Page 29 - Assurance of Sterility for Sensitive Combination Products and Materials
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Sensitive combination products 17
IL-8 (8kDa)
Protection of proteins during sterilization
BMP-2 (26kDa) After sterilization with SPS
DNase (39kDa)
IgM (900kDa) After sterilization w/o SPS
IgG (144kDa) Non-sterilized (A) SPS stabilize the 3-D conformation of proteins, excluding water and protecting from chemical and physical stress during
100 90 80 70 60 50 40 30 20 10 0 sterilization. (B) SPS have been shown to protect a range of functional biomolecules from 8 to 900 kDA, exposed to 25 kGy irradiation.
(B)
Protein activity rate [%]
Irradiation
Protecting layer
(A) Fig. 2.6
