Biophysical Methods For Biotherapeutics
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Biophysical Methods For Biotherapeutics
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Author : Tapan K. Das
language : en
Publisher: John Wiley & Sons
Release Date : 2014-04-28
Biophysical Methods For Biotherapeutics written by Tapan K. Das and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-04-28 with Medical categories.
With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development. • Helps formulation and analytical scientists in pharma and biotech better understand and use biophysical methods • Chapters organized according to the sequential nature of the drug development process • Helps formulation, analytical, and bioanalytical scientists in pharma and biotech better understand and usestrengths and limitations of biophysical methods • Explains how to use biophysical methods, the information obtained, and what needs to be presented in a regulatory filing, assess impact on quality and immunogenicity • With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development.
Biophysical Methods For Biotherapeutics
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Author : Tapan K. Das
language : en
Publisher: John Wiley & Sons
Release Date : 2014-02-27
Biophysical Methods For Biotherapeutics written by Tapan K. Das and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-02-27 with Medical categories.
With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development. • Helps formulation and analytical scientists in pharma and biotech better understand and use biophysical methods • Chapters organized according to the sequential nature of the drug development process • Helps formulation, analytical, and bioanalytical scientists in pharma and biotech better understand and usestrengths and limitations of biophysical methods • Explains how to use biophysical methods, the information obtained, and what needs to be presented in a regulatory filing, assess impact on quality and immunogenicity • With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development.
Characterizing Biotherapeutics
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Author : Jennie R. Lill
language : en
Publisher: John Wiley & Sons
Release Date : 2025-06-04
Characterizing Biotherapeutics written by Jennie R. Lill and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-06-04 with Science categories.
Provides detailed and up-to-date coverage of analytical approaches for biologic drug modalities The development of innovative biologic therapies has revolutionized medicine, but their complexity demands equally advanced analytical approaches. Characterizing Biotherapeutics: Analytical Methods for Diverse Modalities introduces the tools and techniques used to analyze these groundbreaking therapies. Designed to help readers characterize and troubleshoot increasingly diverse and sophisticated therapeutic molecules, this in-depth guide addresses different biologic drugs, their unique analytical challenges, and the methods that enable their analysis. Organized into two comprehensive sections, Characterizing Biotherapeutics first delves into the fundamentals of analytical platforms, providing a robust foundation in techniques such as mass spectrometry and biophysical assays. The second section applies these methods to real-world scenarios, focusing on drug discovery, clinical evaluation, and commercial considerations in drug development. Authors Jennie R. Lill and Wendy Sandoval provide clear guidance tailored to the evolving demands of therapeutic innovations such as structural characterization, high-throughput biophysical assays, and RNA-based therapeutics. Equipping researchers with the knowledge to navigate the challenges posed by increasingly complex biologics, Characterizing Biotherapeutics: Analytical Methods for Diverse Modalities: Discusses new and emerging biological molecule diversity and both traditional analytical methods Provides characterization strategies for large molecule (protein/antibody) based therapeutics Summarizes cutting-edge technologies for novel modalities and antibody protein therapeutics Incorporates the latest advancements in mass spectrometry, functional assays, and biophysical methods Addresses specialized analytical issues for membrane proteins and other challenging targets Presents methodologies for assessing safety and therapeutic potential Characterizing Biotherapeutics: Analytical Methods for Diverse Modalities is an essential reference for analytical scientists, biologists, and mass spectrometrists involved in biomolecule analysis. It is also a valuable resource for graduate students taking advanced courses in biotechnology, drug development, and biotherapeutic analysis, as well as professionals in biotechnology and pharmaceutical industries working to advance biotherapeutic research and development.
Biophysics For Therapeutic Protein Development
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Author : Linda O. Narhi
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-02-26
Biophysics For Therapeutic Protein Development written by Linda O. Narhi and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-02-26 with Medical categories.
This book can be used to provide insight into this important application of biophysics for those who are planning a career in protein therapeutic development, and for those outside this area who are interested in understanding it better. The initial chapters describe the underlying theory, and strengths and weaknesses of the different techniques commonly used during therapeutic development. The majority of the chapters discuss the applications of these techniques, including case studies, across the product lifecycle from early discovery, where the focus is on identifying targets, and screening for potential drug product candidates, through expression and purification, large scale production, formulation development, lot-to-lot comparability studies, and commercial support including investigations.
Biophysical Characterization Of Proteins In Developing Biopharmaceuticals
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Author : Damian J. Houde
language : en
Publisher: Elsevier
Release Date : 2019-11-13
Biophysical Characterization Of Proteins In Developing Biopharmaceuticals written by Damian J. Houde and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-11-13 with Medical categories.
Biophysical Characterization of Proteins in Developing Biopharmaceuticals, Second Edition, presents the latest on the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure, this book explains the best way to achieve this goal using key methods commonly employed in the biopharmaceutical industry. This book will help today's industrial scientists plan a career in this industry and successfully implement these biophysical methodologies. This updated edition has been fully revised, with new chapters focusing on the use of chromatography and electrophoresis and the biophysical characterization of very large biopharmaceuticals. In addition, best practices of applying statistical analysis to biophysical characterization data is included, along with practical issues associated with the concept of a biopharmaceutical's developability and the technical decision-making process needed when dealing with biophysical characterization data. - Presents basic protein characterization methods and tools applicable to (bio)pharmaceutical research and development - Highlights the capabilities and limitations of each technique - Discusses the underlining science of each tool - Empowers industrial biophysical chemists by providing a roadmap for applying biophysical tools - Outlines the needs for new characterization and analytical tools in the biopharmaceutical industry
Analytical Characterization Of Biotherapeutics
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Author : Jennie R. Lill
language : en
Publisher: John Wiley & Sons
Release Date : 2017-07-10
Analytical Characterization Of Biotherapeutics written by Jennie R. Lill and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-07-10 with Science categories.
The definitive guide to the myriad analytical techniques available to scientists involved in biotherapeutics research Analytical Characterization of Biotherapeutics covers all current and emerging analytical tools and techniques used for the characterization of therapeutic proteins and antigen reagents. From basic recombinant antigen and antibody characterization, to complex analyses for increasingly complex molecular designs, the book explores the history of the analysis techniques and offers valuable insights into the most important emerging analytical solutions. In addition, it frames critical questions warranting attention in the design and delivery of a therapeutic protein, exposes analytical challenges that may occur when characterizing these molecules, and presents a number of tested solutions. The first single-volume guide of its kind, Analytical Characterization of Biotherapeutics brings together contributions from scientists at the leading edge of biotherapeutics research and manufacturing. Key topics covered in-depth include the structural characterization of recombinant proteins and antibodies, antibody de novo sequencing, characterization of antibody drug conjugates, characterization of bi-specific or other hybrid molecules, characterization of manufacturing host-cell contaminant proteins, analytical tools for biologics molecular assessment, and more. Each chapter is written by a recognized expert or experts in their field who discuss current and cutting edge approaches to fully characterizing biotherapeutic proteins and antigen reagents Covers the full range of characterization strategies for large molecule based therapeutics Provides an up-to-date account of the latest approaches used for large molecule characterization Chapters cover the background needed to understand the challenges at hand, solutions to characterize these large molecules, and a summary of emerging options for analytical characterization Analytical Characterization of Biotherapeutics is an up-to-date resource for analytical scientists, biologists, and mass spectrometrists involved in the analysis of biomolecules, as well as scientists employed in the pharmaceuticals and biotechnology industries. Graduate students in biology and analytical science, and their instructors will find it to be fascinating and instructive supplementary reading.
Characterization Of Biotherapeutic Products
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Author : Anurag S. Rathore
language : en
Publisher: Frontiers Media SA
Release Date : 2022-11-10
Characterization Of Biotherapeutic Products written by Anurag S. Rathore and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-11-10 with Science categories.
Parenteral Medications Fourth Edition
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Author : Sandeep Nema
language : en
Publisher: CRC Press
Release Date : 2019-07-19
Parenteral Medications Fourth Edition written by Sandeep Nema and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-07-19 with Business & Economics categories.
Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements
Bioanalytical Aspects In Biological Therapeutics
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Author : Xiaohui (Sophia) Xu
language : en
Publisher: John Wiley & Sons
Release Date : 2022-08-23
Bioanalytical Aspects In Biological Therapeutics written by Xiaohui (Sophia) Xu and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-08-23 with Science categories.
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.
Structural Biology In Drug Discovery
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Author : Jean-Paul Renaud
language : en
Publisher: John Wiley & Sons
Release Date : 2020-01-09
Structural Biology In Drug Discovery written by Jean-Paul Renaud and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-01-09 with Medical categories.
With the most comprehensive and up-to-date overview of structure-based drug discovery covering both experimental and computational approaches, Structural Biology in Drug Discovery: Methods, Techniques, and Practices describes principles, methods, applications, and emerging paradigms of structural biology as a tool for more efficient drug development. Coverage includes successful examples, academic and industry insights, novel concepts, and advances in a rapidly evolving field. The combined chapters, by authors writing from the frontlines of structural biology and drug discovery, give readers a valuable reference and resource that: Presents the benefits, limitations, and potentiality of major techniques in the field such as X-ray crystallography, NMR, neutron crystallography, cryo-EM, mass spectrometry and other biophysical techniques, and computational structural biology Includes detailed chapters on druggability, allostery, complementary use of thermodynamic and kinetic information, and powerful approaches such as structural chemogenomics and fragment-based drug design Emphasizes the need for the in-depth biophysical characterization of protein targets as well as of therapeutic proteins, and for a thorough quality assessment of experimental structures Illustrates advances in the field of established therapeutic targets like kinases, serine proteinases, GPCRs, and epigenetic proteins, and of more challenging ones like protein-protein interactions and intrinsically disordered proteins