Pharmaceutical manufacturing news in brief
pharmafile | February 15, 2011 | News story | Manufacturing and Production |Â Â Boehringer Ingelheim, DSM Biologics, Elan, NovasepÂ
Irish drugmaker Elan has forged an alliance with Boehringer Ingelheim to develop and manufacture antibody-based therapeutics. Under the terms of the agreement, Boehringer will perform the technical development, clinical manufacturing and all related regulatory filing activities for antibody-based drugs discovered by Elan. In turn, Elan will lead the discovery science, preclinical activities, clinical development and commercialisation of the antibodies.
DSM Biologics has won a contract from US drugmaker NKT Therapeutics to manufacture supplies of a natural killer cell-based therapeutic which is due to enter clinical trials next year in the infectious disease area. The contract covers the process development and GMP manufacturing by DSM of their lead product iNKT mAb. Clinical supplies of the treatment will be made at DSM’s mammalian bioreactor facilities in Groningen, the Netherlands.
French separations specialist NovaSep has expanded its strategic alliance with InstrAction of Germany in the area of production-scale chromatography to include the purification of taxane compounds used as cancer treatments. The two companies first started working together in 2010, developing a portfolio of chromatography-based purification systems for active pharmaceutical ingredients. “A large number of clinical trials involve paclitaxel and docetaxel, two of the leading anti-cancer APIs marketed today … and also new taxanes, taxane conjugates or combinations between taxanes and other APIs”, said the two firms in a joint statement.
Specialty drugmaker ProStrakan has chosen UK-based contract manufacturer SCM Pharma to make its Ketensin product for hypertensive crisis during and after surgery over the course of a five-year deal. Ketensin is only sold by ProStrakan in the Netherlands at present and is sold in very low volumes. The company said it selected SCM because it specialises in low-volume contracts, can fill various vial sizes and carry out testing on the finished product.
Contract manufacturer Helix Medical has said it plans to build a manufacturing facility in Costa Rica for medical devices with an investment of around $4 million. Once completed in 2012, the plant is expected to employ around 100 people and will carry out services including silicone extrusion, silicone moulding, thermoplastic moulding, and assembly operations.
Molecular Profiles of the UK has installed an XcelloDose micro-dosing system at its facilities as part of an ongoing expansion of its manufacturing capabilities. The system, – sold by Pfizer subsidiary Capsugel – allows capsules and vials to be filled without additional excipients to help deliver the active pharmaceutical ingredient. It can be used to cut the time involved in bringing new drugs to early-stage clinical trials by doing away with the need for formulation development and stability studies.
Phil Taylor
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