Author Archives: Yuki Abe

Figure 2: Building a toolbox of CHO MAb flexible production platforms; shaded area depicts increasing intensification from the batch stainless steel processing of today, to the next-generation continuous processes currently under evaluation, to the further intensified processes of the future, with fewer unit operations.

Standardized Economic Cost Modeling for Next-Generation MAb Production

Historically, in generating material for clinical testing during antibody process development, emphasis was placed on efficacy, product quality, regulatory compliance, and speed. As the biopharmaceutical industry has matured (and with increasing competition), emphasis has shifted toward cost optimization and manufacturability. Reducing the costs of medicines for patients and payers (thereby broadening access to drugs) is now a key driver during development of new therapies as well as modernizing processes for existing molecules. Cost reduction includes providing robust manufacturing processes that…