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Lyophilization of biotechnology products
A T Skrabanja1, A L de Meere, R A de Ruiter
1AKZO NOBEL, N.V. Organon, Oss, The Netherlands.
PDA Journal of Pharmaceutical Science and Technology
|November 1, 1994
Abstract:
In this review the lyophilization of biotechnology products is discussed. It is emphasized that the final quality of a protein product is determined by an interplay between the proper choice of excipients and the freeze-drying process. A crystalline matrix after freeze-drying is detrimental for the protein product. A glassy amorphous state is a prerequisite for stability, however a glassy state as such will not assure sufficient stability. The glass temperature which defines the state of the freeze-dried cake can be influenced by the moisture content and the choice of excipients.