首页|Quantifying methionine sulfoxide in therapeutic protein formulation excipients as sensitive oxidation marker
Quantifying methionine sulfoxide in therapeutic protein formulation excipients as sensitive oxidation marker
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NSTL
Elsevier
Methionine is a common excipient used in therapeutic protein liquid formulations as stabilizer and antioxidant. The oxidation of methionine to methionine sulfoxide can be regarded as a sensitive marker of oxidative stress for drug product storage conditions. In this study, a sensitive HPLC method for the quantification of methionine sulfoxide in formulated protein product was developed and qualified according to regulatory requirements using a SIELC (R) Primesep 100 column with UV detection. The separation involves a mixed-mode mechanism including reversed phase and cationic exchange modalities. The operating range of the method was established between 1 mu M and 35 mu M of methionine sulfoxide. In this testing range, the method was shown to be linear (R-2 > 0.99), accurate (Recovery 92.9 - 103.6%, average recovery = 99.8 +/- 1.4%) and precise (intermediate precision at LoQ, CV = 2.9%). The developed test system was successfully applied to study the effects of temperature and storage conditions on methionine sulfoxide formation in complex therapeutic antibody formulations.
NSTL
Elsevier
