Book Review pubs.acs.org/OPRD
Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals. By Feroz Jameel and Susan Hershenson. Wiley: New York. 2010. 955 + xx pages. €126. he rear cover of this book claims it is “A real-world guide to the production and manufacturing of biopharmaceuticals”. Scientists and engineers turning to this book for key issues in manufacturing, however, will be somewhat disappointed. The focus of the book is on formulation, as the main title indicates, with some chapters relating to process development. As a process chemist I was hoping to read about the development strategies used in biopharmaceuticals, especially those concerning optimisation, control, and reproducibility of the process, and to learn from some case studies. However, the book has little to say on process analytical technology, whereas optimisation and reproducibility are mentioned in a couple of chapters. The best chapters in my view are those that deal with particular unit operations, such as freeze drying, spray drying, and those that look at the impact of the manufacturing process on drug stability and quality. This is one for process chemists and engineers to borrow from the library rather than purchase!
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Trevor Laird, Editor AUTHOR INFORMATION
Notes
The authors declare no competing financial interest.
Published: May 6, 2013 © 2013 American Chemical Society
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dx.doi.org/10.1021/op400098h | Org. Process Res. Dev. 2013, 17, 883−883
