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Published on: March 8, 2018
High-molecular-weight aggregates in repackaged bevacizumab.
Malik Y Kahook1, Lu Liu, Philip Ruzycki
1Department of Ophthalmology, Rocky Mountain Lions Eye Institute, University of Colorado Denver, Aurora, Colorado 80045, USA. malik.kahook@gmail.com
Retina (Philadelphia, Pa.)
|May 12, 2010
Summary
Repackaged bevacizumab syringes from compounding pharmacies showed decreased functional immunoglobulin (IgG) and increased protein aggregates. This particulate matter may cause elevated intraocular pressure in patients with ocular neovascular diseases.
Area of Science:
- Ophthalmology
- Biochemistry
- Pharmaceutical Science
Background:
- Antivascular endothelial growth factor (VEGF) agents like ranibizumab and bevacizumab are crucial for treating ocular neovascular diseases.
- Recent reports suggest a link between these agents and sustained intraocular pressure elevation.
Purpose of the Study:
- To investigate if high-molecular-weight aggregates in repackaged bevacizumab syringes contribute to elevated intraocular pressure.
- To analyze the composition and particulate matter in bevacizumab samples from compounding pharmacies.
Main Methods:
- Enzyme-linked immunosorbent assay (ELISA) and size exclusion chromatography were used to assess protein concentration and aggregation.
- Polyacrylamide gel electrophoresis (PAGE) analyzed immunoglobulin (IgG) heavy and light chains.
- Microflow imaging quantified particulate matter in bevacizumab samples.
Main Results:
- All syringes had similar total protein content, but some compounding pharmacies showed significantly lower functional IgG.
- Batches with reduced IgG (approx. 50%) exhibited a 10-fold increase in micron-sized particulate matter.
- Protein aggregates were observed to increase as IgG concentration decreased.
Conclusions:
- Significant variations in IgG concentration exist in repackaged bevacizumab syringes.
- Increased micron-sized protein aggregates correlate with decreased IgG levels.
- Particulate matter in some samples may obstruct aqueous outflow, potentially causing elevated intraocular pressure.
