Abstract

GOZA-LEON, Osvaldo; FERNANDEZ-AGUILA, Marí; RODRIGUEZ-GARCEL, Rosa Haydee  and  OJITO-MAGAZ, Eduardo. Application of Principal Component Analysis in the purification process of a biopharmaceutical. Vaccimonitor [online]. 2020, vol.29, n.1, pp. 5-13.  Epub Apr 01, 2020. ISSN 1025-0298.

This paper presents the application of the Principal Component Analysis, using the program THE UNSCRAMBLER version 8.0, to the data recorded during two years in the purification stage of a Recombinant Human Erythropoietin plant that is based on several chromatographic steps, similar to the purification process of recombinant proteins that are used as preventive or therapeutic vaccines. Dimensionality was reduced by obtaining two main components that explain 81% of the variance of 18 original variables related to four chromatographic steps. As a result, it was possible to define which variables have the greatest contribution to the variability of the process in the purification stage, allowing to extract useful information to achieve a greater understanding of the process and enrich the control strategies in the plant. These results corroborated practical experiences of plant specialists and allowed for recommendations to be considered in the continuous verification plan of the process, such as proposing three variables as process controls and taking into account that the performance of the second step is the most influential of the performances considered in the variability.

Keywords : biological products; chromatography; Principal Component Analysis.

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