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

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

Editor(s): David J. am Ende

Published Online: 29 OCT 2010 08:19AM EST

Print ISBN: 9780470426692

Online ISBN: 9780470882221

DOI: 10.1002/9780470882221

About this Book

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.

Table of contents

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  1. Part I: Introduction

  2. Part II: Active Pharmaceutical Ingredient (API)

    1. Chapter 13

      Crystallization Design and Scale-Up (pages 213–247)

      Robert Rahn McKeown, James T. Wertman and Philip C. Dell'Orco

    2. Chapter 22

      Kilo Lab and Pilot Plant Manufacturing (pages 417–436)

      Jason C. Hamm, Melanie M. Miller, Thomas Ramsey, Richard L. Schild, Andrew Stewart and Jean W. Tom

  3. Part III: Analytical Methods and Applied Statistics

    1. Chapter 29

      Quality by Design for Analytical Methods (pages 543–562)

      Timothy W. Graul, Kimber L. Barnett, Simon J. Bale, Imogen Gill and Melissa Hanna-Brown

  4. Part IV: Drug Products

    1. Chapter 34

      Process Modeling Techniques and Applications for Solid Oral Drug Products (pages 633–662)

      Mary T. am Ende, Rahul Bharadwaj, Salvador García-Muñoz, William Ketterhagen, Andrew Prpich and Pankaj Doshi

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