Background Cetuximab (CTX) (Erbitux) is a chimeric mouse-human monoclonal antibody IgG1 targeting epidermal growth factor receptor (EGFR). It is approved for use as treatment for metastatic colorectal cancer and squamous cell carcinoma of the head and neck.
Purpose To access the stability of CTX during storage (in dark glass bottles at 4°C refrigerated and at −20°C (frozen) once the single-dose vial (5 mg/mL) had been opened and when diluted (2 mg/mL in saline solution) in the centralised preparation unit.
Material and methods Methods were developed for this purpose and ICH validated (to indicate stability: in addition to calibration, precision, accuracy, etc., stress studies were also conducted) for assessing the physicochemical and the biological stability: ELISA (to test biological activity), (RP)HPLC-DAD (to quantify), (CX)HPLC-DAD (to obtain isoforms profile), (SEC)HPLC-DAD (to detect aggregates) and ESI-qTOF-MS (to assay changes in the molecular weight).
Results The decrease of biological activity was only 5% 24 h after the vial had been opened (5 mg/mL), rising to 14% at day 3, 20% after a week, with a final decrease of 85% for the last day we checked (30 days). The overall quantity of CTX was unchanged for the month assessed. No formation of aggregates was detected in the two weeks tested. Changes in the chromatographic isoforms profile (2 mg/mL) were detected after a week, with significant variations in the isoforms from week 2 up to the end of the study (two months). Molecular weight indicated no major changes in the CTX structure (one month).
Conclusion Both the physicochemical and the biological properties assessed indicated good stability of CTX within 24 h after the vial had been opened. There was not even an important decrease in the biological activity a week after the opening of the medicine (20% decrease) with unchanged physicochemical properties for six days.
References and/or acknowledgements Financial support: PI10/00201 (MICINN, Government of Spain).
No conflict of interest.
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