Manufacturing and Bioprocessing – Biomolecular
2019 PharmSci 360
Breakthroughs like batteries capable of providing power to whole villages, autonomous cars or computer chips that mimic human organs have the potential to change our world for the better. Similarly, innovative new modalities and technologies are playing an increasingly important and prominent role in addressing major societal health challenges. In the area of biopharmaceutical development, new therapies and technologies are changing patient’s lives. Increasingly, Sponsors are pressured to expedite the availability of these therapies for the treatment of unmet medical needs and improved patient health. With the advancements that are occurring within the biopharmaceutical industry and generally within the genetic and molecular biology space we cannot afford to progress emerging technologies, innovation and new modalities forward at a snail’s pace.
Acceleration of drug development to meet clinical timelines can often result in Chemistry, Manufacturing and Controls (CMC) information becoming rate limiting to overall program development, thus, prompting the need to develop appropriate risk-based solutions/strategies to ensure that CMC is not the bottleneck for new marketing applications. Some of these strategies include, but are not limited to, increased use of platform/prior knowledge to support product expiry, increased emphasis on analytical comparability where appropriate, increased emphasis on use of representative lots for commercialization, increased use of post-approval commitments, and flexibility in timing of CMC data submission and review. This presentation will discuss some of the CMC challenges we are faced with due to the pace by which the industry is moving, and the need to provide patients with these innovative and much needed therapies.