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Produktbild: Biopharmaceutical Production Technology

Biopharmaceutical Production Technology

Fr. 602.00

inkl. gesetzl. MwSt., Versandkostenfrei

Beschreibung

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

18.07.2012

Abbildungen

Tabellen, schwarz-weiss, farbige Illustrationen, schwarz-weiss Illustrationen

Herausgeber

Ganapathy Subramanian

Verlag

Wiley-VCH

Seitenzahl

944

Maße (L/B/H)

25/17.7/5.3 cm

Gewicht

2108 g

Auflage

1. Auflage

Sprache

Englisch

ISBN

978-3-527-33029-4

Beschreibung

Portrait

Dr. Ganapathy Subramanian is a biotechnology consultant with over 30 years experience in industry and academia, encompassing the application and development of processing, purification methodologies, and chromatographic systems for largescale use in environmental science, food science, perfumery, cosmetics, and pharmaceuticals. He has also taught extensively in the area of food and medical technology.

 

A chemistry graduate from Madras, India, Dr. Subramanian was awarded his doctorate, from the University of Glasgow, for work on natural products. His main research interests lie in the utilization of natural material separation processes and bioconversions.

 

Dr. Subramanian has written and edited a number of books and articles in the field of biotechnology. For the last 10 years, he has been organizing conferences promoting the integration and sharing of knowledge between academia and industry.

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

18.07.2012

Abbildungen

Tabellen, schwarz-weiss, farbige Illustrationen, schwarz-weiss Illustrationen

Herausgeber

Ganapathy Subramanian

Verlag

Wiley-VCH

Seitenzahl

944

Maße (L/B/H)

25/17.7/5.3 cm

Gewicht

2108 g

Auflage

1. Auflage

Sprache

Englisch

ISBN

978-3-527-33029-4

Herstelleradresse

Wiley-VCH GmbH
product_safety@wiley.com
Wiley-VCH GmbH, Boschstrasse 12, DE-69469 Weinheim

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  • Produktbild: Biopharmaceutical Production Technology
  • PREFACE

     

    Volume 1

     

    PART ONE: Upstream Technologies

     

    STRATEGIES FOR PLASMID DNA PRODUCTION IN ESCHERICHIA COLI

    Introduction

    Requirements for a Plasmid DNA Production Process

    Structure of a DNA Vaccine Production Process

    Choice of Antigen

    Vector DNA Construct

    Host Strains

    Cultivation Medium and Process Conditions

    Lysis/Extraction of Plasmid DNA

    Purification

    Formulation

    Conclusions

     

    ADVANCES IN PROTEIN PRODUCTION TECHNOLOGIES

    Introduction

    Glycoengineering for Homogenous Human-Like Glycoproteins

    Bacteria as Protein Factories

    Mammalian Cell Technology

    Yeast Protein Production

    Baculovirus - Insect Cell Technology

    Transgenic Animal Protein Production

    Plant Molecular Farming

    Cell-Free Protein Production

    Future Prospects

     

    PART TWO: Protein Recovery

     

    RELEASING BIOPHARMACEUTICAL PRODUCTS FROM CELLS

    Introduction

    Cell Structure and Strategies for Disruption

    Cell Mechanical Strength

    Homogenization

    Bead Milling

    Chemical Treatment

    Cellular Debris

    Conclusions

     

    CONTINUOUS CHROMATOGRAPHY (MULTICOLUMN COUNTERCURRENT SOLVENT GRADIENT PURIFI CATION) FOR PROTEIN

    PURIFI CATION

    Introduction

    Overview of Continuous Chromatographic Processes

    Principles of MCSGP

    Application Examples of MCSGP

    Enabling Features and Economic Impact of MCSGP

    Annex 1: Chromatographic Process Decision Tree

     

    VIRUS-LIKE PARTICLE BIOPROCESSING

    Introduction

    Upstream Processing

    Downstream Processing

    Analysis

    Conclusions

    Nomenclature

     

    THERAPEUTIC PROTEIN STABILITY AND FORMULATION

    Introduction

    Protein Stability

    Formulation and Materials

    Screening Methods

    Accelerated and Long-Term Stability Testing

    Analytical Techniques for Stability Testing

    Conclusions

     

    PRODUCTION OF PEGYLATED PROTEINS

    Introduction

    General Considerations

    PEGylation Chemistry

    PEGylated Protein Purification

    Conclusions

     

    PART THREE: Advances in Process Development

     

    AFFINITY CHROMATOGRAPHY: HISTORICAL AND PROSPECTIVE OVERVIEW

    History and Role of Affinity Chromatography in the Separation Sciences

    Overview of Affinity Chromatography: Theory and Methods

    Affinity Ligands

    Affinity Ligands in Practice: Biopharmaceutical Production

    Conclusions and Future Perspectives

     

    HYDROXYAPATITE IN BIOPROCESSING

    Introduction

    Materials and Interaction Mechanisms

    Setting up a Separation

    Separation Examples

    Conclusions

     

    MONOLITHS IN BIOPROCESSING

    Introduction

    Properties of Chromatographic Monoliths

    Monolithic Analytical Columns for Process Analytical Technology Applications

    Monoliths for Preparative Chromatography

    Enzyme Reactors

    Conclusions

     

    MEMBRANE CHROMATOGRAPHY FOR BIOPHARMACEUTICAL MANUFACTURING

    Membrane Adsorbers - Introduction and Technical Specifications

    Comparing Resins and Membrane Adsorbers

    Membrane Chromatography Applications and Case Studies

    Conclusions

     

    MODELING AND EXPERIMENTAL MODEL PARAMETER DETERMINATION WITH QUALITY BY DESIGN FOR BIOPROCESSES

    Introduction

    QbD Fundamentals

    Process Modeling and Experimental Model Parameter Determination

    Process Robustness Study

    Conclusions

    Nomenclature

     

    Volume 2

     

    PART FOUR: Analytical Technologies

     

    BIOSENSORS IN THE PROCESSING AND ANALYSIS OF BIOPHARMACEUTICALS

    Introduction

    Principles and Commercial Applications of Biosensors

    Use of Biosensors in Biopharmaceutical Production and Processing

    Conclusions

     

    PROTEOMICS TOOLKIT: APPLICATIONS IN PROTEIN BIOLOGICAL PRODUCTION AND METHOD DEVELOPMENT

    Introduction

    Applications of Proteomics

    Myths and Misconceptions - Perceived Drawbacks of Proteomics

    Critical Factors for Industrialization of Proteomics

    Case Studies

    Conclusions

     

    SCIENCE OF PROTEOMICS: HISTORICAL PERSPECTIVES AND POSSIBLE ROLE IN HUMAN HEALTHCARE

    Science of 'Omics'

    Major Advances in Biology That Led to the Sciences of 'Omics'

    Mendel's Principles of Inheritance

    One Gene/One Enzyme Concept of Beadle and Tatum

    Watson - Crick Structure of DNA

    Development of Different Technologies Responsible for the Emergence of Genomics and Proteomics

    Genomics

    Proteomics

    Interactomics: Complexity of an Organism Based on the Interactions of Proteins

    Relation between Diseases, Genes, and Proteins: Diseasome Concept

    Proteins as Biomarkers of Human Diseases

    Metabolomics

    Proteomics and Drug Discovery

    Current and Future Benefits of Proteomics in Human Healthcare

     

    PART FIVE: Quality Control

     

    CONSISTENCY OF SCALE-UP FROM BIOPROCESS DEVELOPMENT TO PRODUCTION

    Inhomogeneities in Industrial Fed-Batch Processes

    Effects of Conditions in Industrial-Scale Fed-Batch Processes on the Main Carbon Metabolism

    Effects of Conditions in Industrial-Scale Fed-Batch Processes on Amino Acid Synthesis

    Scale-Down Reactors for Imitating Large-Scale Fed-Batch Process Conditions at the Laboratory Scale

    Improved Two-Compartment Reactor System to Imitate Large-Scale Conditions at the Laboratory Scale

    Description of the Hydrodynamic Conditions in the PFR Part of the Presented Two-Compartment Reactor

    Description of Oxygen Transfer in the PFR Part of the Two-Compartment Reactor

    E. coli Fed-Batch Cultivations in the Two-Compartment Reactor System

    Future Perspectives for the Application of a Two-Compartment Reactor

     

    SYSTEMATIC APPROACH TO OPTIMIZATION AND COMPARABILITY OF BIOPHARMACEUTICAL GLYCOSYLATION THROUGHOUT THE DRUG LIFE CYCLE

    Costs of Inconsistent, Unoptimized Drug Glycosylation

    Scheme 1: Traditional Approach to Comparability of Drug Glycosylation

    Scheme 2: Comparability of Drug Glycosylation Using QbD DS

    Scheme 3: Enhanced QbD Approach to Comparability of Drug Glycosylation

    Conclusions

     

    QUALITY AND RISK MANAGEMENT IN ENSURING THE VIRUS SAFETY OF BIOPHARMACEUTICALS

    Introduction

    QRM and Virus Safety

    Pillars of Safety

    Committee for Proprietary Medicinal Products Guidelines for Investigational Medicinal Products - Risk Management in Practice

    Developing a Robust Risk Minimization Strategy - What Is the Correct Paradigm?

     

    ENSURING QUALITY AND EFFI CIENCY OF BIOPROCESSES BY THE TAILORED APPLICATION OF PROCESS ANALYTICAL TECHNOLOGY AND QUALITY BY DESIGN

    Introduction

    PAT and QbD in Bioprocessing - Engineering Meets Biology

    Aspects of Biological Demands - Selected Examples

    Technical and Engineering Solutions

    Conclusions

     

    PART SIX: Process Design and Management

     

    BIOPROCESS DESIGN AND PRODUCTION TECHNOLOGY FOR THE FUTURE

    Introduction

    Analysis of Biomanufacturing Technologies

    AAC: Anything and Chromatography

    Process Integration

    Process Design and QbD

    Package Unit Engineering and Standardization

    Downstream of Downstream Processing

    Conclusions

     

    INTEGRATED PROCESS DESIGN: CHARACTERIZATION OF PROCESS AND PRODUCT DEFINITION OF DESIGN SPACES

    Introductory Principles

    Original Process Development Paradigm

    The Essential QbD Concepts

    Conclusion

     

    EVALUATING AND VISUALIZING THE COST-EFFECTIVENESS AND ROBUSTNESS OF BIOPHARMACEUTICAL MANUFACTURING STRATEGIES

    Introduction

    Scope of Research on Decision-Support Tools for the Biotech Sector

    Capturing Process Robustness Under Uncertainty

    Reconciling Multiple Conflicting Outputs Under Uncertainty

    Searching Large Decision Spaces Efficiently

    Integrating Stochastic Simulation with Multivariate Analysis

    Conclusions

     

    PART SEVEN: Changing Face of Processing

     

    FULL PLASTICS: CONSEQUENT EVOLUTION IN PHARMACEUTICAL BIOMANUFACTURING

    FROM VIAL TO WAREHOUSE

    Increased Demand, Reduced Volumes, and Maximum Flexibility - Driving Force to Plastic Devices

    Plastic - The Flexible All-Round Replacer: From Material to Function

    Pollution with Plastics: Leachables and Extractables

    Plastics for Storage: Vial and Bag

    Plastics for Cultivation: Flask, Tube, and Unstirred and Stirred Bioreactor

    Plastics for Purification: Column and Membrane

    Case Study: Comparability of Plastic Bag-Based Bioreactors in Cultivation Processes

    Conclusions and Prospects

     

    BIOSMB - TECHNOLOGY: CONTINUOUS COUNTERCURRENT CHROMATOGRAPHY ENABLING A FULLY DISPOSABLE PROCESS

    Introduction

    Continuous Chromatography in Biopharmaceutical Industries

    Process Design Principles

    Case Studies

    Conclusions

     

    SINGLE-USE TECHNOLOGY: OPPORTUNITIES IN BIOPHARMACEUTICAL PROCESSES

    Current Single-Use Technologies

    Future Single-Use Operations

    Automation Requirements in Single-Use Manufacturing

    Qualification and Validation Expectations

    Operator Training

     

    SINGLE-USE BIOTECHNOLOGIES AND MODULAR MANUFACTURING ENVIRONMENTS INVITE PARADIGM SHIFTS IN BIOPROCESS DEVELOPMENT AND BIOPHARMACEUTICAL MANUFACTURING

    Introduction

    Paradigm Shift at Crucell

    Conclusions and General Outlook