Achieving drug products that meet purity, efficacy, and quality standards depends first on cell culture quality and bioreactor performance. New analytical approaches, next-generation therapies, and innovative strategies for culture systems using a range of bioreactor types have led to a better understanding of upstream processes while reducing biopharmaceutical process/development time and costs.
Oxygen kLa Correlation for Rocking-Motion Bioreactors
E. Shaughnessey, et al. (Sanofi)
Single-use rocking-motion bioreactors are popular systems used in biomanufacturing. Previous studies have investigated oxygen transfer at singular set points. The authors characterized oxygen transfer behavior across a wide range of operating conditions relevant to mammalian cell culture in a wave-motion system. Cell-free oxygen transfer experiments were performed in three bag sizes and two different working volumes per bag. The mass transfer coefficient (kLa) was determined across a range of rocking rates and angles.
Demonstrating Scalable T-Cell Expansion in Stirred Tank Bioreactors
Klarer A, et al. (Hitachi Chemical Advanced Therapies, University College London)
One major hurdle in regenerative medicine manufacturing is the development of a reliable, efficient, and scalable method of cell culture. In this study, the authors used a microbioreactor system to produce T-cell expansion data representative of large-scale stirred-tank bioreactors and compared growth in that bioreactor to growth in static cultures. The study focuses on a proof-of-concept for growing healthy donor-derived T-cells from three unique donors.
Single-Use BioreactorsPerformance and Usability Considerations, Part 1 — Performance and Process Control
Sponsored by Thermo Fisher Scientific
Mark T. Smith et al.
Single-use technologies are a propitious option for creating low-cost, efficient, and flexible bioprocesses that are capable of streamlining development stages from process development through commercial manufacturing. The ability to be closed, flexible, and in parallel are key factors for nimble scheduling and manufacturing to maximize production efficiencies. In part 1 of this article, the authors
Focus on reactor performance of its Hyperforma single-use bioreactor to control process parameters.