Process Analytical Technology (PAT) provides a holistic system for measuring, monitoring and controlling key process parameters in a timely manner. PAT is part of the QBD methodology which provides a science based approach for process control of critical quality and performance attributes.<br/>Optical sensors have potential applications in PAT. For example, it has been suggested that these sensors may be used for continuous monitoring of cell density, certain metabolites, and mAb titer in mammalian perfusion cell culture operation. If proven, UV-vis spectral measurements in conjunction with multivariate analysis offer an attractive alternative to existing techniques, e.g. IR and RAMAN.<br/> <br/>In this presentation we provide an early evaluation of the SoloVPE (C-Tech) in conjunction with a Cary 60 UV-vis (Agilent technologies), a spectral instrument setup with multiple path length scanning.  The initial analysis of data however was not predictive of mAb titer. Follow up examination of samples of a Protein A column validated the multivariate analysis and model techniques for data analysis suggesting that likely the lack of correlation between spectral data and mAb titer was due the complex nature of the permeate from the bioreactor.  We hypothesized that the presence of media components, host cell proteins and other species likely interfered with spectral measurement.<br/>

Examination of multivariate model generation using UV-vis spectral data for mAb titer

251st National Meeting (2016)

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