RT Journal Article
SR Electronic
T1 Lyophilization of Biotechnology Products
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 311
OP 317
VO 48
IS 6
A1 Skrabanja, Arno T. P.
A1 De Meere, AndrÉ L. J.
A1 De Ruiter, Rien A.
A1 Van Den Oetelaar, Piet J. M.
YR 1994
UL http://journal.pda.org/content/48/6/311.abstract
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.