ABSTRACT
This chapter outlines the main principles that are important, at least as a starting point for guiding the development of stable lyophilized protein products, there will not be an exhaustive review of all of the published studies, many of which are excellent, on acute and storage stability of lyophilized proteins. It provides an overview of the principles that must be followed, and how essential physical data are obtained and used to meet these criteria. The efficient and consistent production of a stable, freeze-dried, protein product, contained in a mechanically strong and rapidly dissolvable cake, is the ultimate objective during the development of a freeze-drying cycle. A precaution for this single-step drying cycle is that some products may collapse during the transition from primary drying to secondary drying, if the temperature gradient between the shelf and sample at the end of primary drying is too great, resulting in an excessively fast warming rate.
