French firms Novasep and GTP Technology are combining their services and expertise to advance production of monoclonal antibodies (mAbs). The partnership is particularly targeting mAb production for orphan drugs, antibody drug conjugates (ADCs) and diagnostics.

GTP brings know-how at the proof-of-concept/discovery and early clinical stages while Novasep has expertise and plant facilities for late stage production. GTP operates non-GMP bioreactors up to a scale of 50 L, complementing Novasep’s capacities of 50, 200 and 1,000 L for cGMP production, which is said to be ideal for production of 1-10 kg per year.

Alain Lamproye, president of Novasep’s biopharma business unit, said the partners were making mAbs production more flexible by offering customers the required scales for orphan drugs and fast-track projects. “When time is of the essence, it is vital to facilitate the transfer from early stage to late stage production,” he said.

According to Howard Levine, president and CEO at BioProcess Technology Consultants, mAb-related products account for more than 30% of approved biological drugs which had sales of around $84 billion in 2014.

MAbs are complex to produce. As both upstream and downstream production steps have improved in the last 10 years, progress toward high-titer cultivation broth and high purification efficiency has altered processing technologies.

Novasep said its downstream processing platform, based on its proprietary BioSC low-pressure continuous chromatography system for mAbs purification, specifically addresses the new production challenges.