This paper will be published in a “Special Section” of the PDA Journal of Pharmaceutical Science and Technology, in May/June 2015.
The purpose is to provide guidance and drive consistency in regards to microbial control for manufacturers of low bioburden bulk biologics. It 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 BPOG Bioburden Working Group, are intended to assist biopharmaceutical manufacturers develop microbial monitoring strategies and product safety assessments. Each manufacturer is unique, therefore, alternative strategies may be justified and/or qualified.
- 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