Development and Manufacture of Protein Pharmaceuticals

This text focuses on development, manufacture, and commercialization of pharmaceutical protein dosage forms. The text envelops and emphasizes GMP attributes of quality, safety, purity, and strength. Each author provides practical, proven approaches and methods to achieve quality protein dosage forms on a commercial scale. No other book on protein goes into such practical detail on the requirements, and how to meet them, for developing, manufacturing, and gaining regulatory approval of protein dosage forms.Nail, Steve L. is the author of 'Development and Manufacture of Protein Pharmaceuticals' with ISBN 9780306467455 and ISBN 0306467453.