Head of Life Sciences R&D, North America Croda, Inc. Plainsboro, New Jersey
Sponsored By:
Description: Polysorbates (PS) are extensively used in mAb-based formulations to protect against interfacial stresses which can lead to protein aggregation and surface adsorption. In this talk, the audience will gain an appreciation for the complexity of these materials, the importance of how the synthetic approach and purification processes can impact their performance in the final formulation, as well as some of the current approaches used to address formulation stability challenges.
Learning Objectives:
learn about key manufacturing controls for polysorbates contributing to different grades and quality of polysorbates
understand impact of modified fatty acid distribution in polysorbates on mAb formulations and free fatty acid particle formation
understand impact of fractionated polysorbates in mAb formulations
