Pharma manufacturing news in brief
pharmafile | June 26, 2012 | News story | Manufacturing and Production |Â Â Cook Pharmica, Ubichem Fine Chemicals, Unilife Corp, West Pharmaceutical ServicesÂ
Unilfe wins a new syringe contract, West Pharma signs a deal with Amgen, plus facility updates from Cook Pharmica and Ubichem.
Unilife Corp says it has signed a contract to supply its Unifill prefilled syringes for use with an undisclosed, generic auto-immune therapy that is currently delivered using a standard syringe. The seven-year contract will give the unnamed customer exclusive use of Unifill for a specific indication in Western Europe, in return for a fee on top of the negotiated unit price for Unifill, which is designed with safety features that can prevent needlestick injuries and encourage more convenient, safer disposal. The company said it expects to generate sales of 10 million units and $15 million a year from the deal, which gets underway next month.
West Pharmaceutical Services has announced plans to work with Amgen on a project that will evaluate its Daikyo Crystal Zenith technology for containment of biologic drugs. The technology is based on a polymeric container, using elastomeric components with Flurotec barrier film, and provided in a sterile, validated, ready-to-fill format. This avoids the problems associated with using glass vials, such as delamination of glass shards. The Crystal Zenith technology was developed by West’s partner Daikyo Seiko.
Cook Pharmica has been given a green light by the FDA to manufacture commercial product at its facility in Bloomington, Indiana following a pre-approval inspection that took place in February. The inspection covered the company’s new vial filling line, lyophilisation capabilities and quality systems, it said. The Bloomington site manufactures both vials and prefilled syringes under barrier isolation, as well as secondary packaging, and has the capacity to make 15 million vials and 70 million prefilled syringes a year.
Ubichem Fine Chemicals has opened a new 55,000 sq. m. manufacturing site for pharmaceuticals in Hungary that will make multi-tonne quantities of starting materials, intermediates, and other fine chemical products for pharmaceutical and other applications. The company said bringing the plant online has made it one of the largest fine chemical providers in central and eastern Europe (CEE), offering process R&D through pilot-scale cGMP API manufacture to high-volume manufacturing. “We believe we have a competitive edge over intermediate manufacturers based in Asia by leveraging the highly skilled talent pool of chemists and by meeting high quality expectations and strict deadlines, said József Répási, Ubichem’s chief executive.
Phil Taylor
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