Impurity analysis of Rituximab and its biosimilar
2018
Objective
To analyze product- and process-related impurities in original Rituximab and its biosimilar.
Methods
Product-related impurities in Rituximab and its biosimilar were analyzed using size-exclusion high-performance liquid chromatography (SE-HPLC), capillary electrophoresis, and ion-exchange high-performance liquid chromatography (IEX-HPLC). Purity and biological activity of biosimilar charge variants were further determined. Process-related impurities in Rituximab and its biosimilar were analyzed using ELISA and quantitative PCR.
Results
In SE-HPLC analysis, the antibody monomers in original Rituximab and its biosimilar were 98.9% and 99.9%, and polymers were 1.0% and 0.1%, respectively. The capillary electrophoresis showed that low molecular weight impurities were 5.6% in Rituximab and 3.3% in biosimilar, while non-glycosylated heavy chains were 0.6% in both. In IEX-HPLC analysis, acidic and basic peaks were 21.0% and 10.0% for Rituximab, and 17.7% and 9.1% for biosimilar. The main peak fraction of biosimilar had higher purity and complement-dependent cytotoxicity than both acidic and basic peak fractions. The residual quantities of host cell protein and DNA, and of protein A were similar in Rituximab and its biosimilar, mostly below detection limits.
Conclusion
Original Rituximab and its biosimilar have similar category and level of product- and process-related impurities.
Key words:
Antibodies, monoclonal; Biosimilar pharmaceuticals; Drug contamination; Impurity analysis
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