Protein pharmaceuticals form a fast-growing category in the arsenal of drugs. In the coming years, the patents on a number of the first-generation protein pharmaceuticals will expire, opening the door for the development of biogenerics into the market. However, it is very difficult to characterize these compounds so that the results can be replicated in a generic form. This volume details the nature of the different analytical techniques and how they are relevant for characterizing pharmaceutical proteins. In addition to serving the analytical chemist, this book is needed by the formulation scientist who is responsible for design and formulation of a pharmaceutical protein that can be monitored during production and over time. It also will be useful for students, fellows, and research scientists who are working in the academic world and in the pharmaceutical/biotechnology industry on basic aspects of proteins.

Protein pharmaceuticals form a fast-growing category in the arsenal of drugs. In the coming years, the patents on a number of the first-generation protein pharmaceuticals will expire, opening the door for the development of biogenerics into the market. However, it is very difficult to characterize these compounds so that the results can be replicated in a generic form. This volume details the nature of the different analytical techniques and how they are relevant for characterizing pharmaceutical proteins. In addition to serving the analytical chemist, this book is needed by the formulation scientist who is responsible for design and formulation of a pharmaceutical protein that can be monitored during production and over time. It also will be useful for students, fellows, and research scientists who are working in the academic world and in the pharmaceutical/biotechnology industry on basic aspects of proteins.