Pharma manufacturing news in brief
pharmafile | December 21, 2010 | News story | Manufacturing and Production |Â Â Airgas, Anthera Pharmaceuticals, Avid Bioservices, Berlin Packaging, Continental Packaging Solutions, Inno Biologics, Janssen, Merck BioManufacturing Network, Shandong Yanggu Zhongshi Pharmaceutical, SurModicsÂ
Our round-up of manufacturing updates includes a European recall for J&J, new contract manufacturing awards and facility updates from around the world.
Johnson & Johnson subsidiary Janssen has announced a recall of products in Switzerland, specifically 10-count packs of Tylenol suppositories for children, according to the country’s regulator Swissmedic. The reason for the recall is a problem with elevated temperature during shipping or storage of the product, which caused the suppositories to melt and reform. The products are not expected to pose any health hazard.
Berlin Packaging has acquired fellow US company Continental Packaging Solutions, a specialist in plastic and glass containers and closures. The transaction increases the number of Berlin’s sales and warehouse locations in North America to more than 70 and boosts its presence in Asia with the addition of Continental’s Chinese operations. This is Berlin’s second acquisition in the past year after All-Pak, which closed in March.
The FDA has issued a warning letter to Airgas indicating its medical-gas manufacturing operations have violated pharmaceutical regulations. The citations include a failure to investigate properly an incident involving a contaminated nitrogen cylinder, and also filling batches of medical gas products without completing production records. Airgas is currently fighting a hostile takeover bid by rival company Air Products & Chemicals.
US drug delivery firm SurModics considering selling off its pharmaceuticals business, centred on a manufacturing facility in Birmingham, Alabama, to enable it to focus on medical devices and in vitro diagnostics. The facility makes implantable drug delivery systems and was acquired along with its owner Brookwood Pharmaceuticals for $150 million in 2007.
Anthera Pharmaceuticals has selected Merck & Co’s contract manufacturing unit Merck BioManufacturing Network to manufacture clinical and pre-commercial supplies of A-623, an investigational drug in development for autoimmune diseases such as lupus erythematosus. The ‘peptibody’ drug will be manufactured at MBN’s facility in Billingham, UK.
Avid Bioservices says it has been given a contract by an unnamed US and China-based biopharmaceutical company focused on developing biosimilars. Under the terms of the deal, Avid will provide process development and analytical services for a complex biosimilar product to support planned clinical development. Additional terms of this agreement were not disclosed.
Malaysian company Inno Biologics has delivered the first batch of clinical-grade AVDESP – a biosimilar to anaemia treatment darbepoetin alfa – for Indian firm Avesthagen. The two firms have now signed a letter of intent to start commercial manufacturing of AVDESP, which will shortly start clinical testing, as well as another drug called AVENT (a biosimilar version of the rheumatoid arthritis treatment etanercept).
An explosion and fire at a facility operated by Chinese company Shandong Yanggu Zhongshi Pharmaceutical has caused several injuries but no deaths, according to the Xinhua news agency. The incident has been blamed on careless handling of chemicals.
Phil Taylor
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