Handbook of Process Chromatography

Handbook of Process Chromatography

Author: Gunter Jagschies

Publisher: Elsevier

Published: 2007-12-08

Total Pages: 382

ISBN-13: 9780080554518

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This book will update the original edition published in 1997. Since the publication of the first edition, the biotechnology and biologics industries have gained extensive knowledge and experience in downstream processing using chromatography and other technologies associated with recovery and purification unit operations. This book will tie that experience together for the next generation of readers. Updates include: - sources and productivity - types of products made today - experiences in clinical and licensed products - economics - current status of validation - illustrations and tables - automated column packing - automated systems New topics include: - the use of disposables - multiproduct versus dedicated production - design principles for chromatography media and filters - ultrafiltration principles and optimization - risk assessments - characterization studies - design space - platform technologies - process analytical technologies (PATs) - biogenerics - comparability assessments Key Features: - new approaches to process optimiaztion - use of patform technologies - applying risk assessment to process design


Book Synopsis Handbook of Process Chromatography by : Gunter Jagschies

Download or read book Handbook of Process Chromatography written by Gunter Jagschies and published by Elsevier. This book was released on 2007-12-08 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book will update the original edition published in 1997. Since the publication of the first edition, the biotechnology and biologics industries have gained extensive knowledge and experience in downstream processing using chromatography and other technologies associated with recovery and purification unit operations. This book will tie that experience together for the next generation of readers. Updates include: - sources and productivity - types of products made today - experiences in clinical and licensed products - economics - current status of validation - illustrations and tables - automated column packing - automated systems New topics include: - the use of disposables - multiproduct versus dedicated production - design principles for chromatography media and filters - ultrafiltration principles and optimization - risk assessments - characterization studies - design space - platform technologies - process analytical technologies (PATs) - biogenerics - comparability assessments Key Features: - new approaches to process optimiaztion - use of patform technologies - applying risk assessment to process design


Handbook of Process Chromatography

Handbook of Process Chromatography

Author: Gail Sofer

Publisher:

Published: 1997

Total Pages:

ISBN-13:

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Book Synopsis Handbook of Process Chromatography by : Gail Sofer

Download or read book Handbook of Process Chromatography written by Gail Sofer and published by . This book was released on 1997 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:


Handbook of Process Chromatography

Handbook of Process Chromatography

Author: Gail K. Sofer

Publisher: Academic Press

Published: 1997-06-24

Total Pages: 410

ISBN-13:

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With examples from companies with establised processes and approved biotherapeutics, this pack considers the entire scope of process chromatography, including scale-up, regulatory issues, equipment, evaluation studies, scheduling and cost effectiveness.


Book Synopsis Handbook of Process Chromatography by : Gail K. Sofer

Download or read book Handbook of Process Chromatography written by Gail K. Sofer and published by Academic Press. This book was released on 1997-06-24 with total page 410 pages. Available in PDF, EPUB and Kindle. Book excerpt: With examples from companies with establised processes and approved biotherapeutics, this pack considers the entire scope of process chromatography, including scale-up, regulatory issues, equipment, evaluation studies, scheduling and cost effectiveness.


Process Chromatography

Process Chromatography

Author: Gail K. Sofer

Publisher: Academic Press

Published: 2015-09-02

Total Pages: 89

ISBN-13: 1483289176

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Research and development into biological products for therapeutic use has increased dramatically over the last 10 years. With this, strict regulatory requirements have been imposed by authorities such as the U.S. Food & Drug Administration, so that today validation has become a key issue in the biopharmaceutical industry.This concise book addresses validation issues in the chromatography of biotherapeutics. It covers process design, qualification and validation, including an overview of analytical techniques commonly used in the validation of processes. A concluding section comments on product changeover and presents four case studies.


Book Synopsis Process Chromatography by : Gail K. Sofer

Download or read book Process Chromatography written by Gail K. Sofer and published by Academic Press. This book was released on 2015-09-02 with total page 89 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research and development into biological products for therapeutic use has increased dramatically over the last 10 years. With this, strict regulatory requirements have been imposed by authorities such as the U.S. Food & Drug Administration, so that today validation has become a key issue in the biopharmaceutical industry.This concise book addresses validation issues in the chromatography of biotherapeutics. It covers process design, qualification and validation, including an overview of analytical techniques commonly used in the validation of processes. A concluding section comments on product changeover and presents four case studies.


A Practical Handbook of Preparative HPLC

A Practical Handbook of Preparative HPLC

Author: Donald A Wellings

Publisher: Elsevier

Published: 2011-04-18

Total Pages: 176

ISBN-13: 9780080458854

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This book is a distillation of twenty years of practical experience of the high pressure liquid chromatography (HPLC) process. Deliberately steering clear of complex theoretical aspects, this book concentrates on the everyday problems associated with the technique, making it perfect for frequent use in the laboratory and for those in the pharmaceutical, agrochemical and biotechnology industries for the analysis and purification of drugs, small molecules, proteins and DNA. This book... •Provides practical, hands-on advice based on years of experience •Will help ensure optimal design, equipment and separation results for your particular task •Presents system layouts from laboratory to process scale •Will help you to devise or improve record-keeping and documentation systems ·Provides practical, hands-on advice based on years of experience ·Will help ensure optimal design, equipment and separation results for your particular task ·Presents system layouts from laboratory to process scale ·Will help you to devise or improve record-keeping and documentation systems


Book Synopsis A Practical Handbook of Preparative HPLC by : Donald A Wellings

Download or read book A Practical Handbook of Preparative HPLC written by Donald A Wellings and published by Elsevier. This book was released on 2011-04-18 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a distillation of twenty years of practical experience of the high pressure liquid chromatography (HPLC) process. Deliberately steering clear of complex theoretical aspects, this book concentrates on the everyday problems associated with the technique, making it perfect for frequent use in the laboratory and for those in the pharmaceutical, agrochemical and biotechnology industries for the analysis and purification of drugs, small molecules, proteins and DNA. This book... •Provides practical, hands-on advice based on years of experience •Will help ensure optimal design, equipment and separation results for your particular task •Presents system layouts from laboratory to process scale •Will help you to devise or improve record-keeping and documentation systems ·Provides practical, hands-on advice based on years of experience ·Will help ensure optimal design, equipment and separation results for your particular task ·Presents system layouts from laboratory to process scale ·Will help you to devise or improve record-keeping and documentation systems


Protein Chromatography

Protein Chromatography

Author: Giorgio Carta

Publisher: John Wiley & Sons

Published: 2020-06-02

Total Pages: 440

ISBN-13: 352734666X

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An all-in-one practical guide on how to efficiently use chromatographic separation methods Based on a training course that teaches the theoretical as well as practical aspects of protein bioseparation to bioprocess professionals, this fully updated and revised new edition offers comprehensive coverage of continuous chromatography and provides readers with many relevant examples from the biopharmaceutical industry. Divided into two large parts, Protein Chromatography: Process Development and Scale-Up, Second Edition presents all the necessary knowledge for effective process development in chromatographic bioseparation, both on small and large scale. The first part introduces chromatographic theory, including process design principles, to enable the reader to rationalize the set-up of a bioseparation process. The second part illustrates by way of case studies and sample protocols how the theory learned in the first part may be applied to real-life problems. Chapters look at: Downstream Processing of Biotechnology Products; Chromatography Media; Laboratory and Process Columns and Equipment; Adsorption Equilibrium; Rate Processes; and Dynamics of Chromatography Columns. The book closes with chapters on: Effects of Dispersion and Rate Processes on Column Performance; Gradient Elution Chromatography; and Chromatographic Column Design and Optimization. -Presents the most pertinent examples from the biopharmaceutical industry, including monoclonal antibodies -Provides an overview of the field along with design tools and examples illustrating the advantages of continuous processing in biopharmaceutical productions -Focuses on process development and large-scale bioseparation tasks, making it an ideal guide for the professional bioengineer in the biotech and pharma industries -Offers field-tested information based on decades of training courses for biotech and chemical engineers in Europe and the U.S. Protein Chromatography: Process Development and Scale-Up, Second Edition will appeal to biotechnologists, analytical chemists, chromatographers, chemical engineers, pharmaceutical industry, biotechnological industry, and biochemists.


Book Synopsis Protein Chromatography by : Giorgio Carta

Download or read book Protein Chromatography written by Giorgio Carta and published by John Wiley & Sons. This book was released on 2020-06-02 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: An all-in-one practical guide on how to efficiently use chromatographic separation methods Based on a training course that teaches the theoretical as well as practical aspects of protein bioseparation to bioprocess professionals, this fully updated and revised new edition offers comprehensive coverage of continuous chromatography and provides readers with many relevant examples from the biopharmaceutical industry. Divided into two large parts, Protein Chromatography: Process Development and Scale-Up, Second Edition presents all the necessary knowledge for effective process development in chromatographic bioseparation, both on small and large scale. The first part introduces chromatographic theory, including process design principles, to enable the reader to rationalize the set-up of a bioseparation process. The second part illustrates by way of case studies and sample protocols how the theory learned in the first part may be applied to real-life problems. Chapters look at: Downstream Processing of Biotechnology Products; Chromatography Media; Laboratory and Process Columns and Equipment; Adsorption Equilibrium; Rate Processes; and Dynamics of Chromatography Columns. The book closes with chapters on: Effects of Dispersion and Rate Processes on Column Performance; Gradient Elution Chromatography; and Chromatographic Column Design and Optimization. -Presents the most pertinent examples from the biopharmaceutical industry, including monoclonal antibodies -Provides an overview of the field along with design tools and examples illustrating the advantages of continuous processing in biopharmaceutical productions -Focuses on process development and large-scale bioseparation tasks, making it an ideal guide for the professional bioengineer in the biotech and pharma industries -Offers field-tested information based on decades of training courses for biotech and chemical engineers in Europe and the U.S. Protein Chromatography: Process Development and Scale-Up, Second Edition will appeal to biotechnologists, analytical chemists, chromatographers, chemical engineers, pharmaceutical industry, biotechnological industry, and biochemists.


Handbook of Separation Process Technology

Handbook of Separation Process Technology

Author: Ronald W. Rousseau

Publisher: John Wiley & Sons

Published: 1987-05-13

Total Pages: 1028

ISBN-13: 9780471895589

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Surveys the selection, design, and operation of most of the industrially important separation processes. Discusses the underlying principles on which the processes are based, and provides illustrative examples of the use of the processes in a modern context. Features thorough treatment of newer separation processes based on membranes, adsorption, chromatography, ion exchange, and chemical complexation. Includes a review of historically important separation processes such as distillation, absorption, extraction, leaching, and crystallization and considers these techniques in light of recent developments affecting them.


Book Synopsis Handbook of Separation Process Technology by : Ronald W. Rousseau

Download or read book Handbook of Separation Process Technology written by Ronald W. Rousseau and published by John Wiley & Sons. This book was released on 1987-05-13 with total page 1028 pages. Available in PDF, EPUB and Kindle. Book excerpt: Surveys the selection, design, and operation of most of the industrially important separation processes. Discusses the underlying principles on which the processes are based, and provides illustrative examples of the use of the processes in a modern context. Features thorough treatment of newer separation processes based on membranes, adsorption, chromatography, ion exchange, and chemical complexation. Includes a review of historically important separation processes such as distillation, absorption, extraction, leaching, and crystallization and considers these techniques in light of recent developments affecting them.


Handbook of Downstream Processing

Handbook of Downstream Processing

Author: E. Goldberg

Publisher: Springer Science & Business Media

Published: 2012-12-06

Total Pages: 745

ISBN-13: 9400915632

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The last two decades have seen a phenomenal growth of the field of genetic or biochemical engineering and have witnessed the development and ultimately marketing of a variety of products-typically through the manipulation and growth of different types of microorganisms, followed by the recovery and purification of the associated products. The engineers and biotechnologists who are involved in the full-scale process design of such facilities must be familiar with the variety of unit operations and equipment and the applicable regulatory requirements. This book describes current commercial practice and will be useful to those engineers working in this field in the design, construction and operation of pharmaceutical and biotechnology plants. It will be of help to the chemical or pharmaceutical engineer who is developing a plant design and who faces issues such as: Should the process be batch or continuous or a combination of batch and continuous? How should the optimum process design be developed? Should one employ a new revolutionary separation which could be potentially difficult to validate or use accepted technology which involves less risk? Should the process be run with ingredients formulated from water for injection, deionized water, or even filtered tap water? Should any of the separations be run in cold rooms or in glycol jacketed lines to minimize microbial growth where sterilization is not possible? Should the process equipment and lines be designed to be sterilized in-place, cleaned-in-place, or should every piece be broken down, cleaned and autoclaved after every turn?


Book Synopsis Handbook of Downstream Processing by : E. Goldberg

Download or read book Handbook of Downstream Processing written by E. Goldberg and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 745 pages. Available in PDF, EPUB and Kindle. Book excerpt: The last two decades have seen a phenomenal growth of the field of genetic or biochemical engineering and have witnessed the development and ultimately marketing of a variety of products-typically through the manipulation and growth of different types of microorganisms, followed by the recovery and purification of the associated products. The engineers and biotechnologists who are involved in the full-scale process design of such facilities must be familiar with the variety of unit operations and equipment and the applicable regulatory requirements. This book describes current commercial practice and will be useful to those engineers working in this field in the design, construction and operation of pharmaceutical and biotechnology plants. It will be of help to the chemical or pharmaceutical engineer who is developing a plant design and who faces issues such as: Should the process be batch or continuous or a combination of batch and continuous? How should the optimum process design be developed? Should one employ a new revolutionary separation which could be potentially difficult to validate or use accepted technology which involves less risk? Should the process be run with ingredients formulated from water for injection, deionized water, or even filtered tap water? Should any of the separations be run in cold rooms or in glycol jacketed lines to minimize microbial growth where sterilization is not possible? Should the process equipment and lines be designed to be sterilized in-place, cleaned-in-place, or should every piece be broken down, cleaned and autoclaved after every turn?


Scale-Up and Optimization in Preparative Chromatography

Scale-Up and Optimization in Preparative Chromatography

Author: Anurag Rathore

Publisher: CRC Press

Published: 2002-09-26

Total Pages: 368

ISBN-13: 9780203909287

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Presenting guidelines to predict and improve separation system performance, this book contains numerous case studies illustrating the practice of scale-up principles in process development. It offers solutions to limitations that occur in real-world purification schemes; methods to model, optimize, and characterize nonlinear separation processes; d


Book Synopsis Scale-Up and Optimization in Preparative Chromatography by : Anurag Rathore

Download or read book Scale-Up and Optimization in Preparative Chromatography written by Anurag Rathore and published by CRC Press. This book was released on 2002-09-26 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presenting guidelines to predict and improve separation system performance, this book contains numerous case studies illustrating the practice of scale-up principles in process development. It offers solutions to limitations that occur in real-world purification schemes; methods to model, optimize, and characterize nonlinear separation processes; d


Separation Methods in Drug Synthesis and Purification

Separation Methods in Drug Synthesis and Purification

Author: Klara Valko

Publisher: Elsevier

Published: 2000-10-13

Total Pages: 612

ISBN-13: 9780080541099

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Separation Methods in Drug Synthesis and Purification


Book Synopsis Separation Methods in Drug Synthesis and Purification by : Klara Valko

Download or read book Separation Methods in Drug Synthesis and Purification written by Klara Valko and published by Elsevier. This book was released on 2000-10-13 with total page 612 pages. Available in PDF, EPUB and Kindle. Book excerpt: Separation Methods in Drug Synthesis and Purification