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Magne Sivertsen, Øystein Kalsnes Jørstad, Algirdas Grevys, Stian Foss, Jan Terje Andersen, Morten C. Moe; Compounding and storage of aflibercept in prefilled syringes does not affect protein structure or VEGF binding activity. Invest. Ophthalmol. Vis. Sci. 2018;59(9):1441.
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The use of anti-VEGF drugs places an economic burden on the health care system; the drugs areexpensive, and repeated injections are usually required to maintain the therapeutic effect. Thus, there is an unmetneed for more cost-effective procedures. In the present study we evaluated whether the most recently approved anti-VEGF drug, aflibercept, can be compounded and stored in prefilled sterile syringes without compromising its quality,stability or functional properties.
Aflibercept was acquired commercially (Eylea®). Prefilled injection syringes for intravitreal injections wereproduced under standard conditions at the hospital pharmacy and followed validated aseptic production procedures.The syringes were stored under dark conditions at 4°C for 0, 7 or 28 days. Structural integrity, stability and VEGFbinding properties were investigated using nanodrop, SDS-PAGE, size exclusion chromatography (SEC), ELISA andsurface plasmon resonance (SPR).
There were no statistically significant differences in concentrations of aflibercept between samples collectedat D0, D7 and D28 (n=6). The aflibercept behaved identically in protein integrity analyses and VEGF binding activitywas indistinguishable for D7 and D28 samples compared to D0 samples and thus was unaffected by storage.
Aflibercept can be compounded into prefilled sterile syringes and stored for up to 4 weeks withoutcompromising quality, stability or functional properties, including VEGF binding activity and thus should retainunaltered clinical efficacy.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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