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Almac (Craigavon, UK) opened its North American headquarters in Souderton, Pennsylvania. The company’s Clinical Technologies division has moved into the new 240,000-ft2 integrated drug-development facility. In related news, Almac successfully completed an inspection of its Clinical Services UK facility, located in Craigavon, by the Medicines and Healthcare products Regulatory Agency (MHRA).
Goodwin Biotechnology (Plantation, FL), a contract biomanufacturing company, signed a new biopharmaceutical development and manufacturing agreement with a multinational biopharmaceutical client. Goodwin will develop the process to manufacture a unique therapeutic monoclonal antibody conjugate for diagnostic imaging purposes. This product will be manufactured under current good manufacturing practice conditions as a kit for radio-labeling for use in clinical trials. Terms of the manufacturing agreement were not disclosed.
Genmab (Copenhagen), a biotechnology company, formed an agreement to create and develop human antibody therapeutics for disorders of the central nervous system with H. Lundbeck (Copenhagen). Genmab will receive an upfront payment of €7.5 million ($10.3 million) and up to €38 million ($52.3 million) in milestone payments, plus royalties.
Immunovaccine (Halifax, Canada), a vaccine developer, entered into a research program with the National Research Council Canada to evaluate the efficacy of a carbohydrate-based vaccine formulated in DepoVax, the company's proprietary vaccine-delivery platform. The antigen selected for this vaccine formulation is a modified carbohydrate with the potential to be developed into a meningococcal vaccine, as well as a therapeutic cancer vaccine, according to a company press release.
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Advanced Cleanroom Microclean: Fogging is no substitute for cleaning. A thorough cleaning and a Spring clean must be performed prior to any fogging actions. If there is gross contamination – e.g. dust or covered surfaces – then the efficacy of the fogging will be severely reduced. It should also be noted that certain bacteria can remain viable in dust for long periods. Hence, for fogging decontamination to work well, the rooms should be subject to a Super and Spring clean. It is not possible to over-emphasize the importance of thorough cleaning of the room prior to the fogging process.
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Pfizer (New York) signed an agreement with Biocon (Bangalore, Karnataka, India), a biotechnology company, for the worldwide commercialization of Biocon’s biosimilar versions of insulin and insulin analog products: recombinant human insulin, glargine, aspart, and lispro. Pfizer will have exclusive rights to commercialize these products globally, with certain exceptions, including co-exclusive rights in Germany, India, and Malaysia. Biocon is responsible for the clinical development, manufacture, and supply of the products, as well as for obtaining regulatory approval. Pfizer will make upfront payments of $200 million, milestone payments of up to $150 million, and royalties on product sales.
sanofi aventis (Paris) formed a research collaboration with Harvard University focused on translational biomedical research in multiple therapeutic areas such as cancer, diabetes, and inflammation. Harvard University investigators will propose research projects across a wide range of areas, and the funded projects will be selected by a committee comprised of representatives of sanofi-aventis and Harvard.
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Vetter Secondary Podcast: The market for parenteral drugs has been growing for years, and competition in the sector is fierce. The focus on patient- and user-friendliness is intensifying. In response, Germany-based contract manufacturer Vetter built its state-of-the-art Vetter Secondary Packaging facility.
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VWR International, a laboratory supply company, opened its new corporate headquarters at the Radnor Corporate Center in Radnor, Pennsylvania. The new headquarters combines the company’s staff and resources previously housed in two locations near West Chester, Pennsylvania.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected] |
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Agile Therapeutics (Princeton, NJ), a pharmaceutical company focused on women’s healthcare products, appointed Al Altomari president and CEO. Altomari is a former senior manager at Johnson & Johnson (New Brunswick, NJ) who has been serving as Agile’s executive chairman. Thomas Rossi, who joined Agile as president and CEO in 2004, will serve as scientific advisor to the company.
Aldagen (Durham, NC), a biopharmaceutical company, named Lyle A. Hohnke as its CEO. Hohnke succeeds Tom Amick.
Baxter International (Deerfield, IL) formed a new Medical Products business, which combines the company's Renal and Medication Delivery businesses into a single unit. Robert Davis has been appointed corporate vice-president and president of Medical Products. Peter Arduini, corporate vice-president and president of Medication Delivery, is leaving the company for another opportunity. In Baxter’s Bioscience unit, Ludwig Hantson was appointed corporate vice-president and president, filling a position vacated by Joy Amundson, who is leaving after six years of service to the company.
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NSF
Risk-Based Decision Making
San Francisco Airport Marriott Hotel, Burlingame, CA
November 16 - 18, 2010
Course Fee $2675 Discounted Fee $2140
This NSF-DBA interactive course is about good decision making and the appropriate application of risk-based decision making tools and techniques (HACCP, FMEA) in the pharma industry.
The ICH Q9 Quality Risk Management guideline is reviewed and strategies for implementation are covered. Case studies are included.
Ideal for people in Quality, Manufacturing, Product and Process Development, Validation and other technical disciplines.  Read more... |
Discovery Laboratories (Warrington, PA), a biotechnology company, appointed W. Thomas Amick as its CEO. Amick has been serving as Discovery's interim CEO since August of 2009 and has been chairman of the board since March 2007. He will continue to serve as chairman.
Yves Rosconi, president and CEO of Theratechnologies (Montreal), a biopharmaceutical company, will retire on Nov. 30, 2010. John-Michel T. Huss will become president and CEO, effective Dec. 1, 2010. Rosconi will remain available as an advisor until the end of the year.
YM BioSciences (Mississauga, Canada), a biopharmaceutical company, appointed Nick Glover as its CEO, effective Nov. 18, 2010. Glover will also be nominated as a director of the company at the annual general meeting on that date. David Allan, who has been chairman of the company since its founding in 1994 and CEO since 1998, will continue to serve as chairman of the board.
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The presentations from the ICH quality-trio workshop series, held in Bethesda, Maryland, Oct. 6–8, are now available on the ISPE website. The workshop featured members of the ICH Quality Implementation Working Group, including representatives from FDA and EMA, and focused on design space, control strategy, quality systems, and risk management. Also on the website is a downloadable copy of the case study used in the workshop. The case study uses a fictional active pharmaceutical ingredient (API) to describe how to implement quality-based approaches to develop pharmaceutical manufacturing processes. |
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