A result-oriented, practical guide to key approaches, methodologies and tools for designing, modelling and simulating chromatographic processes.

Principles and Practice of Modern Chromatographic Methods, Second Edition takes a comprehensive, unified approach in its presentation of chromatographic techniques. Like the first edition, the book provides a scientifically rigid, but easy-to-follow presentation of chromatography concepts that begins with the purpose and intent of chromatographic theory - the "what and why that are left out of other books attempting to cover these principles. This fully revised second edition brings the content up-to-date, covering recent developments in several new sections and an additional chapter on composite methods. New topics include sample profiling, sample preparation, sustainable green chemistry, 2D chromatography, miniaturization/nano-LC, HILIC, and more. - Contains thorough chapters that begin with an updated schematic overview and a visual representation of the content - Avoids the obfuscation of different terminologies and classification systems that are prevalent in the area, such as the relationship between liquid chromatography and column chromatography - Provides integrated and comprehensive topic coverage based on chromatographic bibliometrics and survey reports on the relative usage of chromatographic techniques

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

Addressing all aspects of the design, modeling and simulation of chromatographic processes, this result-oriented primer provides a practical guide to all the necessary approaches, methodologies and tools. Beginning with key definitions and concepts, it builds up from the most simple to the most complex situations, including multicomponent systems, non-uniform velocity profiles, bed instability, particle size distributions, and the influence of complex environments on chromatographic process design. In addition to covering classical approaches, it introduces efficient tools for investigating chromatographic processes, such as the 'Russian-Lego' approach for linear systems, phenomenological models, and specific shortcuts for deriving the key properties of industrial processes. With an emphasis on real-world problems and applications, step-by step modeling design guidelines, and detailed exercises for self-assessment, this is a must-have guide for practitioners and researchers working in chemical, biochemical, food and pharmaceutical engineering.

All the information and tools needed to set up a successful method validation system Validating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation. It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations. The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal or no complications. This guide focuses on high-performance liquid chromatographic methods validation; however, the concepts are generally applicable to the validation of other analytical techniques as well. Following an overview of analytical method validation and a discussion of its various components, the author dedicates a complete chapter to each step of validation: Method evaluation and further method development Final method development and trial method validation Formal method validation and report generation Formal data review and report issuance Templates and examples for Methods Validation Standard Operating Procedures, Standard Test Methods, Methods Validation Protocols, and Methods Validation Reports are all provided. Moreover, the guide features detailed flowcharts and checklists that lead readers through every stage of method validation to ensure success. All of the templates are also included on a supplementary support site, enabling readers to easily work with and customize them. For scientists and technicians new to method validation, this guide provides all the information and tools needed to develop a top-quality system. For those experienced with method validation, the guide helps to upgrade and improve existing systems.

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.

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.