FREIBURG, HEIDELBERG, Germany, September 29, 2014: greenovation Biotech GmbH and BIOMEVA GmbH announced today the successful production of the world's first GMP (Good Manufacturing Practice)-compliant batch of drug substance manufactured in moss for clinical use. The drug substance, greenovation's pilot candidate Moss-aGal (recombinant human alpha-galactosidase), is planned to be used for clinical testing as a new generation of enzyme replacement therapy in patients with Fabry disease in the near term. Based on broad experience in the production of proteins for preclinical testing, this production technology has been raised to the next level of successful GMP-manufacturing.
The manufacturing of GMP-compliant material is performed in greenovation's state-of-the-art wave-bag bioreactor system, operated by its partner BIOMEVA in dedicated clean-rooms. Greenovation's pilot plant process was transferred to an industrial-scale production plant at BIOMEVA.
The moss-derived Moss-aGal candidate will be tested in the coming months in a clinical phase I/IIa pilot study in Fabry disease patients.
Dr. Thomas Frischmuth, CEO of greenovation, pointed out: "The successful production of the first GMP-compliant drug substance batch of our lead candidate Moss-aGal represents the most important milestone in the history of greenovation Biotech GmbH to date. With this step, the moss platform has been applied for industrial-scale production of demanding customized protein biopharmaceuticals for human use."
Dr. Thomas Pultar, CEO of BIOMEVA, said: "Together with our partner greenovation, we were able to establish a robust GMP-manufacturing process. We managed to transfer this manufacturing process successfully from laboratory to industrial production scale and to fulfill GMP-requirements. It has been shown impressively that moss in bioreactor cell culture can serve as a novel technology for the production of biologic drugs."