What You Need to Know About Process Characterization and Validation For Biologic Processes

A major factor in the growth of the biopharmaceutical industry over the last 20 years has been continuous innovation with monoclonal antibodies (mAbs), which now make up more than 50 percent of the overall biotherapeutic market. A significant driver for success with these therapeutic modalities has been the ability to use templated process and analytical platforms in process development and manufacturing in order to reduce timelines and facilitate robust scale-up.

The ubiquity of mAbs has resulted in a strong body of knowledge across the industry that can be leveraged to support critical risk-mitigation activities during the life cycle of biopharmaceutical drug management. This article focuses on the vital steps of process characterization and validation required for commercialization of your biologic molecule, where process control strategies are developed and implemented to minimize risk and control quality.