Rathore, a scientist in process development, and Sofer, director of regulatory compliance at a biosciences firm, offer practical guidelines, recommendations, and an abundance of industrial case studies demonstrating various techniques and approaches in the validation of biopharmaceutical processes. The book is suitable as a reference for newcomers to the field and provides useful examples to seasoned professionals in biochemistry, medicinal and biopharmaceutical chemistry, biotechnology, and molecular biology, as well as specialists in process development, validation, and quality assurance and control.