Senior Director Merck & Co. Kenilworth, New Jersey, United States
It will be one piece of a larger, 2-hr symposium. this will be the first presentation
1. Patient-centric combination drug product of high concentration biologics: challenges are still there
Speaker: Nicole Buist, Senior Director, Biologics Development and Biopharmaceutics, Merck & Co, Inc.
High-concentration and high-volume biologics offer convenience to health care providers and patients. Therefore, many commercialized IV products and ongoing pipelines are positioned to develop combination drug products. The interplay among formulation, device, and analytical functions ensures a successful drug product. However, the communities are aware of the challenges, including protein stability at high concentration, chemical and mechanism stress from prefilled syringes, and biophysical and biochemical characterization of as-is formulation without dilution. The presentation will emphasize these stability-relevant incidents and tell stories of cross-functional collaborations for high-concentration biologics.
Learning Objectives:
Provide understanding of the challenges facing biologics product developers
Share insights as to how some members of the industry are thinking about these challenges
Close with a brief synopsis of outstanding questions that remain for the field
ce, and analytical functions
