Chemical Engineering in the Pharmaceutical Industry deals with various unique elements in the drug development process within chemical engineering science and pharmaceutical R&D.

Many of the experimental methods related to pharmaceutical process development are learned on the job. This book provides many of those important concepts for R&D Engineers and manufacturing Engineers in the Pharmaceutical Industry. These include basic analytics for quantitation of reaction components– often skipped in ChE Reaction Engineering and kinetics books.

In addition Chemical Engineering in the Pharmaceutical Industry introduces contemporary methods of data analysis for kinetic modeling and extends these concepts into Quality by Design strategies for regulatory filings. For the current professionals, in-silico process modeling tools that streamline experimental screening approaches is also new and presented here. Continuous flow processing, although mainstream for ChE, is unique in this context given the range of scales and the complex economics associated with transforming existing batch-plant capacity.

Contents

Part I: Introduction

1. Chemical Engineering in the Pharmaceutical Industry: An Introduction
2. Current Challenges and Opportunities in the Pharmaceutical Industry
3. hemical Engineering Principles in Biologics: Unique Challenges and Applications
4. Designing a Sustainable Pharmaceutical Industry: the Role of Chemical Engineers
5. Scientific Opportunities through Quality by Design

Part II: Active Pharmaceutical Ingredient (API)

6. The Role of Chemical Engineering in Pharmaceutical API Process R&D
7. Reaction Kinetics and Characterization
8. Understanding Rate Processes in Catalytic Hydrogenation Reactions
9. Characterization and First Principles Prediction of API Reaction Systems
10. Modeling, Optimization, and Applications of Kinetic Mechanisms with OpenChem™
11. Process Safety and Reaction Hazard Assessment
12. Design of Distillation and Extraction Operations
13. Crystallization Design and Scale-Up
14. Scale-Up of Mixing Processes - A Primer
15. Stirred Vessels: Computational Modeling of Multiphase Flows and Mixing
16. Membrane Systems for Pharmaceutical Applications
17. Design of Filtration and Drying Operations
18. The Design and Economics of Large-Scale Chromatographic Separations
19. Milling Operations in the Pharmaceutical Industry
20. Process Scale-up and Assessment
21. Scale-Up Do's and Don’ts
22. Kilo Lab and Pilot Plant Manufacturing
23. Process Development and Case Studies of Continuous Reactor Systems for Production of API and pharmaceutical intermediates
24. Drug Solubility and Reaction Thermodynamics using CosmoRS™
25. Thermodynamics and Relative Solubility Prediction of Polymorphic Systems
26. Towards a Rational Solvent Selection for Conformational Polymorph Screening
27. Molecular Thermodynamics for Pharmaceutical Process Modeling and Simulation
28. The Role of Simulation and Scheduling Tools in the Development and Manufacturing of Active Pharmaceutical Ingredients

Part III: Analytical Methods and Applied Statistics

29. Quality by Design for Analytical Methods
30. Analytical Chemistry for API Process Engineering
31. Quantitative Applications of NMR Spectroscopy
32. Experimental Design for Pharmaceutical Development
33. Multivariate Analysis for Pharmaceutical Development

Part IV: Drug Products

34. Process Modeling Techniques and Applications for Solid Oral Drug Products
35. Process Design and Development for Novel Pharmaceutical Dosage Forms
36. Design of Solid Dosage Formulations
37. Controlled Release Technology and Design of Oral Controlled Release Dosage Forms
38. Design and Scale-Up of Dry Granulation Processes
39. Wet Granulation Processes
40. Spray Atomization Modeling for Tablet Film Coating Processes
41. The Freeze Drying Process: The use of mathematical modeling in process design, understanding and scale up
42. Achieving a Hot Melt Extrusion Design Space for the Production of Solid Solutions
43. Continuous Processing in Secondary Production
44. Pharmaceutical Manufacturing: The Role of Multivariate Analysis in Design Space, Control Strategy, Process Understanding, Troubleshooting, and Optimization

Index

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