Overview of the Impact of Protein Interfacial Instability on the Development of Biologic Products

Abstract

Interfacial phenomena can significantly affect the development, manufacturing, stability, and use of therapeutic proteins. Proteins are exposed to air-liquid, solid-liquid, and liquid-liquid interfaces throughout the product development cycle. The exposure of the protein molecules to different types of interfaces can lead to denaturation and subsequent formation of aggregates and particles. This introduction will emphasize the importance of understanding interfaces and interfacial stresses in the development of biologics. The chapter will also present the overall objectives, scope, and structure of this book. Subsequently, the chapter will introduce the various interfaces encountered in drug development, and the chapter concludes with perspectives on controlling undesired interfacial behavior and future research areas.