PHARMACEUTICAL / BIOTECHNOLOGY
UPDATE
May 2007
McIlvaine Company
Hollister-Stier Acquisition
In a notable overseas acquisition in contract manufacturing sector by an Indian company, Hollister-Stier Laboratories LLC, a Spokane, WA-based contract manufacturer of sterile injectable vials and lyophilization products, was acquired by Jubilant Organosys Ltd., an integrated pharmaceuticals industry player and one of the largest Custom Research and Manufacturing Services (CRAMS) and Drug Discovery and Development Services companies out of India. The purchase price was $122.5 million, with an additional $16 million in capital commitments that will reportedly be put toward the completion of a $30 million, 50,000-square-foot plant expansion begun last year at Hollister-Stier’s 20-acre campus, and a second production line.
Hollister-Stier, one of the leading North American immunotherapy and vaccine companies, also has a well-recognized Allergy Extracts and Products business, which is the second largest in the USA
Eden Biodesign Begins GMP Bio-Production
Eden Biodesign Ltd. has been licensed by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) to manufacture Investigational Medicinal Products (IMPs) at its new facility in Liverpool, U.K. The U.K. National Biomanufacturing Centre came on-line for process and analytical development in May 2006. The MHRA inspection took place earlier this year to certify Eden’s processes and facilities as having reached cGMP standards. The new license will provide legal authority for Eden to manufacture biopharmaceutical drug substances under contract for clients for use in EU clinical trial sites.
Following the successful inspection, the company will provide Cambridge, U.K.-based ImmBio with a range of development and manufacturing services to rapidly advance its influenza vaccine towards a Clinical Trial Application. Eden has also started to supply cGMP clinical manufacturing services to Onyvax, a private U.K. Biotech, for its ovarian cancer vaccine, and extended a project with Silence Therapeutics plc (formerly SR Pharma) to deliver a whole cell microbial immunotherapeutic for the treatment of asthma and as a therapeutic in cancer and tuberculosis.
CMC BioPharma to Work on MAb for Morphotek
Morphotek, Inc., a U.S. subsidiary of Eisai has entered into agreement with CMC Biopharmaceuticals of Copenhagen, Denmark for development, GMP manufacturing and regulatory documentation support of MORAb-028, a therapeutic antibody targeting advanced melanoma and other cancers. MORAb-028 is a human IgM monoclonal antibody that specifically recognizes a cell surface antigen over-expressed on a significant fraction of metastatic melanoma, brain cancers and non-small cell lung carcinoma.
AMRI Acquires Manufacturing Facilities in India
Albany Molecular Research, Inc. (AMRI) has signed an agreement to acquire two pharmaceutical manufacturing sites, along with additional land for future expansion, in Aurangabad and Navi Mumbai, India. AMRI will acquire the assets -- including facilities, employees, products and equipment-- of Ariane Orgachem Pvt. Ltd. in Aurangabad and Ferico Laboratories Ltd. in Navi Mumbai for approximately $11 million in cash. In fiscal 2006, the assets generated around $5 million in revenue.
All of the facilities are currently owned by the Runwal Group and manufacture a range of pharmaceutical intermediates and bulk active ingredients, including treatments for diabetes, heart disease and asthma. As part of the purchase, AMRI will obtain additional land in Aurangabad and plans to invest approximately $15 million to expand capabilities there during the next three years. The proposed expansion includes increasing capacity, as well as bringing these facilities into compliance with FDA regulations for manufacturing clinical trial materials and commercial drug substances.
The size of the facilities, including both the Aurangabad and Navi Mumbai sites, is more than 9,100 square meters, with additional land available for expansion. To ensure a smooth transition, AMRI has established an integration team and plans to continue the employment of the approximately 200 people working at the facilities. Harold Meckler, Ph.D., vice president of science, technology and support services at AMRI, will lead the integration effort during the transition process.
The transaction is expected to close during the second or third quarter of 2007. The transaction is expected to close during the second or third quarter of 2007.
Ireland’s Pacific Land Ltd has Approval from the Vietnamese Government to Build a US$1 Billion Biotechnology Park in Hanoi
HaBiotech will see research into new drugs and products for agriculture and environmental protection. It will be a bio-industrial complex comprising a biology nursery section and hi-tech labs with advanced facilities to facilitate research, development, and training. There will also be areas earmarked for suppliers, manufacturers, and other biotech agencies.
In its first phase the 200 ha park will be situated in the Hanoi Hi-Tech Zone and in the extended part of the Southern Thang Long Industrial Park in Tu Liem district. The second phase will see it expanded to 500 ha.
PLL plans to pump in some $200 million to develop infrastructure. If things go to plan, HaBiotech park will be up and running in three years.
The 1,650 ha Hoa Lac will include a research centre, a software park, a hi-tech industrial area and an administrative and trade complex.
It is one of three projects given top priority by the government. The high-tech park management authorities have licensed six projects with a total capital of US$7.1 million.
Of them, three are operational and the other expected to start construction by the end of the year.
Chennai: The Haven of Medical Research
Chennai has become the hotbed for breakthrough medical research work, thus attracting international collaborations.
Collaborations with prestigious institutes abroad and in the country are a continuous process. Dr Samuel Abraham, Director, Nichi Centre for Regenerative Medicine (NCRM), Chennai, elaborates, "In Chennai, there are 14 or more institutes working on basic research and clinical applications of stem cell, which is the largest in any metro in the country, not only in number but also in diverse areas of the speciality."
A state-of-the-art tissue culture laboratory, the Madras Institute of Research, is being set up at the MIOT Hospitals¸ being the first to commence research on tissue engineered products in South-East Asia.
In fact for tissue engineering alone, Frontier Lifeline also houses an in-house R&D unit, Frontier Tissueline, at TICEL Bio Park at Taramani, Chennai. The unit is dedicated to undertake advanced research in biological cardiovascular implants. The research is funded by the Department of Science and Technology and Department of Biotechnology.
Diabetes
Two of the largest diabetes research centers in this country, the Madras Diabetes Research Foundation (MDRF) and the Diabetes Research Centre Foundation (DRC) are both located in the city and between them produce almost half of all research on diabetes done in India. The MDRF, recognized as an ICMR Advanced Centre for Research, has conducted several path breaking research studies. Large scale studies have been conducted in aspects of epidemiology, nutrition, and diabetes retinopathy and genomic aspects.
The MDRF also specializes in myriad aspects of diabetes like diabetic complications, clinical trials, epidemiology, genomics, vascular biology and nutrition research.
Ophthalmology
Sankara Nethralaya's National Institute for Research in Visual Sciences and Ophthalmology (NIRVO) is also coming to the city. Dr Lingam Gopal, Chairman-Elect, Sankara Nethralaya, says, "We should be able to inaugurate it by March next year."
An MoU has already been signed with the Department of Biotechnology and the National Institute of Health, Bethesda USA, which will help in the exchange of scientific research, and material for collaborative efforts.
Stem Cell Research
Stem cell research is another prime area of focus for Chennai. In basic research, a project on bone marrow transplant is underway and is partly funded by the ICMR. The Phase I trial with bone marrow derived stem cells with conditioning media is currently underway at the research facility at TICEL Bio Park. In Phase II, progenitor cells harvested from blood and entirely antilogous are the best cells available and ready for clinical use. This was performed in collaboration with Sri Venkateswara Institute of Medical Sciences, Tirupati. Another project to look forward to is the Bio-Sciences Park, within the proposed Medicity, spearheaded by Frontier Lifeline, which will harbor a unit specially for R&D. Plans are on the anvil in which expert training, in the field of tissue engineering, for the whole of South East Asia will commence.
Broad based MoUs have been inked with LV Prasad Eye Institute in Hyderabad and Aravind Eye Clinic, Madurai. Other than broad-based agreements, there are individual-based agreements. The institute conducts drug trials for companies, with scientists from the US, New Zealand and Japan.
In technology, a recent acquisition is the Affymetrix machine, a state-of-art technology that does genetic analysis. Millions of genes can be looked and tested in one shot. An analysis that would take one year to identify the gene, will now take few days.
NCRM is also working on Corneal Endothelial Precursor Cells in collaboration with Tokyo University School of Medicine, who gave the technology and specimens and the harvesting was accomplished by Joseph Eye Hospital, Trichy.
Jacobs Receives Contract from Biogen Idec for Biotechnology Project in Denmark
Jacobs Engineering Group Inc. announced that they received a contract from Biogen Idec to provide engineering, procurement, validation, and site support services for the first cell culture manufacturing facility at the greenfield biotechnology plant in Hillerod, Denmark. The manufacturing facility is expected to produce TYSABRI(R) (natalizumab), which is used in the treatment of multiple sclerosis. Officials did not disclose the contract details, but noted that the plant is scheduled to be completed in 2009.
Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. The company creates new standards of care in therapeutic areas with high unmet medical needs and has significant products serving patients in more than 90 countries. This will be their first manufacturing facility in Europe.
Jacobs performed conceptual design for the facility and will execute this new scope of work from their office in Reading, England.
Area is Competing to be the Site of Government Research on Pathogens
A contingent of business, government and academic leaders say they are optimistic North Carolina will make the federal government's short list for a new $450 million research lab.
The group met with officials from the Department of Homeland Security on Wednesday to discuss the proposed Bio- and Agro-Defense Facility and visit the area in Butner where it would be built.
The lab is a 520,000-square-foot facility that would handle some of the deadliest pathogens in the world. It would replace a similar but dated facility in Plum Island, N.Y.
North Carolina was the last of 18 sites visited by Homeland Security. Department staff members plan to cut that list to five sites this summer before doing more reviews.
The area being considered is just a sliver of the Umstead Research Farm. The 4,000-acre farm, run by the state Department of Agriculture, has almost 3,000 undeveloped acres. The group met at the N.C. Biotechnology Center in Research Triangle Park before traveling about 25 miles north to the farm.
The facility would require the highest security rating available, known as BSL-4. No pathogens from a BSL-4 lab have ever spread to nearby communities, according to government reports. The point is important because some of those pathogens have no known cure.
If North Carolina does make the cut, it will trigger 12 to 15 months of more reviews. A final decision is scheduled for late 2008.
Bio-Matrix Takes Step toward Setting Up Adipose Tissue-Derived Stem Cell Bank
Bio-Matrix Scientific Group signed a contract with Validation Systems to hasten the cryogenic storage of stem cells. Validation Systems will help the company complete and finalize its FDA cGMP quality systems documentation. Bio-Matrix reports that once it is finalized and clearance from the State of California is received, stem cell specimens can be cryogenically stored.
Bio-Matrix says it intends to open what it believes to be the first commercial adult stem cell processing and banking facility in the world for harvesting stem cells from adipose tissue.
Bio-Matrix’ new 15,000-sq-ft facility will house the company’s secure Cryogenic Stem Cell Bank, three research labs, aseptic cellular/tissue class 10,000/100 processing laboratory, hematology, microbiology, and flow cytometry laboratories.
U.S. Genomics Awarded $8.6 Million Biodefense Contract
U.S. Genomics received an $8.6-million phase III contract from the U.S. Department of Homeland Security (DHS) Science and Technology Directorate to continue development of its biological sensor for biodefense applications.
According to this 12-month award under the Bioagent Autonomous Networked Detectors (BAND) program, U.S. Genomics will complete prototype development of its system for the detection and identification of airborne pathogens using its DNA-mapping technology. This follows the successful completion on May 15 of an 18-month, $16.2-million phase II BAND contract. U.S. Genomics began working on the BAND program in April 2004 upon award of a $7.5 million phase I contract.
Quintiles Dedicates New Facility in Kansas
Quintiles Transnational Corp. dedicated a new facility in Overland Park, KS.
The 236,000-sq.-ft. building will house Quintiles' regional Clinical Development Services (CDS) and clinical pharmacology units previously located in Kansas City, MO, as well as the Phase I clinical research unit that had been in Lenexa, KS. The new Phase I unit has a 150-bed capacity—three times the size of the Lenexa unit—and can accommodate an additional 200 employees.
Quintiles’ employs approximately 750 full-time workers in the Kansas City area in CDS, Clinical Pharmacology and Phase I.
Pall Opens Life Sciences Center in India
Pall Corp. opened its new Life Sciences Centre of Excellence in Bangalore, India that will provide a full range of fluid management solutions. According to the company, the Centre will drive process optimization innovations for the global life sciences market to meet the evolving opportunities and challenges throughout Asia. The new Centre includes a state-of-the-art proteomics lab and houses a validation lab and a training facility with experts to support Indian and regional customers.
Construction has begun on a $60 Million Center for Biotechnology and Life Sciences at the University of Rhode Island in Kingston
Designed by architect Payette Associates of Boston, the facility is being built under the construction management of Providence-based Gilbane Building Co. The largest academic building project in the University's history, the center of education and research is expected to drive economic development in the state's growing biotechnology industry. To be completed in 2009, the 140,000-square-foot facility will house classrooms, specialty laboratories, support areas for DNA sequencing, faculty offices, incubator space for technology commercialization, a 100-seat classroom, and a two-story, 300-seat auditorium. Several features incorporated in the building are designed to qualify it for LEED (Leadership in Energy and Environmental Design) certification. Among these are an energy efficient heating and cooling system, a 'green' roof partially covered in vegetation to filter pollutants and reduce heating and cooling needs, storm water treatment, and environmentally friendly building materials. The Center for Biotechnology and Life Sciences will be the anchor of the North District of URI's Kingston Campus, which will also be the future home of new buildings for the University's pharmacy, nursing and chemistry programs.
$450 Million Project to Protect U.S. Food / MD. Vies with 10 States for Lab
Maryland's burgeoning role in biodefense research would grow significantly if it wins a national competition for a $450 million laboratory dedicated to protecting agriculture and food supplies against terrorism and disease threats.
The state has said virtually nothing about its hopes for landing the lab even as officials and business leaders have worked to persuade Washington to place it alongside the National Agricultural Research Center at Beltsville.
Department of Homeland Security officials began visiting the 17 sites across 11 states that are vying for the project. The list is scheduled to be narrowed to no more than five sites by the end of next month, with a final decision expected in November 2008.
The 520,000-square-foot lab would employ as many as 300 top-level researchers. It would focus on preventing and controlling animal diseases such as foot-and-mouth and classical swine fever through the use of vaccines and other measures.
The facility, which would replace the outmoded Plum Island Animal Disease Center off Long Island, N.Y., also would assess and research evolving bioterrorism threats over the next five decades.
The consortium lobbying for the lab includes the University of Maryland, College Park, the University of Maryland's Biotechnology Institute and Fort Detrick.
Maryland already is a national biodefense research center, with high-security facilities at Fort Detrick near Frederick and at Aberdeen.
Last year work began on a $128 million National Biodefense Analysis and Countermeasures Center. The 160,000-square-foot complex, which is expected to be completed in 2008, is one of several facilities planned for Fort Detrick, at an overall cost of $1.2 billion. Research goals include ways to prevent and counter the effects of germ warfare.
The budget for Edgewood Chemical Biological Center at Aberdeen Proving Ground has doubled over the past several years. Projects have included evaluating new terror technology and analyzing the Washington postal equipment contaminated in 2001 by mail containing anthrax.
The lab, scheduled to open in 2014, will be managed by the Department of Homeland Security, with joint input from the U.S. Departments of Agriculture and Health and Human Services.
Supporters of the Beltsville location say it has the advantages of available land - a minimum of 30 acres is needed - and compatibility with the work being done there by the U.S. Department of Agriculture.
The 7,000-acre research facility in northern Prince George's County specializes in biofuels, soil conditions, genetics of cattle and poultry, and threats such as e-coli, among other things.
Pahang Gets RM76 Million to Promote Hi-tech Activities
KUANTAN - The state government has received RM76 million under the 9th Malaysian Plan to promote activities related to information, technology and communication (ICT), biotechnology and biodiversity.
This includes the development of Gambang Technology Park that involves the construction of the ICT buildings and biotechnology laboratories, buying equipment and providing basic infrastructure.
State Science, Innovation, Information and Information Technology Committee Chairman Datuk Mohd Sharkar Shamsuddin said the sum also included RM30mil which was a special allocation set aside by the Finance Ministry to ensure Gambang Technology Park moved in the right direction.
The state government had also identified several areas in biotechnology that had the potential to help fill up the state's coffers and the focus would be on agro-biotechnology, healthcare biotechnology and industrial biotechnology.
The herbal industry was an area with such potential and there were a few major projects which had been approved, Mohd Sharkar said. Among them are herbal bio-technology centre owned by Technology Park Malaysia and the formation of Felda Herba Cor-poration that specializes in re-search and development work.
The Cyber Centre will serve as an ICT hub for the eastern region and its launch will be held soon. Investors will be invited to set up operations in Cyber Centre that covers three areas - Kuantan, Gambang and Tanjung Lumpur. The state government estimated investments worth RM170mil to be based in Cyber Centre between 2007 and 2012.
Greenhouse Paves Way for North Carolina State's Fruit and Vegetable Science Institute
Bulldozers and rock crushers are preparing the site for a greenhouse complex that will be part of the North Carolina Research Campus. North Carolina State will conduct plant research at the complex as a part of its Institute for Advanced Fruit and Vegetable Science. Kannapolis also is planning a $2.6 million project to renovate Glenn Avenue to serve the complex and residents.
The site should be ready for construction by the summer and the head house open by the time the NC State lab building opens in the first quarter of 2008.
The complex, when complete, will feature a 75,000 square-foot greenhouse and a 28,000 square-foot head house that will house laboratories, conference and class rooms, cold rooms and freezers, Sanctis said. It will have a boiler plant to supply hot and chilled water to the greenhouse as well.
The centerpiece of the complex will be a 5,000 square-foot food processing plant used to test shelf life, packaging and how cooking affects the nutritional value of the crops.
New Science and Technology Groundbreaking
The official groundbreaking for Clarion University of Pennsylvania’s new $36.4 million Science and Technology Center was May 5. The construction of a new Science and Technology Center is a linchpin for the realization of Clarion University's vision for the next decade and beyond. That vision centers on student learning supported by high quality academic facilities.
The Science and Technology Center, which will replace Pierce Science Center, will facilitate the university's efforts to prepare top-notch science and math teachers to address a recognized national shortage as well as technologically trained professionals to enter other areas of the workforce.
The Commonwealth of Pennsylvania has approved budget funding of $33.7 million to construct the facility, scheduled for completion in spring 2009, with Clarion University to raise $2.7 million in matching funds.
The project is expected to be one of the first LEED (Leadership in Energy and Environmental Design) certified science buildings in Pennsylvania. LEED certification requires meeting national standards and reflects facilities that best meet sustainable environmental energy concerns.
The science and technology building will house many core programs – mathematics, chemistry, physics, geography, geology, molecular biology/biotechnology, archeology, nanotechnology, and anthropology among others. Every Clarion University student will take some classes in the new building, where they will do research alongside faculty in fields such as astrophysics, experimental physics, plasma physics, material science, physics education, and sustainability. The building will house 11 collaborative research laboratories, 25 teaching laboratories, a state-of-the-art computer lab, a science museum, a cold room, and individual resource centers for biology, chemistry, earth science, mathematics, and physics. While provisions have been made for a greenhouse, that structure is not part of the Science and Technology Center. The 98,000 square foot building will also house 55 offices. The current planetarium and auditorium will also be renovated and add another 8,000 square feet to the complex. Smart classrooms will be available throughout the building with wireless Internet inside and outside, allowing students and professors to connect with the entire world through video, computers, and the web.
McIlvaine Company,
Northfield, IL 60093-2743
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