Statistical Methods for Bioprocess Development and Commercializaton

Written as a single source reference that specifically covers statistics for bioprocess development, this text serves as a manual for implementation of QbD principles. It presents current statistical methods and case studies in the area of biotechnical process development and subsequent process characterization and commercialization. It covers topics in bioassay and other analytical method development, with designed experiments for critical process input screening. Other topics covered include multivariate tools for metabolomics and cell culture medium development, short term stability data analysis, process sampling procedures, and multivariate analysis methods for monitoring cell culture and fermentation processes.