By UGA Biopharma…
Russian developer Mabscale in-licensed UGA Biopharma´s biosimilar cell lines
Hennigsdorf, Germany:-UGA Biopharma GmbH (UGA), the leading-edge contract developer of cell lines expressing biologics, has out-licensed two of its innovative ready-to-use biosimilar cell lines to Russia-based biosimilar developer Mabscale.
Mabscale, a subsidiary of Ozon Pharmaceuticals, will now conduct GMP manufacturing and clinical studies to obtain marketing authorizations for the Russian market.
The cell lines in-licensed by Mabscale are among a wide range of ready-to-use biosimilar cell lines for GMP manufacturing developed by UGA. These in-house developed CHO-based cell lines stably express different biosimilar molecules to make them instantly available for in-licensing. Client advantages include direct access to proven cell lines that come bundled with all development data, including high titer and assured quality attributes.
UGA has transferred all required technology for the two biosimilars to Mabscale, including cell lines and bioprocess, which has been successfully upscaled to Mabscale bioreactors for downstream processing (DSP). Titer yield results were in line with UGA predictions.
The biosimilar cell lines will form the basis for products to be generated by Mabscale that have already been analytically tested with high biosimilarity confirmed by Mabscale.
Toxicity studies on one of the UGA biosimilars have been carried out successfully already and will soon peer-reviewed by Russian authorities, as part of Mabscale’s product regulatory approval process. The preclinical studies related to the second UGA Biosimilar will start in the middle of the year 2021.
About UGA Biopharma
UGA Biopharma GmbH is an experienced contract research and development organization of biologics and biosimilars with the capabilities to handle all necessary steps from cell line development and bioprocess development to the development of purification strategies and appropriate analytics.
The company supplies its customers in Germany and abroad from its headquarter in Hennigsdorf, near Berlin. Several clients have used UGA products in clinical trials or in products that have received market authorization.
UGA Biopharma GmbH CRDO activities are centered on cell line development for biologics and biosimilars, specializing in the development of stable expressing CHO cell lines and cell media for the production of biologics and biosimilars for biopharmaceutical companies. Typical clients are biopharma manufacturers, research institutions (like universities and research institutes) as well as start-ups and other CROs that need to outsource CLD, upstream, and/or downstream processing.
UGA’s mission is to fulfil customer requests, recognizing industry needs for high titer, high quality and fast delivery timelines, along with robust CHO cell lines. To this end, UGA can deliver cell lines, reaching titers from 4 to 7 g/L, within four months of receiving the originator sequence.
UGA has also developed its proprietary First CHOice® cell culture media and feeds platform to boost the productivity of cell lines. Furthermore, UGA Biopharma GmbH offers ready-to-use biosimilar cell lines, which allow clients interested in biosimilar development fast track access to a highly biosimilar cell line.
Further information at: www.ugabiopharma.com.
Mabscale LLC is an innovative company focused on providing comprehensive solutions in pharmaceutical biotechnology. It is engaged in development and production of drugs (biosimilars) based on monoclonal antibodies and other recombinant proteins.
In development, Mabscale carries out In-house research and development of biotechnological drugs based on recombinant proteins.
In production, the company operates a full-cycle plant for production of active pharmaceutical ingredients (APIs) based on CHO cell lines and finished dosage forms (FDF).
Based at Togliatti in Samara, Mabscale is a biotechnological project of Ozon Pharmaceuticals, a major force in the Russian pharmaceutical market.
Click on UGA Biopharma Ready-to-Use Biosimilar Cell Lines for detailed information.