White Paper: Characterization Of Hydrolysates To Enhance CHO Cell Culture Process Understanding

The capacity for protein hydrolysates to exert substantial positive impact on cell growth and/or protein production in cell culture systems is well documented. Consequently, biopharmaceutical producers commonly include hydrolysates in their processes as part of a complete medium formulation or a fed-batch bioreactor system. Despite their beneficial effects, however, hydrolysates are by nature an undefined and variable component that makes them undesirable for highly controlled pharmaceutical production processes. Nevertheless, they are often tolerated in order to keep product titers high. This paper describes SAFC Biosciences® successful efforts to mitigate potential risks from the use of hydrolysates by replacing them with a chemically defined (CD) alternative product that incorporates components found in four hydrolysate types. This product — EX-CELLTM CD Hydrolysate Fusion — meets and sometimes exceeds desired performance goals in many Chinese Hamster Ovary (CHO) cell systems.