Identify & Define Your Cell Therapy's Biomanufacturing Approach For Critical Process Parameters (CPPs)

By Josephine Lembong

Cell products are very complex and may never be fully characterized. Therefore, especially for CGT, the process is currently an important aspect of defining the end product, along with the Critical Quality Attributes (CQAs).

The FDA has attributed good manufacturing process control as one of the key factors to ensure successful CGT product development. In order to develop a robust manufacturing process, it is important to identify the Critical Process Parameters (CPPs) and define their ranges of acceptable values.

To help ensure the maintenance of stable CQAs, we strive to maintain a consistent manufacturing process. This process includes CQAs already defined during product development, as well as the unknown ones. A consistent cell therapy manufacturing process entails a good scientific understanding of the process parameters in each unit operation and implementation of appropriate controls. That starts with identifying the CPPs in manufacturing.