Session: Symposium: Enabling Excipients and Approaches for Advancing Formulation and Delivery 1
Understanding Surfactant-Protein Interactions in Mitigating Interface-Induced Protein Particle Formation in Biotherapeutic Solutions Subjected to Interfacial Stresses
Protein-based biotherapeutics, and specifically monoclonal antibodies (mAbs), have recently seen tremendous growth, given their tremendous ability to treat a host of diseases. Unfortunately, they are inherently unstable. Manufacturing, storage and administration of these protein-based biotherapeutics also involves exposure of the biotherapeutic to a wide variety of stresses, that further lead to protein instability and ultimately undesired protein particle formation (PPF). In this talk, I will discuss how coupling tensiometry techniques with microflow imaging techniques can be used to assess and predict the stability of several mAb formulations, both in the absence and presence of interfacial dilatational stress. Specifically, we will discuss how surfactant-biotherapeutic interactions at teh air-water interface can be used to obtain the mechanisms by which surfactants can prevent protein particle formation at interfaces.
Learning Objectives:
Understand the mechanism of interface-induced protein particle formation
Understand the mechanism of competetive adsorption between surfactant and biotherapeutics
Discuss how addition of surfactant can mitigate protein particle formation