Scientists at BioGenes GmbH, Berlin and Greenovation Biotech GmbH, Freiburg, have cooperated to develop a novel host-cell protein (HCP) assay for Greenovation’s Physcomitrella patens expression system.

The data have been published in the Journal BioProcess International in February 2016 by Dabrowska-Schlepp and colleagues.

HCPs are inevitable impurities found in biopharmaceutical products originating from recombinant cell culture. HCPs are a heterogeneous mix of different proteins, and their specific characteristics depend on the kind of organism used as an expression platform. Contamination of a final drug substance with HCPs may lead to immunogenic reactions in the patients who receive the drug.

The analytical assay developed under the collaboration ensures the production of drugs with high quality and purity. Greenovation’s first product, moss-aGal, is a recombinant form of human alpha galactosidase. This has been developed as an enzyme replacement therapy (ERT) for patients with the genetic lysosomal storage disorder Fabry' disease.

"Working step by step, we are successfully accomplishing each milestone for the establishment of Greenovation’s technology as a next-generation biopharmaceutical production system.” says Dr. Thomas Frischmuth, CEO of Greenovation.

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