP Manufacturing Capacity
Advion Signs Lilly Deal, Will Open Bioanalytical Lab
UMass at Lowell to Open Emerging Technologies and Innovation Center
Brown Genomics Center Gets NCRR Support
LyoGo Moves to Purdue Research Park
Cangene bioPharma Completes Renovations
Paragon Bioservices and the University of Maryland Develop Cell Technologies
Transposagen Biopharmaceuticals Expanding
Caliber Opens Plant Production Facility
Vetter’s Chicago Facility Ready for Pharma
MGS Machine Expands Manufacturing Capacity
Pii Expands Manufacturing Capabilities
Pharmatek Adds Spray Drying Capabilities
Merck & Biogen to Expand in North Carolina
Southwest Tennessee Community College Expands
Merck to Add 150 New Employees at Durham Plant
Merck Sells Biomanufacturing Network to Fujifilm
UC Berkeley, Lawrence Berkeley Lab Start Synthetic Biology Institute
Viropro Subsidiary BPD Expands
Ravensburg-Area Vetter Facility Takes Shape
Accovion Expands European Operations
Lotus Pharmaceuticals Facility, China
Lotus Pharmaceuticals' Inner Mongolia Facility
SHL Continues to Expand Taiwan Facilities to Support Autoinjector
Microsoft to Have Hand in Columbia Biotechnology Center
SCHOTT Pharmaceutical Systems Expands
Clinipace Acquires PFC Pharma Focus Ltd.
Dow Invests in Packaging Center of Excellence in Switzerland
Pexco LLC Acquires Mexican Custom Medical Extruder Multitube
Manchester Collaborative Center for Inflammation Research Announced
Prolor Biotech R&D Facility, Weizmann Science Park, Israel
Jubilant Plans Expansions, New Plants
EMD Opens Shanghai Biopharma Training Plant
Academia Sinica Confident Biotech Park Will Pass EPA Review in June
Quotient Expands Its Clinical Facilities
Indian Carbogen Plant Meets Standards
FDA Approves Strides’ Indian Plant
Three New EU Research Infrastructures
Bioniche Life Sciences Center Officially Open
Riken Omics Center Back After Quake
St. Jude Opens Physician Training Center in China
Chinese University Establishes Structural Bio Center
Hebei Aoxing Adopts New API Processing Technology
SMC Ltd. Expands in Costa Rica
Ropack began stickpack production at its new 15,000-sq.-ft dedicated manufacturing suite. The $9 million facility provides uni-dose packaging of solid oral dosage in four Class 100,000
cleanrooms, each with low relative humidity (20%), controlled temperature and controlled residual oxygen to 4%.
To ensure product integrity, mechanical rooms are positioned so that there is no interference from outside elements. Also, according to the company, flow of product and personnel assures cleanliness and efficiency and strict procedures and documentation are followed to maintain the highest standards.
“We have taken every step to ensure that our new dedicated suite far exceeds what is available elsewhere to our clients,” said Yves Massicotte, Ropack's president and chief executive officer. “It is our goal to be the top North American facility for stickpack production and packaging of all humidity- and temperature-sensitive products.”
“Stickpacks are a convenient and highly marketable packaging option, so we are enthusiastic about spearheading efforts in North America,” added Paul Dupont, director of business development. “I believe we can provide the pharmaceutical and consumer health-care industries the highest level of quality and efficiency in stickpack packaging.”
Lonza is expanding its viral-based therapeutics business with the construction of a new, cGMP cleanroom at its Houston, TX operations. Construction and validation of the expansion is expected to be complete in early 2012.
The cleanroom will offer large-scale capacity to support late-stage viral vaccine and gene therapy projects. It will use disposable process systems to support production and fill/finish operations of as many as 2,000 liters. The expansion is part of an effort to reduce clients’ wait times for cleanroom capacity with the ability to run multiple cGMP operations simultaneously.
The cleanroom will benefit customers by offering large-scale capacity to support late- stage viral vaccine and gene therapy projects. It will utilize disposable process systems and be able to support production and fill/finish operations of up to 2,000 liters. Enhanced, EU compliant fill and finish capabilities are in high demand from Lonza’s pharma and biotech customers. The expansion will also notably reduce Lonza’s clients’ wait times for clean room capacity due to the ability to run multiple cGMP operations simultaneously.
Today, viral vaccines are being studied closely for infectious diseases such as AIDS, influenza and malaria. The achievable volumes and relative costs to manufacture virally-delivered vaccines versus traditional egg-based vaccines makes this field a compelling alternative production approach. Viral-delivered gene therapy is also a growing market, with many programs in development for cancer, central nervous system diseases (e.g. Parkinson’s and Huntington’s) and eye-related diseases such as advanced macular degeneration.
Lonza has broad experience in pre-clinical through commercial scale cGMP production of multiple viral products and Lonza’s viral-based therapeutics team has over 15 years of experience in process and analytical assay development and validation, scale-up, cGMP production, product storage and distribution. Lonza also helps clients advance their viral vector and vaccine programs with its significant regulatory experience in the viral field.
“We are very pleased with the growing number of opportunities we are seeing in the viral vaccine and viral vector sector,” said David Enloe, Head of Lonza’s viral-based therapeutics unit. “This investment only furthers our commitment to a leadership position in this exciting space of new therapeutics and vaccines.”
Advion BioServices, a subsidiary of Advion BioSciences, Inc., has opened its new 22,000-sq.-ft. Drug Discovery and Metabolism bioanalytical lab in Indianapolis, IN. This expansion was in response to increased demand for metabolism, ADME screening and other early-stage bioanalytical services, as well as to build upon local partnership in the Indianapolis area.
The new facility will focus on the earlier stage, drug discovery and metabolism bioanalytical services required for the preparation of a molecule’s entry into clinical testing. The site is located in the Purdue Research Park of Indianapolis’ technology center at the Ameriplex Business Park, and has approximately 50 employees.
“For our existing clients, the additional services offer a broader and more comprehensive approach to utilize early-access scientific knowledge and transfer this to later stage analysis,” said David B. Patteson, Advion’s president and chief executive officer. “This should allow us to offer what the clients want, when they need it, while ensuring the scientific integrity and quality are maintained at Advion’s high standards.”
US drug giant Pfizer is investing in additional sterile manufacturing capacity at its facility in Portage, Michigan.
The $21m (€15m) investment will be used to upgrade a production, packaging and quality inspection area at the plant, which makes 50 injectable drugs including Solu-Medrol, Depo-Provera and Solu-Cortef.
Pfizer spokesman Richard Chambers said that: “The latest project will upgrade 6,000 square feet of production space with the latest HVAC systems, enhance vial sterilization systems, reduce energy costs through better lighting and chilled water controls
He added that the firm will “renovate office and lab space, and enhance production efficiency by changing parts of the facility’s interior layout for a better flow of people and materials.”
The expansion, which is tentatively set to begin in mid to late summer according to Chambers, will require an eight-week shutdown of the sterile production area.
“Most of the 200 people who work in that area will be helping with the upgrade, preparing to restart operations, or assisting other units. However, on any given day, as many as 30 colleagues may not have a work assignment.”
The sterile area upgrade follows a $107m expansion of the plant that was completed in 2010 and currently is undergoing validation.
The expansion projects are something of turnaround in the Portage facility’s fortunes given that, in 2007, it was one of the Pfizer’s plants that saw cuts after the market failure of the inhaled insulin product Exubera .
The move also bucks the trend that has seen Pfizer reduce in-house manufacturing capacity in favor of increased outsourcing of pharmaceutical production operations to third parties.
However, according to Chambers, the investment in internal manufacturing is not a change of strategy but part of an effort to balance capacity in line with Pfizer's needs.
“Pfizer strives to build the best globally competitive supply network using both internal and external resources. Accomplishing this requires the right mix of outsourcing, which is a long-standing and ongoing strategy for Pfizer, along with optimization of our internal manufacturing plants.
To gain a foothold with startup medical device manufacturers and OEMs in the Bay Area on the West Coast, privately owned Cretex Cos. Inc. has purchased privately owned injection molder and contract manufacturer Pacific Plastics & Engineering.
“It gives us a West Coast presence that we don’t have right now,” said Lynn Schuler, CEO of Elk River, Minn.-based. “There is a high concentration of medical OEMs and startups. Those companies want a local partner that they can meet with. We can now work together with them more easily on research and development work and developing prototypes.”
“Pacific Plastics is a very solid company and they have an excellent management team that is willing to stay on,” Schuler said.
Pacific Plastics’ plant in Soquel, CA, just outside Santa Cruz, will be the first West Coast operation for Cretex, a nearly 100-year-old company that owns and operates manufacturing businesses in markets ranging from medical to energy, defense, aerospace, construction and manufacturing equipment.
Schuler said the company does not disclose sales or break down results by market segment. It has some 1,700 employees at nearly 40 locations in 38 states. Its medical portfolio of companies includes medical device injection molder Juno Inc., and Meier Tool & Engineering Inc., which makes small, tight-tolerance metal-formed components and subassemblies for the medical, surgical, electronics, aerospace and defense industries.
Both are located in Anoka, Minn. Juno has more than 20 presses, for both thermoset and thermoplastic, ranging from 30-440 tons of clamping force.
A third Cretex medical device company, rms Co., with both its headquarters and a plant in Minneapolis, makes medical device implants and surgical instruments for spinal surgeries, reconstructive orthopedics, cardiovascular and neurological stimulation and endoscopy. Its plant in Memphis, Tenn., exclusively makes orthopedic instruments.
Pacific Plastics, founded 22 years ago by wife and husband Stephanie and Jack Harkness, has nearly 100 employees and seven clean rooms at its 20,000 square-foot plant, which molds and assembles medical and biotech devices. The plant has more than 20 presses, many of them all-electric, ranging in size from 28-230 tons.
The company just added its second Class 10,000 cleanroom in August, according to CEO Stephanie Harkness. It also has five soft-walled Class 8 cleanrooms.
Harkness said Pacific will soon need additional cleanroom space because of continued strong growth. It customers includes more than 150 startup companies and industry giants such as Tyco Healthcare, Johnson & Johnson and Boston Scientific.
The acquisition of Pacific comes less than three years after Cretex bought Meier.
“Pacific complements our current injection molding, precision-machining and machine-stamped businesses,” Schuler said. “We do a lot of the same types of things in the Twin Cities.”
“What sets Pacific apart is its outstanding team people, high-quality products and their ability to turn projects around with quick lead times for their customers,” Schuler said. “That is similar to the way we operate.”
Schuler did not disclose the extent of its medical business portfolio. But he said that the company was “actively seeking acquisitions to expand our footprint” in that area.
“If you think about the demographics of our country, people are living longer, leading more active lifestyles,” he said. “There is a need for products that will help them lead a better quality of life as they age.”
BioCritica, a newly formed biotechnology company, will establish its headquarters in Central Indiana, creating up to 70 new jobs by 2015.
Recently founded by Eli Lilly and Company and a private investor group, BioCritica will develop, market and commercialize products for the critical care hospital market. The company expects to invest more than $5 million in equipment in a to-be-determined site in Central Indiana.
"Indiana's consistently strong growth in the life sciences sector is evidence that not only do we have the talent to power some of the world's top biotechnology companies, but we also have an environment welcoming to the kind of noticeable impact companies like BioCritica and others will have on our state's economy and the quality of life of citizens everywhere," said Mitch Roob, Secretary of Commerce and chief executive officer of the Indiana Economic Development Corporation.
The company will license Lilly's FDA-approved drug for the treatment of severe sepsis, adding other products to its portfolio over time. Sepsis is a poisoning of the blood that affects hundreds of thousands of patients each year, many resulting in death.
"For severe sepsis patients, Xigris is an important life-saving drug," said David Broecker, chief executive officer of BioCritica. "Each year more than 200,000 people die from severe sepsis in the U.S. We look forward to building a company dedicated to saving lives. We also appreciate the support of Lilly, the IEDC and BioCrossroads in helping us get established here in Indiana."
The company plans to begin hiring administrative, commercial and regulatory staff over the summer once it finalizes a site for its new headquarters.
"We are pleased to announce the formation of a new life sciences company in Central Indiana, BioCritica. The collaboration between Lilly and BioCritica will benefit both companies, as well as the patients we serve and the Indianapolis community in which we operate," said John C. Lechleiter, Ph.D., Lilly president, chairman and chief executive officer.
The Indiana Economic Development Corporation offered BioCritica up to $2.9 million in performance-based tax credits and up to $175,000 in training grants based on the company's job creation plans.
BioCritica's establishment in Indiana comes on the heels of a recent announcement from diagnostics product company, HYCOR Biomedical of plans to relocate its headquarters from Garden Grove, Calif. to Central Indiana, adding up to 20 jobs by 2013.
The Texas A&M University System announced that it will seek to establish a National Center for Innovation in Advanced Development and Manufacturing. The purpose of the Center will be to develop medical countermeasures and ensure domestic vaccine manufacturing surge capacity for emerging infectious diseases, pandemic influenza and other threats during public health emergencies utilizing flexible, multiproduct technologies.
The Center will also provide research, education and workforce development programs for students entering diverse careers related to vaccine and medical countermeasure development, manufacturing, testing and approval. The A&M System effort is in direct response to a U.S. Department of Health and Human Services request for proposals published on March 30, 2011.
The A&M System is in discussion with strategic partners including world-class academic, commercial and non-profit institutions to contribute to the proposed Center. The A&M System's potential team includes:
Bavarian Nordic (Copenhagen, Denmark)
Baylor College of Medicine (Houston, Texas)
Blinn College (Brenham and Bryan, Texas)
Caliber Biotherapeutics, LLC (Bryan/College Station, Texas)
deltaDOT Ltd. (London, United Kingdom)
GlaxoSmithKline Biologicals (Rixensart, Belgium)
Kalon Biotherapeutics (College Station, Texas)
Lovelace Respiratory Research Institute (Albuquerque, New Mexico)
Mary Crowley Research Center (Dallas and Bryan, Texas)
PPD, Inc. (Wilmington, North Carolina)
Sartorius (Goettingen, Germany)
The Sabin Vaccine Institute (Washington, D.C.)
Texas A&M Institute for Preclinical Studies (College Station, Texas)
Texas A&M University (College Station, Texas)
Texas Biomedical Research Institute (formerly Southwest Foundation for
Biomedical Research) (San Antonio, Texas)
Texas Children's Hospital (Houston, Texas)
Texas Engineering Experiment Station (College Station, Texas)
Texas Engineering Extension Service (College Station, Texas)
Texas Veterinary Medical Diagnostic Laboratory (College Station, Texas)
University of Texas Medical Branch at Galveston - Galveston National
Laboratory (Galveston, Texas)
Additional team members will be announced in the coming weeks.
"This team represents some of the world's finest scientists, engineers, corporations, and educators in the field. I believe that this distinguished group offers the best opportunity for our country, and
indeed the globe, to achieve security against pandemics and bioterror threats, and in the process, significantly improve global health," said Dr. Brett Giroir, vice chancellor for strategic initiatives at the A&M System and project director.
A North Carolina biotechnology firm says it will spend $70 million to expand its research facility that finds ways to help farmers improve their yields.
Syngenta Biotechnology Inc. will begin construction next month on a 147,000-square-foot facility in the Research Triangle Park. The company employs 400 people in the park near Raleigh.
The company is a subsidiary of Swiss-based agrochemicals giant Syngenta.
Syngenta Biotechnology president Michiel van Lookeren Campagne says the facility will help researchers improve productivity on several key crops including corn, soybeans, sugar cane, rice and vegetables.
The new site will include greenhouses and growth chambers that will allow researchers to control a variety of factors that affect growing conditions.
Proximate to the intellectual hub, Research Triangle Park, the Alexandria Ag-Tech Center will be a 50,000-square-foot agricultural technology research center, which will include 18,000 square feet of flexible greenhouse space.
It will feature cutting-edge individual greenhouse modules and specialized support areas along with innovative shared amenities, providing the ideal environment for emerging ag-tech companies to thrive.
The North Carolina Biotechnology Center hosted an announcement ceremony May 17 with North Carolina Governor Bev Perdue and Alexandria Real Estate Equities, Inc.
The partners announced plans to build the Alexandria Ag-Tech Center/North Carolina, which will be a world-class collaborative greenhouse center for innovative agricultural technology research.
“As complex environmental issues — like the growing world population, limits to world food supply, shrinking natural resources, and the need to develop green technologies — become increasingly urgent, the new Ag-Tech Center along with North Carolina’s commitment to education, innovation and agribusiness will ensure that our state plays a vital role in tackling those challenges,” said Gov. Perdue, in making the announcement at the North Carolina Biotechnology Center.
Growing agricultural technology companies in North Carolina will soon have a world-class destination to develop innovative products. The Alexandria Ag-Tech Center will be a state-of-the-art greenhouse space for research at the intersection of agricultural, biotechnology, clean technology, and human health.
A manufacturer of biologic pharmaceuticals will locate a production facility in the St. Louis County town of Berkeley, MO, retaining 160 workers from a plant it purchased and eventually adding another 160.
The company bought the Centocor Biologics facility and plans to hire about 160 Centocor workers. Gallus also plans to create 160 new jobs over the next five years.
The company says it will invest $20 million to expand the existing facility, thanks in part to financial incentives provided by the state.
Gallus is a contract manufacturer of clinical and commercial-grade bulk biologics products, which are pharmaceuticals produced from cell cultures.
Phlexglobal has expanded in the U.S. with the opening of an office in Philadelphia, PA. The new office will provide Phlexglobal’s trial master file (TMF) services including the PhlexEview eTMF solution, and will initially employ 20 staff, with plans to grow to 50 within the first year. The office will also house a new records center to store live TMF documents for Phlexglobal clients across the U.S.
The opening of the Philadelphia office follows the company’s management buyout (MBO) of the UK private equity firm Inflexion, which will allow Phlexglobal to further expand its provision of clinical trial support for the recent launch of version 3 of its PhlexEview eTMF solution.
Stella Donoghue, Phlexglobal’s managing director, said, “This is an exciting time for Phlexglobal — the launch of a second U.S. office coupled with the recent MBO will provide a valuable platform for the company to move into new markets including Asia-Pacific, while still maintaining a strong presence in the UK and North America.”
Phlexglobal provides clinical research support solutions through its five core services of resourcing, task force, clinical support services, eTMF & document solutions and training.
Alexion, a Connecticut-based biopharmaceutical company is expanding its manufacturing plant in Rhode Island, a move expected to add jobs.
Alexion Pharmaceuticals of Cheshire, Conn. will mark the start of its addition of laboratories and office space in Smithfield.
Alexion, which now employs about 125 in Smithfield, expects to increase its work force there by about 35 percent by the end of next year.
Alexion produces the drug Soliris, the only approved therapy for patients with a rare blood disorder known as paroxysmal nocturnal hemoglobinuria, or PNH.
The expansion included the addition of about 20,000 square feet of labs and office space.
Pacific Biosciences and the Mount Sinai School of Medicine announced a collaboration "to advance research" through the Mount Sinai Institute of Genomics and Multiscale Biology.
The institute will be led by Eric Schadt, who will also continue as chief scientific officer at PacBio.
As part of the collaboration, a Single Molecule Real Time Biology User Facility will be established within the institute, which is the hub of genomics research at Mount Sinai and collaborates with 13 other disease-oriented and core technology-based institutes at Mount Sinai.
PacBio developed the SMRT technology for the real-time analysis of biomolecules with single-molecule resolution. The SMRT Biology User Facility will be outfitted with R&D versions of the SMRT platform called Astros.
The Astros systems were developed for research into biological processes, including DNA sequencing, direct RNA sequencing, protein translation, and ligand binding. The platforms will be available for use by the institute and other collaborators in the eastern half of the US, the partners said. PacBio also will continue to perform collaborations from its headquarters in Palo Alto, Calif.
Financial and other terms of the deal were not disclosed.
"The large-scale generation and integration of multiple sources of biological data combined with clinical information will expand our ability to characterize disease, and ultimately help develop and improve the diagnosis and treatment of patients," Dennis Charney, the Dean of Mount Sinai School of Medicine, said in a statement.
"Multiscale data integration, including genomic, expression, metabolite, protein, and clinical information will ultimately define the future of patient care," said Schadt. "With our intent to collaborate in areas, such as newborn screening for rare genetic disorders, infectious diseases, and cancer we hope to accelerate this revolution, starting by integrating clinical data with previously untapped biological information to build new computational models for predicting human disease."
Biovest International has completed construction of its personalized cancer vaccine production suites in Minnesota, US.
Adding production suites to its 35,000 sq. ft. cell culture site in Minneapolis gives Biovest capacity to manufacture its late-stage, autologous, active immunotherapy for treating non-Hodgkin’s lymphoma.
“This is a key milestone as we are initiating the commissioning and validation processes with the facility currently undergoing comprehensive testing and review”, said Samuel Duffey, president of Biovest.
Production of the vaccine, called BiovaxID, is due to begin at the new suites this summer. Biovest is preparing for meetings with US and international regulators to discuss seeking approvals for BiovaxID.
The Translational Research Institute for Metabolism and Diabetes (TRI), a partnership between Florida Hospital and Sanford-Burnham Medical Research Institute, announced plans with MEI Research, Ltd. to create a state-of-the-art calorimeter laboratory.
The laboratory will feature four calorimeters (also called ‘whole body’ respirometers), which are highly sensitive systems to measure a person’s energy expenditure and the type of food a person is burning. Measurements are made over a few hours to several day- long periods. No mask or mouthpiece is used, therefore studies in a calorimeter room do not cause any discomfort to the volunteer.
“The epidemic of diabetes and obesity in the U.S. are related directly to the persistent and refractory imbalance between calories consumed and insufficient calorie burning,” said Steven R. Smith, PhD, scientific director of the TRI.
Two of the TRI calorimeters will be the first to be designed for precisely measuring energy expenditure at rest or during exercise. These two small rooms will convert between a configuration suitable for measuring the effects of drugs or nutrients on energy and fat metabolism to a configuration specific for careful tests of exercises and physical activities. The other two calorimeters are large units, and are intended for maximum comfort during studies that can last several days.
With both types of calorimeters, the TRI will have the capability to combine these studies of metabolism with metabolite profiling and metabolic signatures identified in Sanford-Burnham laboratories. The overall aim is to develop personalized therapies for obesity and associated diseases based on an individual’s metabolism, said Smith.
Massachusetts Life Sciences Center President & CEO Susan Windham-Bannister joined state and local officials, Organogenesis, Inc. President & CEO Geoff MacKay and employees to celebrate the start of construction of 275 Dan Road. Upon completion in 2013, the company expects the facility to be the world’s largest automated living cell manufacturing plant.
Organogenesis is in the midst of a major, multi-year expansion of its global headquarters, R&D and manufacturing facilities in Canton, Mass.
Organogenesis kicked off the celebration by announcing that it has selected Cambridge-based SMMA/Symmes Maini & McKee Associates as the architect and CRB Consulting Engineers, Inc. as the engineer for the state-of-the-art regenerative medicine manufacturing plant. The company will use advanced robotic and modular manufacturing technologies within this planned facility, which will allow the company to leverage its leadership in the regenerative medicine field to attract substantial resources and jobs to Massachusetts over the next ten years.
The company also announced the purchase of 65 Dan Road in Canton, Mass. Approximately 30 percent of the 78,000 square foot building will be utilized for warehousing/storage with additional space to accommodate the company’s rapid growth. The acquisition of 65 Dan Road brings the company’s total headquarters size to four buildings, comprising 330,000 square feet of space.
“Today we’re honored to have so many state and local officials join us to commemorate the start of construction of this state-of-the-art facility,” said Organogenesis President & CEO Geoff MacKay. “This is a huge milestone for Organogenesis, as well as for the Commonwealth and for the regenerative medicine industry as a whole. We’re growing in Massachusetts in size, in revenue and capacity; and in order to keep pace with our rapid growth, we’re hiring across all departments.”
Organogenesis is in the midst of a major, multi-year expansion of its global headquarters, R&D and manufacturing facilities. The company estimates its total investment in the two-phased expansion will be approximately $63 million.
The Life Sciences Center, charged with implementing the State's ten-year, $1 billion Life Sciences Initiative that was signed into law by Governor Patrick in June of 2008, awarded a $7.4 million grant to Organogenesis, Inc. to help facilitate the expansion. The Center provided $3.7 million in FY 2009 and $3.7 million during FY 2010.
The Massachusetts Office of Business Development worked closely with Organogenesis to create a $12.9 million incentive package, including the Life Sciences Center grant, as well as tax credits for research-and-development expansion. In addition, the State facilitated $5 million in low-interest loans for growth initiatives. The Life Sciences Initiative also addressed tax inequalities when compared with competing states.
As part of the agreement, Organogenesis committed to creating 280 new in-state jobs by 2013, and specifically to creating 17 new in-state jobs in 2011. In the first quarter of 2011, the company surpassed its target expectations for 2011 Massachusetts job creation by adding 19 in-state jobs, with an additional 35 open positions.
Creganna-Tactx Medical is opening an office at the Cleveland Clinic’s Global Cardiovascular Innovation Center (GCIC). The GCIC, located on the healthcare facility’s main campus in Cleveland, Ohio, is an incubator facility supporting the development and commercialization of cardiovascular innovations and medical technologies.
Made possible through a $60 million grant from Ohio’s Third Frontier Project, the GCIC was founded in 2007. The consortium is led by the Cleveland Clinic and comprises Case Western Reserve University, Ohio State University, the University of Cincinnati, the University of Toledo and University Hospitals of Cleveland, along with leading industry economic development partners.
According to Creganna-Tactx officials, the decision to open an office in the new incubator was intended to support companies commercializing innovative medical device technology.
The office will provide product development support to early stage companies, in addition to linking Creganna-Tactx’s customers to the leaders in medical innovation and healthcare delivery.
“Having Creganna-Tactx Medical as part of the clinic team is an important milestone for us. They will provide benefit to GCIC companies and will collaborate with Clinic innovators as we jointly work to develop products that benefit patients in need,” said Chris Coburn, executive director of Cleveland Clinic Innovations.
From this location, the company can facilitate connections to industry-leading physicians and provide customers with enhanced design and development support, end-user feedback, device testing and support for pre-clinical studies and clinical trials. This service further will be bolstered by the company’s recent joint venture agreement with Boston Biomedical Associates (BBA), which will work in partnership with Creganna-Tactx Medical to support customers with clinical, regulatory and quality affairs.
“This move strategically positionsCreganna-Tactx Medical to offer our customers complete support along the full-product life cycle. Working with Cleveland Clinic’s GCIC, we can help bridge the gap between the designer and end-user physician in the development process,” said Randall Sword, business development director at Creganna-Tactx Medical
Headquartered in Galway, Ireland, Creganna-Tactx Medical provides contract design and outsourced manufacturing services to medical device companies. The firm has design and manufacturing operations in the United States, Singapore and Korea.
To stay competitive, Jabil reportedly is investing $10 million in a new injection-molding factory in Shenzhen, China.
The facility is being constructed within a larger existing manufacturing campus that Jabil operates for electronics customers and those in other markets. The molding factory will house 18 Japanese Fanuc injection molding presses to start, though the company plans to increase the number of machines to 50 within two years. Gaet Tyranski, business unit director for the healthcare and life-sciences business of St. Petersburg, Fla.-based Jabil, said the investment was driven by cost pressures among medical device manufacturers.
“I would maintain that the excise tax on medical devices coming out of the most recent [U.S.] healthcare reform act is causing OEMs to look for lower costs to maintain their margins,” he told the weekly newspaper during a January interview at the Shenzhen facility.
“If they predominantly have facilities in Europe and the U.S., they are looking a lot more closely at both moving production overseas and outsourcing more production. I think it is an industry that is experiencing more outsourcing and the outsourcing is moving outside the United States.”
Jabil’s newest facility in Shenzhen will manufacture drug delivery devices for export to the United States and Europe. The facility, however, also will be licensed to make products for the domestic Chinese market, a strategy that eventually could help the company achieve significant future growth. “We are starting to see our customers with an eye toward the domestic markets, China for China and eventually India for India,” Tyranski told Plastics News.
The Shenzhen factory will be able to manufacture 12.5 million disposable drug delivery devices annually, and will be certified to Class 8 cleanroom manufacturing. The operation will be highly automated to help cut down on labor costs, which have been rising quickly in recent years. Jabil employs more than 20,000 people in China, at factories in Tianjin, Suzhou and Wuxi.
Two Rhode Island-based medical textile firms have merged in a move that company officials said sets the stage for future expansion opportunities.
Biomedical Structures LLC, a provider of biomedical textiles for medical devices and other advanced clinical applications, purchased textile manufacturer Concordia Medical LLC, a division of Concordia Manufacturing. Concordia Medical provides medical implant technology using biomaterials for tissue engineering and regenerative medicine. Both firms are located in Warwick, R.I.
Biomedical Structures has expertise in knitting, braiding, weaving and nonwoven technology. The company uses implantable-grade absorbable and non-absorbable biomaterials in orthopedic, general surgery tissue engineering, cardiovascular, bariatric, cosmetic surgery, and veterinary applications, including implantable devices and drug-delivery technologies.
With the addition of Concordia Medical’s textile expertise and volume manufacturing capabilities, Biomedical Structures is targeting “rapid growth” in the fields of orthopedics and regenerative medicine.
According to a 2009 report, the total market potential for tissue engineering and regenerative medicine products is projected to exceed $118 billion by 2013.
Biomedical Structures received an investment from Ampersand Ventures in 2010 with plans to pursue a growth strategy that included equipment and facility investment, expanded engineering capabilities, and product R&D to broaden its reach into core markets. At present, the combined company has 50 employees.
“Since our capital investment in mid 2010, we have committed to increasing our capacity for highly precise and customized manufacturing,” said Biomedical Structures CEO and President John Gray. “With the acquisition of Concordia Medical, not only are we improving our biomedical textile engineering expertise and medical device market penetration, but we are increasing our manufacturing capacity to deliver on complex, sophisticated device applications at the volume our customers require.”
Concordia Manufacturing will retain an ownership stake in Biomedical Structures, and Randal Spencer, the CEO and president of Concordia, will serve on Biomedical’s board and continue to assist the business development of the combined operation.
Terms of the deal were not disclosed.
The management at Medicine LakeExtrusions might want to brush up on their Finnish or Swedish. The Plymouth, Minn.-based supplier of medical-grade thermoplastic extrusions was acquired by Optinova AB, an extruder that specializes influoropolymer medical tubing.
Medicine Lake Extrusions, which was founded in 2004, now will be known as Optinova MLE. The added U.S. capacity will add to Optinova’s facility in Godby, Finland, which is 63,000 square feet (30,000 of which is class 100,000 cleanroom space), includes 27 extrusion lines, 140 employees, an in-house automation department, as well as tooling design and manufacturing.
According to officials of the newly expanded enterprise, the company will offer research and development services; rapid prototyping runs; small-, medium- and high-volume production extrusions; and will position itself as a single-source solutions provider.
A private cell-based therapeutics company and a biomaterials business have merged to create a firm that will focus on cell-based therapy for regenerative medicine. The fusion of Cambridge, Mass.-based and SyntheMed Inc. of Iselin, N.J., has resulted in the birth of Pathfinder Cell Therapy Inc., a company headquartered in Cambridge and led by new CEO and President Richard Franklin and Board Chairman Joerg Gruber. The original Pathfinder discovered a type of mammalian cell found in the kidney, liver, pancreas, lymph nodes, myometrium, bone marrow and blood that one day could help treat diabetes, renal disease and myocardial infarction. SyntheMed developed surgical implant materials and anti-adhesion products.
Pathfinder’s neighbor, InVivo Therapeutics Corp., recently signed a lease to open its first manufacturing and development facility across the Mystic River in Medford, Mass. The company, which develops technologies for the treatment of spinal cord injuries, plans to use the manufacturing plant to produce a polymer scaffold device that treats open wound spinal cord injuries. The company is waiting for clearance from the U.S. Food and Drug Administration (FDA) to begin human clinical trials on the scaffold.
Semprus BioSciences Corp. is preparing to seek FDA approval for a process that would make implantable devices more resistant to bacterial infections over long periods of time. Three months ago, the company received an infusion of $18 million from SR One, the corporate venture capital fund of GlaxoSmithKline PLC and Foundation Medical Partners of Norwalk, Conn. Semprus executives claim the technology the firm developed can add a specially bonded layer to medical devices such as catheters to prevent clotting and fend off bacteria and fungus. “It’s not a coating, but a physical extension of the device itself, which means it lasts much longer than any coating could,” said CEO David Lucchino.
BioEnterprise Corp., a nonprofit group that helps northeastern Ohio companies grow their business, attributed the region’s strength in neurotechnology to collaboration between local research and clinical organizations. Some of the key neurotechnology players in the area include NDI Medical LLC and its spinoffs, Checkpoint Surgical and SPR Therapeutics LLC; Neuros Medical Inc.; Neurowave Systems Inc.; and Synapse Biomedical Inc.
North Carolina, meanwhile, is hoping to create a biotechnology cluster of its own. The Tar Heel State has signed an agreement with Chinese officials to create a biosciences gateway in Research Triangle Park for pharmaceutical, biotechnology and other businesses that want to expand in either country. The agreement calls for a 150,000-square-foot research facility that is expected to open in 2013 on the Research Triangle Park campus of Hamner Institutes for Health Sciences. The nonprofit Hamner will work with Chinese investment firm XY Group to identify opportunities for companies, universities and other organizations.
ISO CERTIFICATIONS:
Blue Ocean Biomedical, a Pembroke Pines, Fla.-based developer and manufacturer of automated load and go cell analysis systems for immune monitoring and related applications, has achieved ISO 13485:2003 certification. President Ernie Thomas called the achievement a “significant milestone” in the company’s overall strategy.
Delcath Systems Inc., a New York, N.Y.-based specialty pharmaceutical and medical device company focused on oncology, has received ISO 13485:2003 certification. President and CEO Eamonn P. Hobbs said the certification will help the company win CE Mark approval for its Hepatic ChemoSAT Delivery System, a product designed to administer high dose chemotherapy and other drugs to diseased organs or regions of the body while controlling the exposure of the medicine.
Ellsworth Adhesives, a global distributor of specialty chemicals and equipment, has achieved ISO 9001:2008 certification for its Germantown, Wis., and Tustin, Calif., facilities. “Obtaining this certification shows our commitment to quality and continual improvement,” said Brett Carlin, the company’s quality manager.
ISO 13485:2003 and ISO 9001:2008 certification has been granted to IncellDx Inc., a Menlo Park, CA-based molecular diagnostics company. President and CEO Bruce Patterson, M.D., said the achievement demonstrates the firm’s commitment to its customers.
Kerecis Limited, an Icelandic tissue regeneration firm, has achieved ISO 13485:2003 certification for the design, development and production of wound and hernia treatment products. G. Fertram Sigurjonsson, the company’s co-founder and board chairman, said the certification validates Kerecis’ commitment to quality and strengthens its ability to enter worldwide markets.
ISO 13485:2003 certification has been granted to the Georgetown, Mass.-based manufacturing facility of UFP Technologies Inc., a provider of specialty packaging, device components and turn-key product solutions for various medical industry sectors. The certification is the second for UFP—its facility in Rancho Dominguez, Calif., is ISO 13485:2003 certified as well. Rich LeSavoy, UFP’s vice president of manufacturing, said the certification will strengthen his company’s ability to become a valuable partner for medical customers.
Volex Group plc, a global designer and manufacturer of interconnect solutions and power cords for the healthcare, industrial, consumer and telecommunications customers, has received ISO 13485:2003 certification for three manufacturing facilities in China, India and Poland. John Conroy, vice president of the company’s healthcare sector, said the achievement has encouraged the firm to be increasingly sensitive to risk assessments and ensures that workers dedicate themselves to the “best possible quality, from new product integration through the product life cycle.”
Fortville, IN based Genesis Plastics Welding has completed a $500,000 expansion of its
cleanroom. The company says the project doubles the size of its original medical cleanroom. In March, Genesis announced plans to add 50,000 square-feet of production space and hire approximately 50 employees.
OmniLytics has relocated from Salt Lake City to Sandy, Utah, US to expand its manufacturing capabilities. In 2010 OmniLytics produced nearly 100,000 litres of bacteriophage product and moving to a site with 60,000 sq. ft. of lab and manufacturing space will support continued growth.
Justin Reber, CEO of OmniLytics, said: “This move not only significantly increases our manufacturing capabilities, but also provides the potential for future expansion onto an additional seven acres of undeveloped property acquired adjacent to the four acre, two building campus.”
OmniLytics is also nearing completion of a master plan for the production facility. This will provide equipment to support production of millions of litres of bacteriophage final product a year.
Precis Engineering is supporting Morphotek in the construction of an $80m (€54m), 60,000 sq ft manufacturing pilot plant in Exton, Pennsylvania, US. The plant will provide Morphotek with biologics for use in early phase clinical trials and is due to be operational in 2012.
"Glass-walled corridors will provide unprecedented access to view clean rooms, production suites, and mechanical systems in operation. The design will let executives tour the facility without having to put on clean-room garments”, said Robert Dick, principal at Precis.
Noble Life Sciences has officially opened a new 6,000 sq. ft. office and laboratory facility in Gaithersburg, MD.
The Maryland-based contract research organization (CRO) cited rapid growth since its inception in 2010 as the driving factor behind the decision to move from its old base in nearby Rockville.
The company, which currently has five full-time employees, said it plans to create 25 new jobs over the next three years.
“Our initial location at the Shady Grove Innovation Centre allowed us to focus on growing the business and enabled us to move into this great new, expanded Gaithersburg facility,” said Ken Carter, president and CEO of Noble.
“The concentration of pharmaceutical and biotechnology companies, leading academic institutions and federal agencies found in Maryland, and in particular Montgomery County, made our decision easy to locate our new facility here.”
The foundations for Noble’s move to Gaithersburg were laid at the beginning of April, when specialist healthcare industry real estate agents, Scheer Partners, negotiated a 78-month lease for the site at 22 Firstfield Road on its behalf.
Noble will share the 50,000 sq. ft. building with a number of other biotech companies, including vaccine developer, Intercell, and the non-profit bioresource centre (BRC), ATCC, but will maintain a small amount of space at its old Rockville, MD, premises.
Glatt Pharmaceutical Services has added new commercial scale cGMP contract manufacturing capacity at its 86,000-sq.-ft. facility in NJ for tablet and capsule production. Added production capabilities include: high shear wet and fluid bed granulating/drying, tablet compression and pan coating, Wurster HS pelletizing and coating, CPS technology direct pelletizing, oven tray drying/curing, blending, milling, sieving and QC. Additional capabilities include organic solvent or aqueous and DEA controlled substance (CII – CV).
“We've made this investment in commercial scale operations in order to provide our clients the speed-to-market and high quality standards demanded in today’s competitive market,” said Oliver Mueller, executive vice president business development, Glatt Pharmaceutical Services.
Advion BioServices plans to open a 22,000-sq.-ft. drug discovery bioanalytical lab in the Purdue Research Park in Indianapolis. The lab is expected to be fully operational by the end of May 2011.
Advion’s primary focus is to provide high-quality, later stage bioanalytical drug development services as required by global regulatory agencies, including the FDA. The new Indianapolis facility will focus on the earlier stage, drug discovery bioanalytical services, evaluating how a potential drug is absorbed and metabolized in experimental models. Many of these services are data-generation activities required for clinical testing preparation.
Advion has also entered into a new, multi-year contract with Lilly to provide a variety of these services to be conducted at the new facility. As part of the agreement, Lilly will transition its drug discovery bioanalytical capability to Advion. All Lilly employees impacted will have the opportunity to join Advion. Financial terms were not disclosed.
“Drug discovery bioanalytical services in Indianapolis are a strategic complement to the regulated drug development bioanalytical services in our Ithaca, NY and Manassas, VA laboratories. Advion has always upheld the highest standards of scientific rigor and looks forward to establishing a center-of-excellence for discovery bioanalytical services in Indianapolis,” said Tom Kurz, president of Advion BioServices, Inc.
Just as its famous mills are a symbol of the Industrial Revolution, Lowell officials hope the state-of-the-art UMass Emerging Technologies and Innovation Center—set to open in fall 2012—will put the struggling city back on the map and at the forefront of the coming revolution in high-tech manufacturing.
“We’re looking forward to this center being able to expand the breadth of the university’s ability to do research that spins off new companies, as well as the depth and sophistication of their ability to do that in certain fields,” said Adam Baacke, Lowell’s assistant city manager for planning and development.
“We definitely think that it bodes well for the city.” The center is a building that will “serve big ideas,” according to University of Massachusetts at Lowell’s Chancellor Marty Meehan.
“We believe the next industrial revolution will be fueled by the work that goes on at the Emerging Technologies and Innovation Center,” he said.
The university last month raised the final steel beam on the four-story, 84,000-square-foot, $70 million center, which will house cleanroom space, wet labs, engineering labs and plastics processing facilities for research and development in the fields of plastics engineering, nanotechnology, electro-optics, and biomedicine.
Brown University has won a $5.1 million grant from the National Center for Research Resources to fund ongoing activities in its Center for Genomics and Proteomics, which provides support and access to resources for a wide range of systems biology research efforts.
Awarded through NCRR's Centers of Biomedical Research Excellence (COBRE) program, the five-year grant will be used to maintain the facility, which provides genomics and other technologies to Brown and other regional Rhode Island research entities, as well as services for fees, said Brown Professor of Medical Science Walter Atwood.
The center also includes proteomics and functional genomics research tools, a transgenic and knockout mice resource, bioimaging facilities, and it provides training, supervision, and consultation in current and emerging research technologies.
The COBRE grants are part of NCRR's Institutional Development Award (IDeA) program, and are used to provide support for biomedical research in states and regions that historically have not received significant levels of funding from the National Institutes of Health.
The grant largely will support the salaries and work provided under service contracts for the genomics facilities at the center, which include tools such as arrays from Affymetrix, Illumina's GAIIx and HiSeq sequencers, and PCR tools, Atwood said. The center currently has six full-time staff members.
Researchers at Brown and in the region are using the center to study "everything from gene expression on a genome-wide scale, genomic markers of autism, aging, cancer," and research conducted by "hundreds of different researchers in the community," Atwood told GWDN.
"The idea in the long-run [for the center] is to make these kinds of facilities self-supporting, mostly by generating user fees," he explained, adding that even getting to fifty percent self-supporting would be a step toward making the center more permanent and would warrant the university's continued support.
As GWDN reported earlier this year, NIH this year will dismantle NCRR in order to start a new center that will focus on translational research, called the National Center for Advancing Translational Sciences. After NCRR is broken up, the current NIH plans call for the IDeA program to be moved to an interim unit run by the Division of Program Coordination and Strategic Initiatives in the Office of the Director.
Atwood said that the NCRR COBRE support has been an important and unique program for Brown, and that in spite of the school's location in the center of the Northeast and its historic reputation, the COBRE funding has filled a need.
He noted that COBRE grants are generally used to support and develop research in states such as North Dakota or Alabama, that have not received large amounts of NIH funding, but pointed out that Brown is a small university that historically focused on undergraduate education.
"Honestly, 10 years ago Brown had very little research infrastructure to speak of, and this program has been hugely important to allow us to get the kinds of modern day research infrastructure we need," said Atwood.
LyoGo, a company that specializes in developing devices to deliver injected freeze-dried drugs, diagnostics and vaccines has become a tenant in the Purdue Research Park.
LyoGo has developed patent-pending technology that stores a lyophilized (freeze-dried) drug in one chamber and liquid diluents in another. Other devices that mix and administer lyophilized drugs require between six and 12 steps to operate. As a result, a majority of freeze-dried drugs are mixed by hand using a syringe and vial.
The steps are dangerous and difficult which can result in needle stick injuries or being intimidated by the process. These concerns hinder patient compliance, resulting in the spread and progression of a disease.
Unlike standard devices, LyoGo-designed devices are projected to be very low cost to manufacture and fill and have a one-step mixing process prior to injection. A drug's shelf life is also improved due to being stored separately from the liquid diluent. Freeze-dried drugs that are kept separate from the liquid until mixing generally don't require much refrigeration and can be stored for years at room temperature, unlike prefilled liquid drugs.
Nearly half of the injected drugs in the development pipeline must be freeze-dried in order to be stored, along with more than 100 types of drugs, diagnostic reagents and vaccines developed in the 1990s and 2000s that now are coming off-patent.
LyoGo has completed preliminary prototyping with Rose-Hulman Ventures and has raised $150,000 in funding in awards from groups like the U.S. Department of Health and Human Services, NASA, and business plan competitions.
Cangene bioPharma has completed an $11m renovation of its sterile filling facility in Baltimore, Maryland, US. Capacity was increased by installing a second production freeze-dryer and the plant was also upgraded in response to evolving regulatory requirements.
“We see increasing opportunities arising from the elimination of fill capacity by many pharmaceutical companies during the economic downturn”, said Vicki Wolff-Long, general manager of Cangene bioPharma.
Paragon Bioservices and the University of Maryland Baltimore (UMB) have formed a public-private partnership for developing and manufacturing stem cell therapies.
The partnership will set up a facility to offer stem cell services, including cell banking and production, on a fee-for-service basis. Life Technologies is also involved with the project.
A Lexington biopharmaceutical company plans to hire 21 more employees by 2013, state officials announced.
Transposagen Biopharmaceuticals creates genetically modified laboratory rats that are used for disease research. The company sells more than 300 different rat models.
The Kentucky Economic Development Finance Authority gave approval Thursday for the state Department of Commercialization and Innovation to offer the company a forgivable loan of $250,000 to assist in buying equipment and paying patent expenses.
Of the 21 new jobs, 16 are classified by the state as high tech and will pay an average annual salary of $58,750 excluding benefits, the state noted. The company also was approved in March for $400,000 in tax incentives to add laboratory space at its operations.
If all the employees are hired, the company will have 37 workers by June 2013.
"We are excited to have received approval for these incentive programs," said Transposagen CEO Eric Ostertag.
A new facility dedicated to manufacturing biopharmaceuticals in plant cell culture - claimed to be the largest of its type in the world - has been officially opened in Texas, USA, by recently-formed company Caliber Biotherapeutics.
The 145,000 sq. ft. facility has the capability of producing up to 100 million doses of infectious vaccines per month, as well as hundreds of thousands of doses of protein-based drugs such as monoclonal antibodies, according to the company.
Caliber was set up earlier this year as a marriage between Texas A&M University in Bryan and privately-held company G-Con LLC, which have been working together in the area of plant cell-based production techniques.
The company has been co-founded by Brett Giroir, vice chancellor for strategic initiatives at Texas A&M, and G-Con's president Barry Holtz. It will focus initially on the use of tobacco plants, rather than egg-based vaccine technology, to produce infectious diseases vaccines, and the on use of plant cells as an alternative to mammalian and microbial cells for making biologics drugs.
Caliber also plans to develop a proprietary product pipeline for cancer and infectious diseases based on cell- and microbial-based production systems.
"With plant-based systems, we have an unprecedented level of flexibility and scalability," said Holtz, who serves as Caliber's chief scientific officer.
"This enables simultaneous production of multiple proteins and rapid change-overs from one product to another in order to meet patients' needs and respond to emerging infectious diseases and bioterror threats."
Caliber sprang out of an earlier initiative entitled Project GreenVax, which was set up with the help of around $40 million in federal funding in early 2010, plus $21 million from its founder partners. G-Con was involved in the construction and management of the facility, including the installation of modular cleanroom 'pods', which house specialized purification and laboratory equipment.
"The Caliber platform is designed to be uniquely agile and responsive, enabling us to accelerate development of products with improved efficacy, reduced cost and enhanced safety," said Giroir, the company's chief medical officer.
Caliber said it will be announcing strategic alliances and its priorities for product development in the coming months.
Vetter, a provider of aseptic prefilled drug delivery systems, announces that its Chicago facility is ready to accept client projects. Located at the Illinois Science + Technology Park in Skokie, IL, the facility provides cGMP filling for vials, syringes, and cartridges, supporting preclinical through phase II products.
The 24,000-sq-ft Chicago facility houses cleanrooms, chemical analysis lab, microbiology lab, cGMP storage area, and administrative offices. Site manager Dr. Claudia Roth has experience designing and establishing clinical manufacturing lines, including freeze-drying operations.
The facility is an expansion of Vetter Development Service, one of the company’s three service divisions, along with Vetter Commercial Manufacturing and Vetter Solutions. Vetter Development Service employs more than 100 personnel in Europe and the United States and supports customer products from preclinical development through market launch. Its service portfolio includes, among others, primary and secondary packaging development, process development, clinical manufacturing, regulatory affairs services, and seamless product transfer to Vetter Commercial Manufacturing. Support includes qualification and validation, engineering, microbiology lab, chemical analysis lab, materials preparation, compounding, aseptic filling, visual inspection, quality assurance, and more.
The site is staffed in large part by experienced professionals from Vetter’s German facilities. Some of these personnel will be replaced by local professionals as they are hired and trained in Vetter best practices.
“Our train-and-replace strategy underscores Vetter’s dedication to consistency and quality, which our customers trust us to deliver,” explains Vetter's Managing Director Peter Soelkner in a press release. “This approach also helps ensure a seamless transfer from Chicago to our commercial manufacturing facilities, once products reach phase III.”
MGS Machine Corp. has more than doubled its manufacturing capacity through the addition of a new facility. Adjacent to the company’s current headquarters, the new building will help expand the company's capacity to provide more line integration and full system FATs.
A complete renovation is underway, including the addition of state-of-the-art communications systems. Measures are being taken to reduce the ongoing operation’s energy consumption, and recycled materials are being used whenever possible. Full occupancy will take place at the end of May 2011.
The new campus is located within 30 minutes of the Minneapolis-St. Paul International Airport.
MGS designs and manufactures packaging and product-handling machinery solutions for a wide variety of industries, including pharmaceutical, medical device, cosmetics, food, and many others.
US drug developer, PharmStar Pharmaceuticals, has reached an agreement to buy a new 24,000 square foot manufacturing facility in Wilson, North Carolina.
PharmStar said that moving R&D and production from its shared headquarters in Rocky Mount, NC, to a standalone facility would help accelerate the commercialization process of its flagship liquid aspirin formula, Aquaprin.
Howard Pyhkitt, PharmStar CEO, said he believed the new site would provide greater economic benefits for the company.
“To better meet FDA CGMP guidelines, it is prudent for Aquaprin to be manufactured in a facility that has only one tenant,” he said.
“While our current location meets these FDA guidelines, it also would require that we continuously monitor and have knowledge of all materials that are located in our building, even those unrelated to PharmStar. After carefully evaluating the economics of these FDA guidelines, it made more sense to move PharmStar into its own building.”
PharmStar’s new facility is located in Wilson Corporate Park, North Carolina, near a third-party pharmaceutical testing site. The company can count Merck, Sandoz, Novartis, Purdue Fredrick, GlaxoSmithKline, and Nature’s Bounty amongst its new neighbors.
Phykitt said he was no stranger to Wilson, and suggested the proximity of other established pharmaceutical companies meant PharmStar had a readily available pool of talented pharmaceutical production, and research personnel to choose from when hiring.
“I have a history in Wilson,” he said, “I know the town, the people and the local economy. It doesn’t get much better for pharmaceutical companies such as ours.”
Meanwhile, Phykitt addressed shareholders’ concerns in the wake of the move and the news that PharmStar was assessing an offer for its old production site in Rocky Mount.
“I made a commitment to shareholders when we restructured the capitalization table that the company has no need to dilute its common stock for at least the next six months,” he said.
“This decision will not affect that commitment.”
Pharmaceutics International Inc. (Pii) has added an MG2G140 capsule filler to its solid oral GMP manufacturing area, expanding its existing commercial manufacturing capabilities. The MG2 G140 capsule filler has an output rate of as many as 140,000 capsules per hour and can dose powder and pellets.
Steve King, senior vice president of Pii said, “Expanding our large-scale manufacturing capabilities with the addition of the MG2 G140 demonstrates Pii’s commitment to enhancing and growing the commercial services provided to our customers. This new capability allows us to better meet the needs of customers in the late and commercial stages of drug development.”
Pharmatek Laboratories, Inc. has added spray drying to its drug formulation and manufacturing capabilities with the purchase of a Buchi B-290 Mini Spray Dryer for formulation feasibility studies and small-scale clinical manufacture. This technology can be used for both oral and parenteral dosage forms.
“Spray drying is an integral technology in Pharmatek’s toolkit for formulating insoluble compounds. The high degree of control and reduced process steps afforded by this process offer a number of advantages over other formulation techniques: enhanced robustness and reproducibility, and the ability to control and create uniform particle size and stabilize volatile and thermo-sensitive compounds,” said Jeffrey Bibbs, chief executive officer and chief scientific officer of Pharmatek.
Almac’s Diagnostics business unit announced the opening of its CLIA registered laboratory.
The opening of the Almac CLIA Laboratory supports the company’s ongoing Biomarker Discovery and Development Strategy by enabling the use of novel tests to stratify and enrich prospective clinical trials. This ability is of key importance as Almac begins to transition the novel biomarkers that they have developed into clinical use, with the resulting potential to inform the drug development process and target therapies to responsive patients.
In addition to standard molecular tests, Almac have a pipeline of both internal clinical tests and companion diagnostic tests with Pharma partners in development that will be delivered from the Almac CLIA Laboratory.
Professor Paul Harkin, President and Managing Director of Almac’s Diagnostics business said, “We are very happy to announce the launch of our CLIA lab, which has been opened to meet both our needs and the needs for our Pharma partners. We have come to a point where the biomarkers we have discovered and assays that we have developed are being used to stratify patients, enrich clinical trials and impact patient treatment decisions. As such, CLIA is a key necessity for the processing of these samples.”
Almac’s genomics laboratories have been supporting biomarker discovery projects for 8 years and already operate under ISO17025 accreditation and work to the principles of GLP.
Biogen Idec and Merck & Co are expanding capabilities and adding jobs in Durham, North Carolina, US.
Merck is adding 70,000 sq. ft. to its facility in Treyburn Corporate Park, north of Durham, to expand vaccine production capabilities. Also, south of Durham in Research Triangle Park (RTP) Biogen is to build an 180,000 sq. ft. site. Both expansions were reported by the Durham Herald Sun.
To support the expansion Merck will hire 150 people in 2011. At the end of 2010 Merck employed 450 people at the site. Following the expansion the bulk live virus production plant will cover 270,000 sq. ft. and support live vaccine production capacity Merck has in Pennsylvania.
Merck also has two fill and finish plants at the Durham site. Since setting up in Treyburn Corporate Park Merck has invested about $900m (€615m) to bring total footprint up to 650,000 sq ft once the latest expansion is complete.
In November the US Food and Drug Administration (FDA) approved the Durham plant for fill and finish of pediatric chicken pox vaccine Varivax (varicella virus vaccine live). The plant may also play a role in producing vaccines for measles, mumps and rubella in the future.
Biogen is to construct an 180,000 sq. ft. building in RTP. Currently Biogen leases a site south of Durham but now plans to move north and break ground in RTP. Biogen already has a manufacturing facility in RTP.
Moving operations and 275 people to the new building in RTP will free up laboratory space, Biogen told the Herald Sun. Biogen expects to add jobs in RTP.
In the past 12 months Medicago and Eisai have also added manufacturing capacity in RTP. Medicago detailed plans to build a 90,000 sq. ft. vaccine plant in August 2010. In May 2010 Eisai opened a 65,000 sq. ft. manufacturing and development facility for intravenous products.
Tennessee 4/19 The Tennessee Board of Regents is seeking bidders to build the Nursing and Biotechnology Facility at Southwest Tennessee Community College in Memphis. The project entails building a three-story, 60,000-sq-ft building to accommodate both the nursing school and the natural-sciences department. The building will include a 250-seat teaching auditorium, lecture rooms, nursing skills labs and labs for biotechnology, biology, microbiology, anatomy and physiology. The project is valued at between $15 million and $25 million.
Merck will add 150 workers in Durham, NC as it expands to produce chickenpox and other live-virus vaccines.
Merck & Co.'s plant will begin making Varivax, a chickenpox vaccine recently approved by the federal Food and Drug Administration.
Plant manager John Wagner said the number of workers at the site should reach 600 by the end of 2011. Merck is expanding the plant from 200,000 square feet to 270,000 square feet.
The company also has plans to add vaccines for measles, mumps and rubella to its products.
Just a year after creating Merck Biomanufacturing Network, Merck & Co. will sell it to Fujifilm, the Japanese photography and imaging company. Merck will become a “key customer” of Fujifilm, according to the companies.
Fujifilm, which faces a declining photography market, already sells instruments to the life sciences and medical sectors. In 2008, its parent, Fujifilm Holdings, entered the pharmaceutical business by buying a majority stake in Japan’s Toyama Chemical. Now, the deal with Merck marks its entry into biopharmaceutical contract manufacturing.
The deal is an important addition for Fujifilm because it brings “diverse capabilities and technical expertise in the production of protein therapeutics,” CEO Shigetaka Komori says. The company won’t confirm a Japanese news report that it is spending $490 million for the business, which has estimated annual sales of $160 million.
Under the agreement, Fujifilm will purchase Merck’s MSD Biologics and Diosynth Biotechnology subsidiaries, operations that form the network. MSD Biologics runs a facility in Billingham, England, that Merck bought from Avecia in early 2010. Diosynth, which Merck acquired through its 2009 purchase of Schering-Plough, has a plant in Research Triangle Park, N.C. The deal also includes manufacturing contracts, business operations, and a technical workforce.
The network produces recombinant proteins, vaccines, and monoclonal antibodies for drug industry customers. Since late last year, Merck has announced four new commercial production agreements.
“We think it makes sense to be acquiring the seeds of new growth businesses,” Credit Suisse analysts wrote about Fujifilm’s pharma-related strategy in a report to clients. Fujifilm, like the Japanese firms Sumitomo Chemical and Mitsubishi Chemical, wants to leverage chemical technologies in the pharmaceuticals area, they note.
A new institute formed by the University of California, Berkeley, and Lawrence Berkeley National Laboratory will work to engineer cells and biological systems to tap discoveries in health, energy and new materials, among other targets.
Agilent Technologies Inc. is the first corporate partner of the Synthetic Biology Institute. UC Berkeley did not say how much Santa Clara-based Agilent (NYSE: A) will pay, but it said the company made a multiyear, multimillion-dollar commitment.
Led by UC Berkeley’s College of Engineering and College of Chemistry, the institute will work to develop inexpensive drugs for treating diseases, methods for producing transportation biofuels from plants, microbes that target tumors, water purification, environmental cleanup and functional new materials.
“Synthetic biology potentially can have as profound an impact in the 21st century as semiconductor technology had in the 20th,” Agilent President and CEO William Sullivan said in a press release. “To get there, we need to engineer biological solutions that are scalable, reliable and safe.”
The institute will be led by director Adam Arkin, a professor of bioengineering and director of the Physical Biosciences Division of Lawrence Berkeley Lab, and associate director Douglas Clark, a professor of chemical and biomolecular engineering and executive associate dean of the College of Chemistry.
Chinese CRO Wuxi PharmaTech will build a small molecule testing lab to service a new Bristol-Myers Squibb (B-MS) analysis contract.
The laboratory in Shanghai, China will be used to conduct quality assurance, stability and related analysis to support all of the US drugmaker's future small-molecule drug submissions worldwide.
The new facility will only be used to provide services for B-MS and will employ a dedicated staff to oversee operations and reporting.
B-MS spokeswoman Jennifer Mauer said that: “WuXi has been a key partner for BMS R&D for the past several years, conducting various non-clinical development activities on a project by project basis” but did not say how many development projects Wuxi will undertake.
The deal is the third major strategic services partnership B-MS has entered into behind the separate deals it signed with US contract research organizations (CRO) Icon and Parexel in June last year.
Now, as then, the US drugmaker stressed the benefits of having a close working relationship with its contractor.
B-MS SVP of non clinical development Mark Powell, said: “[The agreement is] an example of our R&D organization executing our company's BioPharma model by using selective integration to leverage the strengths and talents of both Bristol-Myers Squibb and a valued partner."
Powell also said that the agreement expands the firm’s presence in China, which is one of five target emerging markets it identified as an important growth opportunity in its financial report for 2010.
B-MS’ currently operates one manufacturing facility in China which, like Wuxi’s lab, is located in Shanghai. The plant produces a range of drugs including antibiotics, analgesics and treatments for cardio vascular disorders.
Wuxi is due to announce its financial results for 2010 later.
Biologics Process Development, a wholly-owned subsidiary of Californian contract research organization (CRO), Viropro, has announced it is to double the size of its bioprocess and scale-up laboratory.
The company, which specializes in providing contract laboratory services for the biotech and biopharma industries, claims the expansion will allow it to better serve the needs of existing clients who demand larger processing volumes, whilst potentially attracting new business.
In addition, the company has announced various changes at boardroom level, including the appointment of former BioProcess Technology Consultants (BTC) founder, Howard Levine and former vice president of EU and US pharmaceutical development at Japanese firm, Santen, Pete Fernandes.
Fernandes was previously involved in both the technical and strategic management of early and late-stage drug development of recombinant-derived biologicals and small molecules.
Meanwhile, prior to founding BTC, Levine held positions in process development at both Genentech and Amgen.
Virorpro acquired BPD in 2010 after brokering a deal which saw BPD’s Indian owners, Intas, receive 90 million shares in return. The companies planned to integrate their activities in the area of biotech contract research and manufacturing services (CRAM).
News of BPD’s lab expansion comes soon after parent company Viropro released an update of its long term business plan, claiming its mission is to “become the premier provider of outsourced research, development and manufacturing services for the biopharmaceutical industry.”
The company said the market for biopharmaceutical drugs stood at an estimated $75bn (€53bn), with the rapidly developing Japanese and European markets set to exceed $2bn (€1.4bn) by 2015, driven primarily by an aging population.
Vetter has completed the structural work for its new German facility Ravensburg Vetter West. The structural work on its center for visual inspection and high-bay warehouse for cold-storage and room-temperature products is complete. Interior work and the construction of a power supply system will be finished by late 2011, when operations will begin. The facility will employ more than 230 staff.
The new center for visual inspection and logistics will offer optimized quality control processes and material supply, capable of product delivery around the world. The center will offer advanced-design stability chambers with expanded capacity for long-term stability testing under a range of temperatures. Geothermal energy will be used to regulate temperatures in the high-bay warehouse.
"Our new facility in Erlen reinforces Vetter's position in international markets," says Thomas Otto, Vetter Managing Director. "It combines efficiency and sustainability, and its advanced processes support a high level of product and delivery security. Our investment both in the facility and in renewable energy testifies to our commitment to the region. In Erlen, we are laying important groundwork for Vetter's continuing growth and success on the world market."
German contract research organization (CRO) Accovion has expanded its European operations with the opening of a subsidiary office in London, UK.
The Frankfurt-based company said the UK opening was in line with its strategic plans for 2011, which include establishing offices in several European countries as it seeks to offer clients a broader spectrum of services tailored to a particular country’s needs.
“The UK has always represented key strategic territory for Accovion,” said Ivana Waller, Accovion’s chief operating officer.
“In addition, with our increasing regulatory portfolio, our growing involvement in device pharmacovigilance and health economics, it had become imperative for us to be firmly implanted in London. Our new subsidiary consolidates our presence in Europe and affords us a sure platform to access the considerable local clinical research talent and respond even better to our client’s growing needs.”
According to Waller, the London office serves to “tangibly underscore” the company’s growth target for the year, as it continues to support local and global projects of all types and phases for the pharma, biotech, and medical device industries.
Accovion has appointed former Kendle International project manager and Association of Clinical Research Professionals (ACARP) chief education officer, Carl Naraynassamy, to head up its UK operations.
“We are very pleased to bring on board an experienced managing director - Mr. Naraynassamy – who is well respected for his contributions to the fields of clinical research and pharmaceutical medicine education globally,” said Waller.
News of Accovion’s expansion into the UK comes just six months after the company opened similar subsidiaries in Russia and the Czech Republic.
Speaking in December, Waller said the company had been pursuing clinical research activities for clients in Eastern Europe “for some time”.
China-based prescription drug developer and pharmaceutical manufacturer Lotus Pharmaceuticals is constructing a new headquarters building in Beijing. The new facility will be located in the Chaoyang District, within the premises of its manufacturing facility that was removed from operation in 2010.
The new headquarters broke ground on 9 March 2010. In February 2011, the company decided to expand the facility by an additional two stories at a cost of about $9m. The expansion brings the total construction cost to approximately $48m. The project is currently in the final external and internal furnishing phase, and is slated for completion by the end of 2011.
The project is part of the company's strategy to boost its revenues by catering to the rapidly expanding pharmaceutical market in China. The company expects to generate net revenues of $150m during the first year, once the facility is fully operational.
The company's administration office, sales office, R&D center and production facility are currently spread across various districts of Beijing. Upon completion, the new headquarters will consolidate all operations of the company at one location, thus enabling better coordination between the departments.
"The project is part of the company's strategy to boost its revenues by catering to the rapidly expanding pharmaceutical market in China."
The 34,000m² (365,840 sq. ft.) facility is being built on a 6,700m² parcel of land that earlier housed the company's 50,000ft² manufacturing facility.
The entire facility will be spread over 11 stories. Once completed, it will accommodate a manufacturing plant of good manufacturing practice standards, a research and development center, marketing and sales center, administrative offices and apartments for housing employees. Approximately 10,000m² (108,000ft²) of space will be dedicated to warehouses.
The headquarters building was initially designed to be a nine-floor building spanning approximately 25,000m² (269,000ft²) of area. Two new floors were added to the design to provide about 90 to 120 apartments for employees. The two floors will constitute a gross area of 9,000m² (97,000ft²). The apartments will be allotted to managerial level employees to establish a loyal and stable workforce.
The facility will be outfitted with similar equipment to those in the previous manufacturing facility in the Chaoyang district. It will include liquid phase, gas phase, spectrum and mass spectrum equipment, and a host of purification and distilling equipment.
The Beijing Land Planning Bureau granted permission to use the land for industrial purposes after the company made full payment of the required land value increment taxes in 2009. The land was earlier permitted for green use only.
"The entire facility will be spread over 11 stories."
A series of events has delayed the project completion, including the temporary ban on construction projects during the National People's Congress and Chinese People's Political Consultative Conference in March, and multiple government inspections during several phases of construction to ensure that the facility meets the highest standards of quality.
The facility will be devoted to the manufacturing, research and development of biochemical drugs. It will also develop traditional Chinese medicines, chemical compound medicines and antibiotics.
The interim drug production, until the completion of construction, has been outsourced to Shuanghe Pharmaceutical Group, who has a production facility located near to Lotus Pharmaceuticals' existing facility.
The project is planned to be financed entirely through internal funds. Lotus Pharmaceuticals had paid for approximately $36m of the total construction cost by the end of 2010. The company currently has no plans to procure any loans for the project.
The new headquarters was planned to be launched along with a new manufacturing and storage facility that was to be built in Inner Mongolia. However, the Inner Mongolia project was abandoned in order to concentrate the company's efforts on the Beijing facility. The Inner Mongolia facility was planned to be constructed on a 167 acre site.
SHL has just completed an additional expansion of its Nan Kan 6 facility located in northern Taiwan to ensure that adequate production capacity can be maintained for its OEM/ODM customers. CNC, molding and automation related production have been added to the facility, expanding on our support for these key in-house capabilities. In particular, this facility will house extensive CNC lines which will be utilized by SHL Automation to support production of automated testing and assembly equipment for our medical devices. In addition, these CNC lines will be utilized by SHL Technologies to support its growing need for precision machined components and modules.
Frank Isaksson, GM for Taiwan, commented on this growth stating: "Demand for autoinjectors continues to rise as the number of biologics coming to market steadily increases. The simple fact is that SHL will continue to expand our production capabilities over the next few years and will also find new ways to enhance our utilization of current machinery, people and resources. Several of our biotechnology and pharmaceutical customers are now working with us on multiple projects. With continued expansion in Taiwan, our new facility in the US and future expansion in Europe, we will have the depth of capabilities and resources needed to maintain our leadership position in the auto injector market, including production of other drug delivery devices such as pen injectors and inhalers systems."
SHL currently has six production facilities in Taiwan related to SHL Medical and plans to acquire space at two of its larger facilities as needed. Further expansion related to production facilities has also taken place in North America with SHL's newest facility based in South Florida focusing on the final packaging and assembly of drug delivery devices, such as the Molly autoinjector. SHL will continue to develop additional in-house capabilities to further enhance the range of services we can offer to our clients.
Microsoft confirmed it will assist in the construction of a new biotechnology center in Colombia, El Espectador reported.
The announcement was made by Orlando Ayala, corporate vice president of Microsoft, at the 7th Latin American Faculty Summit in Cartagena, a conference promoting collaboration between computing scientists and researchers in other fields.
The bio-tech center aims to bring together information about biodiversity to enable the Colombian scientific community to carry out projects. It is being developed by the Ministry of Technology and Information with support from Colciencias, the Administrative Department of Science, Technology and Innovation.
Microsoft will be responsible for providing all technology support and will provide a number of internships for Colombians including two reserved for students from the Universidad Nacional, the IT giant stated on its website.
Manizales in the coffee region will be the reported home to the biotechnology center according to a report from Colciencias.
SCHOTT Pharmaceutical Systems, one of the world's leading suppliers of glass tubing and primary packaging for the pharmaceutical industry, continues to expand its global network. The company will open up a new production plant in Russia this month and plans to further strengthen its position in Japan.
At the end of May 2011, the company will officially inaugurate a new manufacturing facility in Russia. Located in Zavolzhe, near the Russian city of Nizhny Novgorod, the new production site will employ around 60 employees initially and will produce premium quality ampoules and vials. All products will be manufactured according to cGMP guidelines (current Good Manufacturing Practices) and meet the high international standards for primary pharmaceutical packaging.
SCHOTT is the first international group, which manufactures primary pharmaceutical packaging made of glass, to open a production facility in Russia. With its packaging expertise and quality commitment, SCHOTT will support Russian pharmaceutical companies in meeting the requirements of 'Pharma 2020'. The company has been selling ampoules, vials, cartridges and syringes to the Russian market since the beginning of the 1990s. So far, Russian customers have been mainly supplied from the existing pharmaceutical packaging site in Hungary.
Furthermore, SCHOTT formed a joint venture with Japanese company Naigai Glass Industry at the end of 2010 in order to strengthen its position in Japan, the world's second largest pharmaceutical market. The new company, SCHOTT NAIGAI K.K., is based in Osaka, Japan, where Naigai has already been operating a production site for many years. Under the terms of the joint venture, Naigai shifted its existing vial manufacturing activities over to the new company and SCHOTT contributed its highly advanced automated inspection system (AIS), which is even more reliable than human eye inspection.
With new business operations in major growth markets such as China and Argentina, SCHOTT has already expanded its global network of pharmaceutical packaging production plants in recent years. With more than 600 production lines in 14 countries around the world, SCHOTT manufactures over seven billion syringes, vials, ampoules, cartridges and special products for the pharmaceutical industry each year.
"Our global production network allows us to be close to our customers who benefit from the high quality and technology standards," says Dr Jürgen Sackhoff, executive vice president of SCHOTT Pharmaceutical Systems. "These global production capacities also allow for supply safety along the entire supply chain."
Ropack, provider of contract manufacturing and packaging services to the global pharmaceutical and consumer healthcare industries, has begun stickpack production in its new 15,000ft² dedicated manufacturing suite. The nearly $9m facility provides uni-dose packaging of solid oral dosage in four Class 100000 cleanrooms, each ensuring low relative humidity (20%), controlled temperature and controlled residual oxygen to 4%.
In addition to state-of-the-industry equipment and technology, the Ropack team has considered every detail to ensure product integrity. For example, mechanical rooms are positioned so that there is no interference from outside elements. Flow of product and personnel ensures cleanliness and efficiency. Strict procedures and documentation are followed to maintain the highest standards.
"We have taken every step to ensure that our new dedicated suite far exceeds what is available elsewhere to our clients," says Yves Massicotte, Ropack's president and CEO. "It is our goal to be the top North American facility for stickpack production and packaging of all humidity- and temperature-sensitive products."
Ropack's project manager, Patrice Joly, agrees. "We have taken extraordinary measures to protect our clients' products and the people who use them."
Stickpacks - slim, tube-shaped packets approximately the size of a stick of gum - have significant consumer acceptance in Europe and Asia. Ropack is taking a primary role in advancing stickpacks in the North American market. "Stickpacks are a convenient and highly marketable packaging option, so we are enthusiastic about spearheading efforts in North America," says Paul Dupont, director of business development. "I believe we can provide the pharmaceutical and consumer healthcare industries the highest level of quality and efficiency in stickpack packaging."
The new production suite is part of Ropack's 210,000ft² of manufacturing, packaging, warehouse and distribution space. In addition to stickpacks, Ropack is equipped to perform standard and cold-form blistering, encapsulation, bottling, sachet filling, syringe assembly, clinical trials and blending.
The launch of the facility coincides with Ropack's 35th anniversary.
Clinipace Worldwide, a global digital clinical research organization (dCRO), and Swiss-based PFC Pharma Focus (PFC) jointly announced a definitive merger agreement under which Clinipace Worldwide has acquired all outstanding shares of privately-held PFC and its subsidiaries. Based in Zurich, Switzerland - with offices in Germany, Israel and India - PFC is a pan-European contract research provider focused on drug and medical device development services and regulatory consulting.
The combination of PFC and Clinipace Worldwide creates a truly global dCRO with centralized North American, South American, and European hubs for strategic drug and medical device product development, clinical operations, data management, regulatory affairs, and GxP/CMC quality assurance. The companies share a collective vision of helping emerging and mid-tier life science firms clients serve patients by substantially accelerating the drug and device development processes via technology-amplified services. Clinipace is strongly differentiated in the marketplace through its proprietary technology -based dCRO value proposition which gives clients more control over timelines and resources, enhanced project visibility, reduced cost, and improved risk mitigation.
"With this acquisition, our third in the past 18 months, we have assembled the right global footprint and the right mix of global therapeutic expertise, strategic product development assets and operational capabilities to uniquely meet the needs of our clients," commented Jeff Williams, CEO and Chairman, Clinipace Worldwide.
"Together with the PFC team we're better positioned to serve the needs of our clients by quickly and efficiently scaling to support their global phase 2-3 trials across a number of therapeutic areas and indications." "This is a great win for our client base as they now have access to Clinipace's extensive experience and capabilities in conducting trials and providing regulatory consulting across North and South America; as well as their proven technology (TEMPO(TM) eClinical platform)," said Kurt Pfister, CEO, European Operations, Clinipace Worldwide (former CEO, PFC Pharma Focus, Ltd.)
The Dow Chemical Company said it is continuing to invest in a “Packaging Center of Excellence” in Horgen, Switzerland to better serve the needs of the packaging industry across Europe, the Middle East and Africa. Dow is doubling the staff of its packaging center to a total of approximately 20-25 people, and significantly expanding its capabilities for testing and prototyping adhesive laminating and film structures for food and beverage packaging needs. The packaging center combines the extensive scientific and technical expertise of Dow’s people, along with equipment and collaboration space for specialty adhesives, resins and formulated films in one place. It will also enhance customers’ ability to test materials and formulations for new package functionality and design. The Center also will hold seminars and forums that will allow package makers and brand owners and others to occasionally share insights about the future needs of the packaging industry.
India’s Veeda Clinical Research has set up a Phase I unit in Malaysia, joining the growing list of contract research organizations (CRO) attracted to the country.
The new 28 bed unit, which is located at Ampang Hospital in the capital Kuala Lumpur, will provide support for early-stage clinical development projects, the first of which are due to start in the next few months.
Veeda set up the facility in collaboration with a team from Malaysian Ministry of Health which, according to group medical director Maurice Cross, was critical to its successful completion.
“Without the help and support of Tan Sri Ismail Merican, the then Medical Director General, Dr Lim Tek Ono and Dato’ SC Teoh in the early days this project would never have got started.” This was echoed by Goh Pik Pin from the Ministry of Health, who added that: “It is very difficult, sometimes, to integrate the approaches of private CROs and Governmental agencies but…we have succeeded and now look forward to beginning a planned series of studies intended to stretch and develop the Unit's capabilities."
The Malaysian Government has courted the contract research sector in the last few years in an effort to strengthen its clinical infrastructure.
Since 2009, companies such as Kendle , Novotech , Quintiles and, most recently, Siro Clinpharm set up a variety of early and late-stage clinical research capabilities in the country.
Veeda, like all of the other recent additions to the Malaysian research sector, cited the rules that govern clinical trials in the country as particularly attractive and a key driver for the investment.
It said that: “Regulatory and start-up times in Malaysia are very favorable even when compared with the Western Countries and are far faster than many evolving countries.”
The firm also said that the National Disease Registry as a key factor in the decision, explaining that it makes the identification of patient populations “especially easy and efficient.”
Lonza is investing CHF24m ($27m) to add cytotoxic manufacturing capacity at its plant in Visp, Switzerland. Investing in multi-kilogram good manufacturing practice (GMP) cytotoxic capacity adds to gram-scale capabilities to allow Lonza to meet clinical and commercial needs from Visp.
“With the anticipated expansion to be completed in the second quarter of 2012, Lonza Visp will offer a fully integrated end-to-end development and manufacturing solution”, said Stefan Stoffel, head of the chemical manufacturing business unit at Lonza.
Products manufactured at the Visp plant will include highly potent active pharmaceutical ingredients (HPAPI), cytotoxics, peptides and antibody drug conjugates. Once the expansion is complete manufacturing scale-up of these products can occur within the Visp plant.
Althea Technologies is to fill commercial drug products for Biotest Pharmaceuticals. The work will be done at Althea’s commercial manufacturing facility in San Diego, California, US, which opened in 2009, and the products will be sold in the US.
"We are very pleased to be selected by Biotest as their strategic partner and commercial filler”, said Rick Hancock, president of Althea Technologies.
Pexco LLC, a leading North American extruder of custom thermoplastic applications, has acquired Multitube Medical Devices S.A. de C.V. of Mexicali, Baja California, Mexico. Multitube specializes in custom extrusions for the medical device, health and safety, and consumer product markets. It primarily serves OEMs in the greater Mexicali and Tijuana region of northwest Mexico.
"This acquisition fulfills both strategic and geographic purposes for our organization," comments Pexco CEO Neil Shillingford. "The Multitube operation is a first-rate facility with cleanroom manufacturing. This acquisition positions Pexco to grow our medical and custom business. The facility's location near Tijuana gives us a presence in this vital manufacturing region that will benefit customers in Mexico and adjacent parts of the United States."
The new Pexco facility totals 17,500 square feet and includes a Class 100,000 medical
cleanroom. The plant employs approximately 40 people operating 10 production lines. According to Richard Brooks, Vice President of Sales and Marketing, Medical, "We are especially excited about bringing our unique technical product offering, including multilumen tubing, para-tubing, co-extrusions, multi-layered, wire-encapsulated tubing, and our new microbore capabilities, to the Baja area market."
Multitube Plant Manager Enrique Preciado remarks, "We are looking forward to working with Pexco and the opportunities a much larger operation brings to our market here in this part of Mexico." Founded in 2002, the privately owned Multitube has been dedicated to serving many of the major medical device manufacturing companies in its vicinity. The operation has also developed a variety of consumer, industrial, and safety product applications for the broader manufacturing base in the area. Pexco first expanded into Mexico in 2000 with its operation in Monterrey, Nuevo Leon.
This facility manufactures extruded products for several of its core specialty segments, including lighting and medical. Pexco maintains that it is actively seeking to grow its business both organically and via acquisition, in current market applications and the larger custom profile and tube extrusion landscape, as well as to new geographies.
"We have an active pipeline and intend to remain focused throughout the year on opportunities of strategic interest to our organization," added Shillingford. About Pexco Part of Saw Mill Capital LLC and based in Atlanta with eight plants in the United States and Mexico, Pexco is a North American leader in the design and fabrication of custom extruded plastics products. It provides standard and specialty parts and components to manufacturers and end-users for a broad range of custom applications, including the aerospace, retail, traffic safety, medical, lighting and fence industries.
Pexco offers a full range of custom design, engineering and fabrication services. Pexco meets the requirements of ISO 9001:2000, holds ISO 14001 registration for all of its manufacturing operations and operates now three Class 100,000 cleanrooms.
GlaxoSmithKline (GSK), The University of Manchester, and AstraZeneca announced the creation of the Manchester Collaborative Center for Inflammation Research (MCCIR), a unique collaboration to establish a world-leading translational center for inflammatory diseases. The project starts out with an initial investment of £5M from each partner over a three year period.
The collaboration between two UK-based pharmaceutical companies, GSK and AstraZeneca, and The University of Manchester, a premier research-led institution, will bring together scientists from both the pharmaceutical industry and academia to work collaboratively on inflammation research and translational medicine.
Scientists will be recruited for new positions to direct the research in line with strategic priorities set jointly by GSK, AstraZeneca and The University of Manchester, with the ultimate goal of translating findings into new and improved treatments. Such advances could potentially benefit the millions of people worldwide affected by diseases associated with chronic inflammation, including asthma, chronic obstructive pulmonary disease, rheumatoid arthritis and inflammatory bowel disease.
Dave Allen, Senior Vice-President of Respiratory Research at GSK, said “The translation of basic research discoveries into new medicines is challenging, but we believe we improve our chances of success through collaborative science. The MCCIR will embody this approach, and I am delighted that GSK has been able to contribute to its development.”
Dr Menelas Pangalos, Executive Vice-President Innovative Medicines at AstraZeneca, said “Inflammatory processes underpin many of our priority areas of research and this is a ground-breaking collaboration. The creation of the new center is indicative of a new era of pre-competitive sharing within the pharmaceutical sector and with academic scientists, to bring our learning together to ensure the faster delivery of effective medicines to patients.
The MCCIR will be formally opened later this year at The University of Manchester and represents a new and truly innovative vehicle to support collaborative research in the UK.
Professor Ian Jacobs, Vice-President of The University of Manchester and Dean of the Faculty of Medical and Human Sciences, commented: The University of Manchester welcomes greatly this opportunity to ensure that some of its fundamental biomedical research will become more closely aligned with the need to develop new therapies for inflammatory diseases. This collaboration builds on the mutual understanding developed between the University and both GSK and AstraZeneca over recent years, and will bring together expertise in biomedical research from the University with the resources and drug discovery expertise from GSK and AstraZeneca to create true partnership and synergy. It firmly establishes the UK and The University of Manchester at the forefront of innovative and enterprising research into inflammatory disease.
Minister for Universities and Science, David Willetts, said: "The announcement made today by The University of Manchester, GlaxoSmithKline and AstraZeneca is a fantastic example of partnership working and its potential to translate cutting-edge science into health and commercial benefits. It is a clear vote of confidence in the UK's world-class academic research base by our leading pharmaceutical companies and is an exciting development."
Prolor Biotech, a clinical phase biopharmaceutical company formerly known as Modigene, has
opened a new corporate headquarters and R&D facility within the Weizmann Science Park, a major biotech cluster located in Ness Ziona, Israel.
The facility is located close to the company's existing facility within the park. Prolor is expected to relocate operations to the new facility by the end of the first half of 2011.
The new facility will propel the Prolor's growth across all fields, including new drug research and clinical development. It will allow the company to develop a host of therapeutic proteins at substantially reduced costs and with quicker production cycles and superior control.
The relocation is subject to positive results from the company's Phase II clinical trial on its longer acting version of human growth hormone. Positive preliminary results from the randomized, open-label and multicenter trial were announced on 11 April 2011; final results are expected to be released by the second half of 2011.
The new facility occupies 10,000ft² of rented space within the park. Its R&D area houses several cleanroom suites designed for the development of therapeutic drug candidates to GMP standards.
The company's existing facility occupies 6,000ft² and has dedicated molecular biology laboratories, cell culture laboratories, in-vitro potency and activity testing laboratories, protein purification laboratories, pharmaceutical development laboratories and analytical development laboratories. The lease of the existing facility is due to expire on 20 January 2012.
"The relocation is subject to positive results from Prolor's Phase II clinical trial on its longer acting version of human growth hormone."
The new facility will produce therapeutic drug candidates. Prolor Biotech's current pipeline of therapeutic proteins and peptides include human growth hormone, interferon ß, factor VIIa, erythropoietin, GLP-1 and OXY-CTP – all of which are in the developmental stage and targeted for markets valued between $1bn and $10bn.
The facility will additionally be dedicated to Phase I clinical studies for new indications of its drug candidates, including both approved drugs and drugs in the clinical stage of development. This will include a drug for hemophilia and obesity. Phase II and III clinical trials will be outsourced to third-party pharmaceutical companies.
The facility will be equipped with Prolor Biotech's proprietary carboxyl terminal peptide (CTP) technology to develop longer-acting, patented versions of therapeutic proteins. CTP is an amino acid sequence released naturally within the body, which is bound to a therapeutic protein.
The technology is compatible with all proteins and has proved to be non-immunogenic to humans when bound to proteins. It prolongs the duration of protein activity within the body. The technology stabilizes therapeutic protein molecules in the blood and reduces its elimination from the body without increasing the level of toxicity or changing the overall biological activity.
"The facility will be equipped with Prolor Biotech's proprietary carboxyl terminal peptide technology."
The global therapeutic proteins market is one of the fastest growing segments of the biopharmaceutical industry. Worldwide sales of therapeutic proteins are projected to reach $77 billion by 2011, according to industry analysts RNCOS. The sector reported a 14% growth in 2008.
Competition is expected to increase over the next ten years as several proteins in the market are expected to go off patent. In addition, improved versions and other therapeutic proteins will pose increased competition to several commercial proteins. Aside from erythropoietin, none of the therapeutic proteins Prolor Biotech has in development has any substitute in the market.
Jubilant Life Sciences is to build an intermediate plant and expand production to continue double-digit growth seen in the fourth quarter.
Extension of production capabilities and improved capacity utilization will be key growth drivers at Jubilant in the coming fiscal year. Execution of this plan will help Jubilant build on fourth quarter double-digit sales growth in life science ingredients.
“We expect to deliver a robust sales growth and better margins across all the businesses on account of increased capacity utilization, commissioning of new plants, innovation led new launches and expansion of market geographies”, said Hari Bhartia, managing director of Jubilant.
Planned production expansions relevant to the pharmaceutical industry include: commissioning of an intermediate plant; a 20 per cent increase in pyridine capacity; construction of a niacinamide facility; and addition of life science chemicals capabilities.
Jubilant has budgeted Rs500 crores ($112m) for capital expenditure in fiscal 2012, mainly for the above plants and agrochemical expansions. When at full capacity utilization Jubilant expects the plants to generate revenues of more than Rs1,200 crores.
Jubilant posted double-digit fourth quarter growth in life science ingredient sales. A 19 per cent uptick in revenues from active pharmaceutical ingredients (API) and strong performance at the life science chemicals unit drove full year sales growth.
Year-on-year growth in fourth quarter generic sales was 24 per cent. Sales of solid dosage forms, up 33 per cent for the full year, and radiopharmaceuticals were the main growth drivers in fiscal 2011.
Despite close to double-digit fourth quarter and full year sales growth at the life science products group operating profit dipped in both reporting periods. Rising expenditure and weak performance at the service unit were responsible for the drop.
Net sales for Jubilant as a whole fell in the fourth quarter, and experienced a modest full year rise, as a result of the service unit dragging on performance. In the fourth quarter service unit sales fell 32 per cent compared to a year ago when figures were buoyed by H1N1 revenues.
Jubilant’s contract manufacturing organization (CMO) benefited from the H1N1 sales a year ago and as such revenues were down 40 per cent in the fourth quarter. This compounded weak performance in earlier quarters and led to a 20 per cent drop in full year sales.
The drug discovery and development solutions unit performed better in the fourth quarter, with revenues flat, but posted a 16 per cent drop in full year sales. Total full year sales at the life science services unit fell 19 per cent to Rs749 crore.
Jubilant expects a turnaround at the service unit in fiscal 2012 to result in a “substantial increase in margins”. Increased capacity utilization is expected to improve margins in the coming year.
Shares in Jubilant were up 7.92 per cent at Rs171.70 at the time of publication.
Quay Pharma has begun investing and expanding in its recently opened Deeside, North Wales facility. The new site has also undergone a successful re-inspection by the MHRA, confirming Quay's GMP compliance.
The site's new equipment includes a state-of-the-art ion chromatography system, which the company added to support two new projects requiring specialist analytical capability. The first of the projects concerned is for a French biopharma that is developing products for severe neurological disorders. The system will be used with pulsed amperometry electrochemical detection to monitor extremely low levels of sugars in a combination drug product. The second project, for a new UK pharma, involves measurement of a cationic drug and its degradation products by conductivity detection.
Quay's formulation development department, which specializes in the development of solid dosages, creams, liquids and gels, has been expanded to include a new pilot facility alongside the laboratory. The pilot lab will offer the capability for early phase work in standard techniques such as tableting, coating and capsule filling, as well as more complex processes such as extrusion spheronization and semi-solid and liquid filling and banding of capsules. It will assist in scale up, as well as providing proof of concept studies and samples for pharmacokinetic (PK) studies.
In addition to these investments, Quay is also planning to introduce new GMP manufacturing suites, with work on these expected to commence 3Q11. Quay Pharma’s chief executive officer, Mike Rubinstein, remarked, “The move to the new premises has effectively quadrupled the available space for these important departments and will allow us to provide a greatly enhanced range of services to both existing and new customers.”
EMD Millipore has opened a training facility in China as an education resource for the country’s rapidly expanding biopharmaceutical manufacturing and development sector.
The 28,000 square foot facility, located in Shanghai’s Zhangjiang Hi-Tech business park, will aim to help customers optimize their upstream and downstream processes in addition to providing guidance on environmental monitoring.
EMD Millipore will also supply validation services to existing customers in the sector according to Jean-Paul Mangeolle, head of the firm’s process solutions business, who said that market need was the key driver for the opening.
“We are responding to China’s commitment to strengthen regulatory requirements designed to ensure drug safety,” Mangeolle explained, adding that “we can support and even train our pharmaceutical customers to meet the new Chinese and global regulations.”
The firm, which formed with Merck KGaA’s acquisition of Millipore in July , said that officials from China’s Food and Drug Administration (SFDA) and scientists from Peking University among the first group to receiving training.
“Both institutions will utilize EMD Millipore’s new Technical Center for training courses specifically created for GMP training and Aseptic process manufacturing.”
Merck KGaA told in-Pharmatechnologist.com that, in addition to the SFDA and Peking University, the facility will be available to biopharmaceutical developers that are not direct customers.
The new Shanghai facility is a continuation of the approach EMD and parent Merck have employed in other emerging manufacturing hubs like Singapore, Brazil and India.
The newest of these, excluding the Shanghai center, is the facility in Nerul, Navi Mumbai, India. The site was opened in January this year as a support base for development services for applications ranging from chromatography for drug discovery.
And, as with the Shanghai opening, the firm stressed the Navi Mumbai center’s provision of training and services to existing customers as the core focus of activities.
Whether EMD also sees these training centers as a way of expanding its customers is unclear, however, establishing the facilities must surely be of some benefit in this regard given that they also provide a showcase for its services.
The China Post news staff, Academia Sinica President Wong Chi-huey, expressed confidence that the National Biotechnology Development Park will pass the environmental impact assessments (EIA) in June and be on its way in developing Taiwan's biotech sector. Construction of the park, which is slated for completion by 2016, has been delayed many times due to environmental concerns. Wong said at the Legislative Yuan meeting in which he gave a detailed report regarding the project, that the Environmental Protection Administration (EPA) has conducted two reviews, one in mid-January and one in mid-April, on the prospective biotech park in Taipei City's Nangang District.
Wong said he is certain, with the amendments and additional notes the Academia Sinica has made to the environmental impact statement, that the project will be approved by June.
Members of the Legislative Yuan asked Wong if the Academia Sinica had a “Plan B” if the project failed to get the approval of the EPA, to which Wong responded that they would reapply again and if that failed, they would give up on plans to build the park.
However, the president of Taiwan's top research institute does not believe it would ever come to that, although Wong does voice his worries regarding the Ministry of National Defense (MND) proposal to consolidate the National Laboratory Animal Center with other building projects, which could impact and jeopardize the entire biotech park development.
Wong emphasized that the animal center is the heart of biomedical development and an important lab for studying diseases, which is an important reason for it to remain separate. There is little reason for such a center to be combined with other constructions, he concluded.
The National Biotechnology Development Park has been key to the government's bid to boost Taiwan's biotech sector. It is set to occupy 25.31 hectares of the 202 Munitions Works in Nangang District, a naturally green habitat with a lot of wetlands.
Quotient Clinical, a business unit of Quotient Bioresearch, announced the completion of a major expansion of its clinical facilities in Nottingham, UK. Bed capacity has been increased by 50 per cent and a dedicated sample processing laboratory for human ADME studies has been incorporated. The new facilities have been inspected and approved for use by the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), and have been awarded Supplementary Accreditation.
The expansion is a direct response to increasing customer adoption of Quotient’s Synthesis-to-Clinic platform, in particular in support of human ADME studies, and reinforces Quotient’s position as a leading provider of 14C-enabled drug development services including Phase 0 microdose, ivMicrotracer, and human metabolism studies.
Synthesis-to-Clinic integrates each component required to undertake a 14C-enabled clinical study into a single supply chain, spanning 14C API radiosynthesis through to the clinical study report. The ability to seamlessly deliver such a program under a single contract, with a single project manager and continuity of scientific input throughout, delivers significant benefits to the drug development project team.
Mark Egerton, MD Quotient Clinical commented: “In parallel with the recent expansion of our Pharmaceutical Sciences laboratory and GMP drug product manufacturing facility, the completion of this clinical expansion is another milestone in the development of our business. It underlines the strength of our Synthesis-to-Clinic platform and the benefits it brings to our global client base. Our expanded facilities will assist the continued development of our services, supporting our customers in taking new and innovative approaches in early drug development.”
Carbogen Amcis’s Indian plant has met industrial standards for the containment and handling of highly potent active pharmaceutical ingredients (HPAPI).
The result ensures that the company – a subsidiary of Dishman Pharmaceuticals - meets all the necessary design specifications for the containment of HPAPIs.
“This is an important milestone for Carbogen Amcis and the Dishman Group,” said Charlie Johnson, head of Switzerland-based Carbogen’s high-potency business unit.
“We have successfully undergone an in-depth and scientifically rigorous qualification process of our containment equipment, led by an external consultancy with a strong reputation and expertise in industrial hygiene.”
Tests at the site in Ahmedabad were carried out by UK-based industrial hygiene consultants, VEGA Environmental Consultants, in accordance with the International Society for Pharmaceutical Engineering’s (ISPE) standardized measurement of equipment particulate airborne concentration (SMEPAC) guidelines – a widely accepted industry standard.
Vega’s consultants checked performance parameters at the Dishman-owned Ahmedabad site using certain industry standard surrogate tests which evaluate whether HPAPI compounds are being safely handled.
A substance designed to mimic the behavior of the HPAPI was used to test the efficacy of isolators for solid handling operations in the manufacturing suites. Operator exposures were then measured, and results found to be below 0.1µg/m³ - well within safe limits.
Workers at the site are involved in manufacturing compounds of the highest occupational exposure band, which include category 1 carcinogens.
Carbogen Amcis was bought by the Dishman Group in 2006, and handles all HPAPI services for the organization – such as developing compounds for preclinical studies, clinical trials and commercial use - through its state-of-the-art facilities in India and Switzerland.
The 4,300 sq. meter (46,268 sq. ft.) site in Ahmedabad was constructed in 2010 at a cost of $20m (€14m), and is fully compliant with current good manufacturing practice (cGMP). It also includes an analytical laboratory and warehouse
Strides’ oncology plant in Bangalore, India has been approved by the FDA, positioning the company to enter the US market.
The plant was set up in 2009 to produce oncology treatments in injectable, tablet and soft gel dosage forms. Now, having received US Food and Drug Administration (FDA) approval the plant, and Stride Arcolab’s specialty business, will expand operations.
“With this approval and the recently announced approval for the sterile complex, we now look forward to scaling up our specialty business through the launch of highly specialized products for the US market”, said Venkat Iyer, CEO of Agila Specialties, a wholly-owned Strides’ subsidiary.
Strides has filed 31 abbreviated new drug applications (ANDAs) for oncology products and expects to begin receiving approvals now the plant has regulatory clearance. Entering the US oncology market will help Strides’ specialty unit hit its 45 per cent year-on-year growth target.
Other major regulatory authorities have already approved the facility. In Europe, Strides has 18 oncology product filings and has also made submissions in other established and emerging markets.
Strides expects to commercialize its first oncology product in the US in the second half of 2011.
Rapid expansion of the specialty business is supported by joint ventures with big pharma. Last year Strides formed, and then expanded, a licensing and supply deal with Pfizer. The deal includes 40 generic products for the US market.
In 2008 Onco Therapies Limited (OTL), a joint venture with Aspen Pharmacare, entered into an out-licensing deal with GlaxoSmithKline for injectable products in 95 emerging markets. OTL operates the newly approved Bangalore plant, which is also used in the GSK deal.
Approval of the OTL-operated plant means all five of Strides’ sterile plants in India have been passed by the FDA.
SCM Pharma has expanded its potent capacity following an $810,000 investment at its UK-based facility. The expansion includes an additional dedicated suite to handle and fill highly potent products such as cytotoxics to cGMP, as well as a new 500-sq.-ft cleanroom dedicated to making potent products. Additionally, the company has developed a production technique to handle continuous throughput via isolators to boost its aseptic processing capacity.
Along with potent products, the company also provides sterile fill finish of C14 radio-labeled compounds to GMP standards, primarily to assist customers carrying out absorption, distribution, metabolism and excretion (ADME) studies at the pre-clinical or clinical trials stage.
Neal Wesley, technical director at SCM Pharma, said, “As the business has developed and grown over the past few years, we have always tried to adapt to our clients’ changing and increasing potent product manufacturing requirements. We have therefore invested heavily into modifying the facility to ensure we can efficiently deal with a range of different potent projects including small pilot scale, clinical trial progression and the market supply of niche licensed products.”
Research Ministers and the European Commission have given the green light to three new pan-European biological science research infrastructures. These extensive new facilities will help boost research and innovation on key societal challenges such as climate change, health and maintaining sufficient supplies of high quality food. The three projects will draw on resources pooled between various Member States and on EU funding. Once complete, they will be open for use by researchers from across the EU and in some cases beyond. France will coordinate an infrastructure for studying how ecosystems respond to environment and land-use changes. The United Kingdom will lead in setting up an infrastructure on systems biology with applications expected in the pharmaceutical, healthcare and agricultural sectors. The third new infrastructure, to be developed in France and Germany, will significantly enhance pan-European access to viruses, bacteria and fungi needed for research on infections affecting humans and crops, as well as for research on bio-security. These infrastructures are part of the updated Roadmap of the European Strategy Forum on Research Infrastructures (ESFRI) issued today. The overall investment for their construction is about € 0.7 billion.
Máire Geoghegan-Quinn, European Commissioner for Research, Innovation and Science, said: “Pooling national and EU resources to build pan-European research infrastructures – rather than each Member State simply going it alone – is common sense and a key part of the EU’s Innovation Union plan. These collaborative efforts create economies of scale, boost EU competitiveness and deliver better value for money for taxpayers. The biological science infrastructures we are announcing today can make a major contribution to tackling some of the toughest problems we face, including climate change and threats to human health and to our food supplies.”
These latest additions to the ESFRI Roadmap also include three energy infrastructure projects already announced in November 2010 (see IP/10/1615).
Three new research infrastructures in biological sciences
Biogeochemical cycles together with biodiversity are vital to climate change and food security issues. The Infrastructure for Analysis and Experimentation on Ecosystems (ANAEE), coordinated by France, will overcome the current fragmentation of ecosystem research in Europe and develop a coordinated set of experimental platforms to analyze, detect and forecast the responses of ecosystems to environmental changes, and to develop appropriate management techniques. For the first time, the project will bring together the major experimental analytical and modeling facilities in ecosystems science in Europe. This will help in understanding terrestrial ecosystems, and the potential impact of climate change. The infrastructure will be in operation from 2015 onwards.
The estimated costs for preparation and construction are € 210 million. Institutions from 20 Member States and Associated Countries are supporting this project.
Contact for ANAEE:
Lise Poulet, Chef du service Presse-Opinion
Tel + 33 1 42 75 91 68
Mobile + 33 6 89 33 80 11, lise.poulet@paris.inra.fr
The Infrastructure for Systems Biology-Europe (ISBE), coordinated by the United Kingdom, aims to support the convergence of life sciences with information technology and system science. In particular it will focus on systems biology connecting the best European research skills, repositories for storing and archiving data and models. This will enable researchers to address how the interaction of biological components leads to the functioning of living organisms and to create models representing these interactions. System biology will have applications in medicine, such as in the design of pharmaceuticals but also an impact on agriculture, healthcare and environment. ISBE will be in operation from 2017 on. The estimated total construction cost is about € 300 million. Organizations from 13 Member States and Associated Countries have demonstrated interest in this infrastructure.
Contact for ISBE:
Richard Kitney, Imperial College London
Tel +44 0 2075945184, R.kitney@imperial.ac.uk
The EU Microbial Resource Research Infrastructure (MIRRI), coordinated by France and to be developed in France and Germany, will improve access to the best microbial resources, i.e. strains of viruses, bacteria and fungi which are the essential raw material for biotechnology. This will have a strong impact on research in the agricultural, food, healthcare and biotechnological sectors. Applications range from research on crop pathogens for sanitary and animal health reasons to research on human pathogens and bio security. MIRRI will build the European platform within the future Global Biological Resource Center Network (GBRCN) for microorganisms. Operation of the infrastructure should start in 2014. The total construction cost is budgeted at approximately € 190 million. Institutions from 24 Member States and Associated Countries are supporting this project.
Contact for MIRRI:
David Smith, Julius Kühn-Institut (JKI)
Tel +49 0 531 5962298, D.smith@cabi.org
Background
The European Strategy Forum on Research Infrastructures (ESFRI) was set up in 2002 after the European Council endorsed a Commission working document proposing the new Forum (see IP/02/621). It comprises senior officials nominated by the Research Ministers of the 27 EU Member States and 10 associated countries (Albania, Croatia, Iceland, Israel, Liechtenstein, Montenegro, Norway, Serbia, Switzerland and Turkey). ESFRI also includes a senior official from the European Commission. The current chair, elected for two years, is Beatrix Vierkorn-Rudolph (Germany).
The first ESFRI Roadmap was published in 2006. In all, there are 48 infrastructures in the updated Roadmap (see Annex). Of these, 10 are currently under construction at a cost of about €3.6 billion and a further 38 are foreseen. Sixteen of those are proceeding so well that construction could start by the end of 2012, thus achieving the EU’s Innovation Union goal of starting to build 60% of the ESFRI infrastructures by 2015. The total construction cost for all the facilities in the Roadmap is estimated at some €16 billion and the operational cost would be around €1.6 billion per year.
Over the next decade ESFRI will focus mainly on the practical implementation of the infrastructures identified in the Roadmap. It will also strengthen cooperation with European research and innovation organizations and with European industry. The Forum also intends to develop an evaluation methodology for pan-European Research Infrastructures.
The ESFRI Research infrastructures are financed primarily with national funds, with support from EU budgets.
The EU’s 7th Framework Programme for Research allocates for the period 2007-13 a budget of €1.7 billion to support research infrastructures, both existing and new. About € 560 million, including a € 200 million contribution to the Risk Sharing Finance Facility, of this is specifically dedicated to new infrastructures. So far about €171 million has been allocated to projects on the ESFRI Road Map for their preparatory phase. About €22.5 million has been set aside for the energy and biological science infrastructures recently added to the Roadmap.
Additional funds of up to € 10 billion are available from EU Structural Funds. Support for the construction of research infrastructures can also be obtained from the European Investment Bank in the form of loans.
Bioniche Life Sciences Inc., a research-based, technology-driven Canadian biopharmaceutical company, officially opened its new Animal Health and Food Safety Vaccine Manufacturing Center at its corporate headquarters in Belleville, Ontario, Canada. This facility represents
the largest livestock vaccine manufacturing facility in Canada, with capacity to supply Canadian animal vaccine requirements and to meet international regulatory standards (Good Manufacturing Practice - GMP).
This expansion provides Bioniche with the capability to produce a wide spectrum of vaccines, with fermentation capabilities of up to 5,000 liters and all downstream processing and supporting utilities.
"This government funding was critical to achieve our vision for a state-of-the-art Canadian vaccine manufacturing facility to produce a range of vaccines to prevent illnesses in animals and to reduce the likelihood of human illness from animal diseases," said Graeme McRae, Chairman, President & CEO of Bioniche Life Sciences Inc. "We are proud of our internal Manufacturing Operations team that worked with a Montreal-based engineering firm and a Belleville-based general construction contractor to complete the project. Approximately 90% of the equipment purchased for the facility was made in Canada."
"The Animal Health and Food Safety Vaccine Manufacturing Center has been designed and built to meet the highest manufacturing standards for future supply of animal vaccines into global markets," said Mohamed Elrafih, Vice-President of Manufacturing Operations at Bioniche Life
Sciences Inc. "19 employees have been hired for the Vaccine Manufacturing Center to date, with a further 7 employees recently hired in other areas of the facility in indirect support positions. An
additional 15 to 20 employees are expected to be hired over the next 18 months."
Once fully commissioned, the first product to be manufactured in the Center will be the Company's O157 cattle vaccine - - directed to reducing the level of this deadly pathogen in water, food and the environment and, in turn, help minimize the potential for infection of humans.
The O157 organism causes no disease in cattle, but cattle are the primary reservoir for it. O157 can cause severe illness and can even be fatal when ingested by humans from contaminated meat, vegetables, other food products, or water. Human exposure and infection with O157 can result in serious health consequences, including abdominal pain and severe bloody diarrhea. In severe cases, kidney damage can occur and progress to serious complications and even death. Lingering, long-term medical conditions can persist in individuals exposed to the bacterium. These include post-infectious irritable bowel syndrome (PI-IBS), reduced kidney function, diabetes, hypertension and reactive arthritis.
At the Official Opening of the Vaccine Manufacturing Center, the company also recognized additional government support associated with its vaccine development. The Rural Economic Development (RED) Program of the Ontario Ministry of Agriculture, Food and Rural Affairs provided a $2 million grant in 2007 to the company in support of market development related to the company's O157 cattle vaccine. More recently (April, 2010), the company received an investment of $750,000 (repayable loan) from the Federal Economic Development Agency for Southern Ontario (FedDev Ontario) for the development of a pilot-scale fermentation facility adjacent to the new Vaccine Manufacturing Center. This facility houses fermentation
equipment and downstream processing to allow small-scale, bench-top processes to be scaled up and readied for commercial-scale production in the Vaccine Manufacturing Center
The company has developed substantial strategic information (trade secret) expertise on inducing bacteria to produce commercial quantities of vaccination proteins during fermentation. These technologies may also be applicable to the development of additional animal health and
food safety vaccines, including for and , for which the Company is already supporting research and development work.
The Food Safety Division of Bioniche Life Sciences Inc. has worked with Canadian university researchers, in particular, Dr. Brett Finlay and his team at the University of British Columbia, to develop and license a cattle vaccine against O157. This vaccine - trademarked - is meant to reduce the level of the bacterium in water, food and the environment and, in turn, reduce the potential infection of humans. It has been fully licensed in Canada since October, 2008. A conditional license is pending in the U.S. has the potential to significantly reduce the amount of O157 shed into the environment by beef and dairy cattle. This organism does not cause illness in cattle, but cattle are the primary reservoir for it. Vaccination of cattle with can help reduce the risk of food and waterborne contamination with O157.
The vaccine has been developed by a strategic alliance formed in September, 2000 and composed of the University of British Columbia (UBC), the Alberta Research Council (ARC), the University of Saskatchewan's Vaccine & Infectious Disease Organization (VIDO), and Bioniche, which holds the rights for worldwide commercialization of the vaccine.
An estimated 100,000 cases of human infection with the O157 organism are reported each year in North America. Two to seven per cent of those people develop haemolytic uremic syndrome (HUS), a disease characterized by kidney failure. Five percent of HUS patients die, many of them children and senior citizens, whose kidneys are more sensitive to damage.
Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary products for human and animal health markets worldwide. The fully-integrated company employs more than 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. The Company's primary goal is to develop proprietary cancer therapies supported by revenues from marketed products in human and animal health.
The Riken Omics Science Center in Yokohama, Japan said that it has resumed its normal research activities in the wake of the large earthquake that struck off the coast of Tohoku, Japan in early March, causing a massive tsunami that leveled parts of the country's northeast coast.
'[W]e have returned to our normal pace of work and have resume all research activities," Piero Carninci, team leader of the Functional Genomics Technology Team, and leader of the Omics Resource, said. "While we anticipate possible issues stemming from power shortages in mid-summer months, the requirement to cut down on power use has resulted in energy-saving measures which themselves are a positive development."
"The only significant impairment Riken suffered was at our Sendai facility, where there was some damage to the building and to research instruments and equipment," Riken President Noyori Ryoji said in a statement on the institute's website. "Repairs will be required, but we are most grateful that there were no injuries to Riken staff and other personnel."
Ryoji also said that Riken's more immediate concern is about "the considerable damage suffered by a number of universities and research institutions" located in or near Tohoku and Kanto.
ICON and ACRONET Corp. have signed an alliance agreement under which the two companies will collaborate to offer global and Japanese pharmaceutical clients a full range of clinical development capabilities to manage trials both regionally and globally.
ACRONET is headquartered in Tokyo with additional offices in Osaka, Fukuoka and New York. ICON has been operational in Japan since 1995 and offers clinical development services and contract staffing from its offices in Tokyo and Osaka.
Alan Morgan, ICON’s group president, Clinical Research Services, said, “Japan is an important center for clinical research and ICON has a well established presence there. Recent changes in the regulatory landscape mean that an increasing number of Japanese based pharmaceutical companies are looking to run development projects on both a domestic and pan regional basis. The alliance between ICON and ACRONET will benefit clients, who can be assured of a wider range of quality drug development services alongside truly global expertise.”
Shogo Nakamori, ACRONET’s president and chief executive officer said, “The number of global clinical trials involving the triad regions of U.S., EU and Japan has increased gradually in recent years and this trend will continue to accelerate. This is one of the challenging areas for the Japanese pharmaceutical industry and ACRONET is now ready to contribute and support the above challenging areas through this alliance with ICON.”
St. Jude Medical Inc. reaffirmed its long-term commitment to the Asian market this week with the debut of its newest physician training center in Beijing, China.
The St. Jude Medical Advanced Technology Center Asia Pacific officially opened on March 22 in a ceremony attended by Sang Yi, the company’s vice president of Asia Pacific, doctors from the Asia Pacific Heart Rhythm Society (APHRS), Ministry of Health officials, and regional cardiologists.
“I am pleased to celebrate the inauguration of our St. Jude Medical Advanced Technology Center Asia Pacific,” Yi said at the facility’s inauguration ceremony. “St. Jude Medical values our relationship and business with China, and believes that our Advanced Technology Center is an important part of a long and prosperous relationship working with physicians throughout China and the entire Asia Pacific region to improve the health, welfare, and quality of life of the people there.”
The training center in China is the latest in a series of such facilities that St. Jude is rolling out across the globe. The company opened its first center in Brussels, Belgium, in 2008, and broke ground on a manufacturing facility and training center in Malaysia earlier this month. St. Jude is planning to open other training centers in Costa Rica, Japan and the United States.
The Centers educate and train doctors on St. Jude’s cardiology, cardiac surgery and arrhythmia management equipment. The facilities also train physicians to use St. Jude products through lectures, peer-to-peer education and hands-on experience using virtual reality technology, according to the company. The Center’s virtual reality experience allows physicians to simulate different procedures and develop clinical skills in a controlled environment. In this environment, physicians can bring to life previous training, directly experience how they would manage complications during procedures, and learn new advanced cardiac care techniques.
Using St. Jude Medical exclusive virtual reality simulators, physicians practice several different procedures in a human-size simulation. The technology mirrors an operating room environment, allowing doctors to use and familiarize themselves with both the St. Jude Medical products and best practices aligned with different techniques.
“To help treat patients using the latest advances in technology, ongoing learning and training is required,” said Prof. Shu Zhang, Director of the Cardiac Arrhythmia Center and Clinical Electrophysiology Laboratory in Beijing Fu Wai Hospital. “With interactive sessions, a virtual reality experience, and curricula developed by Asia’s scientists specializing in arrhythmia management, I believe the training will provide physicians with a unique, hands-on and enjoyable learning experience they can’t find anywhere else.”
St. Jude bigwigs expect more than 2,000 physicians to visit the Center in Beijing each year from throughout Asia; they predict most doctors will come from hospitals in China.
This week’s grand opening of the training Center occurred during an Educational Summit that partnered St. Jude Medical with APHRS and local cardiologists to establish an educational curriculum. The summit was co-chaired by Zhang and included APHRS members from throughout Asia Pacific. The group of leading physicians will help the Advanced Technology Center staff design courses that provide realistic experiences for physicians who help heal cardiac-related illness.
“With all the new developments in the medical industry it is important that corporations such as St. Jude Medical partner with societies, institutions and physicians to help drive continuous learning. APHRS is pleased to partner with St. Jude Medical to help provide a training experience that will be beneficial to clinicians throughout Asia,” said Masayasu Hiraoka, APHRS president.
St. Jude Medical first entered the Chinese market in 1996. Since then, the company’s Chinese operation has grown from fewer than 10 employees to more than 250. In addition to its new Advanced Technology Center, St. Jude has sales offices in Beijing, Guangzhou and both a sales office and distribution center in Shanghai.
The Center for Structural Biology of Tsinghua Univ. (THU-CSB) was established on April 16, 2011.
Prof. Binling Gu, President of Tsinghua Univ., Member of Chinese Academy of Sciences (referred to as Member hereafter), along with Prof. Yigong Shi, founding Director of the CSB, unveiled the plaque for CSB. Prof. Jining Chen, Senior vice President of Tsinghua Univ. announced the Univ.’s decision to establish the center.
CSB represents an integrative program with principal investigators from School of Life Sciences, School of Medicine and Department of Chemistry.
In this post-genomic era, the role played by structural biology is more important than ever. Advances in technology, methodology, and computation have allowed convenient determination of biomolecule structure by non-specialists.
In contrast to the old-day practice of only getting a static structure, there is an increasing demand for comprehensive and dynamic information on macromolecular assemblies. The concept of structural cell biology has taken roots in the minds of new-generation structural biologists. Addressing fundamental questions in biology frequently requires integration of traditional structural biology approaches with single molecule biophysics, molecular dynamics, and other burgeoning technologies.
It is under this broad context that CSB is established at Tsinghua Univ. The missions of CSB are to cultivate young talents in molecular biology and to address challenging biological problems with an integrated approach. Now there are 15 independent laboratories and about 170 post-doctoral research associates, graduate students and technicians.
It has strength in cryo-EM, led by Member Sengfang Sui, X-ray crystallography, led by Shi, and computational biology. These teams are relatively independent and mutually complementary. Their research covers lots of frontier areas in modern structure biology and has already delivered a series of magnificent works. Since 2009, researchers within CSB have published about 25 research articles in top journals including Nature, Science and Cell.
CSB will effectively improve the existing loose collaboration among Tsinghua’s various schools and departments. It will gradually evolve into a platform for interdisciplinary collaboration and exchange of thoughts among scientists from diverse background such as mathematics, biology, chemistry, computer science, engineering disciplines, material science, medicine, and physics.
The CSB people are quite enthusiastic that, in addition to making important discoveries in structural biology, it will engender novel ideas and thoughts that ultimately foster the creation of new research fronts and disciplines. At a higher level, it is hoped that CSB will facilitate innovative and fundamental research in China.
The Frontiers of Protein Sciences Conference is a high-level international academy conference designed to promote scholarly exchanges in the broad areas of protein structure and function. This is the first of an annual conference series. Lots of authentic experts in protein sciences, among whom there are six Members of the American National Academy of Sciences, came to report their latest research results and trends.
There were more than 400 attendees to the ceremony, composed of peers from other universities, industry partners and students, teachers from schools of medicine, chemistry departments and other related schools and departments.
Tablet testing tech specialist Sotax has set up a new unit in India in the first stage of a five year plan to expand its business in the country.
The firm, which makes a wide range of analysis technologies, will use the Mumbai-based unit to target drugmaker’s manufacturing and R&D operations across India and elsewhere in the region.
Sotax also said that, in time the new subsidiary will host workshops and seminars on a variety of topics in the field of drug production ranging from development and production to QA and QC.
In a press release the Switzerland-headquartered firm said the Indian unit will help it “to service Indian pharmaceutical manufactures and R&D centers in a better way.”
Sotax’ investment in India follows just a few months after German machine tool maker Fette Compacting set up a tablet compression and flowability testing center in Goa, India.
China-based Hebei Aoxing is to produce naloxone hydrochloride API after it successfully adopted new drug processing technology.
Hebei Aoxing is a joint venture between China-based Aoxing and Macfarlan Smith, a subsidiary of Johnson Matthey. Production of the new active pharmaceutical ingredient (API), which will meet European and Chinese standards, was made possible by technology from Macfarlan Smith.
President of Johnson Matthey, John Fowler, and managing director Roger Kilburn visited the manufacturing facility in Xinlei City, China, earlier this month. The pair said securing good manufacturing practice (GMP) certification remained a priority.
“We are highly encouraged by and satisfied with the joint venture’s progress following our recent visit to the facility and meeting with the technical personnel involved,” they said in a joint statement.
“We look forward to seeing the joint venture apply for GMP certification and approval of the process change to Macfarlan Smith’s technology by the SFDA [China’s food and drug administration]. With the success to date of the first product, naloxone hydrochloride, we are excited to see the joint venture partners work closely on other API’s moving forward.”
Naloxone hydrochloride represents the first commercial opportunity for the joint venture, which is initially focusing on eight API products. The company claims the next step is to apply for GMP certification of its workshops and approval of the process change.
Zhenjiang Yue, chairman and CEO of Aoxing, said all parties had worked hard to ensure the transfer of new equipment went smoothly, adding that it had already been put to use.
“Under the guidance of Macfarlan Smith technologists, the joint venture has completed the synthesis of three batches of naloxone hydrochloride. This was accomplished at low cost with a quality meeting both European and Chinese pharmacopeia reference standards,” he said.
Yue went on to suggest that the two companies had achieved a great deal in the short time they had been collaborating.
“Since we signed the agreement with Macfarlan Smith, the joint venture has received its foreign investment authorization certificate, manufacturing license, and business license and met all legal requirements,” he said.
SMC Ltd., has joined a growing number of medical device manufactures to open a facility in Costa Rica. The Somerset, WI-based firm has been part of a joint venture in the country for about 10 years, but is set to open the doors of its own facility.
The company broke ground on the building in August, according to Bob Stoesser, vice president and general manager of Western and Central America. The first phase of the facility will be up and running in April and will be 20,000 square feet. Company officials aren’t stopping for too long before tackling next steps. SMC already is planning on expansion. Two additional phases, 20,000 and 50,000 square feet, respectively, are planned “in the near future.”
“We looked all over the country for the best location,” said Stoesser. They chose the Coyol free trade zone located in San Jose. “It’s proximity to the airport and other key logistics made it the best spot.”
The facility—which goes beyond component and subassembly manufacturing (which currently is what SMC does in Costa Rica)—will offer custom molding, assembly, packaging and full supply chain management onsite.
“We’re now able to offer our customers a state-of-the-art facility for clean room device assembly and testing in Costa Rica,” Stoesser added, noting that the new location gives the company flexibility to support the needs of its U.S.-based customers with facilities in Central America as well as provide a low-cost country option for higher labor projects serving the U.S. market.”
In addition to Wisconsin, SMC Ltd. also has locations in California, Massachusetts, Ohio and India—more than 500,000 square feet of medical manufacturing. The company is a contract manufacturer offering design and molding services and finished devices for the medical and pharmaceutical industries.
As GlaxoSmithKline reworks its early-stage research, it is shedding several dozen clinical development jobs at its R&D site in Research Triangle Park, North Carolina. About 50 jobs in the neuroscience unit are being cut. The drug firm is paring back internal R&D as it expands its network of external partnerships.
Takeda Pharmaceutical, Japan’s largest drug company has inaugurated a major corporate R&D center near Tokyo. The move represents a commitment to in-house research at home when most other major drug companies are outsourcing research, licensing compounds, or building R&D facilities abroad.
The $1.8 billion center is located in Shonan, a seaside region of Kanagawa prefecture just south of Tokyo. The new facility will be staffed mostly by researchers who are now based 300 miles away in Osaka. Other researchers in Tsukuba, a science-oriented city an hour by train to the north of Tokyo, will also move to Shonan. The center will accommodate 1,200 scientists and 800 support staff.
“A location so close to Tokyo will make it easier to attract talented scientists,” says Mayo Mita, a pharmaceutical industry analyst at the Tokyo office of investment bank Morgan Stanley. The Osaka facility, she adds, is getting quite old. Mita notes that the center will not focus exclusively on in-house R&D; it will also include work space dedicated to managing external alliances.
Consolidating research activities at the Shonan center will simplify decision making for Osaka-based Takeda, says Mihoko Shinomiya, a Takeda spokeswoman. “This will be our R&D engine,” she says. Until now, the Tsukuba site developed cutting-edge drug discovery techniques, and Osaka conducted the actual R&D.
The new center will also serve as a hub where researchers based at Takeda R&D sites in the U.S., Singapore, and the UK can come to work with their Japanese colleagues. In this multinational environment, Shinomiya adds, people from other countries should be more comfortable becoming part of the Takeda scientific staff permanently based in Japan.
Takeda expects to complete the switch to the new center in October. So far, few employees have said they won’t make the move, Shinomiya says.
The research center is another bold move for Takeda, which acquired U.S.-based Millennium Pharmaceuticals in 2008 for $8.8 billion. The investment is no guarantee of research success, however. “I have no idea whether it will help to replenish the R&D pipeline,” Morgan Stanley’s Mita says.
Another Japanese pharmaceutical company is pursuing a major Western purchase. Daiichi Sankyo announced that it will pay $805 million up front for Plexxikon, a Berkeley, Calif.-based biotech firm.
Plexxikon could score an additional $130 million from the deal if its lead drug candidate, PLX4032, gains marketing approval.
PLX4032 has generated excitement as one of the most promising oncology candidates in the drug pipeline. The small molecule blocks a mutation BRAF, which occurs in about half of patients with melanoma, a form of skin cancer that has proven challenging to combat.
In January, Plexxikon reported early results from a Phase III clinical trial showing PLX4032 increased overall survival of melanoma patients with the BRAF mutation when compared with dacarbazine, the current standard of care. With Roche, its development partner for PLX4032 in the U.S. and Europe, Plexxikon expects to file for regulatory approval in those markets later this year.
In addition to PLX4032, Daiichi gains a Plexxikon compound that blocks three kinases and is expected to begin Phase II trials for the treatment of several cancers later this year. For Daiichi, the purchase adds to an oncology drug portfolio that has expanded in recent years through a marketing pact with Amgen and the purchase of Germany’s U3 Pharma.
The deal is the latest in a spate of licensing agreements and acquisitions by Japanese drug companies. In the past month, Kyowa Hakko Kirin agreed to pay $470 million for Scottish specialty pharma firm ProStrakan; Astellas Pharma forked over $125 million for Aveo Pharmaceuticals’ tivozanib, a cancer drug in Phase III trials; and Astellas agreed to pay $68 million for the European rights to Optimer Pharmaceuticals’ narrow-spectrum antibiotic fidaxomicin, which is under regulatory review in the U.S. and Europe.
The Japanese spending spree is driven by aging product portfolios, government price pressures, and a sudden influx of generic drug competition in Japan that has many firms scrambling to increase their presence abroad, says Michael Latwis. The strength of the yen against the dollar has made U.S. assets particularly attractive, Latwis adds.
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