Novasep and GTP (Gene-to-Proteins) Technology has announced a partnership that combines their expertise in monoclonal antibodies (mAbs) production. The partners aim to facilitate the development of therapeutic and diagnostic candidates for European biopharmaceutical clients.
GTP brings its know-how in producing mAbs at the proof-of-concept /discovery and early clinical stages. Novasep provides expertise and plant facilities for late stage production. The mid-size capacity and full range of services the partners offer fit closely with customer demand regarding expertise and fast-track process development. The partnership particularly targets mAb production for orphan drugs, ADCs and diagnostics.
“I am delighted to launch this partnership with the GTP team, who have accumulated tremendous experience in mAb development and early-stage production. Together, Novasep and GTP are making mAbs production more flexible by offering customers the required scales for orphan drugs and fast-track projects,” said Alain Lamproye, president of the Biopharma BU at Novasep. “When time is of the essence, it is vital to facilitate the transfer from early stage to late stage production. The combined depth and breadth of our expertise along with our trusted resources will bring a range of first-rate services that is of true benefit to our customers.”
GTP has long-standing experience developing production processes and operates non-GMP bioreactors up to a 50L scale. This complements Novasep’s capacity of 50L, 200L and 1,000L for cGMP production, ideal for 1-10kg per year production scales.
“The partnership with Novasep is a great opportunity for us,” said Eric Devic, president of GTP. “Its outstanding production capacities perfectly complement our protein engineering and process development expertise. Working hand in hand with Novasep, we are able to offer our customers a seamless transfer to cGMP production.”
“Monoclonal antibody-related products represent more than 30% of the approved biological drugs. In 2014, these products had total sales of approximately $84 billion (€76.5bn). The majority (77%) of these sales are attributed to full length unconjugated antibodies, with the remainder (23%) attributed to other antibody-related products,” said Howard L. Levine, Ph.D; president and CEO at BioProcess Technology Consultants Inc.
MAbs are known to be complex to produce. As both upstream and downstream production steps have improved over the last decade, progress towards high-titer cultivation broth and high efficiency in purification suites has changed the processing technologies. The state-of-the-art DSP platform, based on the BioSC® continuous chromatography system that Novasep has designed, specifically addresses these new production challenges. This technical offering complements the CMO services Novasep provides for mAb production.