process chromatography a guide to validation

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Process Chromatography

Author : Gail K. Sofer
ISBN : 9781483289175
Genre : Science
File Size : 75. 3 MB
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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.

Handbook Of Process Chromatography

Author : G. K. Sofer
ISBN : 012654266X
Genre : Technology & Engineering
File Size : 22. 93 MB
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This handbook is an excellent reference for graduates and researchers in biotechnology and practitioners in the pharmaceutical industry who wish to develop a commercial chromatographic purification process. The authors guide readers through each step of the development process, beginning with basic chromatography theory and practice and incorporating examples from companies with established processes and approved biotherapeutics. They also cover properties of biological molecules, and reveal pitfalls often encountered in the process. Design strategies are discussed in depth, considering common starting materials and their impact on purification design, scale-up concerns, and validation. The authors use their extensive consulting and teaching experience to present a practical approach to developing an optimal chromatographic process, scaling it up, and meeting requirements set forth by regulatory agencies. The included diskette contains modeling exercises providing valuable insights into the influence of chromatographic parameters on separation results and the impact of process design on production costs, making the Handbook an excellent hands-on teaching tool. Key Features * Considers the entire scope of process chromatography, including scale up, regulatory issues, equipment, evaluation studies, scheduling, and cost-effectiveness * Provides examples from companies with established processes and approved biotherapeutics * Includes an appendix which lists the most pertinent regulatory documents, allowing the user to gather necessary information to comply with global regulatory expectations for process chromatography * Contains a modeling program on the included disk

Validation Of Pharmaceutical Processes Third Edition

Author : James P. Agalloco
ISBN : 1420019791
Genre : Medical
File Size : 33. 87 MB
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Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine validation and six sigma system design; the preparation of aseptic and non-aseptic pharmaceutical products; active pharmaceutical ingredient and biotechnology processes, computerized systems; qualification and cleaning of equipment; analytical methods, calibration and certification. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded is a comprehensive analysis of all of the fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process. Presenting theoretical knowledge and applied practical considerations, this title provides an in-depth discussion of recent advances in sterilization identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions

Handbook Of Process Chromatography

Author : Gunter Jagschies
ISBN : 0080554512
Genre : Science
File Size : 50. 37 MB
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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

Biochromatography

Author : M. A. Vijayalakshmi
ISBN : 9780203302828
Genre : Medical
File Size : 39. 63 MB
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The field of bioseparation, and biochromatography in particular, is advancing very rapidly as our knowledge of the properties of molecules and atomic forces increases. This volume covers the basic principles of biochromatography in detail. It assesses different techniques and includes a large number of applications, providing the reader with a multidisciplinary perspective that gives the insight to master the many chromatographic methods. Biochromatography: Theory and Practice is a valuable tool for graduate and research scientists, technicians, engineers and teachers in a range of fields including biochemistry, biotechnology, biorecognition and chromatography.

Biosimilars And Interchangeable Biologics

Author : Sarfaraz K. Niazi
ISBN : 9781351231305
Genre : Medical
File Size : 47. 41 MB
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What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Strategic Elements explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book also presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.

Validating Chromatographic Methods

Author : David M. Bliesner
ISBN : 9780470042199
Genre : Science
File Size : 31. 48 MB
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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 CD-ROM, 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. Note: CD-ROM/DVD and other supplementary materials are not included as part of eBook file.

Immunoassays In Agricultural Biotechnology

Author : Guomin Shan
ISBN : 0470922680
Genre : Science
File Size : 60. 29 MB
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A very broad range of professionals are using immunoassay technology daily to analyze genetically engineered (GE) crops and related areas, and many of these professionals are completely new to this technology. There is a great need for users to have a book containing technical and practical guidance, and describing limitations and pitfalls of applying immunoassay in agricultural biotechnology. This book focuses on the application of immunoassays to GE plants and related areas. A group of international experts from government agencies, academics and industries, who have many years of related experience, contribute high quality chapters in their areas of expertise. This book covers topics including principles of immunoassay, antibody engineering in AgBiotech, current technologies (formats, kit development, manufacturing and quality control), method validation, applications in trait discovery and product development, applications in grain products and food processing, applications in environmental monitoring, automation and high throughput, reference materials, data interpretation and source of error, and future perspectives and challenges. In addition, to meet the practical needs for a variety of readers from different backgrounds, methods and protocols are included as well.

Method Validation In Pharmaceutical Analysis

Author : Joachim Ermer
ISBN : 9783527672189
Genre : Medical
File Size : 74. 27 MB
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This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing. As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are established as an Analytical Target Profile (ATP). The book chapters are aligned with recently introduced standards and guidelines for manufacturing processes validation and follow the three stages of the analytical lifecycle: Method Design, Method Performance Qualification, and Continued Method Performance Verification. Case studies and examples from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout. The undisputed gold standard in the field.

Selection Of The Hplc Method In Chemical Analysis

Author : Serban C. Moldoveanu
ISBN : 9780128037119
Genre : Science
File Size : 88. 39 MB
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Selection of the HPLC Method in Chemical Analysis serves as a practical guide to users of high-performance liquid chromatography and provides criteria for method selection, development, and validation. High-performance liquid chromatography (HPLC) is the most common analytical technique currently practiced in chemistry. However, the process of finding the appropriate information for a particular analytical project requires significant effort and pre-existent knowledge in the field. Further, sorting through the wealth of published data and literature takes both time and effort away from the critical aspects of HPLC method selection. For the first time, a systematic approach for sorting through the available information and reviewing critically the up-to-date progress in HPLC for selecting a specific analysis is available in a single book. Selection of the HPLC Method in Chemical Analysis is an inclusive go-to reference for HPLC method selection, development, and validation. Addresses the various aspects of practice and instrumentation needed to obtain reliable HPLC analysis results Leads researchers to the best choice of an HPLC method from the overabundance of information existent in the field Provides criteria for HPLC method selection, development, and validation Authored by world-renowned HPLC experts who have more than 60 years of combined experience in the field

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