Characterization of biotechnology pharmaceutical products

This publication addresses the parameters necessary for characterizing the safety, identity, purity, consistency and potency of biotechnology-derived products. The abilities and limitations of current analytical methodologies for defining such products and for assessing their comparability during development are examined. The data reviewed in this volume serve as a foundation for defining the properties of well-characterized products, including proteins and other molecular entitles.This book will be a valuable reference for professionals involved in the development of biotechnology products, including manufacturing process engineers and individuals concerned with quality assurance, quality control, validation, regulatory affairs, and preclinical/clinical development.