Handbook of Process Chromatography Book

Handbook of Process Chromatography


  • Author : Gunter Jagschies
  • Publisher : Elsevier
  • Release Date : 2007-12-08
  • Genre: Science
  • Pages : 382
  • ISBN 10 : 0080554512

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Handbook of Process Chromatography 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 Book

Handbook of Process Chromatography


  • Author : Gail K. Sofer
  • Publisher : Academic Press
  • Release Date : 1997-06-24
  • Genre: Medical
  • Pages : 412
  • ISBN 10 : STANFORD:36105019357438

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Handbook of Process Chromatography Excerpt :

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.

Scale Up and Optimization in Preparative Chromatography Book

Scale Up and Optimization in Preparative Chromatography


  • Author : Anurag Rathore
  • Publisher : CRC Press
  • Release Date : 2002-09-26
  • Genre: Medical
  • Pages : 368
  • ISBN 10 : 0203909283

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Scale Up and Optimization in Preparative Chromatography 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

A Practical Handbook of Preparative HPLC Book

A Practical Handbook of Preparative HPLC


  • Author : Donald A Wellings
  • Publisher : Elsevier
  • Release Date : 2011-04-18
  • Genre: Technology & Engineering
  • Pages : 176
  • ISBN 10 : 0080458858

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A Practical Handbook of Preparative HPLC 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

Process Chromatography Book

Process Chromatography


  • Author : Gail K. Sofer
  • Publisher : Academic Press
  • Release Date : 2015-09-02
  • Genre: Science
  • Pages : 96
  • ISBN 10 : 9781483289175

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Process Chromatography Excerpt :

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 Separation Process Technology Book
Score: 5
From 1 Ratings

Handbook of Separation Process Technology


  • Author : Ronald W. Rousseau
  • Publisher : John Wiley & Sons
  • Release Date : 1987-05-13
  • Genre: Technology & Engineering
  • Pages : 1028
  • ISBN 10 : 047189558X

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Handbook of Separation Process Technology 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.

Handbook of Downstream Processing Book

Handbook of Downstream Processing


  • Author : E. Goldberg
  • Publisher : Springer Science & Business Media
  • Release Date : 2012-12-06
  • Genre: Science
  • Pages : 720
  • ISBN 10 : 9789400915633

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Handbook of Downstream Processing Excerpt :

The last two decades have seen a phenomenal growth of the field of genetic or biochemical engineering and have witnessed the development and ultimately marketing of a variety of products-typically through the manipulation and growth of different types of microorganisms, followed by the recovery and purification of the associated products. The engineers and biotechnologists who are involved in the full-scale process design of such facilities must be familiar with the variety of unit operations and equipment and the applicable regulatory requirements. This book describes current commercial practice and will be useful to those engineers working in this field in the design, construction and operation of pharmaceutical and biotechnology plants. It will be of help to the chemical or pharmaceutical engineer who is developing a plant design and who faces issues such as: Should the process be batch or continuous or a combination of batch and continuous? How should the optimum process design be developed? Should one employ a new revolutionary separation which could be potentially difficult to validate or use accepted technology which involves less risk? Should the process be run with ingredients formulated from water for injection, deionized water, or even filtered tap water? Should any of the separations be run in cold rooms or in glycol jacketed lines to minimize microbial growth where sterilization is not possible? Should the process equipment and lines be designed to be sterilized in-place, cleaned-in-place, or should every piece be broken down, cleaned and autoclaved after every turn?

Handbook of Biogeneric Therapeutic Proteins Book

Handbook of Biogeneric Therapeutic Proteins


  • Author : Sarfaraz K. Niazi
  • Publisher : CRC Press
  • Release Date : 2002-08-15
  • Genre: Medical
  • Pages : 585
  • ISBN 10 : 9781000611328

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Handbook of Biogeneric Therapeutic Proteins 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

Process Validation in Manufacturing of Biopharmaceuticals Book

Process Validation in Manufacturing of Biopharmaceuticals


  • Author : Anurag S. Rathore
  • Publisher : CRC Press
  • Release Date : 2012-05-09
  • Genre: Medical
  • Pages : 532
  • ISBN 10 : 9781439850947

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Process Validation in Manufacturing of Biopharmaceuticals 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 Book

The Essence of Chromatography


  • Author : Colin F. Poole
  • Publisher : Elsevier
  • Release Date : 2002-12-05
  • Genre: Science
  • Pages : 935
  • ISBN 10 : 9780080505862

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The Essence of Chromatography 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

Handbook of Validation in Pharmaceutical Processes  Fourth Edition Book

Handbook of Validation in Pharmaceutical Processes Fourth Edition


  • Author : James Agalloco
  • Publisher : CRC Press
  • Release Date : 2021-10-28
  • Genre: Medical
  • Pages : 1061
  • ISBN 10 : 9781000436013

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Handbook of Validation in Pharmaceutical Processes Fourth Edition Excerpt :

Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: 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 New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture

Biochromatography Book

Biochromatography


  • Author : M. A. Vijayalakshmi
  • Publisher : CRC Press
  • Release Date : 2002-02-14
  • Genre: Medical
  • Pages : 649
  • ISBN 10 : 9780203302828

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Biochromatography 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

Handbook of Analytical Quality by Design Book

Handbook of Analytical Quality by Design


  • Author : Sarwar Beg
  • Publisher : Academic Press
  • Release Date : 2021-01-09
  • Genre: Business & Economics
  • Pages : 222
  • ISBN 10 : 9780128203330

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Handbook of Analytical Quality by Design Excerpt :

Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. Concise language for easy understanding of the novel and holistic concept Covers key aspects of analytical development and validation Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance

Process Architecture in Biomanufacturing Facility Design Book

Process Architecture in Biomanufacturing Facility Design


  • Author : Jeffery Odum
  • Publisher : John Wiley & Sons
  • Release Date : 2017-11-03
  • Genre: Science
  • Pages : 384
  • ISBN 10 : 9781119369172

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Process Architecture in Biomanufacturing Facility Design 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 app

Process Scale Purification of Antibodies Book

Process Scale Purification of Antibodies


  • Author : Uwe Gottschalk
  • Publisher : John Wiley & Sons
  • Release Date : 2011-09-20
  • Genre: Medical
  • Pages : 430
  • ISBN 10 : 9781118210741

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Process Scale Purification of Antibodies 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.