Rathore, a scientist in process development, and Sofer, director of regulatory compliance at a biosciences firm, offer practical guidelines, recommendations, an... » 

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 «