Bioanalytical Aspects In Biological Therapeutics

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.

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.

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.

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.

The first book to offer a blueprint for overcoming the challenges to successfully quantifying biomarkers in living organisms The demand among scientists and clinicians for targeted quantitation experiments has experienced explosive growth in recent years. While there are a few books dedicated to bioanalysis and biomarkers in general, until now there were none devoted exclusively to addressing critical issues surrounding this area of intense research. Target Biomarker Quantitation by LC-MS provides a detailed blueprint for quantifying biomarkers in biological systems. It uses numerous real-world cases to exemplify key concepts, all of which were carefully selected and presented so as to allow the concepts they embody to be easily expanded to future applications, including new biomarker development. Target Biomarker Quantitation by LC-MS primarily focuses on the assay establishment for biomarker quantitation—a critical issue rarely treated in depth. It offers comprehensive coverage of three core areas of biomarker assay establishment: the relationship between the measured biomarkers and their intended usage; contemporary regulatory requirements for biomarker assays (a thorough understanding of which is essential to producing a successful and defendable submission); and the technical challenges of analyzing biomarkers produced inside a living organism or cell. Covers the theory of and applications for state-of-the-art mass spectrometry and chromatography and their applications in biomarker analysis Features real-life examples illustrating the challenges involved in target biomarker quantitation and the innovative approaches which have been used to overcome those challenges Addresses potential obstacles to obtain effective biomarker level and data interpretation, such as specificity establishment and sample collection Outlines a tiered approach and fit-for-purpose assay protocol for target biomarker quantitation Highlights the current state of the biomarker regulatory environment and protocol standards Target Biomarker Quantitation by LC-MS is a valuable resource for bioanalytical scientists, drug metabolism and pharmacokinetics scientists, clinical scientists, analytical chemists, and others for whom biomarker quantitation is an important tool of the trade. It also functions as an excellent text for graduate courses in pharmaceutical, biochemistry and chemistry.

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

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