Analytical methods to support recombinant microbial fermentation process development

Multiple factors must be explored during recombinant microbial fermentation process development for production of bulk drug substance (BDS) and drug product (DP), with limited resources and time constraints. The support of stage-specific analytical methods for BDS/DP identity, purity, quantification, and function are necessary end point analyses along with other process analytical tests (PAT) to help differentiate process variables for decision making. Examples of use of design of experiment (DoE) and case studies of use of various analytical assays will be highlighted.