Microbial control: Microbiological control for affinity capture chromatography processing: an industry perspective

The Microbial Control workstream has addressed the microbial risks and controls associated with affinity capture chromatography, a standard step for bioprocessing. They have written a best practice paper based on their historical findings and best practice guidelines, which has been published in the PDA.

The article sets out an approach to better understand the risks for bioburden, and managing these risks through effective controls during the chromatography process so that bioburden issues will be reduced.

Due to the potential for microbial colonization, affinity capture chromatography requires robust microbiological control. These best practice guidelines are intended to assist biopharmaceutical manufacturers to enhance their microbial control and monitor strategies for chromatography systems.

“The paper has been really well received,” explains Derek Willison-Parry, Drug Substance Phorum Lead. “It is a useful guide for the microbial control within the affinity capture process operation which will control bioburdens in process streams.”

Those who apply the best practice as set out in the PDA article will find they have increased microbial management during this high risk process step.

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BioPhorum Regulatory CMC is affording professionals the opportunity to shape their own collaboration program focused on challenges and opportunities across strategy, science, operations, submissions and compliance. Following a discovery program of work with Heads of Regulatory CMC, in which we identified some key topics of collaboration, we are giving you the opportunity to participate and help us to shape the final collaboration program. This will focus on, filing and review, interactions with Health Authorities, and harmonization. Our mission is not just to discuss, but to deliver applicable outputs and publications that will have an impact – learn more about how you can get involved.

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