This week the Bioprocessing Summit is happening in Boston and virtually.
The popular 9th Annual Rapid Methods to Assess Quality & Stability of Biologics conference track will bring together experts in analytical and formulation development to discuss rapid and practical ways to accelerate prediction and screening for protein instabilities in early- and late-stage development. The conference features case studies, unpublished work on new methods and tools employed in real-time and accelerated stability studies for proteins, cell and gene therapy products, high-throughput analytics, developability assessment, high-throughput analytics, multi-attribute methods, post-translational modifications, and stability in vaccines.
In the category of Biologic Stability, Danny Chou (Compassion BioSolution, LLC) is presenting findings from his recent work on "Accelerated Strategies to Assess Interfacial Stability of Biopharmaceuticals" on Tuesday, August 17th, at 3pm. The talk will focus on the latest developments in rational strategies to evaluate the effects of surface-mediated stress on antibody instability. The focus will be on early detection and mechanistic understanding that will enable the creation of an effective control strategy in the industrial setting.
He is also hosting an in-person interactive discussion at 4:45pm on "Advances in Process Analytical Technology (PAT) for Therapeutic Protein and Cell/Gene Therapy Development and Manufacturing" that will cover the following topics:
- What is the role of PAT in the biopharmaceutical industry? How does this role differ between protein pharmaceutical development/manufacturing and Advanced Medicinal Products like gene therapy and cell therapy?
- What are some of the critical quality attributes that can be monitored by real-time methods and what the key gaps that remain unfulfilled?
- What can we do to make PAT more efficient and easy to implement in the real world?