Biotherapeutics

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Analytical Characterization of Biotherapeutics

Author : Jennie R. Lill
Publisher : John Wiley & Sons
ISBN 13 : 1119053102
Total Pages : 378 pages
Book Rating : 4.1/5 (19 download)

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Book Synopsis Analytical Characterization of Biotherapeutics by : Jennie R. Lill

Download or read book Analytical Characterization of Biotherapeutics written by Jennie R. Lill and published by John Wiley & Sons. This book was released on 2017-08-14 with total page 378 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Developability of Biotherapeutics

Author : Sandeep Kumar
Publisher : CRC Press
ISBN 13 : 1482246155
Total Pages : 297 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Developability of Biotherapeutics by : Sandeep Kumar

Download or read book Developability of Biotherapeutics written by Sandeep Kumar and published by CRC Press. This book was released on 2015-11-18 with total page 297 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceuticals are emerging as frontline medicines to combat several life-threatening and chronic diseases. However, such medicines are expensive to develop and produce on a commercial scale, contributing to rising healthcare costs. Developability of Biotherapeutics: Computational Approaches describes applications of computational and molecular modeling techniques that improve the overall process of discovery and development by removing empiricism. The concept of developability involves making rational choices at the pre-clinical stages of biopharmaceutical drug development that could positively impact clinical outcomes. The book also addresses a general lack of awareness of the many different contributions that computation can make to biopharmaceutical drug development. This informative and practical reference is a valuable resource for professionals engaged in industrial research and development, scientists working with regulatory agencies, and pharmacy, medicine, and life science students and educators. It focuses primarily on the developability of monoclonal antibody candidates, but the principles described can also be extended to other modalities such as recombinant proteins, fusion proteins, antibody drug conjugates and vaccines. The book is organized into two sections. The first discusses principles and applications of computational approaches toward discovering and developing biopharmaceutical drugs. The second presents best practices in developability assessments of early-stage biopharmaceutical drug candidates. In addition to raising awareness of the promise of computational research, this book also discusses solutions required to improve the success rate of translating biologic drug candidates into products available in the clinic. As such, it is a rich source of information on current principles and practices as well as a starting point for finding innovative applications of computation towards biopharmaceutical drug development.

Emerging Protein Biotherapeutics

Author : Iqbal S. Grewal
Publisher : CRC Press
ISBN 13 : 1420063219
Total Pages : 372 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Emerging Protein Biotherapeutics by : Iqbal S. Grewal

Download or read book Emerging Protein Biotherapeutics written by Iqbal S. Grewal and published by CRC Press. This book was released on 2009-06-26 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: Given the speed at which antibody therapy is becoming readily accepted, a comprehensive industry guide is sorely needed. Written by leading international authorities, this book maintains an overall emphasis on various therapeutic approaches and applications and provides critical discussions on the most significant areas of research in biologics. It focuses on the applications of protein biologics in autoimmunity and inflammation, hematological malignancies, and solid tumors. Each chapter clearly presents the most informative and contemporary account of its subject available, making this an unrivaled reference source beneficial to those in both academia and biotechnology industries.

Biotherapeutics

Author : Lyn Jones
Publisher : Royal Society of Chemistry
ISBN 13 : 1849737150
Total Pages : 336 pages
Book Rating : 4.8/5 (497 download)

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Book Synopsis Biotherapeutics by : Lyn Jones

Download or read book Biotherapeutics written by Lyn Jones and published by Royal Society of Chemistry. This book was released on 2013-09-06 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book illustrates the successful partnership of chemistry and biology to advance successful biotherapeutic modalities. Molecular design to create function is common to both chemical and molecular biology, and this text highlights recent developments from these disciplines that have delivered drugs, clinical candidates or significantly advanced biotherapeutic approaches. Biotherapeutics are often considered to be beyond the reach of the medicinal chemist, but this book demonstrates that chemistry has an essential role in the future success of this area, by explaining and describing the chemical biology technologies that underpin specific therapeutic advances and demonstrating the unique value of molecular design and understanding. Covering topics such as selective protein modification, immunopharmacotherapy, chemically programmed vaccinations, nanobodies and antibodies, this book provides essential reading for medicinal and pharmaceutical chemists working in both industry and academia.

Biophysical Methods for Biotherapeutics

Author : Tapan K. Das
Publisher : John Wiley & Sons
ISBN 13 : 1118354680
Total Pages : 380 pages
Book Rating : 4.1/5 (183 download)

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Book Synopsis Biophysical Methods for Biotherapeutics by : Tapan K. Das

Download or read book Biophysical Methods for Biotherapeutics written by Tapan K. Das and published by John Wiley & Sons. This book was released on 2014-02-27 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Biopharmaceutical Processing

Author : Gunter Jagschies
Publisher : Elsevier
ISBN 13 : 0128125527
Total Pages : 1308 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Biopharmaceutical Processing by : Gunter Jagschies

Download or read book Biopharmaceutical Processing written by Gunter Jagschies and published by Elsevier. This book was released on 2018-01-18 with total page 1308 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. Offers a comprehensive, go-to reference for daily work decisions Covers both upstream and downstream processes Includes case studies that emphasize financial outcomes Presents summaries, decision grids, graphs and overviews for quick reference

Formulation and Device Lifecycle Management of Biotherapeutics

Author : Beate Bittner
Publisher : Academic Press
ISBN 13 : 0128237422
Total Pages : 230 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Formulation and Device Lifecycle Management of Biotherapeutics by : Beate Bittner

Download or read book Formulation and Device Lifecycle Management of Biotherapeutics written by Beate Bittner and published by Academic Press. This book was released on 2022-01-14 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today, the pressure on healthcare costs and resources is increasing, and especially for biopharmaceuticals that require parenteral administration, the inherent complex and invasive dosing procedure adds to the demand for efficient medical management. In light of the COVID-19 pandemic the value of drug delivery technologies in enabling a flexible care setting is broadly recognized. In such a setting, patients and their caregivers can choose the place of drug administration based on individual preferences and capabilities. This includes not only dosing in the clinic but also supervised at-home dosing and self-administration for eligible patients. Formulation and Device Lifecycle Management of Biotherapeutics: A Guidance for Researchers and Drug Developers covers the various aspects of improving drug delivery of biological medicines with the ultimate goal to reduce dosing complexity associated with parenteral administration and, thus, enhance patient experience and drug administration-related healthcare capacity. The target audience are multidisciplinary researchers and drug developers in the pharmaceutical industry, biotech companies, and academia involved in formulation and device development. This includes pharmacology and medical experts in charge of generating nonclinical and clinical data to support approval of novel dosing regimens, and drug delivery scientists and engineers responsible for technical particulars of product optimizations. Moreover, professionals in market access and commercial functions are expected to benefit from the discussions about the impact of patient and healthcare provider needs and country-specific reimbursement models on realizing a truly convenient and cost and resource efficient drug delivery solution. Summarizes formulation and device lifecycle management activities that enable customer-centric and sustainable drug delivery for biotherapeutics Describes the pharmacokinetic-based clinical development pathway for subcutaneous dosing alternatives to established intravenous formulations for monoclonal antibodies Details established clinical development pathways supporting the approval of automated subcutaneous injection devices and proposes novel concepts Discusses how to realize home- and self-administration of biotherapeutics in cancer care Highlights aspects of multidisciplinary formulation and device lifecycle management that can be leveraged across different disease areas and introduces a decision architecture on when and how drug developers should embark into related development activities

Accelerated Path to Cures

Author : Josep Bassaganya-Riera
Publisher : Springer
ISBN 13 : 3319732382
Total Pages : 82 pages
Book Rating : 4.3/5 (197 download)

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Book Synopsis Accelerated Path to Cures by : Josep Bassaganya-Riera

Download or read book Accelerated Path to Cures written by Josep Bassaganya-Riera and published by Springer. This book was released on 2018-04-25 with total page 82 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accelerated Path to Cures provides a transformative perspective on the power of combining advanced computational technologies, modeling, bioinformatics and machine learning approaches with nonclinical and clinical experimentation to accelerate drug development. This book discusses the application of advanced modeling technologies, from target identification and validation to nonclinical studies in animals to Phase 1-3 human clinical trials and post-approval monitoring, as alternative models of drug development. As a case of successful integration of computational modeling and drug development, we discuss the development of oral small molecule therapeutics for inflammatory bowel disease, from the application of docking studies to screening new chemical entities to the development of next-generation in silico human clinical trials from large-scale clinical data. Additionally, this book illustrates how modeling techniques, machine learning, and informatics can be utilized effectively at each stage of drug development to advance the progress towards predictive, preventive, personalized, precision medicine, and thus provide a successful framework for Path to Cures.

Biologics, Biosimilars, and Biobetters

Author : Iqbal Ramzan
Publisher : John Wiley & Sons
ISBN 13 : 1119564654
Total Pages : 328 pages
Book Rating : 4.1/5 (195 download)

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Book Synopsis Biologics, Biosimilars, and Biobetters by : Iqbal Ramzan

Download or read book Biologics, Biosimilars, and Biobetters written by Iqbal Ramzan and published by John Wiley & Sons. This book was released on 2021-02-03 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists

Biophysical Methods for Biotherapeutics

Author : Tapan K. Das
Publisher : John Wiley & Sons
ISBN 13 : 0470938439
Total Pages : 380 pages
Book Rating : 4.4/5 (79 download)

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Book Synopsis Biophysical Methods for Biotherapeutics by : Tapan K. Das

Download or read book Biophysical Methods for Biotherapeutics written by Tapan K. Das and published by John Wiley & Sons. This book was released on 2014-04-28 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Biotherapeutic Agents and Infectious Diseases

Author : Gary W. Elmer
Publisher : Springer Science & Business Media
ISBN 13 : 1592597114
Total Pages : 393 pages
Book Rating : 4.5/5 (925 download)

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Book Synopsis Biotherapeutic Agents and Infectious Diseases by : Gary W. Elmer

Download or read book Biotherapeutic Agents and Infectious Diseases written by Gary W. Elmer and published by Springer Science & Business Media. This book was released on 1999-01-07 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: Authoritative investigators active in the discovery, development, and application of biological anti-infective agents concisely review their use and potential in preventing and treating human disease. Focusing on biotherapeutic entities that have been tested in controlled studies, the prominent experts illuminate the scientific underpinnings of their therapeutic power, assess their possible risks in the treatment of infectious diseases, and outline the research needed to better define their effectiveness. In addition, they also consider how biotherapeutic agents may be genetically engineered for maximum intestinal and vaginal production of bioactive substances in vivo. Biotherapeutic Agents and Infectious Diseases brings together all the evidence needed to understand and capitalize on the considerable promise of this significant new class of biotherapeutic entities.

Protein Analysis using Mass Spectrometry

Author : Mike S. Lee
Publisher : John Wiley & Sons
ISBN 13 : 1119359368
Total Pages : 288 pages
Book Rating : 4.1/5 (193 download)

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Book Synopsis Protein Analysis using Mass Spectrometry by : Mike S. Lee

Download or read book Protein Analysis using Mass Spectrometry written by Mike S. Lee and published by John Wiley & Sons. This book was released on 2017-05-26 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Biotherapeutics

Author : Lyn H. Jones
Publisher : Royal Society of Chemistry
ISBN 13 : 1849736014
Total Pages : 331 pages
Book Rating : 4.8/5 (497 download)

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Book Synopsis Biotherapeutics by : Lyn H. Jones

Download or read book Biotherapeutics written by Lyn H. Jones and published by Royal Society of Chemistry. This book was released on 2013 with total page 331 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotherapeutics are often considered to be beyond the reach of the medicinal chemist, but this book demonstrates that chemistry has an essential role in the future success of this area.

Drug Discovery and Development

Author : Izet Kapetanović
Publisher : BoD – Books on Demand
ISBN 13 : 9533076151
Total Pages : 544 pages
Book Rating : 4.5/5 (33 download)

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Book Synopsis Drug Discovery and Development by : Izet Kapetanović

Download or read book Drug Discovery and Development written by Izet Kapetanović and published by BoD – Books on Demand. This book was released on 2011-12-16 with total page 544 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug discovery and development process aims to make available medications that are safe and effective in improving the length and quality of life and relieving pain and suffering. However, the process is very complex, time consuming, resource intensive, requiring multi-disciplinary expertise and innovative approaches. There is a growing urgency to identify and develop more effective, efficient, and expedient ways to bring safe and effective products to the market. The drug discovery and development process relies on the utilization of relevant and robust tools, methods, models, and validated biomarkers that are predictive of clinical effects in terms of diagnosis, prevention, therapy, and prognosis. There is a growing emphasis on translational research, a bidirectional bench to the bedside approach, in an effort to improve the process efficiency and the need for further innovations. The authors in the book discuss the current and evolving state of drug discovery and development.

Biophysical Characterization of Proteins in Developing Biopharmaceuticals

Author : Damian J. Houde
Publisher : Elsevier
ISBN 13 : 0444641742
Total Pages : 586 pages
Book Rating : 4.4/5 (446 download)

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Book Synopsis Biophysical Characterization of Proteins in Developing Biopharmaceuticals by : Damian J. Houde

Download or read book Biophysical Characterization of Proteins in Developing Biopharmaceuticals written by Damian J. Houde and published by Elsevier. This book was released on 2019-11-13 with total page 586 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Medical Innovation and Disease Burden

Author : Sobin George
Publisher : Cambridge University Press
ISBN 13 : 110883230X
Total Pages : 227 pages
Book Rating : 4.1/5 (88 download)

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Book Synopsis Medical Innovation and Disease Burden by : Sobin George

Download or read book Medical Innovation and Disease Burden written by Sobin George and published by Cambridge University Press. This book was released on 2021-06-10 with total page 227 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drawing from recent concepts and data, the book carefully examines responsiveness of drug, vaccine and medical device innovations to public health priorities in India. It also emphasises the need for a responsible and responsive health innovation framework in which interests of all stakeholders are taken care of.

Bioanalytical Aspects in Biological Therapeutics

Author : Xiaohui (Sophia) Xu
Publisher : John Wiley & Sons
ISBN 13 : 1119523281
Total Pages : 404 pages
Book Rating : 4.1/5 (195 download)

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Book Synopsis Bioanalytical Aspects in Biological Therapeutics by : Xiaohui (Sophia) Xu

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 2022-07-06 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.