Handbook of Process Chromatography
Handbook of Process Chromatography

Author: Gunter Jagschies

Publisher: Elsevier

Published: 2007-12-08

Total Pages: 383

ISBN-13: 0080554512

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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 systemsNew 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 assessmentsKey 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 K. Sofer

Publisher: Academic Press

Published: 1997-06-24

Total Pages: 410

ISBN-13:

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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.

A Practical Handbook of Preparative HPLC
A Practical Handbook of Preparative HPLC

Author: Donald A Wellings

Publisher: Elsevier

Published: 2011-04-18

Total Pages: 193

ISBN-13: 0080458858

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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

Publisher: John Wiley & Sons

Published: 1987-05-13

Total Pages: 1028

ISBN-13: 9780471895589

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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 Modern Pharmaceutical Analysis
Handbook of Modern Pharmaceutical Analysis

Author: Satinder Ahuja

Publisher: Academic Press

Published: 2010-11-11

Total Pages: 604

ISBN-13: 0123759811

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Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. - Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it - Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations - Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS

Handbook of Analytical Quality by Design
Handbook of Analytical Quality by Design

Author: Sarwar Beg

Publisher: Academic Press

Published: 2021-01-09

Total Pages: 225

ISBN-13: 0128203331

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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 Chromatography
Process Chromatography

Author: Gail K. Sofer

Publisher: Academic Press

Published: 2015-09-02

Total Pages: 89

ISBN-13: 1483289176

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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.

Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics
Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics

Author: Allan Matte

Publisher: Elsevier

Published: 2020-09-07

Total Pages: 222

ISBN-13: 0081030193

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Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics provides the interested and informed reader with an overview of current approaches, strategies and considerations relating to the purification, analytics and characterization of therapeutic antibodies and related molecules. While there are obviously other books published in and around this subject area, they seem to be either older (c.a. year 2000 publication date) or are more limited in scope. The book will include an extensive bibliography of the published literature in the respective areas covered. It is not, however, intended to be a how-to methods book. Covers the vital new area of R&D on therapeutic antibodies Written by leading scientists and researchers Up-to-date coverage and includes a detailed bibliography