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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
Protein Chromatography by Giorgio Carta,Alois Jungbauer Pdf
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 by Gail K. Sofer,L. E.E. Nystrom Pdf
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.
Process Chromatography by G. K. Sofer,L.-E. Nyström Pdf
Chromatography has today become an integral part of the biotechnology industry, playing a vital role in the purification of biologicals from natural sources as those produced by recombinant DNA and hybridoma techniques. This book is intended as a practical guide and reference source for all those involved in the development of economic chromatographic purification processes. Its purpose extends beyond the description of individual methods to teach the integration of steps, both up and downstream, that lead to a complete process for the successful purification of a desired protein. Researchers, advanced students, senior technicians, and process plant managers working in the biotechnology, biochemical, and pharmaceutical industries will find this text indispensible.
Protein Chromatography by Giorgio Carta,Alois Jungbauer Pdf
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.
Scale-Up and Optimization in Preparative Chromatography by Anurag Rathore,Ajoy Velayudhan Pdf
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
Protein Chromatography by Sinéad T Loughran,John Joseph Milne Pdf
This third edition expands on the previous editions with updated and new chapters on protein chromatography. Chapters detail protein stability and storage, avoiding proteolysis, protein quantitation methods, generation and purification of recombinant proteins, recombinant antibody production, and the tagging of proteins. Written in the format of the highly successful Methods in Molecular Biology series, each chapter includes an introduction to the topic, lists necessary materials and reagents, includes tips on troubleshooting and known pitfalls, and step-by-step, readily reproducible protocols. Authoritative and cutting-edge, Protein Chromatography: Methods and Protocols, Third Edition aims to provide commonly used methods and new approaches to help both new researchers and experts expand their knowledge.
Handbook of Process Chromatography by Gail K. Sofer,Lars Hagel Pdf
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.
Chemometrics in Chromatography by Łukasz Komsta,Yvan Vander Heyden,Joseph Sherma Pdf
Chemometrics uses advanced mathematical and statistical algorithms to provide maximum chemical information by analyzing chemical data, and obtain knowledge of chemical systems. Chemometrics significantly extends the possibilities of chromatography and with the technological advances of the personal computer and continuous development of open-source software, many laboratories are interested in incorporating chemometrics into their chromatographic methods. This book is an up-to-date reference that presents the most important information about each area of chemometrics used in chromatography, demonstrating its effective use when applied to a chromatographic separation.
Quantitative Gas Chromatography for Laboratory Analyses and On-Line Process Control by G. Guiochon,C.L. Guillemin Pdf
Here is an invaluable new book on quantitative gas chromatography which explains how the method can - or should - be used for accurate and precise analysis. Gas chromatography is firmly established as one of the few major methods for the quantitative analysis of complex mixtures. It is fast, accurate and inexpensive, with a broad range of applications. It has however become very complex and involved: over 200 stationary phases, more than 10 detector principles and several very different column types are available from among the catalogs of over 100 manufacturers and major retailers. The progressive changes in the nature of gas chromatography have created new needs for information which are not satisfied by the literature presently available. This book provides a complete discussion of all the problems involved in the achievement of quantitative analysis by gas chromatography, whether in the research laboratory, in the routine analysis laboratory or in process control. For this reason the presentation of theoretical concepts has been limited to the essential, while extensive explanations have been devoted to the various steps involved in the derivation of precise and accurate data. This starts with the selection of the instrumentation and column, continues with the choice of optimum experimental conditions, then calibration and ends with the use of correct procedures for data acquisition and calculations. Finally, there is almost always a way to reduce errors and an entire chapter deals with this single issue. Numerous relevant examples are presented. The first part of the book presents the theoretical background, simple enough to be understood by all analytical chemists, but still complete and up-to-date. It discusses the problems of flow dynamics, retention and band broadening. The changes in band profile associated with column overloading are explained without much recourse to mathematics. The second part describes the gas chromatograph and discusses the properties of each of its parts: gas flow and pressure controller sampling system, oven, column switching valves, detectors. The different implementations, their advantages and drawbacks are discussed and compared. In addition, three chapters present packed column technology, open tubular column technology and some sophisticated new phase systems, respectively. The new phase systems described use adsorbents, modified by coating or grafting organic phase, and carrier gases containing vapors which are sorbed by the stationary phase and modify it, such as steam. The third part discusses the applications in qualitative and quantitative analysis. Calibration, peak integration, sources of errors arising from the various parts of the instrument as well as from the measurement process itself are carefully described in four detailed chapters. Methods to carry out accurate and precise analysis are presented. A last chapter is devoted to process control analysis and gives a number of detailed examples of applications. A lexicon explaining the most important chromatographic terms and a detailed index complete the book. This is a book which no chemical analyst should be without. It should be on the library shelf of all universities, instrument companies and any laboratory and plant where gas chromatography is used.
Process Scale Liquid Chromatography by Ganapathy Subramanian Pdf
This book provides the industrial chromatographer and production scientist with a comprehensive account of process scale liquid chromatography. The basic theory is presented, guiding the reader through system design, simulation and modelling techniques, giving due consideration to economic aspects, as well as safety and regulatory factors. A thorough, up-to-date survey of current techniques and media does stress their advantages and limitations in such a way as to faciliate their application to real-life problems. In view of rapid rate of development in industrial chromatography one chapter provides an assessment of future developments. The chapters are written by acknowledged experts from Europe and the United States.
Optimization of Pharmaceutical Processes by Antonios Fytopoulos,Rohit Ramachandran,Panos M. Pardalos Pdf
Optimization of Pharmaceutical Processes presents contributions from leading authorities in the fields of optimization and pharmaceutical manufacturing. Formulated within structured frameworks, practical examples and applications are given as guidance to apply optimization techniques to most aspects of pharmaceutical processes from design, to lab and pilot scale, and finally to manufacturing. The increasing demand for better quality, higher yield, more efficient-optimized and green pharmaceutical processes, indicates that optimal conditions for production must be applied to achieve simplicity, lower costs and superior yield. The application of such methods in the pharmaceutical industry is not trivial. Quality of the final product is of major importance to human health and the need for deep knowledge of the process parameters and the optimization of the processes are imperative. The volume, which includes new methods as well as review contributions will benefit a wide readership including engineers in pharmaceuticals, chemical, biological, to name just a few.
Preparative Chromatography by H. Schmidt-Traub,Michael Schulte,Andreas Seidel-Morgenstern Pdf
The third edition of this popular work is revised to include the latest developments in this fast-changing field. Its interdisciplinary approach elegantly combines the chemistry and engineering to explore the fundamentals and optimization processes involved.
