PHARMACEUTICAL / BIOTECHNOLOGY
UPDATE
September 2006
McIlvaine Company
North Carolina Central University's BRITE Project Receives $2.3 Million from Golden LEAF Foundation
The Biomanufacturing Research Institute and Technology Enterprise Center for Excellence (BRITE) at North Carolina Central University is receiving another $2.3 million in funding from the Golden LEAF Foundation. The BRITE program helps bolster undergraduate training and workforce development for the state's biotechnology industry.
In 2003, NCCU received $19.1 million from Golden LEAF and the biotechnology industry in to build a 52,000 sq. ft facility to house the program. Officials at North Carolina Central University said the additional $2.3 million in grants was needed to cover increases in construction costs.
The Institute for Genomic Biology at the University of Illinois Set to Open in November
The look of central campus, filled with plenty of 100-year-old buildings, has changed dramatically the last few years with the construction of a 186,000-square-foot institute.
The new $75 million Institute for Genomic Biology is a center for interdisciplinary biotechnology research.
"This is going to be a major event for the campus and the way research is done in biological sciences," said Harris Lewin, the institute's director. The institute, based on bringing researchers from across campus disciplines for projects, was designed for interdisciplinary research, Lewin said.
The building is organized around nine themes: biocomplexity; genomic ecology of global change; genomics of neural and behavioral plasticity; host-microbe systems; mining microbial genomes for novel antibiotics; molecular bioengineering of biomass conversion; precision proteomics; regenerative biology; and tissue engineering.
In the building, researchers will tackle major problems facing the world. They'll look for new antibiotics, new sources for energy and new ways of treating diabetes and cancer.
The $75 million building will house 400 faculty, staff and students, who will start moving in during early November. A dedication is planned for March.
What sets the building apart from other science buildings are the large, open labs, Lewin said. There are also two teaching facilities unique to the building and to campus, he said. Because of the way the building is organized, students can work in a computational lab, for example, doing structural modeling of particular proteins, then go to the adjacent lab to see if the actual protein can be used as a drug.
Construction and operation of the building is funded by state money, but research work is supported by grants. So far, researchers have secured almost $25 million in new funding from agencies such as the National Science Foundation and the U.S. Department of Agriculture.
BioMerieux has Acquired Bacterial Barcodes
BioMerieux, a French company with North American headquarters in Durham, acquired Bacterial Barcodes, a molecular biotechnology company based in Athens, GA
Ferro Pfanstiehl Commissions New Facility
Ferro Pfanstiehl Labs, Inc., part of the Organic Specialties Group of Ferro Corp., has commissioned a new cGMP supercritical fluid-based particle engineering pilot facility. The facility brings additional expertise in particle sizing, purification and formulation to fee-for-service pharmaceutical and biopharmaceutical customers. It will provide ICH Q7A-compliant small-scale manufacturing of drug particles and compounds for use in Phase I and II trials and feasibility studies of engineered particles for any desired drug delivery application.
Ferro Corp.'s supercritical fluid (SCF) technologies utilize low-cost carbon dioxide to produce nano- and micro-particles with a narrow size distribution and consistent morphology. The particles manufactured using these technologies can be used in controlled release, taste masking, respiratory, transdermal and injectable drug delivery applications. Manufacturing benefits include reduced operating costs, near elimination of waste streams, easy recycling of organic solvents, and reduced cycle time.
Metrics Plans $17.5 Million Expansion
Metrics, Inc. is undertaking a $17.5-million facility expansion. The expanded facility will contain more analytical labs, an expanded microbiology lab, additional stability storage capabilities, approximately 9,000 sq. ft. of warehouse space and 17,000 sq. ft. of drug manufacturing space geared toward larger-scale clinical batch manufacture and commercial production. The 47,000-sq.-ft. expansion is expected to be complete in June 2007. The company plans to hire 77 new employees—a 45% increase in staff—to supplement its manufacturing and production capabilities during the next three years.
Amgen a Step Closer to Creating 1,100 Jobs
The largest company to locate in Cork in modern times has cleared its first planning hurdle on the way to constructing a massive biotechnology plant. Amgen, which is the world's largest biotechnology company is proposing to invest in a €800 million plant at Ballyadam, Carrigtwohill, and employ upwards of 1,100 people.
The American company was granted permission by Cork County Council recently to carry out site works and construct a signalized intersection on the main Cork-Midleton road to facilitate construction traffic. It is also in talks with Iarnrod Éireann to provide a rail link to the 133-acre site. Around 750 of the workforce will be given to third-level science graduates. Recruitment is expected to get underway towards the end of next year with production set for 2009. Approximately 1,000 jobs will be created during the plant's construction.
The Hub of a Science Alliance
New research facility in Buckingham Township, PA, helps to broaden region's biotech reach. What started with a Bucks County couple's desire to help a child fight hepatitis B has evolved into a $12 million biotechnology center that promises to educate scientists, spawn research companies and develop treatments against serious diseases, including cancer.
Hailed as the long-awaited result of a unique partnership between Delaware Valley College and the Hepatitis B Foundation, the 62,000-square-foot facility complements a growing biotech industry in the Lehigh Valley region and a state rich in pharmaceutical companies.
''In this renovated space great things will come,'' he said at the morning ceremony. Work by top scientists, he added, will only accelerate the discovery of a cure for hepatitis B, liver cancer and more.
Part new construction, part renovation, the center provides 20 laboratories and millions of dollars in sophisticated equipment for students, staff and biotech companies to learn from each other as they make discoveries, test and market them.
It also received a $250,000 grant as the state's 19th designated Keystone Innovation Zone, an area state-approved for tax breaks, loans and grants to encourage business development and collaboration between universities, entrepreneurs and communities.
The Bucks County center broadens Pennsylvania's efforts to spur economic development with biotech companies. The Lehigh Valley, home to Lehigh University and the Ben Franklin Technology Partners, has been deemed one of 60 biotech hot spots, according to a consultant study last year. Included among some 68 firms the Lehigh Valley Economic Development Corp. identifies as biotech in Lehigh and Northampton counties is B. Braun Medical, which makes safety needles and drug delivery systems in Allentown and Bethlehem; and OraSure Technologies of Bethlehem, maker of a rapid-result tests for HIV and substance abuse.
Some 50 scientists and public health officials work at the Bucks biotechnology center, which is expected to create another 130 jobs in the region. The center holds promise because it grew from a biomedical research center Block and his foundation had persuaded Delaware Valley College officials to build on campus with Thomas Jefferson University and a $7.9 million state grant in 2001.
Research from that partnership produced two new compounds against hepatitis C and B, an experimental treatment for liver cancer and the discovery of blood markers for liver cancer and fibrosis. Several businesses got their start through the partnership as well, including Nucleonics, a Horsham developer of gene-based vaccines and therapies.
Lab space more than quadrupled, from about 7,000 square feet on campus to 35,000 at the new center. And businesses, such as Immunotope, which started in 2003, brought million-dollar equipment, such as a mass spectrometer, generally only available at larger colleges or in private settings.
Immunotope's eight employees are working on vaccines against cancers and chronic viruses, said Vice President Lorraine Keller, and started testing a product on 18 patients with advanced ovarian cancer through Duke University.
BioSante, a company wooed to the Bucks County center from Atlanta, may be best known for finding a way to administer insulin to diabetics through inhalation instead of injection.
If the company can also develop an oral or inhalation therapy for patients with hepatitis B or C to take alpha interferon, Mehta said patients would be able to treat themselves at home instead of going for intravenous treatments once a week.
Bourns College of Engineering Has New Department of Bioengineering
The Bourns College of Engineering has 80 students enrolled in the new Department of Bioengineering. They will focus on developing medical devices, pharmaceutical delivery and cellular factors involved in diseases. The Department will eventually be housed in the proposed 134,000 sq. ft. Materials Science and Engineering building located north of the current site in Bourns Hall. The UC Board of Regents has approved the funding for the building construction in early 2006 with completion expected in 2010.
Department of Bioengineering Approved by the UCR Campus Senate
Nearly 80 bioengineering majors at the University of California, Riverside will, for the first time, have the backing of a full-fledged department when classes resume Sept. 28.
The Department of Bioengineering, on the drawing board since 2000, was approved by the UCR campus’ academic senate in May. Bioengineering at UCR will focus on advancing technologies that help develop medical devices; pharmaceuticals; and uncovering knowledge of the cellular factors involved in diabetes, cancer and other diseases.
The Department of Bioengineering will be the fifth academic department at the Bourns College of Engineering. The college’s established departments include Chemical and Environmental Engineering, Computer Science and Engineering, Electrical Engineering and Mechanical Engineering.
Forty percent of the world’s 6,250 life sciences firms are located in California, according to the California Life Sciences Action Plan. And of the nation’s life sciences industry, 25 percent call the golden state home. UCR is uniquely positioned to become a leader in the education and research in bioengineering with its proximity to two of the state’s three major life sciences industry clusters in the Los Angeles and San Diego areas.
The department will also greatly add value to UCR’s Health Sciences Initiative, which aims to establish a full medical school and an associated Health Sciences Research Institute.
The Bioengineering Department, currently housed in Bourns Hall, will eventually be housed in the proposed 134,000-square-foot Materials Science and Engineering building to be located just north of Bourns Hall and expected to be completed by 2010. The UC Board of Regents approved the funding for the building construction in early 2006.
Merck Plans New Biopharmaceutical Production Facility in Darmstadt, Germany
Merck KGaA is planning a biopharmaceutical production plant at its headquarters in Darmstadt. The plant will cost approximately Euro190 million and close to 200 new positions will be created. This is the second largest investment made by the company in its 338-year history.
Initially, the new plant will produce the monoclonal antibody drug Erbitux for the treatment of colorectal and head and neck cancer. Merck acquired the rights to develop and market Erbitux outside the U.S. and Canada from Imclone. According to the company, Merck first launched Erbitux in 2003 and now markets it in 52 countries. Merck says the oncology drug is its top-selling product.
China Biopharma Manufacturing Partner Obtains Approval to Deliver Flu Vaccine
China Biopharma’s manufacturing joint venture partner, Zhejiang Tianyuan Biopharmaceutical, won approval from the Chinese State Food and Drug Administration (SFDA) to deliver its flu vaccine product for the first batch release of the 2006-07 influenza season. The company has already begun shipping the first lots of its flu vaccine to local Centers for Disease Control & Prevention (China CDCs) and hospitals.
According to Peter Wang, CEO of China Biopharma, the flu vaccine is the inactivated type. “About twenty-five percent of China’s population gets the flu every year,” Wang says. “China represents the largest potential market for flu vaccine. Ten years ago, China only sold about 2,000 doses of flu vaccine. In 2005 that number increased to 25 million and in 2006, it is expected to grow to more than 30 million doses. The market is expected to increase quickly as personal affordability grows.”
Georgia Tech Opens Research Institute in Ireland
The Georgia Institute of Technology and the Georgia Tech Research Institute (GTRI), the applied research arm of the Georgia Institute of Technology, have expanded Georgia Tech’s global reach with the opening of a research institute in Athlone, Ireland. The new institute, with research and collaborations valued at $24 million, will focus on four technology areas that mirror Ireland and Georgia Tech’s research strengths — digital media, radio frequency identification (RFID), biotechnology and sustainable energy.
Georgia Tech Ireland (GT Ireland) will be GTRI’s first applied research facility outside the United States. Over the next five years, the Irish operation plans to build up a portfolio of research programs and collaborations with industry valued in excess of $24 million, and at full operation, it expects to employ 50 highly qualified researchers.
GTRI, which conducts more than $140 million in research and development annually for industry, government and academic institutions across the world, is launching this new enterprise with support from IDA Ireland, the agency responsible for industrial development and overseas investment in Ireland.
The institute will work closely with Irish corporations and universities, the Georgia Tech research community and U.S. companies to provide companies on both sides of the Atlantic with industry-focused research and development that bridge the gap between academic discovery and commercial success.
Georgia Tech Ireland and its research partners will focus on several strategic research strands to provide international leadership in these emerging fields. The institute’s digital media research will include development of a national test bed for Internet protocol television (IPTV), a fully interactive digital television research and development platform offered via fixed and wireless broadband connections. By bringing together developers and users, the institute will explore the potential applications of this emerging technology.
The research with RFID will center on authentication and identification technologies including RF, accoustics and optics for the commercial sector. Using a system engineering approach, the work will provide novel technologies to address complex challenges in global asset tracking, ePedigree and manufacturing.
The institute’s biotechnology research will focus primarily on medical devices for preventive and predictive medicine and manufacturing of medical devices. Here the focus will be on the convergence of pharma, biomedical devices and ICT.
The institute’s energy and environmental research focus will be on enabling technologies and systems models for sustainable energy alternatives. The range of research will span stationary and mobile applications.
GT Ireland’s Athlone location leaves it well situated for collaborative research with a broad range of companies and universities throughout Ireland. Athlone is between Dublin on the east coast and Galway on the west coast. Cork, home of the renowned Tyndall Institute, is on the southern coast. Elan Pharmaceutical and Ericsson are both headquartered in Athlone, and other major corporations have plans to come to the region.
GTRI, established since 1934, has an international standing for its excellence in many areas of science and technology. It employs 1,300 people, including 600 full-time engineers and scientists, of which 73 percent hold advanced degrees.
Althea Wins Vaccine Contract
Althea Technologies has been awarded a cGMP manufacturing contract to produce a DNA-based HIV-1 vaccine. The contract, awarded by Advanced BioScience Laboratories, Inc. (ABL), is under a master agreement with the National Institutes of Health (NIH) and funded by the National Institute of Allergy and Infectious Diseases (NIAID). The $911,549 in funding for Althea's production of the vaccine is provided in its entirety by the NIAID and NIH. The contract will support Althea's efforts for plasmid DNA process development, vaccine production, purification, and regulatory documentation.
The company contends that plasmid DNA vaccines are an attractive alternative to traditional production methods because the vaccines produced are noninfectious, and the manufacturing processes are straightforward and economical. The other significant benefit of this production method is a shelf-life appropriate for public health programs.
Under the NIH multi-year contract managed by ABL for preclinical development and production of this vaccine, Althea will be supporting a larger vaccine development program which is part of an international effort to combat AIDS. This NIAID funded effort is in conjunction with the South African AIDS Vaccine Initiative (SAAVI).
Fluidigm-Singapore Completes Full Manufacturing Operations
Fluidigm Corporation has announced that its Singapore-based manufacturing facility has ramped up to full process R&D and manufacturing operations, less than a year after opening its doors. The rapid startup boosts the Company's entry into the billion dollar real-time qPCR market, enabling production of BioMark(TM) dynamic arrays to supply high-end users. These unique biochips increase qPCR efficiency by orders of magnitude and may replace microwell plates as the industry standard of the future.
"We view our Singapore operation as critical to our long-term success," said Fluidigm CEO Gajus Worthington. "This group has proven its mettle with production of our first product, TOPAZ(R) screening chips. Now, we are poised for high-volume, low-cost manufacturing to meet the demand in a much larger market." Manufacturing engineers at corporate headquarters in South San Francisco collaborated with the Singapore team to bring the facility up to speed. The off-shore strategy takes advantage of Singapore's high-quality talent, which is a legacy of its semiconductor industry.
BioMark dynamic arrays are a class of chips known generally as integrated fluidic circuits (IFCs). IFCs are fabricated using lithographic processes akin to those for integrated electronic circuits, of silicon, but IFCs are made of a rubber-like material and incorporate tens of thousands of microscopic channels, chambers, vias, and valves for nanofluidics.
In 2003, Fluidigm launched the TOPAZ protein crystallization system, which streamlines the process of determining protein structure and drug design. The company is currently introducing the BioMark system, which leverages the unmatched efficiencies of IFCs to study genetic and protein biomarkers related to various medical conditions. Other chips under development address multi-step processes on a nanovolume scale, including synthesis of imaging probes used in positron emission tomography and the preparation of nucleic acids for analysis.