ESETEC® and DoE: A powerful platform for rapid process development of target protein fermentation processes

Using Wacker’s E. coli based secretion technology (ESETEC^®), the target proteins are directed into the culture supernatant, thus avoiding cell breakage or complex refolding steps. The technology is ideally suited for the expression of biopharmaceuticals (e.g. Fab fragments). Selected case studies at different stages show our approach starting from strain selection during feasibility studies until complete process development. DoE (design of experiment) is implemented for different process steps to improve the product yield and to reduce the development time. Based on the first generic fermentation experiments during feasibility studies we define an experimental design space varying significant parameters to analyze the collected data with the DoE program Modde (Umetrix). DoE is also used to establish filtration steps by means of screening experiments during process optimization. The resulting processes are scalable to pilot scale fermentation and filtration, respectively.