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Lower IgG concentration, higher presence of high-molecular-weight aggregates found in some anti-VEGF doses
Retina. 2010;30(6):887-892.
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Significant differences in immunoglobulin G concentration in repackaged doses of bevacizumab syringes may contribute to elevated IOP that mimics glaucomatous changes, according to a study.
Researchers ran enzyme-linked immunosorbent assay, size exclusion chromatography and polyacrylamide gel electrophoresis to analyze Avastin (bevacizumab, Genentech) syringes obtained from three separate compounding pharmacies, as well as bevacizumab from the original vial.
Although all syringes tested contained similar amounts of proteins, syringes from two of three pharmacies had significantly less functional immunoglobulin G (IgG) in the solution, the study authors noted. As well, some samples contained high levels of high-molecular-weight particulates, as much as 10-fold higher than samples from the original vial.
It is unclear, the researchers said, how diminished IgG concentration may affect efficacy or safety of intravitreously delivered doses. The presence of high-molecular-weight aggregates may also warrant further investigation.
"A trend exists for an increase in micron-sized protein aggregates with the decrease in IgG concentration," the authors said. "The presence of protein aggregates and a high number of large molecules in some syringes of bevacizumab obtained from [compounding pharmacies], not seen in samples taken directly from original vials, could potentially lead to obstruction of the outflow pathways."
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