(531b) Performance Characterization and Process Validation of a Mini-Scale Bioreactor  for Recombinant Mammalian Cells

Mandar Makwana, Shashi Hoskatti, Kimberly Yan, Duke Shen,

Brent Chamberlin, Emily Shen, Parviz Shamlou

 

Amgen Bioprocessing Center, Keck Graduate Institute, 535 Watson Drive, Claremont, CA 91711

Reliable scale‐up of mammalian cell culture bioreactors require knowledge of mixing and oxygen transfer occurring during cell culture operation and as the number of therapeutic molecules coming through from discovery increases process design and development engineers have had to develop and validate new technologies and methodologies to speed up time to market, and reduce cost and labor associated with commercial scale operation. In recent years computational fluid dynamics (CFD) analysis of flow and mixing has become industry method of choice process understanding, scale up and scale-down of bioreactors.

In this presentation, CFD simulations will be provided for comparisons of flow patterns, power numbers, and cell culture performance for a new 500 mL scale (Applikon MiniBio 500) and 3L scale (Applikon) bioreactors. Comparison of experimental data (viable cell density, cell viability and specific growth rate) at constant power per unit volume provided a rational basis for scale-up and confirmed the applicability of the MiniBio 500 as a scale-down model of cell culture bioreactor.