Implementing Effective Control Strategies for Biopharmaceutical Manufacturing
Author:
Dr James Parsley
Head of CMC & Principal Consultant
Introduction
Biopharmaceuticals come in many modalities with varied shapes and sizes, and the manufacturing processes can vary considerably in complexity as a result. They can range from antibodies to antibody drug conjugates, cell and gene therapies, vaccines, live biotherapeutic products, enzymes and many more.
Despite this, the overarching regulatory requirements remain the same and therefore, so do the concepts of the control strategy put in place. Namely, the regulatory guidance is in place to ensure that the final product maintains the desired quality, thereby ensuring that safety and efficacy will not be affected.
The level of control applied to the manufacture of biopharmaceutical products should increase while progressing in clinical development and ultimately the marketing authorisation; hence it should be phase appropriate. The risk assessment must take into consideration all stages of the manufacturing process including input materials, the potential for risks incurred throughout the process, the final product and beyond. Each of these stages could be considered as pillars of the overarching control strategy and can be split into the following: 1) release testing 2) in process testing and controls 3) starting materials testing and controls 4) stability testing 5) additional characterization and 6) the facilities and equipment.