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ACTA Pharmaceutica Sciencia 2024 , Vol 62 , Num 2
Study of formulation effects on the charge variant profile of antibody-maytansine conjugates by icIEF method
1 Department of Medicinal Chemistry and Quality Control, Faculty of Pharmacy, Tishreen University, Lattakia, Syria
DOI : 10.23893/1307-2080.APS6219 A whole-column imaging-detection capillary isoelectric focusing method (icIEF) was used to study the effects of formulation and thermal stability on the charge variant profile of maytansinoid antibody conjugates. The unconjugated monoclonal antibody showed a narrow pI range (8.9-9.0), while its conjugates to maytansine derivative had more acidic charge variants )pI values: 7.6 to 9.0(. Four formulation prototypes at acidic pH (5.5) were studied. The presence of acetate and citrate in the formulation of maytansine antibody conjugate led to more heterogeneous charge variant profiles and to a shift to acidic isoforms as a result of amidation of amine groups of N-terminus of the light and heavy chains of the antibody. After forced thermal stress conditions (one month at 40°C), slight modifications in the charge variant profiles of maytansinoid antibody conjugates were observed in the four formulation prototypes compared to the control sample (-80°C), indicating no protein degradation by deamidation. Keywords : antibody, conjugate, charge variant, pI, icIEF

Istanbul Medipol University