Protection during sterilization
- SPS® protect the molecular structure and functionality even of complex proteins
- SPS® effectively protect different proteins and biologics during sterilization with β- or γ-irradiation or ethylene oxide (EtO)
LEUKOCARE’s SPS® technologies protect biologics to allow for terminal sterilization of your products
Recombinant human Thrombin (rhThrombin, developed by Scil Proteins GmbH) was lyophilized using a reference formulation, a sugar based and an SPS® based formulation.
The three sample formulations were stressed by β-irradiation (E-beam) with 15 kGy or 25 kGy followed by accelerated aging with a temperature of 45°C.
After stressing with β-irradiation (E-beam) and temperature only the SPS® protected lyophilized rhThrombin demonstrated an enzyme activity comparable to the control group.
A broad range of proteins and peptides with different molecular weights can be successfully protected by SPS® during sterilization.
Protein activity of IgG and IgM antibodies, enzymes like DNase, BMP-2, cytokines like IL-8 was significantly decreased by β-irradiation (E-beam) with 25 kGy, but maintained if proteins were SPS® protected.