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

As the diversity of therapeutic pipelines rapidly expands to encompass novel formats, unique and exciting challenges have emerged in the development, manufacturing, and characterization of biologics. The diversity in the structures and physiochemical properties of these molecules, such as viral vectors, cell therapies, exosomes, novel protein molecules and configurations, synthetic peptides, and RNA, is driving process innovation in membrane filtration, precipitation, extraction, chromatography, centrifugation, and affinity technologies. Additionally, unlike traditional antibody processes, platform processes for these therapies are still in their infancy and significant challenges remain including process scaling, challenging impurity profiles, low product titers and yield, and evolving regulatory requirements. We encourage submitting papers on high throughput and traditional process development, scale-up/down, modeling, process control/optimization, and quality attribute characterization to further establish new approaches for downstream processing of novel therapeutic format. Submissions on use of creative separation approaches using novel techniques are strongly encouraged.

Ujjwal Bhaskar

Bristol Myers Squibb Co

Appearances