July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Compounding and storage of aflibercept in prefilled syringes does not affect protein structure or VEGF binding
activity
Author Affiliations & Notes
  • Magne Sivertsen
    Department of Ophthalmology, Oslo University Hospital, University of Oslo, Oslo, Oslo, Norway
  • Øystein Kalsnes Jørstad
    Department of Ophthalmology, Oslo University Hospital, University of Oslo, Oslo, Oslo, Norway
  • Algirdas Grevys
    Centre for Immune Regulation and Department of Immunology, Oslo University Hospital, University of Oslo, Oslo, Oslo, Norway
  • Stian Foss
    Centre for Immune Regulation and Department of Immunology, Oslo University Hospital, University of Oslo, Oslo, Oslo, Norway
  • Jan Terje Andersen
    Centre for Immune Regulation and Department of Immunology, Oslo University Hospital, University of Oslo, Oslo, Oslo, Norway
  • Morten C. Moe
    Department of Ophthalmology, Oslo University Hospital, University of Oslo, Oslo, Oslo, Norway
  • Footnotes
    Commercial Relationships   Magne Sivertsen, None; Øystein Jørstad, Alcon (F), Allergan (F), Bayer (F), Novartis (F); Algirdas Grevys, None; Stian Foss, None; Jan Terje Andersen, None; Morten Moe, Bayer (F), Novartis (F)
  • Footnotes
    Support  The work is supported by innovation grants from the South-Eastern Norway Regional Health Authority. J.T.A. was in part supported by the Research Council of Norway through its Centres of Excellence funding scheme (project number 17573) and the Research Council of Norway (Grant no. 230526/F20 and 17573/V40). S.F. was supported by the Research Council of Norway (251037/F20)
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 1441. doi:
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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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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : The use of anti-VEGF drugs places an economic burden on the health care system; the drugs are
expensive, and repeated injections are usually required to maintain the therapeutic effect. Thus, there is an unmet
need 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.

Methods : Aflibercept was acquired commercially (Eylea®). Prefilled injection syringes for intravitreal injections were
produced 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 VEGF
binding properties were investigated using nanodrop, SDS-PAGE, size exclusion chromatography (SEC), ELISA and
surface plasmon resonance (SPR).

Results : There were no statistically significant differences in concentrations of aflibercept between samples collected
at D0, D7 and D28 (n=6). The aflibercept behaved identically in protein integrity analyses and VEGF binding activity
was indistinguishable for D7 and D28 samples compared to D0 samples and thus was unaffected by storage.

Conclusions : Aflibercept can be compounded into prefilled sterile syringes and stored for up to 4 weeks without
compromising quality, stability or functional properties, including VEGF binding activity and thus should retain
unaltered 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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