Bioanalytical Aspects In Biological Therapeutics

Author : Xiaohui (Sophia) Xu
Publisher : John Wiley & Sons
ISBN 13 : 1119523214
Total Pages : 404 pages
Book Rating : 4.15/5 ( download)

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Download or read book Bioanalytical Aspects in Biological Therapeutics written by Xiaohui (Sophia) Xu and published by John Wiley & Sons. This book was released on 2022-08-23 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bioanalytical Aspects in Biological Therapeutics Deepen your understanding of how critical data are generated from bioanalysis In Bioanalytical Aspects in Biological Therapeutics, a team of renowned chemists, immunologists, and biologists delivers a timely and practical exploration of the diverse scientific and technical literature on the bioanalytical investigation of current biotherapeutics under development. The book discusses the challenges and considerations for bioanalytical support, covering a wide range of central topics in the field, including overview and basic immunology for testing of biological therapeutics, pharmacokinetic aspects, clinical immunogenicity prediction and testing, biomarker testing, biotransformation assessment for biologics, statistical aspects of bioanalytical testing, regulatory expectations, and more. Drug development and analysis professionals will learn how critical data are generated from bioanalysis and how proven tools and methods are applied to the development of biologics. Alongside coverage of topics like PK, immunogenicity, neutralizing antibody assays, and the importance of quality control for reagents, readers will benefit from: A thorough overview of the development of biotherapeutics and the role played by bioanalytical tests, as well as basic immunology for bioanalytical testing of biological therapeutics Comprehensive explorations of platform and instrument considerations in bioanalytical testing, pharmacokinetics assays, and biomarker analysis using LC-MS, LBA, and other technologies Practical discussions of immunogenicity prediction, preclinical and clinical anti-drug antibody assays, and bioanalytical schemes for anti-drug neutralizing antibody assays In-depth examinations of critical reagents in bioanalysis Regulatory expectations for bioanalytical method development, validation, and sample testing Perfect for pharmaceutical scientists in industry, Bioanalytical Aspects in Biological Therapeutics will also earn a place in the libraries of pharmaceutical regulators and other professionals working in pharmaceutical companies, as well as graduate students studying bioanalytical assays for biological therapeutics.

Author : Seema Kumar
Publisher : Springer Nature
ISBN 13 : 3030971937
Total Pages : 166 pages
Book Rating : 4.39/5 ( download)

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Download or read book An Introduction to Bioanalysis of Biopharmaceuticals written by Seema Kumar and published by Springer Nature. This book was released on 2022-08-23 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book provides a comprehensive review of the fundamental and practical aspects of bioanalytical support and the integral role it plays in the development of safe and efficacious biopharmaceutical drugs with speed and cost-effectiveness. The book focuses on a broad range of conventional and emerging biopharmaceutical modalities including monoclonal antibody-based therapeutics, gene therapy, cell therapy, peptides and oligonucleotides. The book starts with an introductory overview of bioanalysis showcasing the integral role it plays in understanding the drug disposition (pharmacokinetics/pharmacodynamics and immunogenicity) and the progression of bioanalytical strategy as the drug progresses through discovery and development stages of the program, taking into consideration the continually evolving regulatory landscape. The book further diversifies into individual biopharmaceutical modalities - monoclonal antibodies, antibody-drug conjugates, bispecifics, Fc-fusion proteins, gene therapies, cell therapies, peptides and oligonucleotides. The individual chapters focus on modality-specific bioanalytical assay strategies, critical reagents, assay formats, analytical platforms, associated bioanalytical challenges and mitigation strategies, industry best practices, and the latest understanding of regulatory guidance as applicable to the fast-growing biopharmaceutical landscape.

Author : Mario L. Rocci Jr.
Publisher : Springer
ISBN 13 : 3319548026
Total Pages : 230 pages
Book Rating : 4.29/5 ( download)

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Download or read book Regulated Bioanalysis: Fundamentals and Practice written by Mario L. Rocci Jr. and published by Springer. This book was released on 2017-04-24 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: The editors have engaged leading scientists in the field to participate in the development of this book, which is envisioned as a “one of a kind” contribution to the field. The book is a comprehensive text that puts fundamental bioanalytical science in context with current practice, its challenges and ongoing developments. It expands on existing texts on the subject by covering regulated bioanalysis of both small and large molecule therapeutics from both a scientific and regulatory viewpoint. The content will be useful to a wide spectrum of readers: from those new to bioanalysis; to those developing their experience in the laboratory, or working in one of the many critical supporting roles; to seasoned practitioners looking for a solid source of information on this exciting and important discipline.

Author : Ben Greenstein
Publisher :
ISBN 13 : 9783769254624
Total Pages : 138 pages
Book Rating : 4.27/5 ( download)

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Download or read book Biological Therapeutics written by Ben Greenstein and published by . This book was released on 2011 with total page 138 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Oliver Kayser
Publisher : John Wiley & Sons
ISBN 13 : 3527329943
Total Pages : 677 pages
Book Rating : 4.46/5 ( download)

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Download or read book Pharmaceutical Biotechnology written by Oliver Kayser and published by John Wiley & Sons. This book was released on 2012-05-21 with total page 677 pages. Available in PDF, EPUB and Kindle. Book excerpt: This second edition of a very successful book is thoroughly updated with existing chapters completely rewritten while the content has more than doubled from 16 to 36 chapters. As with the first edition, the focus is on industrial pharmaceutical research, written by a team of industry experts from around the world, while quality and safety management, drug approval and regulation, patenting issues, and biotechnology fundamentals are also covered. In addition, this new edition now not only includes biotech drug development but also the use of biopharmaceuticals in diagnostics and vaccinations. With a foreword by Robert Langer, Kenneth J Germeshausen Professor of Chemical and Biomedical Engineering at MIT and member of the National Academy of Engineering and the National Academy of Sciences.

Author : Chukwuebuka Egbuna
Publisher : Academic Press
ISBN 13 : 0128227990
Total Pages : 302 pages
Book Rating : 4.92/5 ( download)

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Download or read book Analytical Techniques in Biosciences written by Chukwuebuka Egbuna and published by Academic Press. This book was released on 2021-10-21 with total page 302 pages. Available in PDF, EPUB and Kindle. Book excerpt: Analytical Techniques in Biosciences: From Basics to Applications presents comprehensive and up-to-date information on the various analytical techniques obtainable in bioscience research laboratories across the world. This book contains chapters that discuss the basic bioanalytical protocols and sample preparation guidelines. Commonly encountered analytical techniques, their working principles, and applications were presented. Techniques, considered in this book, include centrifugation techniques, electrophoretic techniques, chromatography, titrimetry, spectrometry, and hyphenated techniques. Subsequent chapters emphasize molecular weight determination and electroanalytical techniques, biosensors, and enzyme assay protocols. Other chapters detail microbial techniques, statistical methods, computational modeling, and immunology and immunochemistry. The book draws from experts from key institutions around the globe, who have simplified the chapters in a way that will be useful to early-stage researchers as well as advanced scientists. It is also carefully structured and integrated sequentially to aid flow, consistency, and continuity. This is a must-have reference for graduate students and researchers in the field of biosciences. Presents basic analytical protocols and sample-preparation guidelines Details the various analytical techniques, including centrifugation, spectrometry, chromatography, and titrimetry Describes advanced techniques such as hyphenated techniques, electroanalytical techniques, and the application of biosensors in biomedical research Presents biostatistical tools and methods and basic computational models in biosciences

Author : Alexandru Mihai Grumezescu
Publisher : William Andrew
ISBN 13 : 0128136308
Total Pages : 696 pages
Book Rating : 4.00/5 ( download)

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Download or read book Nanoscale Fabrication, Optimization, Scale-up and Biological Aspects of Pharmaceutical Nanotechnology written by Alexandru Mihai Grumezescu and published by William Andrew. This book was released on 2017-12-11 with total page 696 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nanoscale Fabrication, Optimization, Scale-up and Biological Aspects of Pharmaceutical Nanotechnology focuses on the fabrication, optimization, scale-up and biological aspects of pharmaceutical nanotechnology. In particular, the following aspects of nanoparticle preparation methods are discussed: the need for less toxic reagents, simplification of the procedure to allow economic scale-up, and optimization to improve yield and entrapment efficiency. Written by a diverse range of international researchers, the chapters examine characterization and manufacturing of nanomaterials for pharmaceutical applications. Regulatory and policy aspects are also discussed. This book is a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about how nanomaterials can best be utilized. Shows how nanomanufacturing techniques can help to create more effective, cheaper pharmaceutical products Explores how nanofabrication techniques developed in the lab have been translated to commercial applications in recent years Explains safety and regulatory aspects of the use of nanomanufacturing processes in the pharmaceutical industry

Author : Michael Zhou
Publisher : John Wiley & Sons
ISBN 13 : 047092280X
Total Pages : 564 pages
Book Rating : 4.04/5 ( download)

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Download or read book Regulated Bioanalytical Laboratories written by Michael Zhou and published by John Wiley & Sons. This book was released on 2011-03-31 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides useful information for bioanalytical / analytical scientists, analysts, quality assurance managers, and all personnel in bioanalytical laboratories through all aspects of bioanalytical technical and regulatory perspectives within bioanalytical operations and processes. Readers learn how to develop and implement strategies for routine, non-routine, and standard bioanalytical methods and on the entire equipment hardware and software qualification process. The book also gives guidelines on qualification of certified standards and in-house reference material as well as on people qualification. Finally, it guides readers through stressless internal and third party laboratory audits and inspections. It takes account to most national and international regulations and quality and accreditation standards, along with corresponding interpretation and inspection guides. The author elaborates on highly comprehensive content, making it easy not only to learn the subject but also to quickly implement the recommendations.

Author : Muharrem Ince
Publisher : BoD – Books on Demand
ISBN 13 : 1789858097
Total Pages : 164 pages
Book Rating : 4.99/5 ( download)

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Download or read book Recent Advances in Analytical Chemistry written by Muharrem Ince and published by BoD – Books on Demand. This book was released on 2019-04-10 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on recent and future trends in analytical methods and provides an overview of analytical chemistry. As a comprehensive analytical chemistry book, it takes a broad view of the subject and integrates a wide variety of approaches. The book provides separation approaches and method validation, as well as recent developments and applications in analytical chemistry. It is written primarily for researchers in the fields of analytical chemistry, environmental chemistry, and applied chemistry. The aim of the book is to explain the subject, clarify important studies, and compare and develop new and groundbreaking applications. Written by leading experts in their respective areas, the book is highly recommended for professionals interested in analytical chemistry because it provides specific and comprehensive examples.

Author : N Saraswathy
Publisher : Elsevier
ISBN 13 : 1908818050
Total Pages : 271 pages
Book Rating : 4.58/5 ( download)

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Download or read book Concepts and Techniques in Genomics and Proteomics written by N Saraswathy and published by Elsevier. This book was released on 2011-07-01 with total page 271 pages. Available in PDF, EPUB and Kindle. Book excerpt: Concepts and techniques in genomics and proteomics covers the important concepts of high-throughput modern techniques used in the genomics and proteomics field. Each technique is explained with its underlying concepts, and simple line diagrams and flow charts are included to aid understanding and memory. A summary of key points precedes each chapter within the book, followed by detailed description in the subsections. Each subsection concludes with suggested relevant original references. Provides definitions for key concepts Case studies are included to illustrate ideas Important points to remember are noted