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 Inspector provides precision and speed
The Tablet Print Inspector from Optel Vision (Quebec City, Canada) inspects and verifies linear and circular print information on tablets and capsules. The inspector also verifies dosage forms’ tint, shape, and integrity. The machine’s proprietary optical character verification (OCV) system is adapted to accommodate random print orientation. The configurable OCV tools also take variations between printers and print styles into account. The unit inspects 22,000 tablets/min and “is not a bottleneck for the printing machine,” says Louis Roy, Optel’s president.
Software classifies defects as minor, major, or critical. The inspector’s ejection and alarm levels can be configured to reject individual tablets or generate alarms. In addition, the unit’s ejection system is designed not to break tablets and to reject only defective tablets. By removing the need for manual inspection, the device helps to improve quality and reduce labor charges. |
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AMPAC Fine Chemicals (Rancho Cordova, CA) received a Warning Letter from the US Food and Drug Administration on June 25, 2010 for conditions at its active pharmaceutical ingredient in Rancho Cordova, California, plant. Inspectors found current good manufacturing practice deviations during their Feb 9–19, 2010, visit to the plant, and FDA said in the Warning Letter that Ampac’s responses to the observations noted in February and the company’s corrective actions were “insufficient.”
AstraZeneca (London) and MRC Technology (London), the commercialization company for the UK’s Medical Research Council, will collaborate to share access to their collections of compounds to aid the search for potential new treatments for serious diseases. The collaboration will combine up to 100,000 compounds from AstraZeneca’s collection with MRC Technology’s library of approximately 50,000 compounds. A joint steering committee will decide how to advance promising compounds that could become innovative medicines.
Colorcon (Harleysville, PA), a provider of formulated products for the pharmaceutical industry, acquired the business of Pharmaceutical Coatings (Navi Mumbai, India), including the company's full product portfolio and a new facility in Goa, India, that is currently under construction.
Forest Laboratories (New York) and Merz Pharmaceuticals (Greensboro, NC) entered into settlement agreements with all remaining defendants in patent infringement litigation related to Forest's Namenda (memantine hydrochloride) immediate release tablets. Under the agreements, the first generic versions of memantine would be able to enter the market on Jan. 11, 2015. Under the terms of the agreement, subject to review by the US Federal Trade Commission, Forest and Merz will provide licenses to Amneal (Paterson, NJ), Watson (Corona, CA), Dr. Reddy's (Hyderabad, India), Lupin (Mumbai), Mylan (Hyderabad, India), Orchid (Chennai, India), Sun (Mumbai), Teva (Petach Tikva, Israel), Upsher-Smith (Minneapolis, MN), and Wockhardt (Mumbai). The licenses will permit these companies to launch their generic versions of Namenda either three months prior to the expiration of Namenda’s patent or on the date that each company receives final FDA approval of its abbreviated new drug application.
Lijun International Pharmaceutical (Hong Kong) entered into a memorandum of understanding with Tonghua Dongbao Pharmaceutical (Tonghua, China) under which the companies will establish a joint venture (JV) company in Jilin Province, China. The JV will focus on the manufacture and sale of large volume intravenous infusion solutions. Lijun International will own 55% of the JV company and Tonghua Dongbao will own a 45% stake.
Merck (Whitehouse Station, NJ) and Sinopharm (Shanghai) signed statement of mutual intent. Under the statement, Sinopharm and Merck will cooperate on human papillomavirus vaccine and other mutually-selected vaccine products in China, and will also discuss the potential for promoting and marketing Merck's pharmaceutical products in China, according to a company press release.
Contract research organization PPD (Wilmington, NC) and Microsoft (Redmond, WA) entered into an agreement to jointly implement a technology solution designed to improve efficiency in managing US Food and Drug Administration-mandated risk evaluation and mitigation strategy (REMS) programs. The technology will be based on Microsoft’s Amalga Unified Intelligence System, a data aggregation platform for healthcare professionals, and Microsoft HealthVault, a personal health application platform that lets consumers manage health information online.
ProtAffin (Graz, Austria), a biotechnology company, signed a manufacturing contract with contract manufacturing organization CMC Biologics (Copenhagen, Denmark), for the manufacture of its lead product, PA401, for the treatment of chronic obstructive pulmonary disease (COPD). The contract covers manufacture and supply of PA401 for preclinical development and early clinical development in COPD and related respiratory indications.
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Expansion of Vetter Development Service (VDS)
TThe North American market is critical to Vetter’s strategic global growth as nearly half of its client base is already located here. In order to maximize on this opportunity, Vetter has decided to create a facility, its first outside of Germany, at the Illinois Science + Technology Park in suburban Chicago. The facility, which focuses on preclinical to phase II clinical batch projects, is an expansion of Vetter Development Service. With significant progress already having been made, the facility is scheduled to be operational by beginning of the fourth quarter 2010. 
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The Wellcome Trust, a UK-based global charity, awarded £473,000 ($737,000) to a team of international researchers to create a system that can identify counterfeit and substandard drugs. The team, from King's College London, will work in collaboration with scientists from Lund University, Sweden, to produce an inexpensive and robust instrument for low-income countries. The approach is based on quadrupole resonance spectroscopy, which uses radio waves to study the chemical structure of the drug, through packaging materials such as cardboard, glass, plastic and/or wood, to detect counterfeits, according to a Wellcome press release.
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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Debbie Law, the chief scientific officer of Ablynx (Ghent, Belgium), a biopharmaceutical company, resigned from her position, effective Aug. 31, 2010. Upon leaving Ablynx, Law will return to the United States with her family for personal reasons, according to a company press release.
Agilent Technologies (Santa Clara, CA) appointed Didier Hirsch senior vice-president and CFO. Hirsch has served as acting CFO since April 1, 2010.
Biopharmaceutical company Ambit Biosciences (San Diego) appointed Alan J. Lewis chairman and CEO. Lewis has been serving as executive chairman of Ambit since March 2010, and will now be responsible for the company’s daily operations as CEO.
EKR Therapeutics (Bedminster, NJ), a specialty pharmaceutical company, appointed John E. Bailye as its new CEO and Bill McKee as its new COO. McKee will also serve as the company’s CFO.
Contract research organization NexMed (San Diego) appointed Mohamed Hachicha vice-president of research and development for NexMed USA. Hachicha previously served as senior principal scientist in the pharmacology and drug-discovery department at Forest Laboratories (New York).
Roche (Basel) named Karen Lackey vice-president and head of medicinal chemistry. Lackey will report to Hans-Joachim Boehm, global head of chemistry at Roche, and will be based in the company’s Nutley, New Jersey, facility.
sanofi aventis (Paris) and Merck & Co. (Whitehouse Station, NJ) appointed Raul E. Kohan to the position of CEO of their proposed animal-health joint venture. The joint venture will be called Merial-Intervet, a combination of the animal-health companies Merial and Intervet–Schering-Plough. |
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The European Medicines Agency's Committee for Medical Products for Human Use issued an update on drug reviews by the agency on July 23, 2010. Included in the update is information on Avandia (rosiglitazone), generic drugs, pediatric indications, rotavirus vaccines, and more.
The US Food and Drug Administration issued a warning regarding certain Advair Diskus inhalers that were stolen from a distribution warehouse in 2009 and now have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be guaranteed and the inhalers should not be used, said the agency in its announcement. |
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| Special Considerations in Design Space Development (Part I of III) |
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By Stan Altan, James Bergum, Lori Pfahler, Edith Senderak, Shanthi Sethuraman, Kim Erland Vukovinsky
The authors discuss the statistical tools used in experimental planning and strategy and how to evaluate the resulting design space and its graphical representation.
Coming Soon: Patricia Van Arnum discusses chiral chemistry in the Ingredients Insider column in Pharmaceutical Technology’s August issue. |
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Outsourcing concerns
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