Handbook of Process Chromatography PDF Download
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Author: Gunter Jagschies
Publisher: Elsevier
ISBN: 0080554512
Category : Technology & Engineering
Languages : en
Pages : 383
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Book Description
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
Author: Gunter Jagschies
Publisher: Elsevier
ISBN: 0080554512
Category : Technology & Engineering
Languages : en
Pages : 383
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Book Description
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
Author: Giorgio Carta
Publisher: John Wiley & Sons
ISBN: 352734666X
Category : Science
Languages : en
Pages : 440
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Book Description
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.
Author: Giorgio Carta
Publisher: John Wiley & Sons
ISBN: 3527318194
Category : Science
Languages : en
Pages : 365
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Book Description
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.
Author: Uwe Gottschalk
Publisher: John Wiley & Sons
ISBN: 1119126932
Category : Medical
Languages : en
Pages : 849
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Book Description
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
Author: Georges Guiochon
Publisher: Academic Press
ISBN: 0123705371
Category : Medical
Languages : en
Pages : 991
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Book Description
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.
Author: H. Schmidt-Traub
Publisher: John Wiley & Sons
ISBN: 3527649301
Category : Science
Languages : en
Pages : 545
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Book Description
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.
Author: Gail K. Sofer
Publisher: Academic Press
ISBN: 1483289176
Category : Science
Languages : en
Pages : 89
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Book Description
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.
Author: G. Ganetsos
Publisher: CRC Press
ISBN: 9780824787387
Category : Science
Languages : en
Pages : 812
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Book Description
Describes the latest developments in the scaling-up and application of chromatographic operations and demonstrates that production-scale chromatography is a powerful and invaluable separation process. The book covers every important process design and reveals actual, immediately applicable techniques and is designed to appeal to design, chemical/biochemical, and research and development engineers, process development managers, bioprocess technologists, analytical and clinical chemists and biochemists, pharmacists, and upper-level undergraduate, graduate, and continuing-education students in these disciplines.
Author: Syed S. H. Rizvi
Publisher: Elsevier
ISBN: 0857090755
Category : Technology & Engineering
Languages : en
Pages : 696
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Book Description
Separation, extraction and concentration are essential processes in the preparation of key food ingredients. They play a vital role in the quality optimization of common foods and beverages and there is also increasing interest in their use for the production of high-value compounds, such as bioactive peptides from milk and whey, and the recovery of co-products from food processing wastes.Part one describes the latest advances in separation, extraction and concentration techniques, including supercritical fluid extraction, process chromatography and membrane technologies. It also reviews emerging techniques of particular interest, such as pervaporation and pressurised liquid extraction. Part two then focuses on advances in separation technologies and their applications in various sectors of the food, beverage and nutraceutical industries. Areas covered include dairy and egg processing, oilseed extraction, and brewing. This section discusses the characteristics of different foods and fluids, how food constituents are affected by separation processes and how separation processes can be designed and operated to optimize end product quality.With its team of experienced international contributors, Separation, extraction and concentration processes in the food, beverage and nutraceutical industries is an important reference source for professionals concerned with the development and optimisation of these processes. - Describes the latest advances in separation, extraction and concentration techniques and their applications in various sectors of the food, beverage and nutraceutical industries - Reviews emerging techniques of particular interest, such as pervaporation and pressurised liquid extraction - Explores the characteristics of different foods and fluids and how food constituents are affected by separation processes
Author: Anurag S. Rathore
Publisher: CRC Press
ISBN: 1439850933
Category : Medical
Languages : en
Pages : 535
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Book Description
Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.
