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 Pump facilitates cleaning and maintenance
The FKL “A” positive-displacement pumps from Fristam Pumps (Middleton, WI) are built according to a split-gearbox design that helps users replace bearings and gears. The machines also incorporate labyrinth-style bearing isolators in place of lip seals. The bearing isolators provide a solid barrier that keeps gearbox oil inside and prevents external products and high-pressure spray from entering into the gearbox oil. In addition, the pump’s exterior edges are rounded so that no water sits on top of the device during cleaning, says Duane Ehlke, Fristam’s director of operations. Users do not need to disassemble the device for cleaning in place (CIP). Instead, operators can turn the rotors slowly and run CIP solution through the pump to clean it fully. This characteristic reduces the risk of damaging machine parts and decreases downtime.
The FKL “A” pump’s port-to-port dimensions are customizable, and its gearbox is available in stainless steel in addition to painted cast iron. The pump also can be supplied with Hastelloy and AL6XN materials.
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Biogen Idec (Weston, MA) and Genentech, a member of the Roche Group (Basel), amended their collaboration on antibodies targeting CD20, agreeing that Genentech will have responsibility for the further development of ocrelizumab in multiple sclerosis. Genentech will fund 100% of the costs going forward and will be responsible for development and commercialization. Biogen Idec will receive royalties on US sales of ocrelizumab that will approximate its current 30% interest in the compound. Additionally, the companies have agreed that the commercialization of ocrelizumab will not impact the current profit share of Rituxan (rituximab).
BioTime (Alameda, CA), a biotechnology company focused on regenerative medicine, expanded its corporate headquarters and laboratory facility in Alameda, California. BioTime signed a five-year lease agreement that extends its existing space by 6,000ft2 to 17,000 ft2, enabling the company to provide both office and laboratory space for itself and its subsidiary companies.
Boehringer Ingelheim (Ingelheim, Germany) and MacroGenics (Rockville, MD) formed an alliance to discover, develop, and commercialize antibody-based therapeutics which may span multiple therapeutic areas, including immunology, oncology, respiratory, cardiometabolic, and infectious diseases. These developmental drug candidates will be based on MacroGenics' Dual-Affinity Re-Targeting (DART) platform and will be directed against up to 10 combinations of molecular targets. MacroGenics will receive up to $60 million in upfront payments, fees, and milestones, and could receive up to $210 million for each of the ten DART programs in case of full commercial success of multiple DART products. Boehringer Ingelheim also expects to make a future equity investment in MacroGenics.
Cephalon (Frazer, PA), a biopharmaceutical company, exercised its option to acquire BioAssets Development (Wellesley, MA), a biopharmaceutical company. According to a press release, Cephalon’s decision followed the receipt of interim data from a Phase II placebo-controlled proof-of-concept study evaluating epidural administration of a tumor necrosis factor (TNF) inhibitor for the treatment of sciatica in 45 patients.
In related news, Cephalon signed a convertible note subscription agreement with ChemGenex Pharmaceuticals (Geelong, Australia), an oncology-focused biopharmaceutical company, under which Cephalon will provide up to A$15 million ($14.6 million) to ChemGenex in return for a note that is convertible at A$0.50 ($0.49) per share. This funding will support ChemGenex operations, including clinical activities to complete a planned new drug application submission to the US Food and Drug Administration for omacetaxine for the treatment of chronic myelogenous leukemia patients who have failed two or more tyrosine kinase inhibitors.
Immune Design Corp. (IDC, Seattle), a biotechnology company developing novel vaccines and immunotherapies for infectious disease and cancer, formed a license and development agreement with MedImmune (Gaithersburg, MD), the biologics unit for AstraZeneca (London), for the use and commercialization of IDC’s proprietary glucopyranosyl lipid adjuvant (GLA) as a component in vaccines for select infectious diseases. Under the agreement, IDC grants MedImmune exclusive worldwide rights to research, develop, use, and commercialize the GLA adjuvant in vaccines for specific indications. In return, IDC will receive an upfront licensing fee and potential development, regulatory and commercial milestones totaling $212 million, plus royalty payments on sales of marketed products.
Kadmon Pharmaceuticals (New York), a biopharmaceutical company, acquired Three Rivers Pharmaceuticals (Warrendale, PA), a specialty pharmaceuticals company. Kadmon expects to maintain Three Rivers’s Warrendale, Pennsylvania, headquarters, along with its manufacturing, distribution, commercial and administrative operations. Terms of the agreement were not disclosed.
Contract research organization PPD (Wilmington, NC) and service provider Bend Research (Bend, OR) entered into a collaboration in the areas of formulation development, analytical testing, and clinical-supplies manufacturing to provide a full range of chemistry, manufacturing, and controls (CMC) development services. As part of the collaboration, the two companies will refer potential business opportunities to one another in the areas of compound characterization, particle engineering, formulation development, clinical-trial-material manufacturing, analytical development, stability programs, and GMP release and quality control testing. A key area of collaboration will be inhalation formulation development and particle engineering for drug therapies.
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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Jennerex (San Francisco), a cancer biotherapeutics company, appointed Mark P. Backer senior vice-president of technical operations. Backer will be responsible for all aspects of chemistry, manufacturing, and controls (CMC) in support of the company’s late-stage product, JX-594, as well as pipeline products.
MAP Pharmaceuticals (Mountain View, CA) appointed Thomas P. McCracken vice-president of intellectual property (IP). McCracken will lead the company's IP program in support of the potential commercialization of its lead product candidate, LEVADEX (dihydroergotamine) orally inhaled migraine therapy, and other product opportunities.
Pharmaceutics International (Hunt Valley, MD), a contract development and manufacturing organization, appointed Tony Horton as vice-president of quality assurance. Horton has more than 35 years of experience, and previously worked at companies such as BenVenue (Bedford, OH) and Mylan Laboratories (Canonsburg, PA).
Contract research organization PPD (Wilmington, NC) appointed Andreas Tschirky as leader of BioDuro (Beijing), a drug-discovery services company that PPD acquired last year. In this role, Tschirky will have responsibility for providing scientific and operational leadership and managing the growth of BioDuro. Tschirky was previously general manager of Roche’s (Basel) research and development center in China.
Ricerca Biosciences (Concord, OH), a preclinical contract research organization, appointed William DeMaio senior director of the drug metabolism and pharmacokinetics (DMPK) department. DeMaio was previously associate director of biotransformation at Wyeth Research (now Pfizer) in Collegeville, Pennsylvania, where he was responsible for drug metabolite identification and metabolism characterization by mass spectrometry.
Transdel Pharmaceuticals (La Jolla, CA), a specialty pharmaceutical company focused on transdermal drug delivery, appointed John N. Bonfiglio CEO, president, and as a member of its board of directors.
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The US Pharmacopeia (USP) has announced two new collaborations. One involves working with the Republican State Enterprise National Center for Expertise of Drugs, Medical Products and Equipment of the Ministry of Health of the Republic of Kazakhstan to share standards for the quality, purity, strength, and identity of medicines. Specifically, the Kazahkhstan center will have a five-year renewable right to include written standards from the USP–National Formulary. Second, USP is joining with six government drug-control laboratories in the Middle East and North Africa to improve their capabilities to test the quality of drugs. Government agencies signing onto the network include: UAE: Health Authority of Abu Dhabi; Egypt: National Organization for Drug Control Research; Jordan: Drug Quality Control Laboratory, Jordan Food and Drug Administration; Morocco: Direction de Médicament Et de la Pharmacie; Saudi Arabia: Products Evaluation and Standards-setting and National Drug and Cosmetic Control Laboratories (NDCCL) in Drug Sector, Saudi Food and Drug Authority; and Tunisia: Laboratoire National de Controle des Medicaments.
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Generic-Drug User Fees
FDA Commissioner Hamburg recently discussed the creation of user fees for the generic-drug sector. Do you support the proposal?
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