Division/Committee: [BIOT: Division of Biochemical Technology]

The ever-changing landscape of the biopharmaceutical industry creates new opportunities and challenges in downstream processing. As a result, many organizations are exploring unique approaches to improve productivity, increase the probability of success in manufacturing, and overcome difficult tech transfers. With these drivers, this session will explore advances in process transfer, scaling of unit operations, intensified manufacturing, and Process Analytical Technology (PAT). We welcome abstracts related to the use of fundamental or engineering models to scale unit operations, digital workflows in process transfer and monitoring, and novel approaches for ensuring process-facility fit. Submissions on bioprocess intensification in the form of continuous, semi-continuous, hybrid or any other level of integrated processing are also encouraged, especially those focusing on closed systems. Finally, we hope to explore new developments in the field of PAT with an emphasis on GMP implementation, real-time control, and associated regulatory challenges. Throughout the topics of this session, case studies and the manufacturing application of novel approaches are of particular interest and will be prioritized in selection.

Mayank Vats

Merck & Co Inc

Appearances