Biological Characterization and Assay of Cytokines and Growth Factors

Book excerpt: Cytokines and growth factors have vast therapeutic potentials for a wide range of diseases. Many have been cloned and produced, using recombinant DNA technology, by the biopharmaceutical industry. Of these, several have proved to be extremely successful biological medicines with increasing numbers undergoing clinical trials. One aspect of the successful development of these proteins as therapeutics is assuring quality control. This can mainly be achieved through thorough characterization of the product, both biologically and physico-chemically. In this book, leading scientists from industry, research and regulatory agencies present papers on the various methods currently available for analyzing cytokines and growth factors, including novel, developing technology. A particular focus on bioassays provides a unique and comprehensive coverage of their relevance, design, execution and analysis during product development and manufacture. This volume should be read by all those working on protein therapeutics, as many of the principles described generally apply to any biological product. Scientists working in industry and regulatory authorities will find it a useful reference for drug development and licensing.