By Anthony Stewart, Technical Project Manager, Kymanox Corporation, Morrisville, North Carolina
Biologics, including cell and gene therapies, have become a hot topic in the pharmaceutical industry as their therapeutic applications expand. Challenges of developing biologic drug products include scale-up for commercial manufacturing and production at a high enough purity for effective medical applications. Thus, it is critical to examine the biomanufacturing steps that produce biologic drug products in order to optimize the process for the necessary production scale without losing quality and purity.
Bioreactors are a commonly utilized technology in upstream bioprocessing operations for expansion and production of the target API. Temperature, pH, dissolved oxygen, and agitation are a few of the common Critical Process Parameters (CPPs) for bioreactor operations which are controlled and monitored through various operator and engineering controls throughout the process. In this article, learn how successfully maintaining these parameters helps to optimize product quality, potency, impurity profiles, total cell density and titer/protein concentration (productivity), and ultimately deliver critical drugs to patients.