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Repackaging anti-VEGF may affect drug's quality profile in intravitreal injection use
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MILAN — A quality assessment of repackaged bevacizumab into plastic syringes for intravitreal administration showed a lack of stability and inconsistent results among samples, according to a study.
"Bevacizumab is repackaged into syringes for intravitreal administration. We cannot exclude that some adverse events reported with bevacizumab might be related to packaging," Winfried Amoaku, MD, said at the Euretina congress.
Winfried Amoaku
The study investigated the quality of repackaged Avastin (bevacizumab, Genentech) obtained from five different outlets in the United Kingdom with special manufacturing licenses. Bevacizumab for intravitreal infusion in the original glass vial was used as the reference compound. The quality and stability of the samples were tested at day 1 and day 14.
"We looked at particle size and distribution. At day 1, the protein and IgG contents were similar between all the syringes and the control. No significant changes occurred by day 14," Amoaku said.
However, there were differences in particle size and density.
"Particle size showed no differences at day 1 between batches, but significant differences were seen at day 14. Density was similar between day 1 and day 14 in the control glass vial, but there were significant differences in particle density at day 1 between all the batches and a significant increase in density was seen in all syringes between day 1 and day 14," Amoaku explained.
Safety issues related to these findings should be further investigated.
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Disclosure: Amoaku has no relevant financial disclosures.