Chemical Engineering in the Pharmaceutical Industry: R&D to Manufacturing

Front Cover
David J. am Ende
John Wiley & Sons, Mar 10, 2011 - Technology & Engineering - 904 pages
This book deals with various unique elements in the drug development process within chemical engineering science and pharmaceutical R&D. The book is intended to be used as a professional reference and potentially as a text book reference in pharmaceutical engineering and pharmaceutical sciences. Many of the experimental methods related to pharmaceutical process development are learned on the job. This book is intended to provide many of those important concepts that R&D Engineers and manufacturing Engineers should know and be familiar if they are going to be successful 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.

The book will be split into four distinct yet related parts. These parts will address the fundamentals of analytical techniques for engineers, thermodynamic modeling, and finally provides an appendix with common engineering tools and examples of their applications.

 

Contents

Cover
Chemical Engineering Principles in Biologics
Designinga Sustainable Pharmaceutical Industry
Scientific OpportunitiesThrough Quality
Reaction Kinetics and Characterization
UnderstandingRate Processes in Catalytic
References
Characterizationand
Solubility by Unknown More Stable Form
Toward aRational Solvent Selection
Molecular Thermodynamics for Pharmaceutical
the Development and Manufacturing of Active
Quality by Design for Analytical Methods
References
Quantitative
ExperimentalDesignfor Pharmaceutical

Reactions
Modeling Optimization and Applications
Design of Distillation and Extraction Operations
Crystallization Designand ScaleUp
ScaleUpofMixing Processes APrimer
Stirred Vessels Computational Modeling
Current Challenges andOpportunities in the Pharmaceutical Industry
3Organic SolventNanofiltration inPharmaceutical Industry
Chapter
The Design and Economics of LargeScale
Chapter
ProcessSafetyand Reaction Hazard Assessment
Process ScaleUp and Assessment
Chapter
ScaleUpDosand
References
Process Development and Case Studies
6
Pharma
References
Prediction of Polymorphic Systems
4Fractional Factorials 32 5DesignProjection
Development
Chapter
Process Design and Development for Novel
Design ofSolid Dosage Formulations
ControlledRelease Technologyand Design
Chapter
3Material Behavior Attribute Testingand Process Sensors
4Principles
5ScaleUp
References
Chapter
Spray Atomization Modeling for Tablet Film
The FreezeDrying Process The Use
Achieving a Hot Melt Extrusion Design Space
ContinuousProcessing in Secondary Production
Pharmaceutical Manufacturing TheRole
References
Characterization
Copyright

Other editions - View all

Common terms and phrases

About the author (2011)

DAVID J. AM ENDE is a Research Fellow with over fifteen years experience in chemical research and development with Pfizer, Inc. in Groton, Connecticut.

Bibliographic information