Validation Of Cell Based Assays In The Glp Setting

Author : Uma Prabhakar,Marian Kelley
Publisher : John Wiley & Sons
Page : 312 pages
File Size : 45,8 Mb
Release : 2008-04-30
Category : Science
ISBN : 0470987804

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Validation of Cell-Based Assays in the GLP Setting by Uma Prabhakar,Marian Kelley Pdf

The use of cell-based assays within pharmaceutical and biotechnology companies is driven in large part by the need to evaluate the plethora of drug targets derived from genomics and proteomics. In addition, the potential of biomarkers to facilitate the development of effective and safe drugs is being recognized as an integral part of all phases of drug development, and cell-based technologies are a critical part of biomarker discovery and development. Despite this critical role, cell-based assays have not been standardized and made compliant with Good Laboratory Practice guidelines. In this book, the editors have collected assays for which validation procedures have been developed, making this a vital purchase for anyone using such assays in drug development. This book: Describes the development, optimization and validation of cell-based assays, including procedural documentation required for Good Laboratory Practice Presents validations of cell-based assays for select targets, with step-by-step instructions, allowing the reader to reproduce the assay conditions and results Provides details of techniques used in the evaluation of immunodeficiency, autoimmune and oncological disorders, including assessment of cancer vaccines Offers a compendium of validation parameters that need to be considered when using these methods to develop a new drug Includes detailed protocols for the evaluation of cytokines and of neutralizing antibodies directed against protein therapeutics Validation of Cell-based Assays in the GLP Setting provides the professional with an invaluable reference source, featuring key guidelines. The book will prove extremely useful to all scientists working in the areas of drug development.

Author : W. John W. Morrow,Nadeem A. Sheikh,Clint S. Schmidt,D. Huw Davies
Publisher : John Wiley & Sons
Page : 552 pages
File Size : 49,5 Mb
Release : 2012-06-12
Category : Medical
ISBN : 9781118345344

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Vaccinology by W. John W. Morrow,Nadeem A. Sheikh,Clint S. Schmidt,D. Huw Davies Pdf

Covering all aspects of vaccine research and development in one volume, this authoritative resource takes a comprehensive and systematic approach to the science of vaccinology focusing not only on basic science, but also on the many stages required to commercialize and navigate the regulatory requirements for human application, both in the United States and Europe. Reviews in detail the process of designing a vaccine, from the initial stages of antigen discovery to human application Includes evaluation of vaccine efficacy and safety Details clinical trial design, including regulatory requirements Discusses the emerging field of active cellular immunotherapy Vaccinology: Principles and Practice provides an invaluable resource for clinicians, scientific and medical researchers, lecturers and postdoctoral fellows working in the field of vaccines.

Author : Ge Wu
Publisher : John Wiley & Sons
Page : 452 pages
File Size : 49,7 Mb
Release : 2010-06-25
Category : Science
ISBN : 9780470583111

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Assay Development by Ge Wu Pdf

Essential principles and practice of assay development The first comprehensive, integrated treatment of the subject, Assay Development: Fundamentals and Practices covers the essentials and techniques involved in carrying out an assay project in either a biotechnology/drug discovery setting or a platform setting. Rather than attempting comprehensive coverage of all assay development technologies, the book introduces the most widely used assay development technologies and illustrates the art of assay development through a few commonly encountered biological targets in assay development (e.g., proteases, kinases, ion channels, and G protein-coupled receptors). Just enough biological background for these biological targets is provided so that the reader can follow the logics of assay development. Chapters discuss: The basics of assay development, including foundational concepts and applications Commonly used instrumental methods for both biochemical assays and cell-based assays Assay strategies for protein binding and enzymatic activity Cell-based assays High-throughput screening An in-depth study of the now popular Caliper's off-chip kinase assay provides an instructive, real-world example of the assay development process.

Author : Oliver Kayser,Heribert Warzecha
Publisher : John Wiley & Sons
Page : 677 pages
File Size : 41,6 Mb
Release : 2012-03-27
Category : Science
ISBN : 9783527651252

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Pharmaceutical Biotechnology by Oliver Kayser,Heribert Warzecha Pdf

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 : Yanmei Lu,Boris Gorovits
Publisher : John Wiley & Sons
Page : 500 pages
File Size : 40,8 Mb
Release : 2024-02-28
Category : Medical
ISBN : 9781119852780

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Drug Development for Gene Therapy by Yanmei Lu,Boris Gorovits Pdf

Drug Development for Gene Therapy Industry-centric perspective on translational and bioanalytical challenges and best practices for gene therapies Drug Development for Gene Therapy focuses on the translational and bioanalytical challenges and best practices for gene therapy modalities, presenting a significant body of data, including information related to safety and efficacy, necessary to advance through the development pipeline into clinical use. The text covers bioanalytical methods and platforms including patient screening assays, different PCR tests, enzyme activity assays, ELISpot, NGS, LC/MS, and immunoassays, with FDA and EMA guidelines on gene therapy safety and efficacy, along with companion diagnostics regulations from US and EU perspectives. The chapters offer an in-depth discussion of the basics and best practices for translational biomarkers, bioanalysis, and developing companion diagnostics / lab tests for gene therapies in the pharma and biopharma industries. To aid in reader comprehension, the text includes clinical examples of relevant therapies in related chapters. Some of the core topics covered include study design, immunogenicity, various bioanalytical methods and their applications, and global regulatory issues. Written by two highly qualified authors with significant experience in the field, Drug Development for Gene Therapy includes information on: Bioanalytical methods to detect pre-existing antibodies against adeno-associated viruses (AAV) capsids Detection of cellular immunity and humoral response to viral capsids and transgene proteins, and immunogenicity of gene therapy products Nonclinical and clinical study considerations and methods for biodistribution and shedding Quantification of transgene protein expression and biochemical function, and substrate and distal pharmacodynamic biomarker measurements for gene therapy Detection and quantification of rAAV integration and off-target editing Current regulatory landscape for gene therapy product development and the role of biomarkers and general regulatory considerations for gene therapy companion diagnostics With comprehensive coverage of the subject, Drug Development for Gene Therapy is a must-have resource for researchers and developers in the areas of pharmaceuticals, biopharmaceuticals, and contract research organizations (CROs), along with professors, researchers, and advanced students in chemistry, biological, biomedical engineering, pharmaceuticals, and medical sciences.

Author : Seema Kumar
Publisher : Springer Nature
Page : 166 pages
File Size : 50,6 Mb
Release : 2022-08-23
Category : Science
ISBN : 9783030971939

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An Introduction to Bioanalysis of Biopharmaceuticals by Seema Kumar Pdf

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 : Alexander E. Kalyuzhny
Publisher : Springer Nature
Page : 321 pages
File Size : 40,8 Mb
Release : 2024-06-17
Category : Electronic
ISBN : 9781071636909

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Handbook of ELISPOT by Alexander E. Kalyuzhny Pdf

Author : Scott N. Mueller
Publisher : Frontiers Media SA
Page : 138 pages
File Size : 46,7 Mb
Release : 2022-11-30
Category : Medical
ISBN : 9782832507810

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A Year in Review: Discussions in Immunological Memory by Scott N. Mueller Pdf

Author : Virginia Litwin,Philip Marder
Publisher : John Wiley & Sons
Page : 404 pages
File Size : 52,5 Mb
Release : 2011-04-20
Category : Medical
ISBN : 9780470922781

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Flow Cytometry in Drug Discovery and Development by Virginia Litwin,Philip Marder Pdf

This book covers the unique application of flow cytometry in drug discovery and development. The first section includes two introductory chapters, one on flow cytometry and one on biomarkers, as well as a chapter on recent advances in flow cytometry. The second section focuses on the unique challenges and added benefits associated with the use of flow cytometry in the drug development process. The third section contains a single chapter presenting an in depth discussion of validation considerations and regulatory compliance issues associated with drug development.

Author : Ray Proudlock
Publisher : Academic Press
Page : 460 pages
File Size : 53,5 Mb
Release : 2016-05-28
Category : Medical
ISBN : 9780128010068

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Genetic Toxicology Testing by Ray Proudlock Pdf

Genetic Toxicology Testing: A Laboratory Manual presents a practical guide to genetic toxicology testing of chemicals in a GLP environment. The most commonly used assays are described, from laboratory and test design to results analysis. In a methodical manner, individual test methods are described step-by-step, along with equipment, suggested suppliers, recipes for reagents, and evaluation criteria. An invaluable resource in the lab, this book will help to troubleshoot any assay problems you may encounter to optimise quality and efficiency in your genetic toxicology tests. Genetic Toxicology Testing: A Laboratory Manual is an essential reference for those new to the genetic toxicology laboratory, or anyone involved in setting up their own. Offers practical and consistent guidance on the most commonly-performed tests and procedures in a genetic toxicology lab Describes standard genetic toxicology assays, their methodology, reagents, suppliers, and analysis of their results Includes guidance on general approaches: formulation for in vitro assays, study monitoring, and Good Laboratory Practice (GLP) Serves as an essential reference for those new to the genetic toxicology laboratory, or anyone involved in setting up their own lab

Author : Russell Weiner,Marian Kelley
Publisher : Springer
Page : 0 pages
File Size : 55,7 Mb
Release : 2016-08-30
Category : Medical
ISBN : 3319407929

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Translating Molecular Biomarkers into Clinical Assays by Russell Weiner,Marian Kelley Pdf

This handbook covers established and advanced techniques for biomarker analysis, such as guidelines and strategies for assay validation methods; different mathematical models that are necessary in contemporary drug discovery and development; and evaluation of new cytometry methods. Expertly curated by two practicing professionals in drug development and biotherapeutics, individual chapters are selected for novel and sound research; information is chosen based on its relevance to lab applications and clinical trials, such as the topic of selecting animal models for their relevancy to humans. The book is multifaceted, discussing the ethics and issues with biospecimens and providing an in-depth analysis to the differences between pre-clinical and clinical assay development. The book is an essential read for general readers who need an introduction to the history and background of biomarkers, and it also provides critical analyses of various new validation methods for practitioners and researchers.

Author : Tristan Vaughan,Jane Osbourn,Bahija Jallal
Publisher : John Wiley & Sons
Page : 762 pages
File Size : 49,8 Mb
Release : 2017-12-04
Category : Medical
ISBN : 9783527340866

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Protein Therapeutics, 2 Volume Set by Tristan Vaughan,Jane Osbourn,Bahija Jallal Pdf

In this practice-oriented two volume handbook, professionals from some of the largest biopharmaceutical companies and top academic researchers address the key concepts and challenges in the development of protein pharmaceuticals for medicinal chemists and drug developers of all trades. Following an introduction tracing the rapid development of the protein therapeutics market over the last decade, all currently used therapeutic protein scaffolds are surveyed, from human and non-human antibodies to antibody mimetics, bispecific antibodies and antibody-drug conjugates. This ready reference then goes on to review other key aspects such as pharmacokinetics, safety and immunogenicity, manufacture, formulation and delivery. The handbook then takes a look at current key clinical applications for protein therapeutics, from respiratory and inflammation to oncology and immune-oncology, infectious diseases and rescue therapy. Finally, several exciting prospects for the future of protein therapeutics are highlighted and discussed.

Author : Dana Ferguson
Publisher : Book Review Index Cumulation
Page : 1304 pages
File Size : 49,8 Mb
Release : 2009-08
Category : Language Arts & Disciplines
ISBN : 1414419120

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Book Review Index - 2009 Cumulation by Dana Ferguson Pdf

Book Review Index provides quick access to reviews of books, periodicals, books on tape and electronic media representing a wide range of popular, academic and professional interests. The up-to-date coverage, wide scope and inclusion of citations for both newly published and older materials make Book Review Index an exceptionally useful reference tool. More than 600 publications are indexed, including journals and national general interest publications and newspapers. Book Review Index is available in a three-issue subscription covering the current year or as an annual cumulation covering the past year.

Author : OECD
Publisher : OECD Publishing
Page : 172 pages
File Size : 55,8 Mb
Release : 2018-12-10
Category : Electronic
ISBN : 9789264304796

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OECD Series on Testing and Assessment Guidance Document on Good In Vitro Method Practices (GIVIMP) by OECD Pdf

In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context. To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which ...

Author : Claudio Carini,Mark Fidock,Alain van Gool
Publisher : CRC Press
Page : 1025 pages
File Size : 43,7 Mb
Release : 2019-04-16
Category : Mathematics
ISBN : 9780429574627

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Handbook of Biomarkers and Precision Medicine by Claudio Carini,Mark Fidock,Alain van Gool Pdf

"The field of Biomarkers and Precision Medicine in drug development is rapidly evolving and this book presents a snapshot of exciting new approaches. By presenting a wide range of biomarker applications, discussed by knowledgeable and experienced scientists, readers will develop an appreciation of the scope and breadth of biomarker knowledge and find examples that will help them in their own work." -Maria Freire, Foundation for the National Institutes of Health Handbook of Biomarkers and Precision Medicine provides comprehensive insights into biomarker discovery and development which has driven the new era of Precision Medicine. A wide variety of renowned experts from government, academia, teaching hospitals, biotechnology and pharmaceutical companies share best practices, examples and exciting new developments. The handbook aims to provide in-depth knowledge to research scientists, students and decision makers engaged in Biomarker and Precision Medicine-centric drug development. Features: Detailed insights into biomarker discovery, validation and diagnostic development with implementation strategies Lessons-learned from successful Precision Medicine case studies A variety of exciting and emerging biomarker technologies The next frontiers and future challenges of biomarkers in Precision Medicine Claudio Carini, Mark Fidock and Alain van Gool are internationally recognized as scientific leaders in Biomarkers and Precision Medicine. They have worked for decades in academia and pharmaceutical industry in EU, USA and Asia. Currently, Dr. Carini is Honorary Faculty at Kings’s College School of Medicine, London, UK. Dr. Fidock is Vice President of Precision Medicine Laboratories at AstraZeneca, Cambridge, UK. Prof.dr. van Gool is Head Translational Metabolic Laboratory at Radboud university medical school, Nijmegen, NL.