An evaluation of the stability of granulocyte colony stimulating factor on short-term storage and delivery from an elastomeric infusion system

Aim. To evaluate the stability of granulocyte col ony stimulating factor (G-CSF) (lenograstim) on the 14-day storage and delivery from an elastomeric infusion system (infusion device).

Methods. Infusion devices were filled with two different concentrations of G-CSF and stored for various times at 4°C under sterile conditions. Samples of G-CSF solution were then released through the infusion device and bioassayed on the G-CSF dependent murine cell line G-NFS-60.

Results. There was no statistically significant loss of bioactivity of G-CSF throughout storage and delivery from the devices for the maximum 14-day period tested at either concentration of G-CSF.

Conclusion. The devices can be filled with G-CSF and stored at 4°C for up to 14 days under sterile conditions without loss of biological activ ity, suggesting that these devices are compatible with this biological material and suitable for its short-term storage.