* * * INSIGHT * * *

Time for the Continuous Freeze-Drying System is NOW!

By

Thomas A. Jennings, Ph.D.

ABSTRACT: When I published in December 1999 the INSIGHT titled “The Future of Lyophilization” I thought that the reality of such a system would be years if not decades away. This view point was based on a number of factors. First of all, and perhaps foremost, the relatively low profit margin of the equipment manufacturers is not conducive for these companies to invest most or all of their profits in developing a high technology system that may require several years just to construct and build a working prototype.

The second reason is that the principle users of such a new system would be the manufacturers of pharmaceutical products. Since a license is required from a regulatory agency to manufacture such products, once the license is granted these pharmaceutical companies would be reluctant to make changes in the process, even if it meant increased productivity, especially if such changes would involve extensive studies to show that there was no change in the quality or the stability of the final product. It would be quite rationale for pharmaceutical companies to want to invest in new products rather than just improve the profit margin of existing products. If the continuous system only provides a modest increase in profits for the existing products, how would one justify such an investment to their share holders when the development of new products would greatly increased the overall financial well being of the company.

But recent events have dramatically changed my thinking. As a result of these events, I now feel that the need for the development of the continuous freeze-dryer is not years or decades away but NOW. The change in my thinking has nothing to do with profitability of an existing product nor with a choice between increased productivity or development of new products for the health care industries. It is much more fundamental than that. It appears to be a question of the very survival of the pharmaceutical industry as we know it today.

Voume 3 Number 8                                                                                        August 2000

5 Pages          2  References          No Figures

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