Author: Rodney Pearlman Publisher: Springer Science & Business Media ISBN: 1489912363 Category : Medical Languages : en Pages : 371
Book Description
This is the first volume to make available specific case histories of therapeutic proteins and peptides that have been marketed or are currently under clinical testing. The editors have selected a wide range of molecules derived from monoclonal antibodies, recombinant DNA, and natural and chemical sources to provide formulation scientists with practical examples of the development of pharmaceutical products.
Author: James N. Herron Publisher: Springer Science & Business Media ISBN: 1489910794 Category : Medical Languages : en Pages : 374
Book Description
Proteins are still gaining importance in the pharmaceutical world, where they are used to improve our arsenal of therapeutic drugs and vaccines and as diagnostic tools. Proteins are different from "traditional" low-molecular-weight drugs. As a group, they exhibit a number of biopharmaceutical and formulation problems. These problems have drawn considerable interest from both industrial and aca demic environments, forcing pharmaceutical scientists to explore a domain previ ously examined only by peptide and protein chemists. Biopharmaceutical aspects of proteins, e.g., low oral bioavailability, have been extensively investigated. Although all possible conventional routes of ad ministration have been examined for proteins, no real, generally applicable alter native to parenteral administration in order to achieve systemic effects has yet been discovered. Several of these biopharmaceutical options have been discussed in Volume 4 of this series, Biological Barriers to Protein Delivery. Proteins are composed of many amino acids, several of which are notorious for their chemical instability. Rational design of formulations that optimize the native structure and/or bioactivity of a protein is therefore of great importance when long shelf life is required, as it is for pharmaceutical products. This issue has also been examined in two prior volumes of this series: Volume 2: Stability of Protein Pharmaceuticals (Part A) and Volume 5: Stability and Characterization of Protein and Peptide Drugs.
Author: Ved Srivastava Publisher: Royal Society of Chemistry ISBN: 1788014332 Category : Science Languages : en Pages : 572
Book Description
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.
Author: John F. Carpenter Publisher: Springer Science & Business Media ISBN: 1461505577 Category : Medical Languages : en Pages : 218
Book Description
Recombinant proteins and polypeptides continue to be the most important class of biotechnology-derived agents in today's pharmaceutical industry. Over the past few years, our fundamental understanding of how proteins degrade and how stabilizing agents work has made it possible to approach formulation of protein pharmaceuticals from a much more rational point of view. This book describes the current level of understanding of protein instability and the strategies for stabilizing proteins under a variety of stressful conditions.
Author: Puneet Tyagi Publisher: Elsevier ISBN: 0128210613 Category : Business & Economics Languages : en Pages : 316
Book Description
Oral Delivery of Therapeutic Peptides and Proteins provides a complete overview of the journey scientists pursue to attain protein and peptide oral delivery. The book highlights the physiological challenges that must be accounted for in addition to overcoming protease inhibition and acid stability issues that are commonly mentioned in this area of research. Primary topics include formulation technologies being adopted for oral delivery of proteins and peptides, modification of actives to make them more suited for oral delivery, animal models and their shortcomings in assessing oral bioavailability, and in vitro models to simulate drug absorption and transport. Academics and industry researchers working in formulation development and researchers and advanced students in biotechnology and pharmacy will find this a useful resource. Demonstrates how proteins and peptides transport throughout the gastrointestinal tract and how to evaluate their biological fate when encapsulated into certain delivery systems Examines developing technologies to improve future oral bioavailability Includes the in vitro and preclinical techniques needed for development
Author: Laszlo Otvos Publisher: Humana Press ISBN: 9781588299901 Category : Medical Languages : en Pages : 0
Book Description
Due to their high specificity and low toxicity profile, peptides have once again become central to the development of new drugs. In Peptide-Based Drug Design: Methods and Protocols, expert researchers provide a handbook which offers a selection of research and production tools suitable for transforming a promising protein fragment or stand-alone native peptide into a pharmaceutically acceptable composition. The volume delves into contemporary, cutting-edge subjects such as hit isolation and target validation, computer-aided design, sequence modifications to satisfy pharmacologists, in vivo stability and imaging, and the actual production of difficult sequences. Written in the highly successful Methods in Molecular BiologyTM series format, chapters include readily reproducible, step-by-step laboratory protocols, lists of materials, and the Notes section, which highlights tips on troubleshooting and avoiding known pitfalls. Comprehensive and up-to-date, Peptide-Based Drug Design: Methods and Protocols shows its subject to be an independent science on the rise, and provides scientists with a clear, concise guide for continuing this vital research.
Author: Susanna Wu-Pong Publisher: Springer Science & Business Media ISBN: 1597455326 Category : Medical Languages : en Pages : 374
Book Description
This book provides a comprehensive examination of the newest biopharmaceutical drugs. Among the drugs discussed are ones in the categories of monoclonal antibodies for in-vivo use, cytokines, growth factors, enzymes, immunomodulators, thrombolytics, and immonotherapies including vaccines. Additionally, the volume examines new and emerging technologies, and contains a review of the Human Genome Project.
Author: Francesco M. Veronese Publisher: Springer Science & Business Media ISBN: 3764386797 Category : Medical Languages : en Pages : 289
Book Description
PEGylation technology and key applications are introduced by this topical volume. Basic physical and chemical properties of PEG as basis for altering/improving in vivo behaviour of PEG-conjugates such as increased stability, improved PK/PD, and decreased immunogenicity, are discussed. Furthermore, chemical and enzymatic strategies for the coupling and the conjugate characterization are reported. Following chapters describe approved and marketed PEG-proteins and PEG-oligonucleotides as well as conjugates in various stages of clinical development.
Author: Damian J. Houde Publisher: Elsevier ISBN: 0444641742 Category : Medical Languages : en Pages : 588
Book Description
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
Author: Rodney Pearlman Publisher: Springer Science & Business Media ISBN: 0306474522 Category : Medical Languages : en Pages : 455
Book Description
Leading scientists offer detailed profiles of ten protein drugs currently in development. The case histories of these important new compounds are described from the perspective of their formulation, characterization, and stability. This ready reference also features recent data and an abundance of previously unpublished information. The in-depth coverage includes a highly useful compendium of degradation sites occurring in over 70 proteins. An invaluable aid in the rapid identification of potential `hot spots' in proteins, this accessible compilation allows for inspection of the protein's primary structure and preparation of a hydroflex plot.
Author: Rodney Pearlman
Author: James N. Herron
Author: Ved Srivastava
Author: John F. Carpenter
Author: Puneet Tyagi
Author: Laszlo Otvos
Author: Susanna Wu-Pong
Author: Francesco M. Veronese
Author: Damian J. Houde
Author: Rodney Pearlman