Pharmaceutical manufacturing: news in brief
pharmafile | July 6, 2009 | News story | Manufacturing and Production | Genzyme, Quotient
Pharmafocus presents a round-up of developments in manufacturing, including facility updates from Genzyme, Caraco, MSD, Rottapharm and Almac Pharma Services, Quotient's expansion in radiolabeling and a new benchtop bioreactor from Millipore.
The decontamination of Genzyme's Allston Landing plant will take longer than expected, said the company, extending interruptions in the supply of Cerezyme (imiglucerase) for Gaucher disease and Fabrazyme (agalsidase beta) for Fabry disease. It had originally expected production to restart by the end of this month. Analysts have estimated the shutdown could cost the firm between $100 million and $300 million in lost sales.
US Marshals, working on behalf of the Food and Drug Administration, have seized active pharmaceutical ingredients (APIs) and finished products with an estimated value of around $20 million from generic drugmaker Caraco Pharmaceutical's facilities in Michigan. The action was taken because of suspected breach of Good Manufacturing Practice (GMP) standards. In a statement the FDA said the action was intended "to lead to major changes at Caraco's facilities".
Merck, Sharp & Dohme will spend $65 million expanding its pharmaceutical facilities in Puerto Rico. The project includes building a new plant at its site in the city of Barceloneta which will employ around 30 people when completed in late 2010, according to local press reports. In addition to the Barceloneta site, MSD also operates a plant in Arecibo and employs more than 900 people in Puerto Rico.
Cambridge, UK-based Quotient Bioresearch has said it will invest £15 million in a new manufacturing facility for radiochemicals in Cardiff, Wales, as part of its agreement to acquire Amersham Radiolabeling Services from GE Healthcare. ARS provides custom synthesis of carbon-14 and tritium labelled compounds to the pharmaceutical and biotechnology industries. The new facility is due to come online in 2010, to coincide with the transfer of ARS' business activities to Quotient.
Italy's Rottapharm is investing seven million euros in its Irish manufacturing operations in a project that will add three new manufacturing and packaging lines and boost staffing at the facility by 35 people to 150. The plant was originally set up in 1999 and primarily makes capsule, sachet and tablet formulations of Rottapharm's Dona (glucosamine sulphate) for joint health.
Contract manufacturing and development company Almac Pharma Services has completed the first stage of a $15 million expansion programme at its manufacturing facility in Craigavon, Northern Ireland. When completed the project will increase manufacturing space at the unit by 30,000 sq. ft, as well as increase analytical and microbiological testing capacity.
Millipore has introduced a single-use benchtop bioreactor that is ready for use 'out of the box'. The 3-liter CellReady Bioreactor, part of the company's Mobius line, is designed for use by process development scientists. The disposable unit is intended to replace traditional glass benchtop bioreactors and has been developed by Millipore in collaboration with Netherlands-based Applikon Biotechnology.
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