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

Handbook of Biogeneric Therapeutic Proteins is the first book to offer extensive coverage of all aspects of generic 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. The handbook 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. ---------------------Features--------------------- · Integrates all issues related to selection, intellectual property protection, regulation, manufacturing and testing · Includes full formulation details about every biological product approved by the FDA · Consolidates a broad range of resource materials about suppliers, manufacturers, and testing facilities · Presents a single source of practical guidelines for establishing production facilities for making biological products