Book Review pubs.acs.org/OPRD
Process Understanding: For Scale-Up and Manufacture of Active Ingredients trivial, and it does require a multidisciplinary team throughout development. A truth worth repeating! Who should read this book? I would recommend everyone to read it, especially the parts that are not from your own discipline. If you are a development chemist, you should find much important learning in the engineering sections! Why not learn how impurities affect crystal growth or how the Kolmogorov space helps us understand mixing, or why not learn how to make ruby crystals by the Czochralski method and much, much moreand it is all in one book! Get your own copy now!
Process Understanding: For Scale-Up and Manufacture of Active Ingredients, 1st ed. Edited by Ian Houson. Wiley-VCH: Weinheim, Germany. 370 pp. 2011 ISBN: 978-3-527-32584-9. mongst my colleagues we often asked ourselves: “Why has no one written a book on Process Understanding?”, and we joked we would probably have to write it ourselves. Then, by chance, I stumbled onto Process Understanding: For Scale-Up and Manufacture of Active Ingredients, edited by Ian Houson. I just had to get my hands on it! Next year the FDA framework for Quality by Design celebrates its 10-year anniversary. Back then we were fully occupied with trying to resolve the CFR 21 part 11 issues on electronic records and electronic signatures (ER/ES). The pendulum swung back and forth before the business would settle, and a reasonable consensus developed to allow us to move on. Today ER/ES issues have become Business as Usual and our focus is now shifting towards Process Understanding and Quality by Designthis divine gift to the scientist community! Finally, we are again asked to produce a more complete picture including rational and sound evidence describing the whole production process, from start to finish. We are no longer asked to analyse our end-products to death! I think the term “freedom to operate” really applies well here. Ian Houson and colleagues have done a great job in summarising many various disciplines and aspects of the manufacture of Active Pharmaceutical Ingredients (API). The overall topic is daunting! Still, the authors manage to include many advanced aspects and a fair bit of details, too. It is, however, not the level of details and the complex issues that make the book difficult to read. I really had to stand up on one foot and read it aloud to stay awake! A few more examples from real life in a narrative style would have made the reading easier. Bulleted lists and tables should be used to clarify and be kept as brief as possible. What is the point of having bulleted lists with long-winded sentences? Perhaps summarising each chapter and reiterating take-home messages could have helped to some extentif teaching is part of the task? Personally, I would have liked there to be discussion on scientific methodology to a greater extenttopics closely related to logic and even philosophy. What are good practices for laboratory-derived evidence? When can I use qualitative chromatographic data? When is Design of Experimentation (DoE) the best available technology, and when is a Physical Organic Approach better for producing undisputable proof? The authors point out that too often chemists optimize the reactions and, for example, work hard to reduce impurities that are easily purged in the downstream processing. Process engineers are only put on the projects in a very late phase, and by then the route has been frozen, and workup procedures are already decided. Is it far too late to care for mixing, mass and energy transport, or even innovative alternative technologies such as countercurrent extraction in flow setups? Scale-up is not
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© XXXX American Chemical Society
Jörgen Blixt
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Chemovix AB Lostigen 25, SE-151 50 Enhörna, Sweden
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The authors declare no competing financial interest.
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dx.doi.org/10.1021/op400218n | Org. Process Res. Dev. XXXX, XXX, XXX−XXX
