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Peptide therapy has become a key strategy in innovative drug development, however, one of the potential barriers for the development of novel peptide drugs in the clinic is their deficiencies in clearly defined chemistry, manufacturing and controls (CMC) strategy from clinical development to commercialization. CMC can often become a rate-limiting step due to lack of knowledge and lack of a formal policy or guidelines on CMC for peptide-based drugs. Regulators use a risk-based approach, reviewing applications on a case-by-case basis.Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing, and Controls covers efficient manufacturing of peptide drug substances, a review of the process for submitting applications to the regulatory authority for drug approval, a holistic approach for quality attributes and quality control from a regulatory perspective, emerging analytical tools for the characterisation of impurities, and the assessment of stability.This book is an essential reference work for students and researchers, in both academia and industry, with an interest in learning about CMC, and facilitating development and manufacture of peptide-based drugs.

This book covers the latest developments in the physical biology of proteins and peptides. Key insights into microscopic and macroscopic approaches to describe biologically relevant macromolecules and their interactions are provided. This book also covers a wide range of tools, including theoretical methods as statistical mechanics, normal mode analysis, kinetic theory and stochastic processes, and all-atom and coarse-grained molecular dynamics simulations. New experimental techniques are also discussed, particularly related to amiloidogenic peptides and their mutations. This is an excellent book for molecular biologists, physicists, computational scientists, and chemists. It covers cutting-edge research in this exciting, interdisciplinary research field.This book also:Discusses the latest developments in the physical biology of proteins, peptides and enzymes covering theoretical, computational, and experimental approachesBroadens readers'understanding on the role of intra- and inter-molecular interactions as a fundamental cornerstone of macroscopic biological properties of macromoleculesProvides a wide and useful perspective on different aspects of the physics, biology, and chemistry of proteins and peptides suitable for interdisciplinary research.

The field of peptide based cancer vaccines has evolved tremendously in the last decade of this century. The exploration on how to apply the peptide knowledge for vaccination purposes began when it was demonstrated that these peptides after being mixed into adjuvants actually induced T cell responses that could prevent virus infections and tumor growth in experimental animal models. The results of animal models are currently translated into clinical applications with all their associated difficulties and heterogeneity. Initial promising data do appear, warranting further research in this area. This book pays tribute to key researchers in the field.