PT  - JOURNAL ARTICLE
AU  - Skrabanja, Arno T. P.
AU  - De Meere, AndrÉ L. J.
AU  - De Ruiter, Rien A.
AU  - Van Den Oetelaar, Piet J. M.
TI  - Lyophilization of Biotechnology Products
DP  - 1994 Nov 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 311--317
VI  - 48
IP  - 6
4099  - http://journal.pda.org/content/48/6/311.short
4100  - http://journal.pda.org/content/48/6/311.full
SO  - PDA J Pharm Sci Technol1994 Nov 01; 48
AB  - 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.