Full Description
Proteins are exposed to various interfacial stresses during drug product development. They are subjected to air-liquid, liquid-solid, and, sometimes, liquid-liquid interfaces throughout the development cycle-from manufacturing of drug substances to storage and drug delivery. Unlike small molecule drugs, proteins are typically unstable at interfaces where, on adsorption, they often denature and form aggregates, resulting in loss of efficacy and potential immunogenicity. This book covers both the fundamental aspects of proteins at interfaces and the quantification of interfacial behaviors of proteins. Importantly, this book introduces the industrial aspects of protein instabilities at interfaces, including the processes that introduce new interfaces, evaluation of interfacial instabilities, and mitigation strategies. The audience that this book targets encompasses scientists in the pharmaceutical and biotech industry, as well as faculty and students from academia in thesurface science, pharmaceutical, and medicinal chemistry areas.
Contents
1. Overview of the impact of protein interfacial instability on the development of biologic products .- 2. Protein adsorption at a gas-aqueous interface.- 3. Interfacial behaviors of proteins.- 4. Interfacial stresses during drug substance purification processes.- 5. Evaluation of interfacial stress during drug product development.- 6.Relating interfacial shear and dilatations stress-es to protein aggregation in mAbs.- 7. Analytical techniques for evaluating protein instability at interfaces.- 8. Analysis of aggregates and particles.- 9. Protein interfacial instability of mixing and lyophilization during drug product manufacturing process scale-up and tech transfer.- 10. Excipients: Characterization, purpose, and selection.- 11. Interfacial stress and proteins prepared in the solid state.- 12. Interfaces in protein drug delivery: device concern.- 13. Future perspectives.
