Quantitative analysis of monoclonal antibodies by cation-exchange chromatofocusing.
A robust cation-exchange chromatofocusing method was developed for the routine analysis of a recombinant humanized monoclonal IgG antibody. We compare the chromatofocusing method to the conventional cation-exchange chromatography (CEX) employing a salt gradient and show clear advantages of chromatofocusing over CEX. We demonstrate the suitability of the present chromatofocusing method for its intended purpose by testing the validation characteristics. To our knowledge, this is the first chromatofocusing method developed for the routine analysis of monoclonal antibody charge species.
Rozhkova
Anna
A
Solvias AG, Analytics Klybeck, 4002 Basle, Switzerland. anna.rozhkova@solvias.com
D000911:Antibodies, Monoclonal / Q000032:analysis* / Q000302:isolation & purification; D043424:Carboxypeptidase B / Q000737:chemistry; D002412:Cations / Q000737:chemistry; D002852:Chromatography, Ion Exchange / Q000379:methods*; D004355:Drug Stability; D006801:Humans; D007074:Immunoglobulin G / Q000032:analysis; D016014:Linear Models; D018892:Proton-Motive Force; D011994:Recombinant Proteins / Q000032:analysis* / Q000302:isolation & purification; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012965:Sodium Chloride / Q000737:chemistry
D000911:Antibodies, Monoclonal; D002412:Cations; D007074:Immunoglobulin G; D011994:Recombinant Proteins; D012965:Sodium Chloride; D043424:Carboxypeptidase B