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[资源] Process Understanding--For Scale-Up and Manufacture of Active Ingredients

When I was asked to be the editor for a book on Process Understanding, I was
delighted as it provided me with an opportunity to cover something that I have
found challenging throughout my career as an industrial process development
chemist. During my doctoral studies, I had specialized in one discipline and was
encouraged to work very much on my own. However, when I started working in
industry, I was suddenly being asked to work with a whole range of people and
disciplines, often with no detailed knowledge of what they did. Then, as I gained
experience, I learned that the other disciplines with whom I worked often have
information that can be really helpful to me in the work I did (occasionally, I even
had useful information for them!).
Even after 15+ years of working in active ingredients development and manufacture,
I am still learning about what is important to other disciplines and how
aspects of their work can really help me in the work I do. This book is a continuation
of that learning and is intended to be relevant to both people who start new and
experienced process technologists.
This book is not designed to be a detailed technical treatise on each of the
subject areas, but to provide a valuable introduction to a range of subject areas
that are vital to the successful development and manufacture of active chemical
ingredients. The reader will be introduced to the areas that must be understood
throughout the active ingredients lifecycle right from the route selection through
to established manufacture. This book should help the reader understand what
is important to other/all disciplines involved in the lifecycle, leading to improved
interdisciplinary working, smoother technical transfer between disciplines, and
more efficient process development and manufacture.
Process understanding is the underpinning knowledge that allows the manufacture
of chemical entities to be carried out economically, sustainably, robustly, and
to the required quality. This area has risen in importance in the last few years,
particularly, with the recent impetus from the ‘‘Quality by Design’’ initiative from
the US Food and Drug Administration. This move to a more science- and risk-based
approach is already well entrenched in a number of fine chemicals companies and
it is heartening to see fundamental scientific understanding being placed back at
the core of process development and manufacture.
Many process development/scale-up books focus on specific products and tell
you the story of one chemical entity. There is relatively little written about the
eneral principles and underlying philosophy of what information was required
to underpin the decisions made. This book will seek to provide a broad view
of what process understanding means to different disciplines and gives readers
the opportunity to think about what is important to other people/disciplines and
stages throughout the product life cycle. This book will seek to show how process
understanding is, not only necessary, but can also deliver a real competitive
advantage within the pharmaceuticals and fine chemicals industry.
Although the authors were chosen primarily for their technical expertise, they
have also been selected to provide a balanced view owing to their geographical
spread and with a mix of academic and industry, pharmaceuticals, and fine
chemicals backgrounds. It is hoped that the reader will benefit from such a
breadth of experience. I have tried to include both established areas for process
development such as safety and scale-up of equipment as well as examining some of
the more emerging topics such as Quality by Design, semi-quantitative modeling,
and outsourcing (contract manufacture).
And finally, I leave with you this thought .. ...... .
We know there are known knowns; there are things we know we know. We also
know there known unknowns; that is to say we know there are some things we do
not know. But there are also unknown unknowns – the ones we don’t know we
don’t know ....
12 February, 2002 Donald Rumsfeld, The Pentagon
The latter are the ones we should worry about and are why I agreed to be the
editor of this book!

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2015-04-07 23:39:43, 2.13 M