New Data Provides Validation For greenovation Biotech GmbH’s Moss-Based Expression System As A GMP-Compliant Biopharmaceutical Production System -Successful Collaboration With BioGenes
• Novel P. patens-specific host-cell protein assay developed for GMP-compliant production in moss
• New data published in BioProcess International, February 2016
FREIBURG, Germany, February 17, 2016
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 (http://www.bioprocessintl.com/analytical/upstream-validation/development-of-a-novel-host-cell-protein-assay-supporting-the-physcomitrella-patens-expression-system/ ).
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.
About BioGenes GmbH
BioGenes GmbH, Berlin, specializes in highly sophisticated and customized antibody and immunoassay development and is an experienced and reliable partner for process development improvements in all areas of quality control, diagnostics and drug discovery. BioGenes is certified to meet the international requirements and regularities of quality assurance and animal welfare. The Company maintains long-term relationships with research institutes, universities and biotech and pharmaceutical companies, including eight of the ten largest pharmaceutical companies in the world. The company has been evaluated by a leading global accounting and auditing firm to be one of the leading companies in HCP assay development.
Contact and further information:
Dagmar Schwertner-Knoll, Tel. +49 30 65762380
e-mail: d.schwertner@biogenes.de
web: www.biogenes.de
About Greenovation Biotech GmbH
Greenovation develops plant-made next-generation therapeutics using its proprietary BryoTechnology platform. The company aims to optimize the production of highly-efficient glycoproteins for the treatment of rare diseases. Greenovation is a privately owned biopharmaceutical company based in Heilbronn, Germany. It was founded in 1999 by Prof. Dr. Ralf Reski and Prof. Dr. Gunter Neuhaus. Today, Greenovation Biotech GmbH is majority-owned by Zukunftsfonds Heilbronn and L-EigenkapitalAgentur (Karlsruhe).
Contact and further information:
Greenovation Biotech GmbH
Manon Bartusel, Tel. +49 761 470 99 0
e-mail: mbartusel@greenovation.com
web: www.greenovation.com
• New data published in BioProcess International, February 2016
FREIBURG, Germany, February 17, 2016
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 (http://www.bioprocessintl.com/analytical/upstream-validation/development-of-a-novel-host-cell-protein-assay-supporting-the-physcomitrella-patens-expression-system/ ).
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.
About BioGenes GmbH
BioGenes GmbH, Berlin, specializes in highly sophisticated and customized antibody and immunoassay development and is an experienced and reliable partner for process development improvements in all areas of quality control, diagnostics and drug discovery. BioGenes is certified to meet the international requirements and regularities of quality assurance and animal welfare. The Company maintains long-term relationships with research institutes, universities and biotech and pharmaceutical companies, including eight of the ten largest pharmaceutical companies in the world. The company has been evaluated by a leading global accounting and auditing firm to be one of the leading companies in HCP assay development.
Contact and further information:
Dagmar Schwertner-Knoll, Tel. +49 30 65762380
e-mail: d.schwertner@biogenes.de
web: www.biogenes.de
About Greenovation Biotech GmbH
Greenovation develops plant-made next-generation therapeutics using its proprietary BryoTechnology platform. The company aims to optimize the production of highly-efficient glycoproteins for the treatment of rare diseases. Greenovation is a privately owned biopharmaceutical company based in Heilbronn, Germany. It was founded in 1999 by Prof. Dr. Ralf Reski and Prof. Dr. Gunter Neuhaus. Today, Greenovation Biotech GmbH is majority-owned by Zukunftsfonds Heilbronn and L-EigenkapitalAgentur (Karlsruhe).
Contact and further information:
Greenovation Biotech GmbH
Manon Bartusel, Tel. +49 761 470 99 0
e-mail: mbartusel@greenovation.com
web: www.greenovation.com