Page 28 - Assurance of Sterility for Sensitive Combination Products and Materials

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

Protecting layer

(A) Fig. 2.6