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Process Chromatography

Process Chromatography Author Gail K. Sofer
ISBN-10 9781483289175
Release 2015-09-02
Pages 96
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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

Handbook of Process Chromatography Author G. K. Sofer
ISBN-10 012654266X
Release 1997
Pages 387
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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



Handbook of Process Chromatography

Handbook of Process Chromatography Author Gunter Jagschies
ISBN-10 0080554512
Release 2007-12-08
Pages 382
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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



Validating Chromatographic Methods

Validating Chromatographic Methods Author David M. Bliesner
ISBN-10 9780470042199
Release 2006-09-11
Pages 354
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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.



Validation of Pharmaceutical Processes Third Edition

Validation of Pharmaceutical Processes  Third Edition Author James P. Agalloco
ISBN-10 1420019791
Release 2007-09-25
Pages 760
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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

Handbook of Process Chromatography Author Gunter Jagschies
ISBN-10 0080554512
Release 2007-12-08
Pages 382
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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



Process Validation in Manufacturing of Biopharmaceuticals Third Edition

Process Validation in Manufacturing of Biopharmaceuticals  Third Edition Author Anurag S. Rathore
ISBN-10 9781439850947
Release 2012-05-09
Pages 532
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Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.



Validating Chromatographic Methods

Validating Chromatographic Methods Author David M. Bliesner
ISBN-10 9780470042199
Release 2006-09-11
Pages 354
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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.



Handbook of Analytical Validation

Handbook of Analytical Validation Author Michael E. Swartz
ISBN-10 9781420014488
Release 2012-04-24
Pages 220
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Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook: Contains practical, up-to-date guidelines for analytical method validation Summarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modifications Covers development, optimization, validation, and transfer of many different types of methods used in the regulatory environment Simplifying the overall process of method development, optimization and validation, the guidelines in the Handbook apply to both small molecules in the conventional pharmaceutical industry, as well as well as the biotech industry.



Method Validation in Pharmaceutical Analysis

Method Validation in Pharmaceutical Analysis Author Joachim Ermer
ISBN-10 9783527672189
Release 2014-08-27
Pages 440
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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

Selection of the HPLC Method in Chemical Analysis Author Serban C. Moldoveanu
ISBN-10 9780128037119
Release 2016-11-01
Pages 598
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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



Modern Sample Preparation for Chromatography

Modern Sample Preparation for Chromatography Author Serban C. Moldoveanu
ISBN-10 9780444543226
Release 2014-10-18
Pages 453
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Sample preparation is applied to make real world samples amenable for chromatographic analysis, or to improve the results of this type of analysis. A wide variety of procedures are applied for this purpose, and their description is the main goal of the present book. The principles of these procedures are explained, discussing their advantages and disadvantages, and their applicability to different types of samples as well as their fit for different types of chromatographic analysis. This provides a guide for choosing the appropriate sample preparation for a given analysis. The book also contains numerous literature references and examples of sample preparation for different matrices. The material is presented in three parts, one discussing physical methods used in sample preparation such as filtration, distillation, solvent extraction, solid phase extraction, electro-separations. Presents in a systematic way numerous techniques applied for sample preparation for chromatographic analysis Provides an up to date source of information regarding the progress made in sample preparation for chromatography Describes examples for specific type of matrices, providing a guide for choosing the appropriate sample preparation method for a given analysis



Analytical Method Development and Validation

Analytical Method Development and Validation Author Michael E. Swartz
ISBN-10 9781482229776
Release 1997-05-16
Pages 96
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Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.



Biopharmaceutical Processing

Biopharmaceutical Processing Author Gunter Jagschies
ISBN-10 9780128125526
Release 2018-01-18
Pages 1308
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Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. Offers a comprehensive, go-to reference for daily work decisions Covers both upstream and downstream processes Includes case studies that emphasize financial outcomes Presents summaries, decision grids, graphs and overviews for quick reference



Column Handbook for Size Exclusion Chromatography

Column Handbook for Size Exclusion Chromatography Author Chi-san Wu
ISBN-10 9780080529394
Release 1999-03-19
Pages 637
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Column Handbook for Size Exclusion Chromatography is the first comprehensive reference to provide everything one needs to know about commercial analytical and preparative columns for size exclusion and gel filtration chromatography (SEC and GFC). SEC is now widely used as a quality assurance method in the polymer industry (both synthetic and biopolymers) to determine molecular weight and molecular weight distribution. The Handbook contains contributions from every column manufacturer around the world and from many experienced column users. It covers the technology, characterization, application, evaluation, maintenance, and quality control of analytical and preparative columns for SEC and GFC. Also included are columns for two closely related techniques, hydrodynamic chromatography and high osmotic pressure chromatography. Key Features * Evaluate and select columns with confidence for specific applications * Optimize separations and improve the ruggedness of analytical methods * Extend the service time of a column * Establish a quality-control program to ensure consistency in column performance * Avoid the expense of column damage or purchases that do not give the expected results



High Temperature Liquid Chromatography

High Temperature Liquid Chromatography Author Thorsten Teutenberg
ISBN-10 9781849731096
Release 2010-06-03
Pages 220
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High-temperature liquid chromatography has attracted much interest in recent years but has not yet recognized its full potential in the chromatographic community. There is a widespread reluctance in industry to use temperature to speed up the separation process, influence the selectivity of a separation or implement novel detection techniques. However, the technology has now matured and could revolutionize chromatography as we see it today. Better equipment, such as heating systems able to generate faster heating rates, is becoming more readily available. Also, columns based on silica gel, which can withstand higher temperatures for an extended period, are now being introduced. Nevertheless, further technological and methodical efforts are needed to establish the method in a regulated environment like the pharmaceutical industry. This is the only text to cover all the practical aspects, as well as the underlying theoretical principles, of setting up an HPLC system for high temperature operation. It is not intended solely for academics but will also benefit the researcher interested in more practical considerations. The author is a recognized expert and has conducted several studies with partners from industry to validate the method. Many real examples from these studies have been included in the book. The aim is to support practitioners in the creation of their own protocols without the need to rely solely on trial and error. The book starts with a brief definition of high temperature liquid chromatography before going on to cover: system set up; the heating system; mobile phase considerations; suitable stationary phases; method development using temperature programming; analyte stability, and special hyphenation techniques using superheated water as a mobile phase. In each chapter, experimental data is used to illustrate the main statements and the advantages over conventional HPLC are evaluated. The book concludes with a critical outlook on further developments and applications underlining the necessary advances needed to make high temperature HPLC more robust.



Supercritical Fluid Chromatography

Supercritical Fluid Chromatography Author Colin F. Poole
ISBN-10 9780128093672
Release 2017-02-16
Pages 572
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Supercritical fluid chromatography (SFC) is a rapidly developing laboratory technique for the separation and identification of compounds in mixtures. Significant improvements in instrumentation have rekindled interest in SFC in recent years and enhanced its standing in the scientific community. Many scientists are familiar with column liquid chromatography and its strengths and weaknesses, but the possibilities brought to the table by SFC are less well-known and are underappreciated. Supercritical Fluid Chromatography is a thorough and encompassing reference that defines the concept of contemporary practice in SFC and how it should be implemented in laboratory science. Given the changes that have taken place in SFC, this book presents contemporary aspects and applications of the technique and introduces SFC as a natural solution in the larger field of separation science. The focus on state-of-the-art instrumental SFC distinguishes this work as the go-to reference work for those interested in implementing the technique at an advanced level. Edited and authored by world-leading chromatography experts Provides comprehensive coverage of SFC in a single source Extensive referencing facilitates identification of key research developments More than 200 figures and tables aid in the retention of key concepts