Microbial control: Microbial monitoring for biological drug substance manufacturing: an industry perspective

The purpose of this paper is to provide guidance and drive consistency in regards to microbial control for manufacturers of low-bioburden bulk biologics. This paper provides recommendations based on biologics produced using cell cultures such as monoclonal antibody(mAb)-based products and recombinant protein manufacturing process. These recommendations, from the members of the BioPhorum Bioburden Working Group, are intended to assist biopharmaceutical manufacturers develop microbial monitor-ing strategies and product safety assessments. Each manufacturer is unique, therefore, alternative strategies maybe justified and/or qualified.

This paper focuses on the following topics:

● Microbial in-process monitoring during inoculum expansion

● Culture expansion, and protein purification process of bulk drug substances

● Setting alert/action levels limits

● Objectionable organisms in bulk biologics, responding to bioburden excursions

● Assessing impact to product quality

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