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Immunogenicity of Biopharmaceuticals is the first book to comprehensively address the potential of an immune response to biopharmaceuticals. It is intended to give a broad overview of the current state-of-the-art regarding this subject. The chapters range from an overview of the immune system and factors that may trigger the immune system, via detection of antibodies and clinical implications, to various case examples and the regulatory view on immunogenicity.
Protein pharmaceuticals form a fast-growing category in the arsenal of drugs. This book explores the nature of different analytical techniques and the way in which they are related to pharmaceutical proteins. In addition to serving the analytical chemist, this book is needed by the formulation scientist who is responsible for design and formulation of a pharmaceutical protein that can be monitored during production and over time.
The aim of this book is to present a range of analytical methods that can be used in formulation design and development and focus on how these systems can be applied to understand formulation components and the dosage form these build. To effectively design and exploit drug delivery systems, the underlying characteristic of a dosage form must be understood--from the characteristics of the individual formulation components, to how they act and interact within the formulation, and finally, to how this formulation responds in different biological environments. To achieve this, there is a wide range of analytical techniques that can be adopted to understand and elucidate the mechanics of drug de...
Although infrared spectroscopy has been applied with success to the study of important biological and biomedical processes for many years, key advances in this vibrant technique have led to its increasing use, ranging from characterisation of individual macromolecules (DNA, RNA, lipids, proteins) to human tissues, cells and their components. Infrared spectroscopy thus has a significant role to play in the analysis of the vast number of genes and proteins being identified by the various genomic sequencing projects. Whilst this book gives an overview of the field it highlights more recent developments, such as the use of bright synchrotron radiation for recording infrared spectra, the developm...
Newcomers to the field of biopharmaceuticals require an understanding of the basic principles and underlying methodology involved in developing protein- and nucleic acid-based therapies for genetic and acquired diseases. Biomaterials for Delivery and Targeting of Proteins and Nucleic Acids introduces the principles of polymer science and che
This book describes how to address the analysis of aggregates and particles in protein pharmaceuticals, provides a comprehensive overview of current methods and integrated approaches used to quantify and characterize aggregates and particles, and discusses regulatory requirements. Analytical methods covered in the book include separation, light scattering, microscopy, and spectroscopy.
The volume details techniques, methods, and conceptual developments to further the study of protein aggregation with emphasis on the pleiomorphic proteins implicated in etiology of neurodegeneration. Chapters guide readers through in vitro and in vivo studies of fibrillization and liquid-liquid phase separation processes, and offer a comprehensive account of the state-of-art of structural studies of protein aggregation. Written in the format of the highly successful Methods in Molecular Biology series, each chapter includes an introduction to the topic, lists necessary materials and reagents, includes tips on troubleshooting and known pitfalls, and step-by-step, readily reproducible protocols. Authoritative and cutting-edge, Protein Aggregation: Methods and Protocols aims to be useful and practical guide to new researchers and experts looking to expand their knowledge.
Advances in biotechnology have provided scientists with an increasing number of biopharmaceuticals such as novel peptide and protein drugs as well as nucleic acid based drugs for gene therapy. However, successful delivery of these biopharmaceuticals is a major challenge because their molecular properties lead to poor physical and chemical stability in the body and limited membrane permeability. Therefore researchers are developing a range of new delivery technologies and materials to enable these new drugs to be delivered intact to their target sites. Delivery Technologies for Biopharmaceuticals describes strategies to overcome the main barriers for successful delivery of therapeutic peptide...
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