Handbook of Process Chromatography
Handbook of Process Chromatography

Author: Gunter Jagschies

Publisher: Elsevier

Published: 2007-12-08

Total Pages: 383

ISBN-13: 0080554512

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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 systemsNew 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 assessmentsKey Features:- new approaches to process optimiaztion- use of patform technologies- applying risk assessment to process design

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.

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.

Protein Chromatography
Protein Chromatography

Author: Giorgio Carta

Publisher: John Wiley & Sons

Published: 2010-06-08

Total Pages: 365

ISBN-13: 3527318194

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With its focus on process development and large-scale bioseparation tasks, this is tailor-made reading for the professional bioengineer in both the biotech and pharmaceutical industries. Following a tried-and-tested concept, this guide has been developed over several years in training courses for biotech and chemical engineers in Europe and the U.S. The first part deals with the theory, introducing chromatography and its dynamics, as well as discussing mass transfer and dispersion effects. The second part then goes on to cover equipment and protocols, determining the retention factor and HETP from isocratic and elution experiments, as well as the mass transfer and intraparticle diffusivity from batch and shallow-bed adsorption experiments.

Fundamentals of Preparative and Nonlinear Chromatography
Fundamentals of Preparative and Nonlinear Chromatography

Author: Georges Guiochon

Publisher: Academic Press

Published: 2006-03-21

Total Pages: 991

ISBN-13: 0123705371

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The second edition of Fundamentals of Preparative and Nonlinear Chromatography is devoted to the fundamentals of a new process of purification or extraction of chemicals or proteins widely used in the pharmaceutical industry and in preparative chromatography. This process permits the preparation of extremely pure compounds satisfying the requests of the US Food and Drug Administration. The book describes the fundamentals of thermodynamics, mass transfer kinetics, and flow through porous media that are relevant to chromatography. It presents the models used in chromatography and their solutions, discusses the applications made, describes the different processes used, their numerous applications, and the methods of optimization of the experimental conditions of this process.

Preparative Chromatography
Preparative Chromatography

Author: H. Schmidt-Traub

Publisher: John Wiley & Sons

Published: 2012-09-27

Total Pages: 545

ISBN-13: 3527649301

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Completely revised and substantially extended to reflect the developments in this fast-changing field. It retains the interdisciplinary approach that elegantly combines the chemistry and engineering involved to describe the conception and improvement of chromatographic processes. It also covers recent advances in preparative chromatographic processes for the separation of "smaller" molecules using standard laboratory equipment as well as the detailed conception of industrial chemical plants. The increase in biopharmaceutical substances is reflected by new and revised chapters on different modifications of continuous chromatography as well as ion-exchange chromatography and other separation principles widely used in biochromatography. Following an introductory section on the history of chromatography, the current state of research and the design of chromatographic processes, the book goes on to define the general terminology. There then follow sections on stationary phases, selection of chromatographic systems and process concepts. A completely new chapter deals with engineering and operation of chromatographic equipment. Final chapters on modeling and determination of model parameters as well as model based design, optimization and control of preparative chromatographic processes allow for optimal selection of chromatographic processes. Essential for chemists and chemical engineers in the chemical, pharmaceutical, and food industries.

Preparative Chromatography for Separation of Proteins
Preparative Chromatography for Separation of Proteins

Author: Arne Staby

Publisher: John Wiley & Sons

Published: 2017-02-02

Total Pages: 608

ISBN-13: 1119031176

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Preparative Chromatography for Separation of Proteins addresses a wide range of modeling, techniques, strategies, and case studies of industrial separation of proteins and peptides. • Covers broad aspects of preparative chromatography with a unique combination of academic and industrial perspectives • Presents Combines modeling with compliantce useing of Quality-by-Design (QbD) approaches including modeling • Features a variety of chromatographic case studies not readily accessible to the general public • Represents an essential reference resource for academic, industrial, and pharmaceutical researchers

Process Scale Purification of Antibodies
Process Scale Purification of Antibodies

Author: Uwe Gottschalk

Publisher: John Wiley & Sons

Published: 2017-03-02

Total Pages: 755

ISBN-13: 1119126924

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Promoting a continued and much-needed renaissance in biopharmaceutical manufacturing, this book covers the different strategies and assembles top-tier technology experts to address the challenges of antibody purification. • Updates existing topics and adds new ones that include purification of antibodies produced in novel production systems, novel separation technologies, novel antibody formats and alternative scaffolds, and strategies for ton-scale manufacturing • Presents new and updated discussions of different purification technologies, focusing on how they can address the capacity crunch in antibody purification • Emphasizes antibodies and innovative chromatography methods for processing

Preparative Chromatography for Separation of Proteins
Preparative Chromatography for Separation of Proteins

Author: Arne Staby

Publisher: John Wiley & Sons

Published: 2017-03-06

Total Pages: 577

ISBN-13: 1119031109

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Preparative Chromatography for Separation of Proteins addresses a wide range of modeling, techniques, strategies, and case studies of industrial separation of proteins and peptides. • Covers broad aspects of preparative chromatography with a unique combination of academic and industrial perspectives • Presents Combines modeling with compliantce useing of Quality-by-Design (QbD) approaches including modeling • Features a variety of chromatographic case studies not readily accessible to the general public • Represents an essential reference resource for academic, industrial, and pharmaceutical researchers

Validation of Pharmaceutical Processes
Validation of Pharmaceutical Processes

Author: James P. Agalloco

Publisher: CRC Press

Published: 2007-09-25

Total Pages: 762

ISBN-13: 1420019791

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Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va