Integrated Process Model Applications Linking Bioprocess Development to Quality by Design Milestones.

ABSTRACT: Maximizing the value of each available data point in bioprocess development is essential in order to reduce the time-to-market, lower the number of expensive wet-lab experiments, and maximize process understanding. Advanced in silico methods are increasingly being investigated to accomplish these goals. Within this contribution, we propose a novel integrated process model procedure to maximize the use of development data to optimize the Stage 1 process validation work flow. We generate an integrated process model based on available data and apply two innovative Monte Carlo simulation-based parameter sensitivity analysis linearization techniques to automate two quality by design activities: determining risk assessment severity rankings and establishing preliminary control strategies for cri

SUBMITTER: Taylor C 

PROVIDER: S-EPMC8614990 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature