Downstream Processing

  1. Process Development and Integration
    1. Purification Strategy Development
      1. RIPP Scheme
        1. Recovery
          1. Isolation
            1. Purification
              1. Polishing
              2. Decision Trees for Step Selection
                1. Platform Approaches
                  1. Process Robustness
                  2. Process Integration
                    1. Unit Operation Sequencing
                      1. Hold Step Minimization
                        1. Process Flow Optimization
                          1. Material Balance
                          2. Scale-Up and Scale-Down
                            1. Scaling Principles
                              1. Geometric Similarity
                                1. Kinetic Similarity
                                  1. Dynamic Similarity
                                  2. Scale-Down Model Development
                                    1. Model Design
                                      1. Validation Studies
                                        1. Predictive Capability
                                        2. Scale-Up Challenges
                                          1. Equipment Limitations
                                            1. Process Variations
                                              1. Risk Assessment
                                            2. Process Analytical Technology
                                              1. Real-Time Monitoring
                                                1. In-line Sensors
                                                  1. On-line Analysis
                                                    1. At-line Testing
                                                    2. Process Control Strategies
                                                      1. Feedback Control
                                                        1. Feedforward Control
                                                          1. Model Predictive Control
                                                          2. Data Management
                                                            1. Data Acquisition Systems
                                                              1. Data Analysis Tools
                                                              2. Real-Time Release Testing
                                                                1. Principles and Benefits
                                                                  1. Implementation Strategies
                                                                2. Process Economics
                                                                  1. Cost Analysis
                                                                    1. Capital Expenditure
                                                                      1. Operating Expenditure
                                                                        1. Cost of Goods Analysis
                                                                        2. Economic Optimization
                                                                          1. Yield Improvement
                                                                            1. Throughput Enhancement
                                                                              1. Resource Utilization
                                                                              2. Investment Decisions
                                                                                1. Technology Selection
                                                                                  1. Facility Planning

                                                                              Previous

                                                                              7. Stage 6: Formulation and Final Processing

                                                                              Go to top

                                                                              Next

                                                                              9. Quality and Regulatory Aspects