A major limitation of biological therapeutics is their propensity for degradation particularly in aqueous
solutions hence resulting in their short shelf-life. In this study, the stability of trastuzumab (Herceptin®) intravenous (i.v.)
solutions, an IgG1 monoclonal antibody (mAb), indicated for the treatment of HER2 positive breast cancer, stored under
refrigerated conditions, was evaluated over 28 days. No change in visual appearance or average particle size was
observed. The pH values of the trastuzumab i.v. solutions remained stable over time. Interestingly, no change in
trastuzumab monomer concentration was observed throughout the 28-day study, as determined by SEC-HPLC. SDSPAGE
showed only a monomer band corresponding to the molecular weight of trastuzumab. Circular dichroism spectra
obtained following 28-day storage demonstrated integrity of the secondary structural conformation of trastuzumab.
Results from this study show that trastuzumab i.v. solutions remain physically and structurally stable on storage at 2-8°C
for 28 days. These findings suggest that trastuzumab in solution may not be as sensitive to degradation as expected for a
mAb and therefore may have important implications in extending trastuzumab shelf life for clinical use and reducing
associated healthcare cost.
Keywords: Trastuzumab, stability, protein aggregation, SEC, particle size, SDS-PAGE, Circular dichroism
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