Developing A Robust Manufacturing Process For Live Biotherapeutic Products

Developing a new live biotherapeutic product (LBP) involves significant effort being placed into the preclinical aspects of the target strain, such as to provide the best possible drug against the target condition. This is an important first stage, but sponsors often wait until the requirement for preclinical studies to evaluate whether the target strain can be manufactured at scale. This can lead to delays in manufacturing and incursion of additional costs.

By developing a robust process that can be commercially transferred upon the successful completion of clinical work, sponsors can ensure maximum market returns are possible after a long investment period. LBP growth requirements are specific to the strain and the stage of the manufacturing process. Constant checks and development through the early stages are critical to identify all the optimal conditions in combination rather than isolation.

Identifying and partnering with a microbial CDMO that understands which methods may be appropriate for a particular LBP can help ensure maximum potency. Examine the role of communication and collaboration in maintaining a productive CDMO partnership and how the right partner will help streamline processes, save time and money, and move these next-generation therapeutics into clinical use.