Handbook of Biogeneric Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues

Description

Handbook of Biogeneric Therapeutic Proteins is the first book to offer extensive coverage of all aspects of generic or biosimilar biological products, from the scientific basis through the marketing issues. This practical book includes comprehensive information on establishing a manufacturing system and securing regulatory approval for biogeneric pharmaceutical products. It explains how to establish facilities to manufacture the raw materials used in biological products and how to prepare finished products. The author also provides details about the Chemistry, Manufacturing, and Controls (CMC) section of the FDA's New Drug Application for Biological Products.

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