Detection and Quantification of Antibodies to Biopharmaceuticals

Detection and Quantification of Antibodies to Biopharmaceuticals
Author: Michael G. Tovey
Publisher: John Wiley & Sons
Total Pages: 316
Release: 2011-07-12
Genre: Medical
ISBN: 1118075676
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The definitive book on the neutralization of recombinant biopharmaceuticals Recombinant biopharmaceuticals are an important tool for treating a range of illnesses; however, their efficacy can be severely impaired by their immunogenicity. When introduced into the body, these pharmaceuticals can cause the immune system to produce anti-drug antibodies (ADAs) that neutralize their effects. The first and only book to cover neutralization in connection with biopharmaceuticals and the measurement and application of neutralizing antibodies in modern medicine at any real length, Detection and Quantification of Antibodies to Biopharmaceuticals: Practical and Applied Considerations offers a comprehensive and in-depth look at all the principal aspects of the detection and quantification of antibodies that are essential to understanding and responding to the challenges they present. Bringing together a large-scale review of neutralization and biopharmaceuticals and the ability to measure, detect, and apply antibodies to modern science and medicine with international regulatory perspectives, the expectations of regulatory authorities, and the strengths and weaknesses of various assays, the book describes several novel ideas for detecting ADAs. Designed to serve as a resource for biopharmaceutical drug development, the book provides biotechnology companies and pharmaceutical drug development specialists, as well as non-experts, with key insights into the design, optimization, and qualification of assays, the establishment of sampling strategies, the choice of appropriate assay end-points, and data analysis for the detection and quantification of neutralizing antibodies.

Monoclonal Antibodies

Monoclonal Antibodies
Author: Harleen Kaur
Publisher: Elsevier
Total Pages: 260
Release: 2021-08-03
Genre: Medical
ISBN: 0128223197
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Monoclonal antibodies (mAbs) are naturally occurring complex biomolecules. New engineering methods have turned mAbs into a leading therapeutic modality for addressing immunotherapeutic challenges and led to the rise of mAbs as the dominant class of protein therapeutics. mAbs have already demonstrated a great potential in developing safe and reliable treatments for complex diseases and creating more affordable healthcare alternatives. Developing mAbs into well-characterized antibody therapeutics that meet regulatory expectations, however, is extremely challenging. Obstacles to overcome include the determination and development of physiochemical characteristics such as aggregation, fragmentation, charge variants, identity, carbohydrate structure, and higher-order structure (HOS). This book dives deep into mAbs structure and the array of physiochemical testing and characterization methods that need to be developed and validated to establish a mAb as a therapeutic molecule. The main focus of this book is on physiochemical aspects, including the importance of establishing quality attributes such as glycosylation, primary sequence, purity, and HOS and elucidating the structure of new antibody formats by mass spectrometry. Each of the aforementioned quality attributes has been discussed in detail; this will help scientists in researching and developing biopharmaceuticals and biosimilars to find practical solutions to physicochemical testing and characterization. Describes the spectrum of analytical tests and characterization methods necessary for developing and releasing mAb batches Details antibody heterogeneity in terms of size, charge, and carbohydrate content Gives special focus to the structural analysis of mAbs, including mass spectrometry analysis Presents the basic structure of mAbs with clarity and rigor Addresses regulatory guidelines - including ICH Q6B - in relation to quality attributes Lays out characterization and development case studies including biosimilars and new antibody formats

Sample Preparation in LC-MS Bioanalysis

Sample Preparation in LC-MS Bioanalysis
Author: Wenkui Li
Publisher: John Wiley & Sons
Total Pages: 384
Release: 2019-03-12
Genre: Science
ISBN: 111927429X
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Revised and Expanded Handbook Provides Comprehensive Introduction and Complete Instruction for Sample Preparation in Vital Category of Bioanalysis Following in the footsteps of the previously published Handbook of LC-MS Bioanalysis, this book is a thorough and timely guide to all important sample preparation techniques used for quantitative Liquid Chromatography–Mass Spectrometry (LC-MS) bioanalysis of small and large molecules. LC-MS bioanalysis is a key element of pharmaceutical research and development, post-approval therapeutic drug monitoring, and many other studies used in human healthcare. While advances are continually being made in key aspects of LC-MS bioanalysis such as sensitivity and throughput, the value of research/study mentioned above is still heavily dependent on the availability of high-quality data, for which sample preparation plays the critical role. Thus, this text provides researchers in industry, academia, and regulatory agencies with detailed sample preparation techniques and step-by-step protocols on proper extraction of various analyte(s) of interest from biological samples for LC-MS quantification, in accordance with current health authority regulations and industry best practices. The three sections of the book with a total of 26 chapters cover topics that include: Current basic sample preparation techniques (e.g., protein precipitation, liquid-liquid extraction, solid-phase extraction, salting-out assisted liquid-liquid extraction, ultracentrifugation and ultrafiltration, microsampling, sample extraction via electromembranes) Sample preparation techniques for uncommon biological matrices (e.g., tissues, hair, skin, nails, bones, mononuclear cells, cerebrospinal fluid, aqueous humor) Crucial aspects of LC-MS bioanalytical method development (e.g., pre-analytical considerations, derivation strategies, stability, non-specific binding) in addition to sample preparation techniques for challenging molecules (e.g., lipids, peptides, proteins, oligonucleotides, antibody-drug conjugates) Sample Preparation in LC-MS Bioanalysis will prove a practical and highly valuable addition to the reference shelves of scientists and related professionals in a variety of fields, including pharmaceutical and biomedical research, mass spectrometry, and analytical chemistry, as well as practitioners in clinical pharmacology, toxicology, and therapeutic drug monitoring.

Capillary Gel Electrophoresis

Capillary Gel Electrophoresis
Author: Andras Guttman
Publisher: Newnes
Total Pages: 391
Release: 2021-12-04
Genre: Science
ISBN: 0080931359
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Capillary Gel Electrophoresis and Related Microseparation Techniques covers all theoretical and practical aspects of capillary gel electrophoresis. It also provides an excellent overview of the key application areas of nucleic acid, protein and complex carbohydrate analysis, affinity-based methodologies, micropreparative aspects and related microseparation methods. It not only gives readers a better understanding of how to utilize this technology, but also provides insights into how to determine which method will provide the best technical solutions to particular problems. This book can also serve as a textbook for undergraduate and graduate courses in analytical chemistry, analytical biochemistry, molecular biology and biotechnology courses. Covers all theoretical and practical aspects of capillary gel electrophoresis Excellent overview of the key applications of nucleic acid, protein and complex carbohydrate analysis, affinity-based methodologies, micropreparative aspects and related microseparation methods Teaches readers how to use the technology and select methods that are ideal for fundamental problems Can serve as a textbook for undergraduate and graduate courses in analytical chemistry, analytical biochemistry, molecular biology and biotechnology courses

Drug Development and Safety

Drug Development and Safety
Author:
Publisher: BoD – Books on Demand
Total Pages: 184
Release: 2024-07-10
Genre: Medical
ISBN: 0850142318
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This book provides a detailed overview covering all aspects of drug development, from synthesis and manufacturing to delivery strategies, and ensuring a thorough understanding of the field. This book will show how new drugs are made. The chapters also give inside information on regulatory authorities so that drugs meet the necessary standards for quality. Drug Development and Safety effortlessly switches over to drug delivery technologies by exploring ground-breaking methods that are changing medicine forever. Controlled-release drug delivery systems represent some of the current breakthroughs while using nanoparticles for treating cancer stands among other recent therapeutic innovations. Each chapter has been authored by a leading scientist or expert in that particular field, and various viewpoints will be presented to provide a fuller understanding of the subjects concerning the safety of drugs. The book will be for chemists, pharmacists, and biologists, and it will be their only guide while navigating the challenging pharmaceutical science terrain.

Biopharmaceuticals

Biopharmaceuticals
Author: Basanta Behera
Publisher: CRC Press
Total Pages: 295
Release: 2020-12-07
Genre: Medical
ISBN: 1351013149
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Biopharmaceuticals: Challenges and Opportunities This book highlights how the traditional microbial process technology has been upgraded for the production of biologic drugs how manufacturing processes have evolved to meet the global market demand with quality products under the guidelines of internally recognized regulatory bodies. It also carries information on how, armed with a deeper understanding of life-threatening diseases, biopharmaceutical companies and the life sciences industry have developed formal and informal partnerships with researchers in institutes, universities, and other R&D organizations to fulfil timely, quality production with perfect safety and security. One of the most interesting aspects of this book is the conceptual development of personalized medicine (or precision medicine) to provide the right treatment to the right patient, at the right dose at an earlier stage of development, for genetic diseases. Besides this, it also highlights the most challenging aspects of modern biopharmaceutical science, focusing on the hot topics such as design and development of biologic drugs; the use of diversified groups of host cells belonging to animals, plants, microbes, insects, and mammals; stem cell therapy and gene therapy; supply chain management of biopharmaceuticals; and the future scope of biopharmaceutical industry development. This book is the latest resource for a wide circle of scientists, students, and researchers involved in understanding and implementing the knowledge of biopharmaceuticals to develop life-saving biologic drugs and to bring awareness to the development of personalized treatment that can potentially offer patients a faster diagnosis, fewer side effects, and better outcomes. Features: Explains how the traditional cell culture methodology has been changed to a fully continuous or partially continuous process Explains how to design and fabricate living organs of body by 3D bioprinting technology Focuses on how a biopharmaceutical company deals with various problems of regulatory bodies and develops innovative biologic drugs Narrates in detail the updated information on stem cell therapy and gene therapy Explains the development strategies and clinical significance of biosimilars and biobetters Highlights the supply chain management of biopharmaceuticals

Biosimilars and Interchangeable Biologics

Biosimilars and Interchangeable Biologics
Author: Sarfaraz K. Niazi
Publisher: CRC Press
Total Pages: 612
Release: 2016-01-05
Genre: Medical
ISBN: 1498743501
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What's the Deal with Biosimilars?Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set th

HPLC and UHPLC for Practicing Scientists

HPLC and UHPLC for Practicing Scientists
Author: Michael W. Dong
Publisher: John Wiley & Sons
Total Pages: 410
Release: 2019-07-23
Genre: Science
ISBN: 1119313767
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A concise yet comprehensive reference guide on HPLC/UHPLC that focuses on its fundamentals, latest developments, and best practices in the pharmaceutical and biotechnology industries Written for practitioners by an expert practitioner, this new edition of HPLC and UHPLC for Practicing Scientists adds numerous updates to its coverage of high-performance liquid chromatography, including comprehensive information on UHPLC (ultra-high-pressure liquid chromatography) and the continuing migration of HPLC to UHPLC, the modern standard platform. In addition to introducing readers to HPLC’s fundamentals, applications, and developments, the book describes basic theory and terminology for the novice, and reviews relevant concepts, best practices, and modern trends for the experienced practitioner. HPLC and UHPLC for Practicing Scientists, Second Edition offers three new chapters. One is a standalone chapter on UHPLC, covering concepts, benefits, practices, and potential issues. Another examines liquid chromatography/mass spectrometry (LC/MS). The third reviews at the analysis of recombinant biologics, particularly monoclonal antibodies (mAbs), used as therapeutics. While all chapters are revised in the new edition, five chapters are essentially rewritten (HPLC columns, instrumentation, pharmaceutical analysis, method development, and regulatory aspects). The book also includes problem and answer sections at the end of each chapter. Overviews fundamentals of HPLC to UHPLC, including theories, columns, and instruments with an abundance of tables, figures, and key references Features brand new chapters on UHPLC, LC/MS, and analysis of recombinant biologics Presents updated information on the best practices in method development, validation, operation, troubleshooting, and maintaining regulatory compliance for both HPLC and UHPLC Contains major revisions to all chapters of the first edition and substantial rewrites of chapters on HPLC columns, instrumentation, pharmaceutical analysis, method development, and regulatory aspects Includes end-of-chapter quizzes as assessment and learning aids Offers a reference guide to graduate students and practicing scientists in pharmaceutical, biotechnology, and other industries Filled with intuitive explanations, case studies, and clear figures, HPLC and UHPLC for Practicing Scientists, Second Edition is an essential resource for practitioners of all levels who need to understand and utilize this versatile analytical technology. It will be a great benefit to every busy laboratory analyst and researcher.

Drug Hypersensitivity

Drug Hypersensitivity
Author: Werner J. Pichler
Publisher: Karger Medical and Scientific Publishers
Total Pages: 440
Release: 2007-01-01
Genre: Medical
ISBN: 3805582692
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Approaches the phenomenon of drug hypersensitivity in a comprehensive manner. Besides epidemiological aspects, it addresses the immunological mechanisms underlying these complicated reactions which go far beyond the IgE-mediated drug allergies also considered in this book. The book also covers clinical manifestations and new diagnostic methods, and introduces some recetly established animal models. Many topics are treated from multiple perspectives, and the 33 chapters are thoroughly cross-referenced.

Comprehensive Biotechnology

Comprehensive Biotechnology
Author:
Publisher: Newnes
Total Pages: 5304
Release: 2011-08-26
Genre: Science
ISBN: 0080885047
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The second edition of Comprehensive Biotechnology, Six Volume Set continues the tradition of the first inclusive work on this dynamic field with up-to-date and essential entries on the principles and practice of biotechnology. The integration of the latest relevant science and industry practice with fundamental biotechnology concepts is presented with entries from internationally recognized world leaders in their given fields. With two volumes covering basic fundamentals, and four volumes of applications, from environmental biotechnology and safety to medical biotechnology and healthcare, this work serves the needs of newcomers as well as established experts combining the latest relevant science and industry practice in a manageable format. It is a multi-authored work, written by experts and vetted by a prestigious advisory board and group of volume editors who are biotechnology innovators and educators with international influence. All six volumes are published at the same time, not as a series; this is not a conventional encyclopedia but a symbiotic integration of brief articles on established topics and longer chapters on new emerging areas. Hyperlinks provide sources of extensive additional related information; material authored and edited by world-renown experts in all aspects of the broad multidisciplinary field of biotechnology Scope and nature of the work are vetted by a prestigious International Advisory Board including three Nobel laureates Each article carries a glossary and a professional summary of the authors indicating their appropriate credentials An extensive index for the entire publication gives a complete list of the many topics treated in the increasingly expanding field