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Cost-effective manufacturing of biopharmaceutical products is rapidly gaining in importance, while healthcare systems across the globe are looking to contain costs and improve efficiency. To adapt to these changes, industries need to review and streamline their manufacturing processes.
This two volume handbook systematically addresses the key steps and challenges in the production process and provides valuable information for medium to large scale producers of biopharmaceuticals.
It is divided into seven major parts:
- Upstream Technologies
- Protein Recovery
- Advances in Process Development
- Analytical Technologies
- Quality Control
- Process Design and Management
- Changing Face of Processing
With contributions by around 40 experts from academia as well as small and large biopharmaceutical companies, this unique handbook is full of first-hand knowledge on how to produce biopharmaceuticals in a cost-effective and quality-controlled manner.

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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 B

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