GREENOVATION - Pharmaceutical Protein Production in Moss






DQS-Quality Management

Customized Protein Biopharmaceuticals

Protein Production for the Pharmaceutical Industry

greenovation biotech GmbH is a specialty biopharmaceutical company developing the next generation of therapeutic proteins using its proprietary eukaryotic Physcomitrella-based BryoTechnology™- platform.

 

Manufacturing of GMP-compliant material is performed in greenovation's state-of-the-art wave-bag bioreactor system, operated by its partner BIOMEVA, Heidelberg, Germany in dedicated clean-rooms. The successful production of the world's first GMP (Good Manufacturing Practice)-compliant batch of drug substance manufactured in moss for clinical use was announced in September 2014. The drug substance, greenovation's pilot candidate Moss-aGal (recombinant human alpha-galactosidase), is planned to be used in a Phase I/IIa clinical trial as a new generation of enzyme replacement therapy in patients with Fabry disease by the end of 2014. greenovation is closely associated to PROTAGEN Protein Services GmbH, Heilbronn, Germany, a GMP certified analytic laboratory for CMC, product quality and comparability studies.