Detection And Quantification Of Antibodies To Biopharmaceuticals

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Detection and Quantification of Antibodies to Biopharmaceuticals

Michael G. Tovey
Detection and Quantification of Antibodies to Biopharmaceuticals Book PDF

Author : Michael G. Tovey
Publisher : John Wiley & Sons
Page : 316 pages
File Size : 42,5 Mb
Release : 2011-07-12
Category : Medical
ISBN : 9781118075678

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Detection and Quantification of Antibodies to Biopharmaceuticals by Michael G. Tovey Pdf

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.

Antibodies—Advances in Research and Application: 2013 Edition

Anonim
Antibodies Advances in Research and Application 2013 Edition Book PDF

Author : Anonim
Publisher : ScholarlyEditions
Page : 531 pages
File Size : 52,6 Mb
Release : 2013-06-21
Category : Medical
ISBN : 9781481672818

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Antibodies—Advances in Research and Application: 2013 Edition by Anonim Pdf

Antibodies—Advances in Research and Application: 2013 Edition is a ScholarlyEditions™ book that delivers timely, authoritative, and comprehensive information about Monoclonal Antibodies. The editors have built Antibodies—Advances in Research and Application: 2013 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Monoclonal Antibodies in this book to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Antibodies—Advances in Research and Application: 2013 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.

Monoclonal Antibodies

Harleen Kaur,Dietmar Reusch
Monoclonal Antibodies Book PDF

Author : Harleen Kaur,Dietmar Reusch
Publisher : Elsevier
Page : 260 pages
File Size : 49,7 Mb
Release : 2021-08-03
Category : Medical
ISBN : 9780128223192

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Monoclonal Antibodies by Harleen Kaur,Dietmar Reusch Pdf

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

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

Joerg Bluemel,Sven Korte,Emanuel Schenck,Gerhard Weinbauer
The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment Book PDF

Author : Joerg Bluemel,Sven Korte,Emanuel Schenck,Gerhard Weinbauer
Publisher : Academic Press
Page : 716 pages
File Size : 45,8 Mb
Release : 2015-03-13
Category : Medical
ISBN : 9780124171466

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The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment by Joerg Bluemel,Sven Korte,Emanuel Schenck,Gerhard Weinbauer Pdf

The Nonhuman Primate in Drug Development and Safety Assessment is a valuable reference dedicated to compiling the latest research on nonhuman primate models in nonclinical safety assessment, regulatory toxicity testing and translational science. By covering important topics such as study planning and conduct, inter-species genetic drift, pathophysiology, animal welfare legislation, safety assessment of biologics and small molecules, immunotoxicology and much more, this book provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing. A comprehensive yet practical guide, this book is intended for new researchers or practicing toxicologists, toxicologic pathologists and pharmaceutical scientists working with nonhuman primates, as well as graduate students preparing for careers in this area. Covers important topics such as species selection, study design, experimental methodologies, animal welfare and the 3Rs (Replace, Refine and Reduce), social housing, regulatory guidelines, comparative physiology, reproductive biology, genetic polymorphisms and more Includes practical examples on techniques and methods to guide your daily practice Offers a companion website with high-quality color illustrations, reference values for safety assessment and additional practical information such as study design considerations, techniques and procedures and dosing and sampling volumes

Biopharmaceuticals

Basanta Behera
Biopharmaceuticals Book PDF

Author : Basanta Behera
Publisher : CRC Press
Page : 295 pages
File Size : 54,7 Mb
Release : 2020-12-07
Category : Medical
ISBN : 9781351013147

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Biopharmaceuticals by Basanta Behera Pdf

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

Sarfaraz K. Niazi
Biosimilars and Interchangeable Biologics Book PDF

Author : Sarfaraz K. Niazi
Publisher : CRC Press
Page : 575 pages
File Size : 53,6 Mb
Release : 2016-01-05
Category : Medical
ISBN : 9781498743501

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Biosimilars and Interchangeable Biologics by Sarfaraz K. Niazi Pdf

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 that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Tactical Elements explores the development and manufacturing of biosimilars and targets challenges surrounding the creation of these products. This includes manufacturing, production costs, and intellectual property barriers, particularly in regulated markets (regulatory agencies are still in the process of developing guidelines). It addresses the complexity of biological drugs, and it discusses specific structural elements vital to the functionality, immunogenicity, and safety of biosimilar products. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume provides an overall understanding of the hurdles, difficulties, and practicalities of developing a strong plan. It introduces a step-by-step approach for creating a strategy that helps develop and manufacture a biosimilar product while reducing overall production costs and meeting the requirements of biosimilarity based on analytical and functional, pharmacokinetic, pharmacodynamic (where applicable), and nonclinical toxicology or toxicokinetic similarity (where appropriate) while remaining competitive in the market.

Comprehensive Biotechnology

Anonim
Comprehensive Biotechnology Book PDF

Author : Anonim
Publisher : Newnes
Page : 5304 pages
File Size : 52,7 Mb
Release : 2011-08-26
Category : Science
ISBN : 9780080885049

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Comprehensive Biotechnology by Anonim Pdf

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

State-Of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization

John E. Schiel,Darryl L. Davis,Oleg V. Borisov,Oleg Borisov
State Of the Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2 Biopharmaceutical Characterization Book PDF

Author : John E. Schiel,Darryl L. Davis,Oleg V. Borisov,Oleg Borisov
Publisher : ACS Symposium
Page : 0 pages
File Size : 41,9 Mb
Release : 2016-06-24
Category : Medical
ISBN : 0841230293

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State-Of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization by John E. Schiel,Darryl L. Davis,Oleg V. Borisov,Oleg Borisov Pdf

"Distributed in print by Oxford University Press."

Biopharmaceuticals

Ming-Kung Yeh,Yuan-Chuan Chen
Biopharmaceuticals Book PDF

Author : Ming-Kung Yeh,Yuan-Chuan Chen
Publisher : BoD – Books on Demand
Page : 140 pages
File Size : 40,9 Mb
Release : 2018-09-19
Category : Medical
ISBN : 9781789237184

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Biopharmaceuticals by Ming-Kung Yeh,Yuan-Chuan Chen Pdf

Biopharmaceuticals are derived from biological sources, either live organisms or their active components; nowadays, they are mainly produced by biotechnologies. Biopharmaceuticals are extensively used in the treatment of various diseases such as cardiovascular, metabolic, neurological diseases, cancer, and others for which there are no available therapeutic methods. With the advance of science, biopharmaceuticals have revolutionized the treatment, prevention, and diagnosis of many patients with disabling and life-threatening diseases. Innovative biopharmaceuticals definitely improve the life quality of patients and enhance the effectiveness of the healthcare system. This book encompasses the discovery, production, application, and regulation of biopharmaceuticals to demonstrate their research achievement, prospects, and challenges. We expect the significance of biopharmaceuticals to be revealed and emphasized by this book.

Approaches to the Conformational Analysis of Biopharmaceuticals

Roger L. Lundblad
Approaches to the Conformational Analysis of Biopharmaceuticals Book PDF

Author : Roger L. Lundblad
Publisher : CRC Press
Page : 366 pages
File Size : 54,8 Mb
Release : 2009-12-15
Category : Medical
ISBN : 1439807817

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Approaches to the Conformational Analysis of Biopharmaceuticals by Roger L. Lundblad Pdf

The activity of many biopharmaceutical polymers is dependent on conformation, and the next several years will see increased interest in the conformational analysis of these polymers resulting from the development of biosimilar or "follow-on" biological products. While a wide variety of approaches to analysis exists, finding the most viable ones would be much easier with a consolidated reference that details the benefits and cost of each approach, with an emphasis on real results and real products. Explores the Growing Role of Conformational Analysis in Comparing Generic Biopharmaceuticals Approaches to the Conformational Analysis of Biopharmaceuticals gathers the most useful techniques and methods into a single volume, putting the greatest emphasis on those approaches that have proven the most fruitful. Rather than cover specific uses of techniques in detail, this book provides commercial biotechnologists and researchers with the information and references they need to make good choices about the technology they choose to use. With a large number of references that direct readers to primary source material, it includes studies drawn from the gamut of current literature, covering physical methods, such as differential scanning calorimetry, light scanning, and analytical ultracentrifugation. It also addresses chemical methods, such as hydrogen–deuterium exchange and trace labeling, along with infrared, ultraviolet, and Raman spectroscopy. Written by Roger Lundblad, a true pioneer in protein science, this volume supplies the necessary information researchers need to access when deciding on the most cost-effective approach, including: Comparability of biopharmaceuticals Characterization of follow-on biologics Quality attributes of protein biopharmaceuticals Confrontational analysis of biopharmaceutical products With a clear focus on relevant commercial biotechnology, this book belongs on the shelves of those serious researchers who are paving the way for the next generation of biopharmaceutical polymers.

Sample Preparation in LC-MS Bioanalysis

Wenkui Li,Wenying Jian,Yunlin Fu
Sample Preparation in LC MS Bioanalysis Book PDF

Author : Wenkui Li,Wenying Jian,Yunlin Fu
Publisher : John Wiley & Sons
Page : 384 pages
File Size : 40,5 Mb
Release : 2019-03-12
Category : Science
ISBN : 9781119274292

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Sample Preparation in LC-MS Bioanalysis by Wenkui Li,Wenying Jian,Yunlin Fu Pdf

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

Andras Guttman,László Hajba
Capillary Gel Electrophoresis Book PDF

Author : Andras Guttman,László Hajba
Publisher : Newnes
Page : 391 pages
File Size : 47,8 Mb
Release : 2021-12-04
Category : Science
ISBN : 9780080931357

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Capillary Gel Electrophoresis by Andras Guttman,László Hajba Pdf

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

Mass Spectrometry in Biopharmaceutical Analysis

Igor A. Kaltashov,Guanbo Wang,Shunhai Wang
Mass Spectrometry in Biopharmaceutical Analysis Book PDF

Author : Igor A. Kaltashov,Guanbo Wang,Shunhai Wang
Publisher : Walter de Gruyter GmbH & Co KG
Page : 280 pages
File Size : 54,6 Mb
Release : 2021-11-22
Category : Science
ISBN : 9783110546187

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Mass Spectrometry in Biopharmaceutical Analysis by Igor A. Kaltashov,Guanbo Wang,Shunhai Wang Pdf

Biopharmaceuticals are a unique class of compounds due to their extreme structural complexity. The current text puts together a variety of the state‐of‐the art approaches that use mass spectrometry to evaluate various aspects of biopharmaceutical products ranging from monitoring stress‐related structural changes to their quantitation in pharmacokinetic studies.

Protein Analysis using Mass Spectrometry

Mike S. Lee,Qin C. Ji
Protein Analysis using Mass Spectrometry Book PDF

Author : Mike S. Lee,Qin C. Ji
Publisher : John Wiley & Sons
Page : 288 pages
File Size : 49,8 Mb
Release : 2017-05-26
Category : Science
ISBN : 9781119359364

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Protein Analysis using Mass Spectrometry by Mike S. Lee,Qin C. Ji Pdf

Presents Practical Applications of Mass Spectrometry for Protein Analysis and Covers Their Impact on Accelerating Drug Discovery and Development Covers both qualitative and quantitative aspects of Mass Spectrometry protein analysis in drug discovery Principles, Instrumentation, Technologies topics include MS of peptides, proteins, and ADCs , instrumentation in protein analysis, nanospray technology in MS protein analysis, and automation in MS protein analysis Details emerging areas from drug monitoring to patient care such as Identification and validation of biomarkers for cancer, targeted MS approaches for biomarker validation, biomarker discovery, and regulatory perspectives Brings together the most current advances in the mass spectrometry technology and related method in protein analysis

Quantitative and Qualitative Determination Technologies of Counterfeit Drugs

Ronny Priefer
Quantitative and Qualitative Determination Technologies of Counterfeit Drugs Book PDF

Author : Ronny Priefer
Publisher : CRC Press
Page : 192 pages
File Size : 53,8 Mb
Release : 2023-08-10
Category : Medical
ISBN : 9781000914016

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Quantitative and Qualitative Determination Technologies of Counterfeit Drugs by Ronny Priefer Pdf

Drugs are often counterfeited to reduce manufacture costs, while still marketing it at as an authentic product. Increased incidence of drug counterfeiting is most noticeable in developing countries, which may not have the resources to supply counterfeit detection devices on a large scale. It is important to consider the problems caused and to propose options for controlling and reducing the prevalence of counterfeit medications. Various technologies are needed to identify the chemical properties of a questioned medicinal product, which can then be used to determine its authenticity. This volume focuses on current technological approaches that are able to detect counterfeited pharmaceuticals. Features Focuses on current technological approaches that are able to detect counterfeited pharmaceuticals Assesses the chemical methods of identifying counterfeit medicinal products and explains the theoretical underpinnings of the methods Provides case study type examples of the application for analysis of suspected counterfeit pharmaceuticals Discusses the detection and analysis of counterfeit drugs, and appropriate tools for combating this issue The editor draws on his experience as a respected chemist and prolific author in the field to provide this unique text on drug counterfeiting detection