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.

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 Organis