Continuous Pharmaceutical Processing and Process Analytical Technology

Continuous Pharmaceutical Processing and Process Analytical Technology

Dubey, Atul; Narang, Ajit S.

Taylor & Francis Ltd

10/2024

478

Mole

9780367712150

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Section I: Design and Control: Continuous Manufacturing of Small Molecule Drug Substances and Products

1. A Survey of Continuous API Syntheses: Insights at the Interface of Chemistry and Chemical Engineering.

2. Development of Continuous Pharmaceutical Crystallization.

3. Residence Time Distribution in Continuous Manufacturing.

4. Powder Electrostatics in Continuous Pharmaceutical Manufacturing.

5. Continuous Impregnation Processes

6. Leveraging a mini-batch wise continuous direct compression (CDC) approach to optimize efficiency in process development, on-demand manufacturing and continuous process verification (CPV).

7. Predictive In-Vitro Dissolution for Real-time Release Test (RTRT) for Continuous Manufacturing Process on Drug Product.

Section II: Design and Control: Continuous Manufacturing of Large Molecule Drug Substances and Products

8. Continuous Manufacturing of Biologics Drug Products: Challenges of Implementing Innovation in cGMP.

9. Modernizing manufacturing of parenteral products: from batch to continuous lyophilization.

Section III: Process Analytical Technologies

10. Near-infrared Spectroscopy as Process Analytical Technology in Continuous Solid Dosage Form Manufacturing.

11. The Role of Process Analytical Technology (PAT) in Biologics Development.

12. Moving to Manufacturing - Lessons Learned in A Career in Process Analytical Technology.

Section IV: Modeling, Design Space, and Future Outlook

13. End-to-end Design Space for Continuous Manufacturing of pharmaceuticals: Understanding interactions across integrated continuous operations.

14. Control strategies in continuous direct compression.

15. Framework for the validation of mechanistic and hybrid models as Process Analytical tools in the pharmaceutical Industry.

16. Understanding the History of Continuous Manufacturing in Other industries to Guide Future Development in Pharmaceuticals.

17. Process Systems Engineering Tools towards Digital Twins of Pharmaceutical Continuous Manufacturing Processes
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Continuous manufacturing;Drug development;Continuous pharmaceutical processing;Drug development technology;Process analytical technologies;Need analysis;Soft Sensor Model;PLS.;American Chemical Society;Moisture Content;NIR Measurement;Granule Size Distribution;Magnesium Stearate;PAT Tool;Ich Q13;Cm;RTD Data;RTD Experiment;Tablet Press;Content Uniformity;Ft NIR Spectrometer;Ich Q2;API Concentration;Flowsheet Model;Drug Substance;PLS Model;Continuous Blending;Cm Process;Parametric Control Strategy;Tablet Weight;NIR Probe