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Continuous biomanufacturing : innovative technologies and methods

Subramanian, G., 1935- editor.

Continuous biomanufacturing : innovative technologies and methods

Subramanian, G., 1935- editor.

9783527699896

9783527699902

1 online resource

Continuous Biomanufacturing: Innovative Technologies and Methods; Contents; List of Contributors; Part One: Overview of State-of-the-Art Technologies and Challenges; Chapter 1: Continuous Bioprocess Development: Methods for Control and Characterization of the Biological System; 1.1 Proposed Advantages of Continuous Bioprocessing; 1.1.1 Introduction; 1.2 Special Challenges for Continuous Bioprocesses; 1.2.1 The Biological System in Continuous Biomanufacturing; 1.2.2 Inherent Changes in the Microbial System -- Problem of Evolution; 1.2.3 Lack of Process Information.

1.2.3.1 Models-Based Process Development and Control for Continuous Processes1.2.3.2 Engineering Approach to Complex Systems; 1.2.4 Limited Control Strategies; 1.2.4.1 Traditional Control Strategies for Continuous Cultures; 1.3 Changes Required to Integrate Continuous Processes in Biotech; 1.3.1 A Better Physiological Understanding of the Organisms and Their Responses on the Reactor Environment; 1.3.1.1 Model Complexity; 1.3.1.2 Models; 1.3.2 Model-Based Process Monitoring; 1.3.3 Implementation of Model Predictive Control; 1.3.3.1 Model-Based Control.

1.4 Role of Iterative Process Development to Push Continuous Processes in Biotech1.4.1 Methods for Development of Continuous Processes; 1.4.1.1 Alternative: Fed-Batch as a System to Simulate Quasi Steady-State Conditions; 1.4.2 Mimicking Industrial Scale Conditions in the Lab: Continuous-Like Experiments; 1.4.2.1 A Simple Model for Continuous Processes; 1.4.2.2 Continuous-Like Fed-Batch Cultivations; 1.4.3 Fast and Parallel Experimental Approaches with High Information Content; 1.4.3.1 Computer-Aided Operation of Robotic Facilities; 1.4.3.2 Model Building and Experimental Validation.

1.5 ConclusionsReferences; Chapter 2: Tools Enabling Continuous and Integrated Upstream and Downstream Processes in the Manufacturing of Biologicals; 2.1 Introduction; 2.2 Continuous Upstream Processes; 2.2.1 Continuous Bioprocesses: With or Without Cell Recycle?; 2.2.2 Early/Scale-Down Perfusion Development; 2.2.3 Feeding and Operational Strategies in Perfusion Processes; 2.2.4 Cell Retention Devices; 2.3 Continuous Downstream Processes; 2.3.1 Continuous Liquid Chromatography (CLC); 2.3.1.1 Continuous Annular Chromatography (CAC).

2.3.1.2 True and Simulated Moving Bed Chromatography (TMB/SMB)2.3.1.3 Multicolumn Countercurrent Solvent Gradient Purification (MCSGP); 2.3.1.4 Periodic Countercurrent Chromatography (PCC); 2.3.1.5 Continuous Countercurrent Tangential Chromatography (CCTC); 2.3.2 Nonchromatographic Continuous Processes; 2.3.2.1 Continuous Aqueous Two-Phase Systems; 2.3.2.2 Continuous Protein Precipitation; 2.3.3 Straight-Through Processes; 2.3.4 Continuous Virus Clearance Processes; 2.4 Integrated Continuous Processes; 2.5 Concluding Remarks; References.

This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous processes in the biopharmaceutical industry. Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream operations. Special emphasis is given to process control and monitoring, including such topics as 'quality by design' and automation. The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities.

John Wiley and Sons

Pharmaceutical biotechnology.

Biopharmaceutics.

Biochemical engineering.

Biologicals.

Manufactured Materials -- trends

Biological Products

Biopharmaceutics

Biotechnologie pharmaceutique.

Biopharmacie.

Génie biochimique.

Médicaments biologiques.

MEDICAL -- Pharmacology.

Biochemical engineering

Pharmaceutical biotechnology

Subramanian, G., 1935-

https://onlinelibrary.wiley.com/doi/book/10.1002/9783527699902