Pharma manufacturing news in brief
This week’s roundup includes contract manufacturing updates from CMC Biologics, West-Ward and Aenova, plus a Catalent deal in Japan and some good news for Sun Pharma.
Denmark’s CMC Biologics and US-based Inspiration Biopharmaceuticals have signed a supply agreement for the manufacture of bulk IB1001 (intravenous recombinant factor IX), a treatment for individuals with haemophilia B in phase III clinical testing. Under the terms of the agreement, CMC Biologics will manufacture IB001 for at least six years starting this autumn. Further details of the agreement were not disclosed.
Hikma Pharmaceuticals subsidiary West-Ward is refocusing its business in the wake of its acquisition of Baxter’s sterile injectable manufacturing facility in New Jersey, USA, in order to increase its share of the contract manufacturing market. The company believes that a trend towards reduction or elimination of production capacity among CMOs is leading to shortages in some medicines, and it plans to plug the gap.
German contract manufacturer Aenova Group has set up a new tablet production line at its manufacturing facility in Tittmoning, due to open officially later this week, which will boost its output capacity by around 20% to 12 billion oral dosage forms a year. Around 40 additional jobs have been created as a result of the expansion, adding to the company’s current workforce of around 1,500 people.
Toyoba Biologics will co-promote Catalent Pharma Solutions‘ mammalian cell line platform GPex in Japan under the terms of a newly-signed deal between the two companies. The GPEx system is used to engineer stable, high-expression cell lines designed to speed biologics development. Toyobo is a biologics supplier and contract provider of large-scale clinical and commercial bioreactors in Japan, with a large-scale manufacturing facility located in Shiga.
India’s Sun Pharmaceutical has said it has resolved the issues raised in a US FDA warning letter prompted by an inspection of its manufacturing facility in Cranbury, New Jersey, last year. A re-inspection by the agency in August led to the clean bill of health. Another facility operated by recently-acquired subsidiary Caraco in Detroit remains under scrutiny, however, with production there suspended until the plant can be brought up to code.
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