Source: Annales Pharmaceutiques Francaises
Area: Evidence > Medicines Management > References
Introduction: The anti-angiogenic monoclonal antibody, bevacizumab, is currently used by intravitreal administration as an off-label drug to treat age-related macular degeneration or other ophthalmological diseases. For this purpose, commercial bevacizumab is repackaged in 1mL polypropylene syringes under sterile conditions. However, no complete study on the stability of this hospital-based preparation is available.
Methods: Commercial bevacizumab (25 mg/mL; Avastin) was aseptically repackaged in 1 mL polypropylene syringes, stored at 4C, and analysed on the day of preparation (D0), and after 30 days (D30) and 90 days (D90). Some syringes were kept for up to 8 months to observe possible instability. Several complementary and stability-indicating analytical methods were used to assess in detail the primary, secondary and tertiary structure of the antibody during storage: ionic chromatography, size-exclusion chromatography, peptide mapping, 2nd ...
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