Pharma manufacturing news in brief
pharmafile | March 19, 2012 | News story | Manufacturing and Production | Recipharm, manufacturing, production
Sweden’s Recipharm has been contracted by ViroPharma to carry out commercial-scale production of Plenadren (hydrocortisone modified release tablet), developed for the treatment of adrenal insufficiency in adults, in preparation for the product’s European launch.
Plenadren is an oral, once daily dual-release hydrocortisone tablet that comprises an outer layer that releases the drug immediately, and a delayed release inner core. The deal will also provide product material in the near-term for named-patient supply of the drug.
DSM Pharmaceutical Products has extended its contract with Agennix for the manufacture of talactoferrin, a drug in trials for non-small cell lung cancer. Under the renewed agreement DSM will manufacture commercial quantities of talactoferrin “in anticipation of positive phase III clinical data and product approval”.
The contract includes the opportunity to significantly expand production capacity as needed. Agennix was forced to drop talactoferrin in a second indication – severe sepsis – last month after disappointing Phase II/III results.
GE Healthcare said it has reached an agreement to acquire US disposable manufacturing equipment manufacturer Xcellerex in a deal that will “expand its offering of products and services for the manufacture of biopharmaceuticals such as recombinant proteins, antibodies and vaccines”.
Xcellerex has built a business around single-use production components such as bioreactors, mixing systems and assembly equipment that offers advantages such as faster installation, lower capital investment, reduced risk of cross-contamination, and increased flexibility compared with traditional stainless steel systems. The acquisition is expected to close in the second quarter.
Abbott Laboratories plans to invest $270 million in a new manufacturing facility in Ohio, USA, to expand manufacturing capacity for its liquid adult nutritional products Ensure and Glucerna. The Tipp City plant will employ around 240 staff and specialise in aspetic packaging technology. Later this year Abbott is due to split its pharma business from its other operations, including the $6 billion nutritionals unit.
A bill (HR 4056) introduced into the US House of Representatives by Rep. Brian Bilbray is seeking to end a requirement for biopharmaceutical manufacturers in California, USA, to undergo duplicative and costly inspections by the California Department of Public Health’s Food and Drug Branch (CFDB). The state is the only one in the country to insist on such inspections, which are carried out in addition to the statutory federal inspections by the FDA.
Phil Taylor
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