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 Mixers enable high yields
Oystar Huettlin’s HTG and HBG high-shear mixers for wet granulation incorporate a Z-shaped Gentlewing impeller designed to enable fast and uniform mixing. A vertical segment of the impeller reaches from the bottom to the top of the bowl, thus providing a greater granulation area than traditional designs do, according to Nicolas Michel, vice-president of the company’s pharmaceutical process division. This design helps increase yields by preventing product from sticking to the vessel walls or lid.
For granulation lines, Oystar links the mixer units to HDGC fluid beds. Process air is forced through radial slots in the fluid bed’s discjet, thus setting the product in motion as soon as it is transferred from the mixer. This feature increases material’s wall speed and starts the drying process instantly. One of the fluid bed’s five independent filters is blown back at any given time, and the unit constantly uses 80% of its maximum filtration area.
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Amgen agreed to acquire the biotechnology company BioVex Group for as much as $1 billion, which includes $425 million in cash at closing and as much as $575 million in milestone payments. Amgen will gain BioVex’s Phase III oncolytic vaccine OncoVEX(GM-CSF) as a result of the transaction.
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Biopharmaceutical company GenVec and the US Naval Medical Research Center (NMRC) will collaborate to support their dengue fever vaccine research. Under a separate contract with the Henry M. Jackson Foundation for the Advancement of Military Medicine, GenVec will receive funding for the development and preparation of vaccines related to this program. GenVec will design and manufacture the next-generation vaccine candidates, which will use GenVec’s adenovector technology and be manufactured using GenVec’s proprietary cell line. NMRC will be responsible for preclinical animal studies, including studies in nonhuman primates.
Genzyme will build a new EUR 250-million manufacturing plant in Geel, Belgium, for Myozyme (alglucosidase alfa) and Lumizyme (alglucosidase alfa) for Pompe disease. The new plant will include 8000 L of production capacity. Commercial approvals for the new site are expected to start in late 2014. Genzyme currently produces Myozyme and Lumizyme at an adjacent plant in Geel, where it is increasing production capacity to 12,000 L with the addition of a third bioreactor scheduled for approval by the end of this year. Genzyme is also continuing its 160-L production in the US for patients with infantile-onset Pompe disease. The company expects to add roughly 150 new jobs with the expansion, thus bringing the total workforce at the site to nearly 600 people.
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Interphex
Thousands of pharmaceutical, biologic, generic, and contract services professionals gather annually at INTERPHEX (March 29-31, 2011, Javits Convention Center, New York City) to see new products, network, and learn about emerging trends surrounding drug manufacturing. At INTERPHEX 2011, you’ll find the solutions and education you need to ensure quality, improve efficiency, and solve your manufacturing and supply chain problems. Register for a free exhibit hall pass at
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Mylan, a generic-drug and specialty-pharmaceutical company, entered into a settlement agreement with Pfizer resolving litigation related to Caduet Tablets, 2.5 mg/10, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, known generically as Amlodipine Besylate/Atorvastatin Calcium Tablets. Under the agreement, pending litigation will be dismissed and Mylan may begin to market and sell a generic version of Caduet on Nov. 30, 2011, or earlier under certain circumstances. Additional details are confidential, and the agreement is subject to review by the US Department of Justice (DOJ) and the Federal Trade Commission (FTC). Mylan also resolved litigation with Pfizer related to Lipitor Tablets, 10 mg, 20 mg, 40 mg, and 80 mg, known generically as Atorvastatin Calcium Tablets. The terms of the agreement are confidential, and the agreement is subject to review by the DOJ and FTC.
Novartis agreed to acquire Genoptix, a laboratory-service provider. Novartis will commence an all-cash tender offer for outstanding shares of common stock of Genoptix at $25 per share. The transaction is worth, on a fully diluted basis, a total equity value of approximately $470 million and an enterprise value of $330 million. Genoptix will become part of the Novartis Molecular Diagnostics unit.
The OYSTAR Group, a supplier of packaging machines, restructured to combine its three US subsidiaries to form OYSTAR North America. The merger includes the subsidiaries formerly known as OYSTAR Jones, OYSTAR USA, and OYSTAR Packaging Technologies. The restructuring efforts began 18 months ago, according to a company press release.
Contract research organization Quintiles opened its new 86-bed Phase I research facility in Hyderabad, India, at Apollo Health City. Quintiles also has existing operations in Ahmedabad, Bangalore, Delhi, and Mumbai.
Sanofi-aventis extended its tender offer $69 for each outstanding share of common stock of Genzyme until Feb. 15, 2011. The tender offer was previously scheduled to expire on Jan. 21, 2011.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com |
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Cambridge Biomedical, a contract laboratory service organization, appointed John Reddington as COO. Reddington recently served as president and CEO of Sirtex Medical.
Catalyst Pharmaceutical Partners, a biopharmaceutical company, promoted Steven R. Miller to the newly created position of COO. Miller will also retain his position and responsibilities as Catalyst’s chief scientific officer.
John H. Johnson, senior vice-president of Eli Lilly and Company and president of Lilly Oncology, resigned, effective Jan. 28, 2011. A successor will be chosen in the coming weeks. Johnson will become CEO of Savient Pharmaceuticals, effective Jan. 31, 2011. He was CEO of ImClone Systems when the company was acquired by Lilly in November 2008.
Biopharmaceutical company Helix BioMedix promoted Robin L. Carmichael to vice-president and COO. Carmichael joined the company in 2007 as vice-president of marketing and business development.
Jennerex, a biotherapeutics company, appointed Ursula Fritsch to the newly created position of vice-president of regulatory affairs.
Medpace, a Cincinnati-based clinical research organization, appointed Dan Weng as vice-president, rest of world. Weng is responsible for the company’s business in Asia, the Pacific Rim, Latin America, and South Africa.
PolyMedix, an emerging biotechnology company, promoted Bozena Korczak to senior vice-president of drug development and chief development officer. Korczak joined PolyMedix in November 2007 as vice-president of drug development.
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Take the 8th Annual Global BioManufacturing Survey |
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Budget trends, new technologies, capacity, outsourcing and hiring issues, downstream processing, disposables, cost cutting, and quality initiatives, are just a few of the important topics covered in this year's 8th Annual Biopharmaceutical Manufacturing Report and Survey held by BioPlan Associates, Inc. Last year, more than 400 biomanufacturers and suppliers participated globally, and this year we're expecting even more. You will receive a free summary of the results from the study. In addition, for each completed survey, BioPlan Associates will donate $10 (up to $10,000) to the Global Alliance for Vaccine Initiative, or American Cancer Society.
Coming Soon: A position paper discusses a risk-based approach to process validation in the February issue of Pharmaceutical Technology. |
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FDA Recalls
FDA recently was granted the authority to issue recalls for food products. Should the agency have this power for pharmaceuticals as well?
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View the poll archive. |
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