A Comprehensive Guide to Crucial Attributes of Therapeutic Proteins in Biological Pharmaceuticals With this book, Dr. Raju offers a valuable resource for professionals involved in research and development of biopharmaceutical and biosimilar drugs. This is a highly relevant work, as medical practitioners have increasingly turned to biopharmaceutical medicines in their search for safe and reliable treatments for complex diseases, while pharmaceutical researchers seek to expand the availability of biopharmaceuticals and create more affordable biosimilar alternatives. Readers receive a thorough overview of the major co-translational modifications (CTMs) and post-translational modifications (PTMs) of therapeutic proteins relevant to the development of biotherapeutics. The majority of chapters detail individual CTMs and PTMs that may affect the physicochemical, biochemical, biological, pharmacokinetic, immunological, toxicological etc. properties of proteins. In addition, readers are guided on the methodology necessary to analyze and characterize these modifications. Thus, readers gain not only an understanding of CTMs/PTMs, but also the ability to design and assess their own structure-function studies for experimental molecules. Specific features and topics include: Discussion of the research behind and expansion of biopharmaceuticals Twenty chapters detailing relevant CTMs and PTMs of proteins, such as glycosylation, oxidation, phosphorylation, methylation, proteolysis, etc. Each chapter offers an introduction and guide to the mechanisms and biological significance of an individual CTM or PTM, including practical guidance for experiment design and analysis An appendix of biologic pharmaceuticals currently on the market, along with an assessment of their PTMs and overall safety and efficacy This volume will prove a key reference on the shelves of industry and academic researchers involved in the study and development of biochemistry, molecular biology, biopharmaceuticals and proteins in medicine, particularly as biopharmaceuticals and biosimilars become ever more prominent tools in the field of healthcare.

Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing. • Guides readers through the complex landscape involved with developing biosimilar versions of monoclonal antibody (mAb) drugs • Features flow charts, tables, and figures that clearly illustrate processes and makes the book comprehensible and accessible • Includes a review of FDA-approved mAb drugs as a quick reference to facts and useful information • Examines new technologies and strategies for improving biosimilar mAbs

A Comprehensive Guide to Crucial Attributes of Therapeutic Proteins in Biological Pharmaceuticals With this book, Dr. Raju offers a valuable resource for professionals involved in research and development of biopharmaceutical and biosimilar drugs. This is a highly relevant work, as medical practitioners have increasingly turned to biopharmaceutical medicines in their search for safe and reliable treatments for complex diseases, while pharmaceutical researchers seek to expand the availability of biopharmaceuticals and create more affordable biosimilar alternatives. Readers receive a thorough overview of the major co-translational modifications (CTMs) and post-translational modifications (PTMs) of therapeutic proteins relevant to the development of biotherapeutics. The majority of chapters detail individual CTMs and PTMs that may affect the physicochemical, biochemical, biological, pharmacokinetic, immunological, toxicological etc. properties of proteins. In addition, readers are guided on the methodology necessary to analyze and characterize these modifications. Thus, readers gain not only an understanding of CTMs/PTMs, but also the ability to design and assess their own structure-function studies for experimental molecules. Specific features and topics include: Discussion of the research behind and expansion of biopharmaceuticals Twenty chapters detailing relevant CTMs and PTMs of proteins, such as glycosylation, oxidation, phosphorylation, methylation, proteolysis, etc. Each chapter offers an introduction and guide to the mechanisms and biological significance of an individual CTM or PTM, including practical guidance for experiment design and analysis An appendix of biologic pharmaceuticals currently on the market, along with an assessment of their PTMs and overall safety and efficacy This volume will prove a key reference on the shelves of industry and academic researchers involved in the study and development of biochemistry, molecular biology, biopharmaceuticals and proteins in medicine, particularly as biopharmaceuticals and biosimilars become ever more prominent tools in the field of healthcare.

A single volume collection that surveys the exciting field of plant-made pharmaceuticals and industrial proteins This comprehensive book communicates the recent advances and exciting potential for the expanding area of plant biotechnology and is divided into six sections. The first three sections look at the current status of the field, and advances in plant platforms and strategies for improving yields, downstream processing, and controlling post-translational modifications of plant-made recombinant proteins. Section four reviews high-value industrial and pharmacological proteins that are successfully being produced in established and emerging plant platforms. The fifth section looks at regulatory challenges facing the expansion of the field. The final section turns its focus toward small molecule therapeutics, drug screening, plant specialized metabolites, and plants as model organisms to study human disease processes. Molecular Pharming: Applications, Challenges and Emerging Areas offers in-depth coverage of molecular biology of plant expression systems and manipulation of glycosylation processes in plants; plant platforms, subcellular targeting, recovery, and downstream processing; plant-derived protein pharmaceuticals and case studies; regulatory issues; and emerging areas. It is a valuable resource for researchers that are in the field of plant molecular pharming, as well as for those conducting basic research in gene expression, protein quality control, and other subjects relevant to molecular and cellular biology. Broad ranging coverage of a key area of plant biotechnology Describes efforts to produce pharmaceutical and industrial proteins in plants Provides reviews of recent advances and technology breakthroughs Assesses realities of regulatory and cost hurdles Forward looking with coverage of small molecule technologies and the use of plants as models of human disease processes Providing wide-ranging and unique coverage, Molecular Pharming: Applications, Challenges and Emerging Areas will be of great interest to the plant science, plant biotechnology, protein science, and pharmacological communities.

Post-translational modifications serve many different purposes in several cellular processes such as gene expression, protein folding and transport to appropriate cell compartment, protein-lipid and protein-protein interactions, enzyme regulation, signal transduction, cell proliferation and differentiation, protein stability, recycling and degradation. Although several-hundred different modifications are known, the significance of many of them remains unknown. The enormous versatility of the modifications which frequently alter the physico-chemical properties of the respective proteins represents an extraordinary challenge in understanding their physiological role. Since essential cellular functions are regulated by protein modifications, an improvement of current understanding of their meaning might allow new avenues to prevent and/or alleviate human and animal diseases.

How the amino acid sequence of a protein determines its three-dimensional structure is a major problem in biology and chemistry. Leading experts in the fields of NMR spectroscopy, X-ray crystallography, protein engineering and molecular modeling offer provocative insights into current views on the protein folding problem and various aspects for future progress.

This book focuses on the mechanical properties of cells, discussing the basic concepts and processes in the fields of immunology, biology, and biochemistry. It introduces and explains state-of-the-art biophysical methods and examines the role of mechanical properties in the cell/protein interaction with the connective tissue microenvironment. The book presents a unique perspective on cellular mechanics and biophysics by combining the mechanical, biological, physical, biochemical, medical, and immunological views, highlighting the importance of the mechanical properties of cells and biophysical measurement methods. The book guides readers through the complex and growing field of cellular mechanics and biophysics, connecting and discussing research findings from different fields such as biology, cell biology, immunology, physics, and medicine. Featuring suggestions for further reading throughout and addressing a wide selection of biophysical topics, this book is an indispensable guide for graduate and advanced undergraduate students in the fields of cellular mechanics and biophysics.

This book focuses on respiratory proteins, the broad hemoglobin family, as well as the molluscan and arachnid hemocyanins (and their multifunctional roles). Featuring 20 chapters addressing invertebrate and vertebrate respiratory proteins, lipoproteins and other body fluid proteins, and drawing on the editors’ extensive research in the field, it is a valuable addition to the Subcellular Biochemistry book series. The book covers a wide range of topics, including lipoprotein structure and lipid transport; diverse annelid, crustacean and insect defense proteins; and insect and vertebrate immune complexes. It also discusses a number of other proteins, such as the hemerythrins; serum albumin; serum amyloid A; von Willebrand factor and its interaction with factor VIII; and C-reactive protein. Given its scope, the book appeals to biologists, biomedical scientists and clinicians, as well as advanced undergraduates and postgraduates in these disciplines. Available as a printed book and also as an e-book and e-chapters, the fascinating material included is easily accessible.

Biophysical Characterization of Proteins in Developing Biopharmaceuticals, Second Edition, presents the latest on the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure, this book explains the best way to achieve this goal using key methods commonly employed in the biopharmaceutical industry. This book will help today's industrial scientists plan a career in this industry and successfully implement these biophysical methodologies. This updated edition has been fully revised, with new chapters focusing on the use of chromatography and electrophoresis and the biophysical characterization of very large biopharmaceuticals. In addition, best practices of applying statistical analysis to biophysical characterization data is included, along with practical issues associated with the concept of a biopharmaceutical's developability and the technical decision-making process needed when dealing with biophysical characterization data. - Presents basic protein characterization methods and tools applicable to (bio)pharmaceutical research and development - Highlights the capabilities and limitations of each technique - Discusses the underlining science of each tool - Empowers industrial biophysical chemists by providing a roadmap for applying biophysical tools - Outlines the needs for new characterization and analytical tools in the biopharmaceutical industry

This extensive volume covers basic and advanced aspects of peptide antibody production, characterization and uses. Although peptide antibodies have been available for many years, they continue to be a field of active research and method development. For example, peptide antibodies which are dependent on specific posttranslational modifications are of great interest, such as phosphorylation, citrullination and others, while different forms of recombinant peptide antibodies are gaining interest, notably nanobodies, single chain antibodies, TCR-like antibodies, among others. Within this volume, those areas are covered, as well as several technical and scientific advances: solid phase peptide synthesis, peptide carrier conjugation and immunization, genomics, transcriptomics, proteomics and elucidation of the molecular basis of antigen presentation and recognition by dendritic cells, macrophages, B cells and T cells. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols and tips on troubleshooting and avoiding known pitfalls. Comprehensive and authoritative, Peptide Antibodies: Methods and Protocols serves as an ideal reference for researchers exploring this vital and expansive area of study.