Barbara Blodi // Publications // Sep 01 2019

PubMed ID: 29746405

Author(s): Peterson JS, Rockwell K Jr, Scott IU, Ip MS, VanVeldhuisen PC, Blodi BA; SCORE2 Investigator Group. Long-term physical stability, sterility, and anti-VEGF bioactivity of repackaged bevacizumab in 2-ml glass vials. Retina. 2019 Sep;39(9):1802-1809. doi: 10.1097/IAE.0000000000002212. PMID 29746405

Journal: Retina (Philadelphia, Pa.), Volume 39, Issue 9, Sep 2019

PURPOSE Repackaged bevacizumab in single-dose, prefilled syringes for intravitreal injection is available, but with shelf life limited from 60 days to 90 days. For the Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2), 2-mL sterile glass vials were used rather than prefilled syringes to provide a longer shelf life for study supplies.

METHODS Repackaged bevacizumab in glass vials was tested at release and, for 1 lot, after 1, 3, 6, and 12 months for physical stability, including concentration, purity and appearance, and for sterility and endotoxins. Vials from 2 lots were tested at release and after 20 months and 21 months, respectively. One lot was tested at 21 months for anti-VEGF bioactivity compared with a fresh supply of commercial bevacizumab.

RESULTS Repackaged bevacizumab in 2-mL glass vials continued to meet all quality release specifications and remain sterile for up to 21 months. In addition, no degradation in anti-VEGF bioactivity was observed at 21 months compared with a fresh bevacizumab control.

CONCLUSION Bevacizumab can be repackaged into small, single-dose glass vials for intravitreal injection and the qualities of the commercial product maintained, including anti-VEGF bioactivity, for up to 21 months in refrigerated storage. Consideration should be given to repackaging bevacizumab for ophthalmic use in small glass vials as opposed to plastic syringes.