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

Divisions of Immunobiology and Informatics National Institute for Biological Standards and Control, Hertfordshire, UK

Rose Gaines-Gas

Divisions of Immunobiology and Informatics National Institute for Biological Standards and Control, Hertfordshire, UK

Robin Thorpe

Divisions of Immunobiology and Informatics National Institute for Biological Standards and Control, Hertfordshire, UK

Anthony Richard Mire-Sluis

Divisions of Immunobiology and Informatics National Institute for Biological Standards and Control, Hertfordshire, UK

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.

Key Words: Infusion device • chemotherapy; cytokine • G-CSF • granulocyte colony stimulating factor • lenograstim.

Journal of Oncology Pharmacy Practice, Vol. 2, No. 2, 107-112 (1996)
DOI: 10.1177/107815529600200203


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