Bioreactor Design and Operation

  1. Downstream Processing Interface
    1. Impact of Upstream Conditions
      1. Product Quality Attributes
        1. Protein Folding
          1. Glycosylation Patterns
            1. Aggregation Tendency
              1. Stability Properties
              2. Impurity Profiles
                1. Host Cell Proteins
                  1. DNA Content
                    1. Endotoxin Levels
                      1. Media Components
                      2. Cell Physiology Effects
                        1. Cell Viability
                          1. Cell Lysis
                            1. Metabolic State
                              1. Stress Response
                            2. Cell Harvesting Methods
                              1. Centrifugation
                                1. Batch Centrifugation
                                  1. Continuous Centrifugation
                                    1. Disc Stack Separators
                                      1. Tubular Bowl Centrifuges
                                      2. Filtration
                                        1. Microfiltration
                                          1. Crossflow Filtration
                                            1. Dead-End Filtration
                                              1. Filter Selection
                                              2. Flocculation
                                                1. Chemical Flocculants
                                                  1. Bioflocculation
                                                    1. Settling Characteristics
                                                  2. Primary Recovery
                                                    1. Cell Disruption
                                                      1. Mechanical Methods
                                                        1. Chemical Methods
                                                          1. Enzymatic Methods
                                                          2. Solid-Liquid Separation
                                                            1. Clarification Methods
                                                              1. Debris Removal
                                                                1. Filtration Systems
                                                                2. Initial Concentration
                                                                  1. Ultrafiltration
                                                                    1. Precipitation
                                                                      1. Extraction
                                                                    2. Integration Strategies
                                                                      1. In-Situ Product Removal
                                                                        1. Adsorption Systems
                                                                          1. Extraction Systems
                                                                            1. Membrane-Based Removal
                                                                              1. Crystallization
                                                                              2. Continuous Processing
                                                                                1. Integrated Systems
                                                                                  1. Process Intensification
                                                                                    1. Real-Time Monitoring
                                                                                    2. Process Analytical Technology
                                                                                      1. Quality Monitoring
                                                                                        1. Process Control
                                                                                          1. Decision Making

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                                                                                      9. Specialized Bioreactor Systems

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                                                                                      11. Validation and Regulatory Compliance