Felix Franks on Critical-to-Quality Process Parameters for Lyophilization

Overview:

The inventor of the stabilization process used to formulate Exubera has found that mentioning the glassy state has often produced a similar effect in his pharma listeners. Due to lack of interdisciplinary understanding, he says, freeze drying is still “hit or miss” at many pharmaceutical companies. In Chapter 3 of his best-selling book, he outlines product and process parameters.