Continuous Chromatography of MAbs Using BioSC: Process Design and Regulatory Considerations

BioSc LabThis webcast features: Vincent Monchois, Strategic Project Director, Biopharma, Novasep

Challenges in bio-manufacturing up to commercial stage include improving lead times, securing the process, improving productivity, and reducing COGs. The implementation of a continuous manufacturing process is a viable solution to address these challenges.

The chromatography step represents one of the key stages of a manufacturing process for (bio)pharmaceutical compounds. Continuous chromatography was originally developed by the Petroleum industry in the 1960s and has been successfully implemented in the Food-processing industry since the 70s. It is now time for the Pharmaceutical Industry to move to continuous chromatography and replace the standard technologies of bio-production.

Integration of this technology needs to take into account new approaches for process design and for addressing regulatory requirements.

A case study using continuous chromatography for MAb purification with BioSC® will be provided in order to illustrate how this move can be sustained:

    • For process development, by making continuous chromatography implementation easier starting at early clinical development stages and by designing a complete continuous process for MAb purification based on BioSC® technology
    • For drug substance release, by proposing approaches in line with regulatory expectations.