This book has been designed to gather as much of the technology for the conformational analysis of biopharmaceutical polymers as possible into a single volume. It is not intended to cover the use of a specific technology in detail. Rather, it is intended to provide sufficient information and references to establish the basis for the selection of a specific experimental approach that would be the most cost-effective in the study of biopolymer conformation. Thus, coverage of some technologies is brief since they have little application to biotechnology products; this is not meant to suggest, however, that such technologies are not of great value in basic science studies. There is also an emphasis to describe studies where multiple technologies were used to address conformational change.

The next several years will see increased interest in the conformational analysis of biopharmaceutical polymers resulting from the development of biosimilar or "follow-on" biological products. The activity of many biopharmaceutical polymers is dependent on conformation. Thus, a comparison of a "generic" (off-patent) biological medicinal product with the originator product includes conformational analysis. A clear understanding of what any differences between products mean or do not mean is critical; thus, the need for independent methods of analysis. It is hoped that this book will emphasize the need for science over hype, the need for rational analysis rather than "smoke and mirrors." Also, renaming a technique does not increase its value in any way.

Finally, I would be remiss if I did not thank Professor Bryce Plapp of the University of Iowa for his continued support of the thermodynamically challenged. Professor Charles Craik of the University of California at San Francisco has also provided some useful advice as has Professor Don Gabriel of the University of North Carolina at Chapel Hill. I am also most indebted to Jill Jurgensen and Barbara Norwitz of Taylor & Francis for their support.

0 0

Post a comment