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

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.

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.

This book is a distillation of twenty years of practical experience of the high pressure liquid chromatography (HPLC) process. Deliberately steering clear of complex theoretical aspects, this book concentrates on the everyday problems associated with the technique, making it perfect for frequent use in the laboratory and for those in the pharmaceutical, agrochemical and biotechnology industries for the analysis and purification of drugs, small molecules, proteins and DNA.This book...•Provides practical, hands-on advice based on years of experience•Will help ensure optimal design, equipment and separation results for your particular task•Presents system layouts from laboratory to process scale•Will help you to devise or improve record-keeping and documentation systems ·Provides practical, hands-on advice based on years of experience·Will help ensure optimal design, equipment and separation results for your particular task·Presents system layouts from laboratory to process scale·Will help you to devise or improve record-keeping and documentation systems

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.

Surveys the selection, design, and operation of most of the industrially important separation processes. Discusses the underlying principles on which the processes are based, and provides illustrative examples of the use of the processes in a modern context. Features thorough treatment of newer separation processes based on membranes, adsorption, chromatography, ion exchange, and chemical complexation. Includes a review of historically important separation processes such as distillation, absorption, extraction, leaching, and crystallization and considers these techniques in light of recent developments affecting them.