Pharmaceutical Book from C.H.I.P.S.

Chemical Engineering in the Pharmaceutical Industry
R&D to Manufacturing
edited by David J. am Ende

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.


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)

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

Part III: Analytical Methods and Applied Statistics

  1. Quality by Design for Analytical Methods
  2. Analytical Chemistry for API Process Engineering
  3. Quantitative Applications of NMR Spectroscopy
  4. Experimental Design for Pharmaceutical Development
  5. Multivariate Analysis for Pharmaceutical Development

Part IV: Drug Products

  1. Process Modeling Techniques and Applications for Solid Oral Drug Products
  2. Process Design and Development for Novel Pharmaceutical Dosage Forms
  3. Design of Solid Dosage Formulations
  4. Controlled Release Technology and Design of Oral Controlled Release Dosage Forms
  5. Design and Scale-Up of Dry Granulation Processes
  6. Wet Granulation Processes
  7. Spray Atomization Modeling for Tablet Film Coating Processes
  8. The Freeze Drying Process: The use of mathematical modeling in process design, understanding and scale up
  9. Achieving a Hot Melt Extrusion Design Space for the Production of Solid Solutions
  10. Continuous Processing in Secondary Production
  11. Pharmaceutical Manufacturing: The Role of Multivariate Analysis in Design Space, Control Strategy, Process Understanding, Troubleshooting, and Optimization


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Chemical Engineering in the Pharmaceutical Industry
R&D to Manufacturing
edited by David J. am Ende

2011 (available now) • 887 pages • $198.95 + shipping
Texas residents please add 6.75 % sales tax

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