Long-Term physical stability, sterility, and anti-vegf bioactivity of repackaged bevacizumab in 2-ml glass vials

Jan S. Peterson, Kenneth Rockwell, Ingrid U. Scott, Michael S. Ip, Paul C. Vanveldhuisen, Barbara A. Blodi

Research output: Contribution to journalArticle

2 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1802-1809
Number of pages8
JournalRetina
Volume39
Issue number9
DOIs
StatePublished - Sep 1 2019

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All Science Journal Classification (ASJC) codes

  • Ophthalmology

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