Biotherapeutics

Biotherapeutics

Author: Lyn Jones

Publisher: Royal Society of Chemistry

Published: 2013-09-06

Total Pages: 336

ISBN-13: 1849737150

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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.


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.


Analytical Characterization of Biotherapeutics

Analytical Characterization of Biotherapeutics

Author: Jennie R. Lill

Publisher: John Wiley & Sons

Published: 2017-08-14

Total Pages: 378

ISBN-13: 1119053102

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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.


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.


Biophysical Methods for Biotherapeutics

Biophysical Methods for Biotherapeutics

Author: Tapan K. Das

Publisher: John Wiley & Sons

Published: 2014-04-28

Total Pages: 380

ISBN-13: 0470938439

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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.


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.


Formulation and Device Lifecycle Management of Biotherapeutics

Formulation and Device Lifecycle Management of Biotherapeutics

Author: Beate Bittner

Publisher: Academic Press

Published: 2022-01-14

Total Pages: 230

ISBN-13: 0128237422

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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


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


Developability of Biotherapeutics

Developability of Biotherapeutics

Author: Sandeep Kumar

Publisher: CRC Press

Published: 2015-11-18

Total Pages: 312

ISBN-13: 1482246155

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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


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 312 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


Biopharmaceutical Processing

Biopharmaceutical Processing

Author: Gunter Jagschies

Publisher: Elsevier

Published: 2018-01-18

Total Pages: 1308

ISBN-13: 0128125527

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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


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


Biologics, Biosimilars, and Biobetters

Biologics, Biosimilars, and Biobetters

Author: Iqbal Ramzan

Publisher: John Wiley & Sons

Published: 2021-02-03

Total Pages: 328

ISBN-13: 1119564654

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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


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


Biotherapeutics

Biotherapeutics

Author: Lyn H. Jones

Publisher: Royal Society of Chemistry

Published: 2013

Total Pages: 331

ISBN-13: 1849736014

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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.


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

Drug Discovery and Development

Author: Izet Kapetanović

Publisher: BoD – Books on Demand

Published: 2011-12-16

Total Pages: 544

ISBN-13: 9533076151

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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.


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.


Medical Innovation and Disease Burden

Medical Innovation and Disease Burden

Author: Sobin George

Publisher: Cambridge University Press

Published: 2021-06-10

Total Pages: 227

ISBN-13: 110883230X

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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.


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.