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J&J Voluntarily Recalls Certain OTC Products
McNeil Consumer Healthcare is voluntarily recalling certain lots of over-the-counter products in the Americas, the United Arab Emirates, and Fiji.
Lonza Closes Sites in North America and UK
Lonza Group (Basel) plans to reinforce its presence in Asia, including its platform in Nansha, China, and to close its Conshohocken, Pennsylvania; Shawinigan, Canada; and Wokingham, United Kingdom, sites in 2010.
EU Outlines Health Priorities
The EU’s Commissioner-designate for Health and Consumer Policy, John Dalli, said that he is looking forward to the challenge of integrating the pharmaceutical area into public health as part of his role. |
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 Flowmeter facilitates reproducible gas chromatography
The GFM Pro Flowmeter from Thermo Fisher Scientific (Milford, MA) is designed to ensure accurate and reproducible chromatography. The instrument’s probe measures vacuum flows from 0.5 to 500 mL/min and from -0.5 to -500 mL/min. It also measures the volumetric flow gases with an accuracy of ±2%, which helps enable column-to -column reproducibility. When the measured flow exceeds 600 mL/min, the unit protects itself by shutting itself off automatically. The instrument is rated as explosion-proof and is thus suitable for measuring flammable or explosive gases
The probe is applied directly to the gas-flow stream, and the instrument clearly displays the measured flow rate on a liquid crystal display. Operators can use the probe as a benchtop or handheld unit. The device has an ergonomic design and side grips that are intended to provide durability. Scientists can save data easily and store them on a memory card.
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analytica, March 23 – 26, 2010 in Munich, Germanyy
The world’s leading trade fair for Laboratory Technology, Analysis and Biotechnology. More than 1,000 exhibitors and 33,000 trade visitors attended analytica 2008. The 2010 show promises to be the most international analytica to date - there has been a 13% increase in international exhibitors so far. More information at  www.analytica.de/en |
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Altea Therapeutics (Atlanta, GA) entered a preclinical and clinical development agreement with KAI Pharmaceuticals (South San Francisco, CA) to develop certain KAI proprietary peptides using Altea’s PassPort transdermal delivery system. The two companies will examine the transdermal delivery of some KAI compounds.
Catalent Pharma Solutions (Research Triangle Park, NC) acquired advanced fine-powder filling capability. Catalent’s purchase of Harro Höfliger’s Omnidose filling equipment allows it to offer customers fully scaleable, dry-powder inhaler (DPI) filling capability. In other news, Catalent installed and qualified a ZED in-line blister card sealer at its Clinical Supply Services facility in Philadelphia.
Celgene (Summit, NJ) completed its acquisition of Gloucester Pharmaceuticals (Cambridge, MA) following the required waiting period. Under the terms of the merger agreement, Celgene acquired Gloucester Pharmaceuticals for $340 million in cash plus up to an additional $300 million payable upon achievement of certain future regulatory milestones.
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CEL-SCI (Vienna, VA), a late-stage oncology company and developer of vaccines and therapeutics for infectious diseases, completed the validation process for all utilities and manufacturing equipment at its manufacturing facility in Maryland. The validation will allow CEL-SCI to move forward with its drug-manufacturing plans for the investigational cancer drug Multikine. The facility is now ready to offer contract manufacturing services.
Charles River Laboratories International (Wilmington, MA), a contract-research organization, will suspend operations at its Preclinical Services facility in Shrewsbury, Massachusetts, by mid 2010. The suspension is expected to reduce the company’s operating costs by $20 million this year.
Compass Pharma Services (Clifton, NJ) expanded its blister-packaging capacity for contract pharmaceutical packaging and contract vitamin packaging customers by installing a new, high-speed blister-packaging machine. The new blister-packaging system (Uhlmann thermoformer UPS4) operates at 50 cycles /min.
GenVec (Gaithersburg, MD) signed a drug-development deal with Novartis (Basel). The two companies will collaborate to discover treatments for hearing loss and balance disorders. GenVec is licensing the worldwide rights to its preclinical hearing-loss and balance-disorders program to Novartis. In return, GenVec will receive a $5-million up-front payment, and Novartis has purchased $2 million in GenVec common stock. GenVec will also receive money from Novartis for a research program focused on developing additional adenovectors for hearing loss.
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FDA issued a Warning Letter to McNeil Healthcare (Fort Washington, PA), a subsidiary of Johnson & Johnson (New Brunswick, NJ), on Jan. 15, 2010, regarding one of its Puerto Rico facilities (Sector Montones, Las Piedras). An inspection concluded on Jan. 8, 2010,"identified significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals," said the letter. Specific violations included the "failure to thoroughly investigate any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed;" "failure of your Quality Control Unit to ensure a thorough investigation in accordance with 21 CFR. § 211.192 with conclusions and follow up accomplished as required by 21 CFR. § 211.198;" and "failure to submit NDA-Field Alert Reports (FARs) within three working days of receipt of information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug products as required by 21 CFR. § 314.81 (b)(1)(ii).
Pillar5 Pharma (Arnprior, Ontario), a newly formed Canadian company, acquired the former Pfizer manufacturing site in Arnprior, Ontario, from Keata Pharma.
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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Last week, US Food and Drug Administration Commissioner Margaret A. Hamburg addressed the nation’s healthcare professionals in an official letter thanking them for their efforts during the 2009 H1N1 siwne-flu outbreak. The letter noted that, as of Dec. 30, 2009, 99.3 million doses of H1N1 vaccines had been distributed and that the vast majority (94%) of adverse events reported were classified as "non-serious" (e.g., soreness at the vaccine injection site).
According to a new report form the Biotechnology Information Institutes’ online biopharmaceutical database, FDA approvals of new biopharmaceutical products increased significantly in 2009. The agency approved 16 new biopharmaceutical entities last year, the highest since 2005, says the report.
The Active Pharmaceutical Ingredient Committee (APIC) of the European Chemical Industry Council (CEFIC) reports that the Supplier Qualification and Management Guideline is available on its website. CEFIC is the trade association representing European chemical manufacturers, and APIC is a committee representing manufacturers of active pharmaceutical ingredients (APIs) and intermediates. The guidance was issued in December 2009 and is designed to share the best practices of APIC member companies on systems to be implemented to adequately manage suppliers through the complete life cycle of a product. The guideline applies to four categories: noncritical raw materials, critical raw materials (including API starting materials), registered intermediates, and APIs.
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Adolor (Exton, PA) appointed Michael D. Adelman vice-president, marketing and sales; David P. Geoghegan vice-president, manufacturing; and Kevin Darryl White vice-president, regulatory affairs.
The Association of Clinical Research Organizations elected William Sharbaugh, chief operating officer of PPD (Wilmington, NC), its chair for 2010; and Joe Herring, chairman and chief executive officer of Covance (Princeton, NJ), its chair-elect.
CEL-SCI (Vienna, VA) appointed Todd S. Burkhart vice-president of manufacturing/facilities and commercial operations for its manufacturing facility. He has more than 30 years experience in the manufacture and process development of biologicals, medical devices, and other active pharmaceutical ingredients (APIs).
The global Parental Drug Association elected Maik Jornitz as its chair. He is group vice-president, product management filtration/fermentation technologies at Sartorius Stedim Biotech (Aubagne, France). Anders Vinther was elected as the group’s chair-elect. He is vice-president of corporate quality system & support at Genentech (South San Francisco, CA). |
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Report from Brazil |
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| Hellen Berger |
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According to most analysts, the global pharmaceutical industry is
going through a consolidation phase. But is Brazil's pharmaceutical industry
following the trend? Find out in the January issue of PharmTech.
Coming Soon: Authors representing EFPIA and PhRMA tackle implications and
opportunities for QbD applications to analytical methods in Pharmaceutical Technology's February issue.
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Lyophilization
Recently, the following statement was made about lyophilization:
"To remove water by freezing it, subliming the ice and then condensing the
water vapor is time consuming, wasteful in energy consumption and very
expensive in hardware. An easier option is to evaporate (boil) the water."
Do you agree with this statement?
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View the poll archive. |
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