Manufacturing news in brief
pharmafile | December 14, 2009 | News story | Manufacturing and Production | Alexion, Codexis, Dishman, Dow
Pharmafocus’ round-up of developments in pharmaceutical manufacturing includes facility updates from Dishman, Alexion, Stirling Products, RL Fine Chemicals and Cambrex, as well as a Dow spin-out and catalyst deal for Codexis.
Dishman Netherlands has opened a high containment facility to manufacture vitamin D analogues and high-potency active pharmaceutical ingredients in Veenendaal. The production laboratory includes six dedicated clean rooms with the capability to scale up to 1kg. Dishman expects an FDA compliance audit in the first half of next year.
Alexion Pharmaceuticals has won the backing of a European Medicines Agency advisory committee for a back-up manufacturing facility for Soliris (eculizumab), its treatment for rare genetic blood disorder paroxysmal nocturnal haemoglobinuria (PNH), in the US. The plant in Smithfield, Rhode Island, has been recommended for approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP), putting the facility on track for full approval early next year.
Dow Chemical has spun out its Pseudomonas fluorescens-based gene expression technology for producing recombinant proteins into a new company called Pfenex Inc with around 20 employees. The technology can produce higher yields in biologics production compared to existing systems based on Escherichia coli. Dow will retain a minority stake in the new company.
Australian healthcare company Stirling Products has agreed to acquire a Canadian pharmaceutical manufacturing facility for $4.1 million, subject to final approvals. The licensed pharmaceutical facility was formerly owned by a Canadian drugmaker which has gone into administration. The 46,400 sq. ft. comprises manufacturing space, laboratories, warehousing and office space and is fully operational.
Codexis has signed a second agreement this year with Teva Pharmaceutical Industries covering the use of biocatalysis technology for the manufacture of three of Teva’s pharmaceutical products. In January Teva signed up to use Codexis’ catalysts for one product. The biocatalysts are designed to lower pharmaceutical process development and manufacturing costs.
India’s RL Fine Chemicals, which specialises in the manufacture of APIs to treat central nervous system disorders, has set up a formulation R&D unit as an interim step towards being able to manufacture finished dosage forms, according to a Pharmabiz report. The company is also planning to expand into cardiovascular disease and diabetes.
US contract manufacturer Cambrex Corp has been given a clean bill of health from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its manufacturing site in Charles City, Iowa, following an audit conducted in July 2009. The MHRA approval not only covers product filings for the UK but also applies to product filings for the entire EU. The inspection has been assigned an inspection frequency of 30 months, the longest allowable gap, said the firm.
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