Protection During Sterilization

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

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The SPS protected lyophilized rhThrombin demonstrates an enzyme activity comparable to the control group after stressing with β-irradiation (E-beam).

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.

Protein activity of IgG and IgM antibodies, enzymes like DNase, BMP-2, cytokines like IL-8 was significantly decreased by -irradiation (E-beam) with 25 kGy, but maintained if proteins were SPS protected.

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.