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Process Development Programme Key to Avecia/
Zymogenetics Partnership
Avecia has delivered the first quantities of the recombinant version of human Factor XIII protein from its Billingham UK Advanced Biologics Centre to US based ZymoGenetics Inc. (Nasdaq: ZGEN). The delivery marks successful completion of an extensive process development programme by Avecia Biotechnology, and follow-on GMP batches are already underway.
Recombinant human (rh) Factor XIII, produced in a yeast expression system, is being developed by ZymoGenetics to reduce perioperative bleeding following cardiopulmonary bypass surgery. Factor XIII, the last enzyme in the coagulation cascade, cross-links fibrin strands in a blood clot to make the clot stronger, and reduce the chance of rebleeding.
With its combined track record in microbial process development services and manufacture, Avecias Biologics business was chosen by ZymoGenetics to develop a robust and scaleable process and to manufacture clinical product in compliance with current Good Manufacturing Practice (GMP).
We are extremely pleased about our partnership with Avecia and the success they have achieved in manufacturing GMP rh Factor XIII to support our clinical development activities," stated Bruce L.A. Carter, Ph.D., President and Chief Executive Officer of ZymoGenetics. Rh Factor XIII is our most advanced project for which we intend to file an investigational new drug application (IND) with the FDA in late 2002".
ZymoGenetics Inc., of Seattle, Washington (USA) is biopharmaceutical company focused on the discovery, development and commercialisation of protein therapeutics for the prevention or treatment of human diseases.
Avecia is a strategically focused service provider to the biotechnology and pharmaceutical industry, helping customers to commercialize new and advanced medicines through innovative process science and GMP manufacturing technology. Avecia has considerable process development experience with a wide range of micro-organisms, and has been making biologics at Billingham since 1997.
In February, the company announced a US $100m expansion programme to build one of the worlds most advanced facilities for manufacturing microbially-derived biologics. The investment, at Billingham, will create an additional 40,000 litres of capacity. With the first phase on stream during 2003, Avecias new facility will bring integrated capacity on a single site for process development, clinical trials and large-scale manufacturing to cGMP standards.
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