13 Oktober 2014

First GMP-compliant batch of a biologic drug substance from a moss expression system produced for clinical use

New plant derived substance to be tested as new generation of enzyme replacement therapy

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.”

 

About greenovation Biotech GmbH

greenovation Biotech GmbH is a specialty biopharmaceutical company developing customized protein biopharmaceuticals using its proprietary eukaryotic Physcomitrella-based BryoTechnologyTM-platform.

Clonal stable moss lines are developed for a sustainable, cGMP-compliant manufacturing of protein biopharmaceutical candidates. Key features of BryoTechnologyTM: photoautotrophic process ▪ easy to cultivate in animal-derived-component-free and antibiotic-free purely mineral media ▪ rapid genome customization to express demanding proteins ▪ genetically stable genomic integration ▪ eukaryotic post-translational modifications ▪ straightforward genetic glyco-engineering ▪ highly homogeneous glycosylation pattern ▪ targeted elimination of plant-type glyco-forms ▪ protein excretion into the media.

Large scale production using the photoautotrophic moss lines is performed in certified, disposable bag-based reactors of the wave-type. Supply as well as full physico-chemical and biological characterization of GMP-material for clinical use has been established at greenovation’s specialized partner companies BIOMEVA GmbH and Protagen Protein Services GmbH (PPS).

greenovation has two pre-clinical programs under development, in the area of orphan lysosomal storage diseases (LSD): The enzymes moss alpha-galactosidase (Moss-aGal) for treating patients with Fabry Disease and moss glucocerebrosidase for treating patients suffering from Gaucher’s Disease. With the Moss-aGal program greenovation plans entering into a clinical phase I/IIa trial by the end of 2014.

 

About BIOMEVA GmbH

BIOMEVA GmbH is an experienced and reliable contract manufacturer (CMO) for the biopharmaceutical industry and dedicated to meeting the high demands on the production of pharmaceutical proteins using microbial and plant cell cultures.

Since 1993 BIOMEVA has been producing more than 400 batches of GMP-compliant material for pharmaceutical and biotech companies. Partners benefit from BIOMEVA‘s demonstrably proven operational expertise in the transfer, the development, and scale-up and validation of GMP processes.

BIOMEVA’s state-of-the-art GMP-production facility and extensive technical expertise are recognized worldwide and provide the necessary support for regulatory approval.

Biomeva is privately held and located in Heidelberg, Germany.

 

Contacts

greenovation Biotech GmbH
Manon Bartusel
Tel. +49 761 470 99 0
e-mail: mbartusel@greenovation.com

BIOMEVA GmbH
Dr. Thomas Pultar
Tel. +49 6221 9026 0
e-mail: t.pultar@biomeva.com

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