Process Analytical Technology Pat

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Process Analytical Technology

Katherine A. Bakeev
Process Analytical Technology Book PDF

Author : Katherine A. Bakeev
Publisher : John Wiley & Sons
Page : 576 pages
File Size : 42,9 Mb
Release : 2010-04-01
Category : Science
ISBN : 9780470689608

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Process Analytical Technology by Katherine A. Bakeev Pdf

Process Analytical Technology explores the concepts of PAT and its application in the chemical and pharmaceutical industry from the point of view of the analytical chemist. In this new edition all of the original chapters have been updated and revised, and new chapters covering the important topics of sampling, NMR, fluorescence, and acoustic chemometrics have been added. Coverage includes: Implementation of Process Analytical Technologies UV-Visible Spectroscopy for On-line Analysis Infrared Spectroscopy for Process Analytical Applications Process Raman Spectroscopy Process NMR Spectrscopy: Technology and On-line Applications Fluorescent Sensing and Process Analytical Applications Chemometrics in Process Analytical Technology (PAT) On-Line PAT Applications of Spectroscopy in the Pharmaceutical Industry Future Trends for PAT for Increased Process Understanding and Growing Applications in Biomanufacturing NIR Chemical Imaging This volume is an important starting point for anyone wanting to implement PAT and is intended not only to assist a newcomer to the field but also to provide up-to-date information for those who practice process analytical chemistry and PAT. It is relevant for chemists, chemical and process engineers, and analytical chemists working on process development, scale-up and production in the pharmaceutical, fine and specialty chemicals industries, as well as for academic chemistry, chemical engineering, chemometrics and pharmaceutical science research groups focussing on PAT. Review from the First Edition “The book provides an excellent first port of call for anyone seeking material and discussions to understand the area better. It deserves to be found in every library that serves those who are active in the field of Process Analytical Technology.”—Current Engineering Practice

Process Analytical Technology for the Food Industry

Colm P. O'Donnell,Colette Fagan,P.J. Cullen
Process Analytical Technology for the Food Industry Book PDF

Author : Colm P. O'Donnell,Colette Fagan,P.J. Cullen
Publisher : Springer
Page : 301 pages
File Size : 42,7 Mb
Release : 2014-11-03
Category : Technology & Engineering
ISBN : 9781493903115

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Process Analytical Technology for the Food Industry by Colm P. O'Donnell,Colette Fagan,P.J. Cullen Pdf

The Process Analytical Technology (PAT) initiative aims to move from a paradigm of ‘testing quality in’ to ‘building quality in by design’. It can be defined as the optimal application of process analytical technologies, feedback process control strategies, information management tools, and/or product–process optimization strategies. Recently, there have been significant advances in process sensors and in model-based monitoring and control methodologies, leading to enormous opportunities for improved performance of food manufacturing processes and for the quality of food products with the adoption of PAT. Improvements in process efficiency, reduced product variability, enhanced traceability, process understanding, and decreased risk of contamination are some of the benefits arising from the introduction of a PAT strategy in the food industry. Process Analytical Technology for the Food Industry reviews established and emerging PAT tools with potential application within the food processing industry. The book will also serve as a reference for industry, researchers, educators, and students by providing a comprehensive insight into the objectives, challenges, and benefits of adopting a Process Analytical Technology strategy in the food industry.

PAT Applied in Biopharmaceutical Process Development And Manufacturing

Cenk Undey,Duncan Low,Jose C. Menezes,Mel Koch
PAT Applied in Biopharmaceutical Process Development And Manufacturing Book PDF

Author : Cenk Undey,Duncan Low,Jose C. Menezes,Mel Koch
Publisher : CRC Press
Page : 330 pages
File Size : 41,8 Mb
Release : 2011-12-07
Category : Medical
ISBN : 9781439829455

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PAT Applied in Biopharmaceutical Process Development And Manufacturing by Cenk Undey,Duncan Low,Jose C. Menezes,Mel Koch Pdf

As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development. Process Analytical Technologies (PAT) applied in biopharmaceutical process development and manufacturing have received significant attention in recent years as an enabler to the QbD paradigm. PAT Applied in Biopharmaceutical Process Development and Manufacturing covers technological advances in measurement sciences, data acquisition, monitoring, and control. Technical leaders present real-life case studies in areas including measuring and monitoring raw materials, cell culture, purification, and cleaning and lyophilization processes via advanced PAT. They also explore how data are collected and analyzed using advanced analytical techniques such as multivariate data analysis, monitoring, and control in real-time. Invaluable for experienced practitioners in PAT in biopharmaceuticals, this book is an excellent reference guide for regulatory officials and a vital training aid for students who need to learn the state of the art in this interdisciplinary and exciting area.

Drying Technologies for Biotechnology and Pharmaceutical Applications

Satoshi Ohtake,Ken-ichi Izutsu,David Lechuga-Ballesteros
Drying Technologies for Biotechnology and Pharmaceutical Applications Book PDF

Author : Satoshi Ohtake,Ken-ichi Izutsu,David Lechuga-Ballesteros
Publisher : John Wiley & Sons
Page : 394 pages
File Size : 40,9 Mb
Release : 2020-06-02
Category : Medical
ISBN : 9783527341122

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Drying Technologies for Biotechnology and Pharmaceutical Applications by Satoshi Ohtake,Ken-ichi Izutsu,David Lechuga-Ballesteros Pdf

A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.

Pharmaceutical Quality by Design

Walkiria S. Schlindwein,Mark Gibson
Pharmaceutical Quality by Design Book PDF

Author : Walkiria S. Schlindwein,Mark Gibson
Publisher : John Wiley & Sons
Page : 368 pages
File Size : 43,8 Mb
Release : 2018-01-05
Category : Science
ISBN : 9781118895214

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Pharmaceutical Quality by Design by Walkiria S. Schlindwein,Mark Gibson Pdf

A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.

Cell Culture Engineering

Gyun Min Lee,Helene Faustrup Kildegaard
Cell Culture Engineering Book PDF

Author : Gyun Min Lee,Helene Faustrup Kildegaard
Publisher : John Wiley & Sons
Page : 436 pages
File Size : 51,5 Mb
Release : 2020-01-13
Category : Science
ISBN : 9783527343348

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Cell Culture Engineering by Gyun Min Lee,Helene Faustrup Kildegaard Pdf

Offers a comprehensive overview of cell culture engineering, providing insight into cell engineering, systems biology approaches and processing technology In Cell Culture Engineering: Recombinant Protein Production, editors Gyun Min Lee and Helene Faustrup Kildegaard assemble top class authors to present expert coverage of topics such as: cell line development for therapeutic protein production; development of a transient gene expression upstream platform; and CHO synthetic biology. They provide readers with everything they need to know about enhancing product and bioprocess attributes using genome-scale models of CHO metabolism; omics data and mammalian systems biotechnology; perfusion culture; and much more. This all-new, up-to-date reference covers all of the important aspects of cell culture engineering, including cell engineering, system biology approaches, and processing technology. It describes the challenges in cell line development and cell engineering, e.g. via gene editing tools like CRISPR/Cas9 and with the aim to engineer glycosylation patterns. Furthermore, it gives an overview about synthetic biology approaches applied to cell culture engineering and elaborates the use of CHO cells as common cell line for protein production. In addition, the book discusses the most important aspects of production processes, including cell culture media, batch, fed-batch, and perfusion processes as well as process analytical technology, quality by design, and scale down models. -Covers key elements of cell culture engineering applied to the production of recombinant proteins for therapeutic use -Focuses on mammalian and animal cells to help highlight synthetic and systems biology approaches to cell culture engineering, exemplified by the widely used CHO cell line -Part of the renowned "Advanced Biotechnology" book series Cell Culture Engineering: Recombinant Protein Production will appeal to biotechnologists, bioengineers, life scientists, chemical engineers, and PhD students in the life sciences.

Process Analytical Technology Pat

Gerard Blokdyk
Process Analytical Technology Pat Book PDF

Author : Gerard Blokdyk
Publisher : Createspace Independent Publishing Platform
Page : 124 pages
File Size : 41,5 Mb
Release : 2017-10-07
Category : Electronic
ISBN : 1978038798

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Process Analytical Technology Pat by Gerard Blokdyk Pdf

What is our formula for success in Process Analytical Technology PAT ? Who are the Process Analytical Technology PAT improvement team members, including Management Leads and Coaches? How do we keep improving Process Analytical Technology PAT? Does Process Analytical Technology PAT analysis isolate the fundamental causes of problems? What potential environmental factors impact the Process Analytical Technology PAT effort? This best-selling Process Analytical Technology PAT self-assessment will make you the assured Process Analytical Technology PAT domain leader by revealing just what you need to know to be fluent and ready for any Process Analytical Technology PAT challenge. How do I reduce the effort in the Process Analytical Technology PAT work to be done to get problems solved? How can I ensure that plans of action include every Process Analytical Technology PAT task and that every Process Analytical Technology PAT outcome is in place? How will I save time investigating strategic and tactical options and ensuring Process Analytical Technology PAT opportunity costs are low? How can I deliver tailored Process Analytical Technology PAT advise instantly with structured going-forward plans? There's no better guide through these mind-expanding questions than acclaimed best-selling author Gerard Blokdyk. Blokdyk ensures all Process Analytical Technology PAT essentials are covered, from every angle: the Process Analytical Technology PAT self-assessment shows succinctly and clearly that what needs to be clarified to organize the business/project activities and processes so that Process Analytical Technology PAT outcomes are achieved. Contains extensive criteria grounded in past and current successful projects and activities by experienced Process Analytical Technology PAT practitioners. Their mastery, combined with the uncommon elegance of the self-assessment, provides its superior value to you in knowing how to ensure the outcome of any efforts in Process Analytical Technology PAT are maximized with professional results. Your purchase includes access to the $249 value Process Analytical Technology PAT self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next. Your exclusive instant access details can be found in your book.

Portable Spectroscopy and Spectrometry, Applications

Richard A. Crocombe,Pauline E. Leary,Brooke W. Kammrath
Portable Spectroscopy and Spectrometry Applications Book PDF

Author : Richard A. Crocombe,Pauline E. Leary,Brooke W. Kammrath
Publisher : John Wiley & Sons
Page : 608 pages
File Size : 46,8 Mb
Release : 2021-04-28
Category : Science
ISBN : 9781119636434

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Portable Spectroscopy and Spectrometry, Applications by Richard A. Crocombe,Pauline E. Leary,Brooke W. Kammrath Pdf

The most comprehensive resource available on the many applications of portable spectrometers, including material not found in any other published work Portable Spectroscopy and Spectrometry: Volume Two is an authoritative and up-to-date compendium of the diverse applications for portable spectrometers across numerous disciplines. Whereas Volume One focuses on the specific technologies of the portable spectrometers themselves, Volume Two explores the use of portable instruments in wide range of fields, including pharmaceutical development, clinical research, food analysis, forensic science, geology, astrobiology, cultural heritage and archaeology. Volume Two features contributions by a multidisciplinary team of experts with hands-on experience using portable instruments in their respective areas of expertise. Organized both by instrumentation type and by scientific or technical discipline, 21 detailed chapters cover various applications of portable ion mobility spectrometry (IMS), infrared and near-infrared (NIR) spectroscopy, Raman and x-ray fluorescence (XRF) spectroscopy, smartphone spectroscopy, and many others. Filling a significant gap in literature on the subject, the second volume of Portable Spectroscopy and Spectrometry: Features a significant amount of content published for the first time, or not available in existing literature Brings together work by authors with assorted backgrounds and fields of study Discusses the central role of applications in portable instrument development Covers the algorithms, calibrations, and libraries that are of critical importance to successful applications of portable instruments Includes chapters on portable spectroscopy applications in areas such as the military, agriculture and feed, hazardous materials (HazMat), art conservation, and environmental science Portable Spectroscopy and Spectrometry: Volume Two is an indispensable resource for developers of portable instruments in universities, research institutes, instrument companies, civilian and government purchasers, trainers, operators of portable instruments, and educators and students in portable spectroscopy courses.

Multivariate Analysis in the Pharmaceutical Industry

Ana Patricia Ferreira,Jose C. Menezes,Mike Tobyn
Multivariate Analysis in the Pharmaceutical Industry Book PDF

Author : Ana Patricia Ferreira,Jose C. Menezes,Mike Tobyn
Publisher : Academic Press
Page : 464 pages
File Size : 43,9 Mb
Release : 2018-04-24
Category : Medical
ISBN : 9780128110669

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Multivariate Analysis in the Pharmaceutical Industry by Ana Patricia Ferreira,Jose C. Menezes,Mike Tobyn Pdf

Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each step. It includes an overview of regulatory guidance specific to the use of these methods, along with perspectives on the applications of these methods that allow for testing, monitoring and controlling products and processes. The book seeks to put multivariate analysis into a pharmaceutical context for the benefit of pharmaceutical practitioners, potential practitioners, managers and regulators. Users will find a resources that addresses an unmet need on how pharmaceutical industry professionals can extract value from data that is routinely collected on products and processes, especially as these techniques become more widely used, and ultimately, expected by regulators. Targets pharmaceutical industry practitioners and regulatory staff by addressing industry specific challenges Includes case studies from different pharmaceutical companies and across product lifecycle of to introduce readers to the breadth of applications Contains information on the current regulatory framework which will shape how multivariate analysis (MVA) is used in years to come

How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems

Fernando Muzzio,Sarang Oka
How to Design and Implement Powder to Tablet Continuous Manufacturing Systems Book PDF

Author : Fernando Muzzio,Sarang Oka
Publisher : Elsevier
Page : 442 pages
File Size : 50,6 Mb
Release : 2022-04
Category : Medical
ISBN : 9780128134795

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How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems by Fernando Muzzio,Sarang Oka Pdf

How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control. With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing. Discusses the development of strategy blueprints in the design of continuous processes Shows how to create process flowsheet models from individual unit operation models Includes a chapter on characterization methods for materials, the use of statistical methods to analyze material property data, and the use of material databases Covers the evolving regulatory expectations for continuous manufacturing Provides readers with ways to more effectively navigate these expectations

Process Systems Engineering for Pharmaceutical Manufacturing

Ravendra Singh,Zhihong Yuan
Process Systems Engineering for Pharmaceutical Manufacturing Book PDF

Author : Ravendra Singh,Zhihong Yuan
Publisher : Elsevier
Page : 698 pages
File Size : 40,7 Mb
Release : 2018-03-16
Category : Technology & Engineering
ISBN : 9780444639660

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Process Systems Engineering for Pharmaceutical Manufacturing by Ravendra Singh,Zhihong Yuan Pdf

Process Systems Engineering for Pharmaceutical Manufacturing: From Product Design to Enterprise-Wide Decisions, Volume 41, covers the following process systems engineering methods and tools for the modernization of the pharmaceutical industry: computer-aided pharmaceutical product design and pharmaceutical production processes design/synthesis; modeling and simulation of the pharmaceutical processing unit operation, integrated flowsheets and applications for design, analysis, risk assessment, sensitivity analysis, optimization, design space identification and control system design; optimal operation, control and monitoring of pharmaceutical production processes; enterprise-wide optimization and supply chain management for pharmaceutical manufacturing processes. Currently, pharmaceutical companies are going through a paradigm shift, from traditional manufacturing mode to modernized mode, built on cutting edge technology and computer-aided methods and tools. Such shifts can benefit tremendously from the application of methods and tools of process systems engineering. Introduces Process System Engineering (PSE) methods and tools for discovering, developing and deploying greener, safer, cost-effective and efficient pharmaceutical production processes Includes a wide spectrum of case studies where different PSE tools and methods are used to improve various pharmaceutical production processes with distinct final products Examines the future benefits and challenges for applying PSE methods and tools to pharmaceutical manufacturing

New Bioprocessing Strategies: Development and Manufacturing of Recombinant Antibodies and Proteins

Bob Kiss,Uwe Gottschalk,Michael Pohlscheidt
New Bioprocessing Strategies Development and Manufacturing of Recombinant Antibodies and Proteins Book PDF

Author : Bob Kiss,Uwe Gottschalk,Michael Pohlscheidt
Publisher : Springer
Page : 473 pages
File Size : 40,6 Mb
Release : 2018-12-06
Category : Science
ISBN : 9783319971100

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New Bioprocessing Strategies: Development and Manufacturing of Recombinant Antibodies and Proteins by Bob Kiss,Uwe Gottschalk,Michael Pohlscheidt Pdf

This book review series presents current trends in modern biotechnology. The aim is to cover all aspects of this interdisciplinary technology where knowledge, methods and expertise are required from chemistry, biochemistry, microbiology, genetics, chemical engineering and computer science. Volumes are organized topically and provide a comprehensive discussion of developments in the respective field over the past 3-5 years. The series also discusses new discoveries and applications. Special volumes are dedicated to selected topics which focus on new biotechnological products and new processes for their synthesis and purification. In general, special volumes are edited by well-known guest editors. The series editor and publisher will however always be pleased to receive suggestions and supplementary information. Manuscripts are accepted in English.

Continuous Biomanufacturing

Ganapathy Subramanian
Continuous Biomanufacturing Book PDF

Author : Ganapathy Subramanian
Publisher : John Wiley & Sons
Page : 628 pages
File Size : 45,8 Mb
Release : 2017-12-26
Category : Science
ISBN : 9783527340637

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Continuous Biomanufacturing by Ganapathy Subramanian Pdf

This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous processes in the biopharmaceutical industry. Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream operations. Special emphasis is given to process control and monitoring, including such topics as 'quality by design' and automation. The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities.

Development and Validation of Analytical Methods

Christopher M. Riley,Thomas W. Rosanske
Development and Validation of Analytical Methods Book PDF

Author : Christopher M. Riley,Thomas W. Rosanske
Publisher : Elsevier
Page : 349 pages
File Size : 55,9 Mb
Release : 1996-05-29
Category : Science
ISBN : 0080530354

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Development and Validation of Analytical Methods by Christopher M. Riley,Thomas W. Rosanske Pdf

The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters. Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic. This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.

Handbook of Process Chromatography

Gunter Jagschies,Gail K. Sofer,Lars Hagel
Handbook of Process Chromatography Book PDF

Author : Gunter Jagschies,Gail K. Sofer,Lars Hagel
Publisher : Elsevier
Page : 382 pages
File Size : 43,5 Mb
Release : 2007-12-08
Category : Science
ISBN : 0080554512

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Handbook of Process Chromatography by Gunter Jagschies,Gail K. Sofer,Lars Hagel Pdf

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