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 IntroductionRequirements for a Plasmid DNA Production ProcessStructure 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 FormulationConclusions 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 ConsiderationsPEGylation Chemistry PEGylated Protein PurificationConclusions 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 MethodsAffinity Ligands Affinity Ligands in Practice: Biopharmaceutical Production Conclusions and Future Perspectives HYDROXYAPATITE IN BIOPROCESSING Introduction Materials and Interaction Mechanisms Setting up a SeparationSeparation Examples Conclusions MONOLITHS IN BIOPROCESSING IntroductionProperties 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 AdsorbersMembrane Chromatography Applications and Case StudiesConclusions 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 IntroductionApplications 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 DiseasesMetabolomics 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 BIOMANUFACTURINGFROM 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 BagPlastics 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 IndustriesProcess 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 CrucellConclusions and General Outlook

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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 IntroductionRequirements for a Plasmid DNA Production ProcessStructure 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 FormulationConclusions 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 ConsiderationsPEGylation Chemistry PEGylated Protein PurificationConclusions 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 MethodsAffinity Ligands Affinity Ligands in Practice: Biopharmaceutical Production Conclusions and Future Perspectives HYDROXYAPATITE IN BIOPROCESSING Introduction Materials and Interaction Mechanisms Setting up a SeparationSeparation Examples Conclusions MONOLITHS IN BIOPROCESSING IntroductionProperties 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 AdsorbersMembrane Chromatography Applications and Case StudiesConclusions 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 IntroductionApplications 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 DiseasesMetabolomics 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 BIOMANUFACTURINGFROM 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 BagPlastics 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 IndustriesProcess 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 CrucellConclusions and General Outlook

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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 IntroductionRequirements for a Plasmid DNA Production ProcessStructure 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 FormulationConclusions 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 ConsiderationsPEGylation Chemistry PEGylated Protein PurificationConclusions 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 MethodsAffinity Ligands Affinity Ligands in Practice: Biopharmaceutical Production Conclusions and Future Perspectives HYDROXYAPATITE IN BIOPROCESSING Introduction Materials and Interaction Mechanisms Setting up a SeparationSeparation Examples Conclusions MONOLITHS IN BIOPROCESSING IntroductionProperties 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 AdsorbersMembrane Chromatography Applications and Case StudiesConclusions 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 IntroductionApplications 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 DiseasesMetabolomics 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 BIOMANUFACTURINGFROM 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 BagPlastics 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 IndustriesProcess 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 CrucellConclusions and General Outlook

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