ABEC, a leading global provider of integrated process solutions and services for biopharmaceutical manufacturing, today announced a successful demonstration of their Custom Single Run™ (CSR™) Bioreactor at a confidential biotech client. ABEC delivered a CSR Bioreactor custom designed to match the performance of the client’s large-scale stainless steel production bioreactors. The CSR Bioreactor showed equivalent process performance, greatly simplifying the client’s scale-up and transfer of new products from development to production.
Scale-up and transfer of cell culture processes from single use bioreactors can be challenging. The single use bioreactors currently on the market are standardized systems with little or no design flexibility to accommodate specific process needs. Performance of these systems can also degrade at larger scale. Process transfer and scale-up can therefore require significant development effort and/or compromises to performance.
CSR is a unique paradigm for single use implementation. Systems can be custom-engineered for optimum process performance, greatly simplifying scale-up and transfer. For this effort, ABEC determined the baseline blending and mass transfer characteristics of the client’s stainless steel production bioreactors, and delivered a 200L CSR Bioreactor engineered for equivalent performance. The 200L CSR not only demonstrated equal or better oxygen transfer rates (OTR) and blend times, but also equivalent viable cell density and product titer.
“This collaboration provided our client with a clear path for rapid scale-up of more than 10x in volume as well as seamless transfer of cell culture processes across different sites and between stainless steel and single use platforms,” said Scott Pickering, ABEC President and CEO. “We are pleased that our innovative CSR approach is demonstrating genuine value to our clients.”
Visit with ABEC (Stand #3759 & #3760) March 21-23, Interphex 2017, Javits Convention Center, NYC.