Resumen

REGALADO-FONSECA, Ivis; MORA-MONTES DE OCA, Osvaldo  y  ZUMALACARREGUI-DE CARDENAS, Lourdes. Application of Principal Component Analysis on dimers formation during a monoclonal antibody's purification. Vaccimonitor [online]. 2020, vol.29, n.3, pp. 109-117.  Epub 01-Dic-2020. ISSN 1025-0298.

Nimotuzumab is produced at the Center of Molecular Immunology (CIM). It is obtained from the culture, fermentation, and purification in the cell line NS0/H7. This product has a high demand both domestically and internationally for the treatment of head and neck cancer. The use of adequate technologies for the large-scale production of this product following good manufacturing practices and reasonable production costs becomes a necessity to introduce this therapeutic antibody in high demand markets with high-quality requirements. The increase in dimers in the final product will affect its quality, which in turn affects the efficiency and effectiveness of the process. Production databases were used to perform principal component analysis using The Unscrambler 10.4 software. The conductivity of the adjusted product, pH at the output product in the protein column and membrane, the mass of supernatant, and of the eluate are detected as the variables with a higher influence on aggregate formation. The Pareto analysis was carried out to determine the critical parameters of the process: pH of elution and adjust buffers, and adjusted products, pH at the exit of protein column and membrane, the mass of protein in the eluate, and in the supernatant, and the conductivity of the adjusted product.

Palabras clave : Monoclonal antibodies; purification; data analysis.

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