Commercialization of a drug is a monumental milestone that hinges on years of lifecycle management. As a product enters commercialization, product sponsors are positioned to derive demand from a fluid market. Analysis of supply will inevitably question the cost of goods sold (COGS) and whether it is a process of scale-out or scale-up. In some cases, the decision must be made on how to scale up the process, which may require leaving the existing 2,000 L single-use bioreactor (S.U.B.) systems and moving the process into larger stainless steel vessels. Up until this point, there is a volumetric gap separating the single-use technology and stainless steel bioreactors. Existing 2,000 L S.U.B.s are supply chain limiting, while stainless steel systems can pose other challenges when demand remains fluid.
In this portion of Thermo Fisher's application note series, the goal was to evaluate the performance of the DynaDrive S.U.B., HyPerforma S.U.B., and Cytiva™ XCellerex™ XDR S.U.B. using four different cell lines with an XCellerex XDR S.U.B.–specific process developed in either the HyPerforma or XCellerex XDR systems for each cell line. These experiments were designed to demonstrate that these processes could be successfully transferred across different systems without impacting the process performance or product quality. A range of host cell platforms and processes was selected to demonstrate robustness and applicability across the diverse landscape in upstream bioprocessing.
If this topic interests you, please view Part 1 and Part 2 of this series as well.