Webinar: Formulation Strategies to Prevent Protein Degradation
August 3, 2017, Thu 12:30 PM EDT.
Organized by: Product Attributes and Biological Consequences Focus Group
Moderated by: Tapan Das, Bristol-Myers Squibb
About the Webinar: Assessment of product attributes is an evolving process from the discovery phase to clinical stages to product approval & commercial manufacturing. In the early discovery and development stages, detailed understanding of every quality attribute may not be meaningful, rather the emphases are on establishing safety and biological function of the product and producing them in a consistent manner. When developing a commercial process & formulation, appropriate analytical, structural, and biological assays are developed that are capable of studying the components in a heterogeneous biologics product, and understand its impact on function, safety, stability, microbiological safety, and dosage form integrity.
In order to achieve the above goals, it is important that pharmaceutical and biotechnology scientists have fundamental understanding of protein formulation and analytical development. Specifically, it is important that industry and academic pharmaceutical scientists are up to speed regarding formulation strategies that prevent protein degradation.
- Discuss strategies and mechanisms for preventing physical degradation
- Review strategies and mechanisms for preventing chemical degradation
- Explain novel analytical methods, especially for particle analysis (sub-visible and visible particles).
Dr. Tim Menzen is one of the contributors.