Voices of Biotech
Podcast: MilliporeSigma says education vital to creating unbreakable chain for sustainability
MilliporeSigma discusses the importance of people, education, and the benefits of embracing discomfort to bolster sustainability efforts.
September 21, 2016
Date: Sep 21, 2016
Duration: 20 Min
Sponsored by Novasep
This 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.
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