Lyophilization of biotechnology products.
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.
AKZO NOBEL, N.V. Organon, Oss, The Netherlands.
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D001709:Biotechnology / Q000592:standards; D004356:Drug Storage; D005612:Freeze Drying / Q000592:standards*; D011786:Quality Control; D011994:Recombinant Proteins / Q000737:chemistry / Q000592:standards
D011994:Recombinant Proteins