Resumen

MORA-MONTES DE OCA, Osvaldo; ZUMALACARREGUI-DE CARDENAS, Lourdes; REGALADO-FONSECA, Ivis  y  HERNANDEZ-DE LA ROSA, Lourdes. Mathematical model for predicting the formation of aggregates in the purification process of a monoclonal antibody. Vaccimonitor [online]. 2021, vol.30, n.2, pp. 60-68.  Epub 20-Mayo-2021. ISSN 1025-0298.

The use of monoclonal antibodies in the fight against cancer is becoming more and more the selected therapy. The introduction of monoclonal antibodies highly demanded in international markets, with high quality requirements needs the production of monoclonal antibodies on a large scale. The increase of dimers in the final product affects its quality, therefore, the efficiency and effectiveness of the process. The objective of this work was to obtain a mathematical model to relate the percentage of dimers with the most influential operating variables. A multiple linear regression model was obtained using Statgraphics Centurion XVII version 17.2.00 software. The model was validated with new production data with a mean error of validation below 20%. The significant variables were: supernatant IgG mass; IgG mass in the effluent from Protein A capture column; pH of the effluent from Protein A capture column; pH of the adjusted product and conductivity of the effluent from anionic exchange membrane. A working interval for each of the influential variables were established, in order to reduce dimers below 3%.

Palabras clave : monoclonal antibodies; purification; data analysis; mathematical model.

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