A WORD FROM FELIX FRANKS
Pharmaceutical Freeze-Drying
Among the diverse offerings of the BioUpdate Foundation, the course on Pharmaceutical Freeze-Drying takes pride of place. It was first held in 1992 in the Netherlands and has since then been mounted annually in several European countries, and even in the U.S.A., with varying success. The Foundation has succeeded in attracting a faithful following, mainly from Benelux and Scandinavian countries. The remarkable feature, at least to us, the Course Organisers, is the almost total absence of U.K. interest. Can it really be that the U.K. pharmaceutical industry is on top of the subject? We do not believe that to be the case.
Careful, constructive and ruthless editing
Some time during the mid 1990s, I first had the idea of writing a book on the subject. That was around the time when the industry first woke up to the realisation that the materials science of amorphous states played a major role in determining the attributes of freeze-dried pharmaceutical preparations. This was coupled with a nagging unease about the existing books on the subject. The dissatisfaction was twofold: with one notable exception, recent books consist of edited volumes, usually the proceedings of conferences. To my mind, that format is not ideal for the telling of a coherent story; there is duplication and there are gaps. There are also some chapters that really have nothing to do with the main subject. Unless the editing has been careful, constructive and yes, ruthless, then different styles will clash, nomenclature adopted by different authors will not match, leading to misunderstanding and confusion. The second issue is one of language. With international conference proceedings, some contributors will not have English as first language. We all admire the ability of our foreign colleagues to understand, speak and produce passable written English. But to develop a fluent style requires more than a textbook knowledge of the language. Here, the function of the editor becomes crucial, and that has not always been the case in edited freeze-drying volumes.
Freeze-drying ‘under protest’
I spent much time turning the subject over in my mind; industrial pharmaceutical freeze-drying is a mosaic, almost a Babel, of different disciplines, each with its own jargon. In the end I decided, reluctantly, that a new, single author book was in order. It was my good fortune at the time to have a knowledgeable colleague, Tony Auffret, to assist me in the task. He and I had been, and are still presenting BioUpdate courses. I felt that our joint training and experience qualified us to undertake such a venture. What was our experience? We were catapulted into freeze-drying in order to generate funds for our stabilisation projects which were meant to demonstrate that freeze-drying could be supplanted by other forms of drying that were more efficient, less wasteful in energy consumption and more cost effective. We therefore practised freeze-drying “under protest”, so to speak. Nevertheless, our consulting services appeared to be popular, and during the lifetime of our company, Pafra Biopreservation, we managed to complete of the order of 200 freeze-drying audits for companies worldwide, including 18 of the 20 largest international pharmaceutical companies. As Tony Auffret put it: “We only see the hospital cases.” The BioUpdate courses are based on the experiences we gained from solving problems of these hospital cases, and the book is based on the same experiences.
The ‘product’ to take centre stage
Where should the emphasis be placed in such a book? After having read most of what was already on offer, I decided that “the product” must take centre stage. Hardware aspects, patenting, regulation, scale-up problems, GMP matters, sterile rooms, vial stoppering etc are all dealt with elsewhere, but purposeful formulation and matters affecting stability usually get short shrift. The book is therefore chemistry and materials science centred.
My thanks
I thank the editorial staff of the Royal Society of Chemistry for help, guidance and patience. This was not an easy task, but the first edition was sold out in less than one year. I thank all those who have unknowingly contributed to this book by attending our course or brought us their freeze-drying problems for solution. As a Canadian bumper sticker had it: “Engineers have problems, chemists have solutions.”
Freeze-drying of Pharmaceuticals and Biopharmaceuticals: Principles and Practice
Felix Franks in association with Tony Auffret
RSC Publishing, The Royal Society of Chemistry, Cambridge, 2007
ISBN-13: 978-0-85404-268-5