Biomay Starts GMP Operations (Oct. 2008)

Biomay has started GMP operations for manufacturing recombinant biopharmaceuticals. The first GMP batch which has already been released is the recombinant birch pollen allergen Bet v 1a. It will be investigated in a clinical trial at the Medical University of Vienna.

The successful start is the result of intensive preparation activities during the preceding months. Biomay has designed, built, qualified and put into operation a multi-product facility dedicated to microbial-derived products (proteins and plasmid DNA). The plant is separated in two independently operated clean rooms, class D for fermentation and pre-purification, and class C (plus class A sterile hood) for purification and aseptic filling. The plant construction activities were accompanied with the establishment of a Quality Assurance system (GMP certificate July 2008) and the development of regulatory-compliant production processes.

“This is a ground-breaking milestone for Biomay. We have demonstrated that although being a small team, we are able to produce active biopharmaceutical ingredients at high quality,” says Hans Huber, Head of Production. Biomay is going to produce two more clinical products before the end of 2008. Furthermore, Biomay will offer GMP  contract manufacturing services.