Institute of Cellular Medicine, Newcastle University, Newcastle Upon Tyne, UK.
Eye (Lond). 2013 Sep;27(9):1090-7. doi: 10.1038/eye.2013.139. Epub 2013 Jun 21.
To compare the quality and stability of unlicensed, repackaged bevacizumab intended for intravitreal injection, as provided by five licensed compounding pharmacies in the United Kingdom, with bevacizumab in its original glass vial.
Repackaged bevacizumab was obtained from five UK suppliers. Samples were analyzed at two time points (day 1 and day 14). Microflow imaging was performed to evaluate subvisible particle size, particle density, and particle size distribution. Protein concentration, immunoglobulin G (IgG) content, and molecular weight were also determined.
A significant difference in subvisible particle density was observed between bevacizumab batches from the five suppliers on day 1 (P<0.001). An increase in subvisible particle density was observed between day 1 and 14 for repackaged bevacizumab from all suppliers (all P<0.05), but not the reference compound. Protein concentration, IgG content, and molecular weight were comparable between batches from each supplier and the reference bevacizumab.
The study results indicate that the quality of bevacizumab repackaged into prefilled plastic syringes is variable among the different compounding pharmacies in the United Kingdom. Furthermore, particle density may increase with storage in repackaged syringes. It is noteworthy that particle size distribution in both the repackaged and reference bevacizumab fell outside of the range specified by the United States Pharmacopeia for injectable ophthalmic solutions. These data highlight the need for further research into the use of unlicensed, repackaged bevacizumab intended for intravitreal injection.
比较 5 家英国持牌调配药厂提供的未经许可、重新包装的贝伐单抗（用于玻璃小瓶）与原始玻璃小瓶贝伐单抗的质量和稳定性。
从 5 家英国供应商处获得重新包装的贝伐单抗。在两个时间点（第 1 天和第 14 天）进行分析。采用微流成像技术评估亚可见颗粒的粒径、颗粒密度和粒径分布。还测定了蛋白浓度、免疫球蛋白 G（IgG）含量和分子量。
在第 1 天，5 家供应商的贝伐单抗批次之间的亚可见颗粒密度存在显著差异（P<0.001）。所有供应商的重新包装贝伐单抗在第 1 天到第 14 天之间观察到亚可见颗粒密度增加（均 P<0.05），但参考化合物则没有。各供应商的批次与参考贝伐单抗之间的蛋白浓度、IgG 含量和分子量相当。
研究结果表明，英国不同调配药厂重新包装的贝伐单抗质量存在差异。此外，在重新包装的注射器中储存时，颗粒密度可能会增加。值得注意的是，重新包装和参考贝伐单抗的粒径分布均超出美国药典规定的可注射眼用溶液范围。这些数据突出表明需要进一步研究未经许可、重新包装的贝伐单抗（用于玻璃小瓶）用于玻璃小瓶的眼部注射的使用。
