Bücher von Sarfaraz K. (Therapeutic Proteins International Niazi

This comprehensive bioprocessing textbook deals with the basic concepts, definitions, methods, and applications of the use of biological catalysts to deliver products of high value and utility, from alcohol to recombinant monoclonal antibodies to common day use fuel. It covers all modern aspects, including the means of processing that are required for drug processing to the use of biofuels, downstream bioprocessing, bioprocess design, and regulatory affairs, among many other cutting-edge topics. Applications and case studies are incorporated throughout.

The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products.