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The partnership aims to facilitate the development of therapeutic and diagnostic candidates for European biopharmaceutical clients.
Novasep, a supplier of services and technologies for the life sciences industry, and GTP (Gene-to-Proteins) Technology, a contract development manufacturing organization (CDMO) providing recombinant protein and process development services, announced on March 21, 2016 a partnership that combines their knowledge of monoclonal antibodies (mAbs) production. The partners aim to facilitate the development of therapeutic and diagnostic candidates for European biopharmaceutical clients.
According to a press announcement, GTP is knowledgeable about producing mAbs in the discovery and early clinical stages, and Novasep has plant facilities for late-stage production. GTP operates non-GMP bioreactors up to a 50L scale. This capacity complements Novasep’s capacity of 50 L, 200 L and 1000 L for cGMP production, used for 1-10 kg per year production scales. The partnership particularly targets mAb production for orphan drugs, antibody-drug conjugates, and diagnostics.
MAbs are known to be complex to produce. As upstream and downstream production steps for mAbs have improved over the last decade, progress towards high-titer cultivation broth and high efficiency in purification suites has changed the processing technologies. The DSP platform, based on the BioSC continuous chromatography system designed by Novasep, specifically addresses these new production challenges.
Source: Andrew Lloyd and Associates