Building on the realization of continuous manufacturing for commercial small molecule APIs and drug products, the dominos finally are beginning to fall into place for the advancement of integrated processes for biopharmaceutical applications. Regulatory engagement, novel and disruptive process and measurement technologies, and simple economics all are playing key roles in recent progress. This forum, intended for a broad audience of scientists and business leaders across the MassBio community, will explore how each of these change-agents are helping to overcome long-time deterrents and, in doing so, have the potential for improving manufacturing reliability and product quality – thereby reducing risks to patients and other key stakeholders.

Discussion and Key Take-Aways Will Include:

1. Establishing the business case for continuous biomanufacturing – when and for what applications does it make sense?
2. Applying single-use technologies, automation, and other innovations to enable success in downstream continuous processing.
3. Advances in measurement and process analytical technologies to enable process/product understanding in alignment with regulatory guidances.