Design of Experiments for Modeling of Fermentation Process Characterization in Biological Drug Production

Abstract

Biological products are increasingly important, and therefore the industry has begun to adopt quality by design, as recommended by the ICH and the U.S. FDA. Smaller companies, however, have faced difficulties in employing full-scale experiments or the quality by design strategy. Thus, this study provides an alternative way to build a model from existing data with experimental software that does not require full-scale experiments. This empirical study hopes to provide a practical way to improve the efficiency of smaller biopharmaceutical companies and researchers. Moreover, the models provided here can be applied to process characterization in recombinant protein production.