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American Pacific Corporation (Las Vegas) announced that its subsidiary, AMPAC Fine Chemicals (Rancho Cordova, CA), expanded its pharmaceutical chemicals business into LaPorte, Texas. The LaPorte plant is a multi-purpose manufacturing facility specializing in the production of registered intermediates and active pharmaceutical ingredients for the pharmaceutical industry.
The biopharmaceutical company Array BioPharma (Boulder, CO) signed a drug-development pact with Novartis (Basel) for the worldwide development of the small-molecule MEK inhibitors ARRY-162, its back-up, ARRY-300, and other MEK inhibitors. MEK is a key protein kinase in the RAS/RAF/MEK/ERK-pathway, which signals cancer cell proliferation and survival. Array will receive an upfront and milestone payment of $45 million and is eligible to receive an additional $422 million if certain clinical, regulatory, and commercial milestones are achieved.
AstraZeneca (London) and the biotechnology company Silence Therapeutics (London) extended their collaboration to develop new approaches for the delivery of short interfering ribonucleic acid molecules. Financial details were not disclosed.
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Baxter’s BioPharma Solutions (Deerfield, IL) next month will complete its third capacity expansion at the company’s cytotoxic contract manufacturing facility in Halle, Germany. The expansion includes the addition of a large-scale lyophilization unit to increase freeze-drying capacity. An additional phase of expansion will be completed by 2012.
Boehringer Ingelheim (Ingelheim, Germany) is nearing completion of a new production site in Ingelheim.The additional manufacturing capacities will be used to produce the anticoagulant Pradaxa (dabigatran etexilate).The new plant is expected to be completed by 2011.
Charles River Laboratories (Wilmington, MA), a contract-research organization, is acquiring WuXi AppTec (Shanghai), a drug research and development outsourcing company with more than 4,000 employees in China and the US. The combined company will retain the name Charles River and will offer support for research programs. Financial terms were not disclosed.
Cleveland BioLabs (CBLI, Buffalo, NY) formed a drug-discovery and development company focused on anticancer compounds with funding from a Russian venture capital firm. The new company, Incuron, is a joint venture between CBLI and Bioprocess Capital Ventures, a Russian Federation venture capital fund managed by the limited liability company, Bioprocess Capital Partners. The total size of the fund is 3 billion rubles (approximately $100 million). Incuron's mission is to develop anticancer therapies based on drug candidates of the Curaxin family.
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Excipient manufacturer Colorcon (West Point PA) acquired the pharmaceutical excipient company NP Pharm, a division of Ethypharm (Paris). Financial terms were not disclosed.
The US Food and Drug Administration approved a supplemental biologics license application from CSL Behring (CSL, King of Prussia, PA) to extend the shelf life for Privigen, immune globulin intravenous (human), 10% liquid, from 24 to 36 months. CSL manufactures plasma-derived and recombinant therapies.
The chemical/fine-chemicals company Evonik Industries (Dossenheim Germany) started a production plant for active pharmaceutical ingredients in Nanning, Guangxi Province, China. The plant was set up in collaboration with a European pharmaceutical company for which Evonik will produce various active ingredients under a multiyear supply contract and in compliance with current good manufacturing practices.
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Citing business reasons, Forest Laboratories (New York) ended a drug-development deal for the development and markeing of dutogliptin, an antidiabetes drug, with the biopharmaceutical company Phenomix (San Diego, CA).
Fornix BioSciences (Lelystad, The Netherlands) a developer of diagnostic and therapeutic allergen products, sold its Dutch allergy division to ALK-Abelló (ALK, Horsholm, Denmark ) for EUR 19.6 million (approximately $25.9 million). ALK is a global pharmaceutical company focused on allergy treatment, prevention, and diagnosis. The sale is scheduled to be completed in July 2010.
The Universities of Glasgow, Edinburgh, Strathclyde, and Heriot-Watt signed a crystallization research pact with several pharmaceutical companies, including GlaxoSmithKline (London), AstraZeneca (London), and Schering-Plough, now part of Merck & Co. (Whitehouse Station, NJ). The research collaboration, which has received funding from the Scottish Funding Council, will focus on improving crystallization technology for manufacturing.
Genentech (South San Francisco, CA) will pay the biopharmaceutical company Seattle Genetics (Bothell, WA) $9.5 million to renew exclusive licenses to specific targets and extend the research term under the parties' existing antibody-drug conjugate collaboration agreement.
SCHOTT Pharmaceutical Systems, a division of SCHOTT North America (Lebanon PA), will begin mass production of its staked syringe-system SCHOTT InJentle at its Lebanon, Pennsylvania, facility at the end of this year. The syringe was developed for the special requirements of highly sensitive drugs.
Therapeutic Proteins (Chicago, IL), a developer of a proprietary processes to manufacture recombinant proteins, completed its independent, dedicated, follow-on biologics manufacturing facility. The facility is located at University Technology Park at the Illinois Institute of Technology.
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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| Earlier this month, the US Food and Drug Administration issued a Warning Letter to the Global Research and Development division of Pfizer (New York) in London, Connecticut. The letter concerns an investigation that took place in spring 2009 which found that the manufacturer “did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations.” Specifically, FDA pointed out the company’s failure to ensure proper monitoring of the investigation, including compliance with 21 CFR 312.50, and failure to keep investigators informed of new observations reported to the sponsor of the drug regarding adverse effects and safe use. Other recent Warning Letters can be found on the FDA CDER website.
FDA issued a consent decree last week to halt the marketing of an unapproved sterilization system manufactured by Steris (Mentor, OH). The company has been selling tabletop systems for endoscopes and other devices used to sterilize heat-sensitive instruments and medical devices. “When device manufacturers fail to comply with FDA’s regulations, they put patients at increased risk. As this consent decree shows, we will take whatever steps are necessary to make sure that all manufacturers are complying with FDA’s regulations,” said the FDA press release on the consent decree. |
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Amgen (Thousand Oaks, CA) appointed Robert A. Bradway as its president and chief operating officer effective May 11, 2010. Bradway will report to Kevin Sharer, Amgen's chairman and chief executive officer, and will be responsible for the company's global commercial operations, manufacturing operations, strategy and corporate development, information technology, global government affairs and compliance. Amgen also announced the retirement of George J. Morrow, executive vice-president of global commercial operations, effective Jan. 31, 2011.
AVI BioPharma (Bothell, WA), a developer of RNA-based drugs, appointed J. David Boyle II, AVI’s CFO, as interim president and chief executive officer.
Baxter International (Deerfield, IL) appointed Ludwig Hantson its corporate vice-president and president, international.
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Tablet Manufacture
During tablet manufacture, what is the most common problem encountered by
your company?
Poor weight uniformity
Poor content uniformity
Poor formulation design
Inadequate equipment maintenance
Incorrect equipment operation
Other
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Monitoring system ensures complete records
