Long-Term Physical Stability, Sterility, and Anti-VEGF Bioactivity of Repackaged Bevacizumab in 2-ML Glass Vials

Publication Type
Journal Article
Year of Publication
2018
Authors
Peterson, Jan S; Rockwell, Kenneth; Scott, Ingrid U; Ip, Michael S; VanVeldhuisen, Paul C; Blodi, Barbara A; The SCORE2 Investigator Group
Secondary
Retina
Date Published
2018 May 09
Keywords
glass vials; intravitreal injection; Repackaged bevacizumab; SCORE2; Study of COmparative Treatments for REtinal Vein Occlusion 2
Abstract

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.