Manufacturing news in brief

pharmafile | June 22, 2010 | News story | Manufacturing and Production |  Almac, CPL Biologicals, KV Pharma, KV Pharmaceutical, NerPharMa, ProBioGen 

German contract manufacturer ProBioGen is bought by Egypt’s Minapharm, plus there are facility updates from NerPharMa DS, CPL Biologicals and Almac Group and further turmoil at KV Pharma in the US.

Egyptian pharmaceutical company Minapharm has acquired a 95% stake in German contract manufacturer ProBioGen in a deal valued at around 30 million euros. The two companies have been working together on the development of a cell-line to produce interferon beta and other biosimilar products since 2007. ProBioGen has also appointed Wieland Wolf, formerly of Rentschler Biotechnologie GmbH, as new the chief executive of the company.

The Italian Medicines Agency (AIFA) has approved a facility operated by contract manufacturer NerPharMa DS for the production of pixantrone, Cell Therapeutic’s drug candidate for relapsed/refractory aggressive non-Hodgkin’s lymphoma. The US Food and Drug Administration cleared the facility back in March. Since then, the FDA has said CTI will need to conduct another trial before it can consider pixantrone’s approval. Meanwhile the company says it is preparing a European marketing application for the drug.

CPL Biologicals, a joint venture between India’s Cadila Pharmaceuticals and US company Novavax, says that its facility near Ahmedabad for the manufacture of vaccines using a virus-like particle technology is currently undergoing validation. The plant started construction in October 2009 and will be able to make up to 60 million vaccine doses based on Novavax’s VLP technology each year. The initial focus of the joint venture is the production of influenza vaccines. VLPs mimic the external structure of viruses but lack the live genetic material that causes viral replication and infection.

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Northern Ireland’s Almac Group says it has completed a £2 million programme to add sachet production capacity at its pharmaceutical manufacturing facility in Craigavon. The expansion has been sponsored by a client and includes new dispensing and blending suites, sachet-filling and packaging lines in a 5,500 sq.ft. facility. The unit will be able to handle an output of more than 120 million sachets a year.

There’s turmoil at generic drugmaker KV Pharmaceutical with the firm’s chairman Terry Hatfield, chief financial officer Stephen Stamp and board member John Sampson all resigning, saying they have serious concerns about the capabilities of the recently-elected board and senior management. Last week, the board voted out interim president and chief executive David van Vliet within hours of his appointment. KV is still trying to get its business back on track after serious manufacturing problems at its now-closed Ethex Corp subsidiary led to criminal charges and more than $27 million in fines.

Phil Taylor

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