Development and Manufacture of Protein Pharmaceuticals

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This text focuses on development, manufacture, and commercialization of pharmaceutical protein dosage forms. It 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. It delves deep into practical detail on the requirements, and how to meet them, for developing, manufacturing, and gaining regulatory approval of protein dosage forms.