Handbook of Process Chromatography

Handbook of Process Chromatography
Author: Gunter Jagschies,Gail K. Sofer,Lars Hagel
Publsiher: Elsevier
Total Pages: 382
Release: 2007-12-08
ISBN: 9780080554518
Category: Science
Language: EN, FR, DE, ES & NL

Handbook of Process Chromatography Book Excerpt:

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

Handbook of Process Chromatography

Handbook of Process Chromatography
Author: Gail Sofer
Publsiher: Unknown
Total Pages: 135
Release: 1997
ISBN: 1928374650XXX
Category: Chromatographic analysis
Language: EN, FR, DE, ES & NL

Handbook of Process Chromatography Book Excerpt:

Handbook of Process Chromatography

Handbook of Process Chromatography
Author: Gail K. Sofer,Lars Hagel
Publsiher: Academic Press
Total Pages: 387
Release: 1997-07-08
ISBN: 1928374650XXX
Category: Science
Language: EN, FR, DE, ES & NL

Handbook of Process Chromatography Book Excerpt:

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 Biogeneric Therapeutic Proteins

Handbook of Biogeneric Therapeutic Proteins
Author: Sarfaraz K. Niazi
Publsiher: CRC Press
Total Pages: 584
Release: 2002-08-15
ISBN: 1000611329
Category: Medical
Language: EN, FR, DE, ES & NL

Handbook of Biogeneric Therapeutic Proteins Book Excerpt:

More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all the regulato

Scale Up and Optimization in Preparative Chromatography

Scale Up and Optimization in Preparative Chromatography
Author: Anurag Rathore,Ajoy Velayudhan
Publsiher: CRC Press
Total Pages: 368
Release: 2002-09-26
ISBN: 9780203909287
Category: Medical
Language: EN, FR, DE, ES & NL

Scale Up and Optimization in Preparative Chromatography Book Excerpt:

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

Process Validation in Manufacturing of Biopharmaceuticals

Process Validation in Manufacturing of Biopharmaceuticals
Author: Anurag S. Rathore,Gail Sofer
Publsiher: CRC Press
Total Pages: 532
Release: 2012-05-09
ISBN: 1439850941
Category: Medical
Language: EN, FR, DE, ES & NL

Process Validation in Manufacturing of Biopharmaceuticals Book Excerpt:

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

The Essence of Chromatography

The Essence of Chromatography
Author: Colin F. Poole
Publsiher: Elsevier
Total Pages: 936
Release: 2002-12-05
ISBN: 0080505864
Category: Science
Language: EN, FR, DE, ES & NL

The Essence of Chromatography Book Excerpt:

The knowledge base of chromatography continued to expand throughout the 1990s owing to its many applications to problems of contemporary interest in industry, life and environmental sciences. Organizing this information into a single text for a diverse group of scientists has become increasingly difficult. The present book stemmed from the desire to revise Chromatography Today, written by the same author with Salwa K. Poole, and published in 1991. This title is considered to be one of the definitive texts on chromatography. It was soon realized however, that a simple revision would not provide the desired result of a contemporary picture of the practice of chromatography at the turn of the century. The only workable solution was to start afresh, maintaining the same general philosophy and concept for Chromatography Today where possible, while creating essentially a new book. The format of the new book is modular, with extensive cross-references to permit rapid location of related material using different separation concepts. Important features are extensive tabulation of essential data for performing separations and an extensive bibliography to the most recent literature. This title is intended as a suitable text for graduate level courses in the separation sciences and as a self-study guide for professional chromatographers wishing to refresh their background in this rapidly expanding field. The Essence of Chromatography presents a comprehensive survey of modern chromatography and is an effective replacement for Chromatography Today. · Comprehensive and authoritative coverage of chromatographic techniques · Contains extensive coverage of recent literature on this subject · Ideal text for graduates and suitable for professional chromatographers

Biochromatography

Biochromatography
Author: M. A. Vijayalakshmi
Publsiher: CRC Press
Total Pages: 544
Release: 2002-02-14
ISBN: 0203302826
Category: Medical
Language: EN, FR, DE, ES & NL

Biochromatography Book Excerpt:

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 mult

Process Scale Purification of Antibodies

Process Scale Purification of Antibodies
Author: Uwe Gottschalk
Publsiher: John Wiley & Sons
Total Pages: 456
Release: 2011-09-20
ISBN: 1118210743
Category: Medical
Language: EN, FR, DE, ES & NL

Process Scale Purification of Antibodies Book Excerpt:

Traditional column chromatography dominates current purification technology, and many of the productivity gains that have been achieved have relied on upscaling such devices. However, this comes with a cost penalty and the pharmaceutical industry has reached the point at which further upscaling becomes economically unsupportable. This book offers a broad-based reassessment of old and new purification methods, incorporating an analysis of innovative new trends in purification. The book has wide coverage of different antibody purification strategies and brings together top-tier experts to address problems in process-scale antibody purification.

Principles and Practice of Modern Chromatographic Methods

Principles and Practice of Modern Chromatographic Methods
Author: Kevin Robards,Danielle Ryan
Publsiher: Academic Press
Total Pages: 530
Release: 2021-05-01
ISBN: 012822097X
Category: Science
Language: EN, FR, DE, ES & NL

Principles and Practice of Modern Chromatographic Methods Book Excerpt:

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

Process Architecture in Biomanufacturing Facility Design

Process Architecture in Biomanufacturing Facility Design
Author: Jeffery Odum,Michael C. Flickinger
Publsiher: John Wiley & Sons
Total Pages: 384
Release: 2017-11-03
ISBN: 1119369177
Category: Science
Language: EN, FR, DE, ES & NL

Process Architecture in Biomanufacturing Facility Design Book Excerpt:

Essential information for architects, designers, engineers, equipment suppliers, and other professionals who are working in or entering the biopharmaceutical manufacturing field Biomanufacturing facilities that are designed and built today are radically different than in the past. The vital information and knowledge needed to design and construct these increasingly sophisticated biopharmaceutical manufacturing facilities is difficult to find in published literature—and it’s rarely taught in architecture or design schools. This is the first book for architects and designers that fills this void. Process Architecture in Biomanufacturing Facility Design provides information on design principles of biopharmaceutical manufacturing facilities that support emerging innovative processes and technologies, use state-of-the-art equipment, are energy efficient and sustainable, and meet regulatory requirements. Relying on their many years of hands-on design and operations experience, the authors emphasize concepts and practical approaches toward design, construction, and operation of biomanufacturing facilities, including product-process-facility relationships, closed systems and single use equipment, aseptic manufacturing considerations, design of biocontainment facility and process based laboratory, and sustainability considerations, as well as an outlook on the facility of the future. Provides guidelines for meeting licensing and regulatory requirements for biomanufacturing facilities in the U.S.A and WHO—especially in emerging global markets in India, China, Latin America, and the Asia/Pacific regions Focuses on innovative design and equipment, to speed construction and time to market, increase energy efficiency, and reduce footprint, construction and operational costs, as well as the financial risks associated with construction of a new facility prior to the approval of the manufactured products by regulatory agencies Includes many diagrams that clarify the design approach Process Architecture in Biomanufacturing Facility Design is an ideal text for professionals involved in the design of facilities for manufacturing of biopharmaceuticals and vaccines, biotechnology, and life-science industry, including architects and designers of industrial facilities, construction, equipment vendors, and mechanical engineers. It is also recommended for university instructors, advanced undergraduates, and graduate students in architecture, industrial engineering, mechanical engineering, industrial design, and industrial interior design.

Process Validation in Manufacturing of Biopharmaceuticals

Process Validation in Manufacturing of Biopharmaceuticals
Author: Gail Sofer
Publsiher: CRC Press
Total Pages: 402
Release: 2000-03-24
ISBN: 1420001655
Category: Science
Language: EN, FR, DE, ES & NL

Process Validation in Manufacturing of Biopharmaceuticals Book Excerpt:

A study of biopharmaceutical process validation. It aims to enable developers and producers to ensure safe products, reduce the risk of adverse reactions in patients, and avoid recalls by outlining sophisticated validation approaches to characterize processes, process intermediates, and final product fully. The text emphasizes cost effectiveness while determining what level of validation is required for different phases of development, license application, and process improvements.

A Practical Handbook of Preparative HPLC

A Practical Handbook of Preparative HPLC
Author: Donald A Wellings
Publsiher: Elsevier
Total Pages: 176
Release: 2011-04-18
ISBN: 9780080458854
Category: Technology & Engineering
Language: EN, FR, DE, ES & NL

A Practical Handbook of Preparative HPLC Book Excerpt:

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

Handbook of Separation Process Technology

Handbook of Separation Process Technology
Author: Ronald W. Rousseau
Publsiher: John Wiley & Sons
Total Pages: 1024
Release: 1987-05-13
ISBN: 9780471895589
Category: Technology & Engineering
Language: EN, FR, DE, ES & NL

Handbook of Separation Process Technology Book Excerpt:

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.

Expanded Bed Chromatography

Expanded Bed Chromatography
Author: B. Mattiasson
Publsiher: Springer Science & Business Media
Total Pages: 272
Release: 2013-04-17
ISBN: 940171519X
Category: Technology & Engineering
Language: EN, FR, DE, ES & NL

Expanded Bed Chromatography Book Excerpt:

Expanded bed adsorption chromatography is a novel processing technique for the purification of biomolecules, combining clarification, concentration and initial purification in one step. By such an integration it is possible to reduce the number of steps in the purification process, to shorten the processing time and to improve the yields. The technology is new, and interesting developments have taken place concerning the adsorbents, the processing technology and potential applications. Both small-scale laboratory processes and larger industrial processes are being developed. Expanded bed chromatography is one of the most exciting new developments in downstream processing in recent years. The technology will be a standard procedure when new biotechnological processes are being developed.

Purification of Alpha 1 antitrypsin Using a Three step Chromatography Process

Purification of Alpha 1 antitrypsin Using a Three step Chromatography Process
Author: Elizabeth Zapalac
Publsiher: Unknown
Total Pages: 346
Release: 2003
ISBN: 1928374650XXX
Category: Electronic Book
Language: EN, FR, DE, ES & NL

Purification of Alpha 1 antitrypsin Using a Three step Chromatography Process Book Excerpt:

Protein Therapeutics

Protein Therapeutics
Author: Zuben E. Sauna,Chava Kimchi-Sarfaty
Publsiher: Springer
Total Pages: 182
Release: 2017-07-19
ISBN: 3319418181
Category: Science
Language: EN, FR, DE, ES & NL

Protein Therapeutics Book Excerpt:

Medicinal chemistry is both science and art. The science of medicinal chemistry offers mankind one of its best hopes for improving the quality of life. The art of medicinal chemistry continues to challenge its practitioners with the need for both intuition and experience to discover new drugs. Hence sharing the experience of drug research is uniquely beneficial to the field of medicinal chemistry. Drug research requires interdisciplinary team-work at the interface between chemistry, biology and medicine. Therefore, the topic-related series Topics in Medicinal Chemistry covers all relevant aspects of drug research, e.g. pathobiochemistry of diseases, identification and validation of (emerging) drug targets, structural biology, drugability of targets, drug design approaches, chemogenomics, synthetic chemistry including combinatorial methods, bioorganic chemistry, natural compounds, high-throughput screening, pharmacological in vitro and in vivo investigations, drug-receptor interactions on the molecular level, structure-activity relationships, drug absorption, distribution, metabolism, elimination, toxicology and pharmacogenomics. In general, special volumes are edited by well known guest editors

Supercritical Fluids Technology in Lipase Catalyzed Processes

Supercritical Fluids Technology in Lipase Catalyzed Processes
Author: Sulaiman Al-Zuhair,Hanifa Taher
Publsiher: CRC Press
Total Pages: 176
Release: 2018-10-08
ISBN: 0429596332
Category: Science
Language: EN, FR, DE, ES & NL

Supercritical Fluids Technology in Lipase Catalyzed Processes Book Excerpt:

Enzymes are currently used in various industries, most commonly in food, detergents, and pharmaceuticals production. Lipases are hydrolytic enzymes that demonstrate great potential as an alternative to conventional catalysts in a number of industrial applications. A complete understanding of enzymes, and their proteins structure and environmental behavior, can greatly aid in the further development of industrial applications. Supercritical Fluids Technology in Lipase Catalized Processes provides basic information about enzymes, their sources, reaction kinetics, and main industrial applications. The book focuses in lipases. their main sources, structure, and features, with an emphasis on their specificity and interfacial activity, and presents proven techniques for isolating, extracting, and purifying. Comprised of six compact chapters, this comprehensive guide introduces: Immobilization techniques and immobilized lipases that allow repeated use (which is essential from an economic point of view) Different bioreactor configurations using immobilized lipases The latest information on the available technologies in lipolytic reactions The advantages of nonaqueous media in biochemical synthesis over aqueous and solvent-free systems Material on the use of lipases in nonaqueous media to overcome the drawbacks usually encountered with the use of conventional chemical catalysts The use of supercritical fluids (SCFs) as a green alternative reaction medium Factors affecting the physical properties of lipases in this medium and, hence, their activity and stability A case study using supercritical carbon dioxide (SC-CO2) for biodiesel production Novel, cutting-edge technology, using immobilized enzymes to reduce the overall production cost Supercritical Fluids Technology in Lipase Catalized Processes outlines the main industrial applications of common enzymes and discusses relevant challenges and innovations emerging in the field.

Downstream Industrial Biotechnology

Downstream Industrial Biotechnology
Author: Michael C. Flickinger
Publsiher: John Wiley & Sons
Total Pages: 872
Release: 2013-07-17
ISBN: 111861898X
Category: Science
Language: EN, FR, DE, ES & NL

Downstream Industrial Biotechnology Book Excerpt:

An affordable, easily accessible desk reference on biomanufacturing, focused on downstream recovery and purification Advances in the fundamental knowledge surrounding biotechnology, novel materials, and advanced engineering approaches continue to be translated into bioprocesses that bring new products to market at a significantly faster pace than most other industries. Industrial scale biotechnology and new manufacturing methods are revolutionizing medicine, environmental monitoring and remediation, consumer products, food production, agriculture, and forestry, and continue to be a major area of research. The downstream stage in industrial biotechnology refers to recovery, isolation, and purification of the microbial products from cell debris, processing medium and contaminating biomolecules from the upstream process into a finished product such as biopharmaceuticals and vaccines. Downstream process design has the greatest impact on overall biomanufacturing cost because not only does the biochemistry of different products ( e.g., peptides, proteins, hormones, antibiotics, and complex antigens) dictate different methods for the isolation and purification of these products, but contaminating byproducts can also reduce overall process yield, and may have serious consequences on clinical safety and efficacy. Therefore downstream separation scientists and engineers are continually seeking to eliminate, or combine, unit operations to minimize the number of process steps in order to maximize product recovery at a specified concentration and purity. Based on Wiley's Encyclopedia of Industrial Biotechnology: Bioprocess, Bioseparation, and Cell Technology, this volume features fifty articles that provide information on down- stream recovery of cells and protein capture; process development and facility design; equipment; PAT in downstream processes; downstream cGMP operations; and regulatory compliance. It covers: Cell wall disruption and lysis Cell recovery by centrifugation and filtration Large-scale protein chromatography Scale down of biopharmaceutical purification operations Lipopolysaccharide removal Porous media in biotechnology Equipment used in industrial protein purification Affinity chromatography Antibody purification, monoclonal and polyclonal Protein aggregation, precipitation and crystallization Freeze-drying of biopharmaceuticals Biopharmaceutical facility design and validation Pharmaceutical bioburden testing Regulatory requirements Ideal for graduate and advanced undergraduate courses on biomanufacturing, biochemical engineering, biophar- maceutical facility design, biochemistry, industrial microbiology, gene expression technology, and cell culture technology, Downstream Industrial Biotechnology is also a highly recommended resource for industry professionals and libraries.

Enzymes Biotechnology Handbook

Enzymes Biotechnology Handbook
Author: NIIR Board of Consultants & Engineers
Publsiher: ASIA PACIFIC BUSINESS PRESS Inc.
Total Pages: 490
Release: 2004-01-01
ISBN: 8178330784
Category: Biotechnology
Language: EN, FR, DE, ES & NL

Enzymes Biotechnology Handbook Book Excerpt:

Industrial biotechnology is the practice of using cells to generate industrially useful products. An enzyme is a protein that catalyzes, or speeds up, a chemical reaction. Enzymes are the focal point of biotechnological processes, without them biotechnology as a subject would not exist. The main advantage of enzymes compared to most other catalysts is their stereo, region and chemo selectivity and specificity. Enzymes are responsible for many essential biochemical reactions in micro organisms, plants, animals, and human beings. Biotechnology processes may have potential in energy production, specifically in the substitution of renewable plant biomass for fossil feedstock. This will depend on the development of enzymes able to degrade cellulose in plant biomass and designing methods to recycle or dispose of spent biomass. With time, research, and improved protein engineering methods, many enzymes have been genetically modified to be more effective at the desired temperatures, pH, or under other manufacturing conditions typically inhibitory to enzyme activity (e.g. harsh chemicals), making them more suitable and efficient for industrial or home applications. Enzymes are used in the extraction of natural products, as catalysts in organic chemistry, in clinical analysis, in industrial processes, and so on. The application of enzymes is found in many different fields and it is one of the good sectors to venture. In coming few years it is estimated that world enzyme demand will average annual increases of 6.3 percent. This book basically deals with principles of industrial enzymology, basis of utilization of soluble and immobilized, enzymes in industrial processes, principles of immobilization of enzymes, enzymes in clinical analysis principles, practical aspects of large-scale protein purification, the applications of enzymes in industry, use of enzymes in the extraction of natural products, data on techniques of enzyme immobilization and bio affinity procedures etc. In this book you can find all the basic information required on the fundamental aspects of the enzymes, their chemistry, bio chemistry as well as detailed information of their applications a wide variety of industrial processes etc. The book is very useful for research scholars, technocrats, institutional libraries and entrepreneurs who want to enter into the field of manufacturing of enzymes.