Development of an analytical platform for PAT monitoring of an etanercept bioprocess through an intedrated chemometric modelling approach

CHIAPPINI, FABRICIO A.; ALCARAZ, MIRTA; AZCARATE, SILVANA M.; TEGLIA, CARLA; FORNO, GUILLERMINA; GOICOECHEA, HECTOR

Lisboa

Congreso; 27 th ESACT Meeting European Society for Animal Cell Technology; 2022

Background and novelty: Process Analytical Technology (PAT) constitutes a methodological framework promoted by Food and Drug Administration (FDA) that encourages pharma industry to implement highperformance analytical techniques, increasing the efficiency in process design, monitoring and control. In PAT development, chemometrics plays a fundamental role for biochemical data modelling. In this work, a mammalian cell-based bioprocess for etanercept production was studied, focusing on two main issues. Firstly, at the end of the fermentation step, the cell culture experiments an unpredictable drop in cell viability. Hence, the assessment of this variable through cell counting may not provide information sufficiently in advance to take corrective actions. Secondly, as the product concentration is monitored through an off-line univariate chromatographic method (HPLC), a considerable delay usually occurs between sampling and results. The purpose of this investigation was to develop a PAT platform for the at-line monitoring of cell viability and etanercept concentration.