LONG-TERM PHYSICAL STABILITY, STERILITY, AND ANTI-VEGF BIOACTIVITY OF REPACKAGED BEVACIZUMAB IN 2-ML GLASS VIALS
| Autor: | Michael S Ip, Jan S. Peterson, Kenneth Rockwell, Ingrid U. Scott, Paul C. VanVeldhuisen, Barbara A Blodi |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
Vascular Endothelial Growth Factor A
medicine.medical_specialty Bevacizumab Sterility Drug Storage Angiogenesis Inhibitors Shelf life Vial Article Drug Stability Medicine Humans Drug packaging Drug Packaging Anti vegf business.industry Syringes General Medicine Surgery Ophthalmology Infertility Intravitreal Injections Physical stability Glass business Ophthalmic use medicine.drug |
| Zdroj: | Retina |
| ISSN: | 1539-2864 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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