Spectral Markers for T Cell Death and Apoptosis-A Pilot Study on Cell Therapy Drug Product Characterization Using Raman Spectroscopy.

J Pharm Sci

Large Molecule Drug Product Development, Biotherapeutics Development, Janssen Research & Development LLC, Spring House, PA 19477, USA.

Published: December 2021

Application of Raman spectroscopy as a T cell characterization tool supporting cell therapy drug product development has been evaluated. Statistically significant correlations between a set of Raman signals and established flow cytometry markers associated with apoptosis of T cells detected during drug product cryopreservation are presented in this study. Our study results demonstrate the potential of Raman spectroscopy for label-free measurements of T cell characteristics relevant to cell therapy product design and process control.

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http://dx.doi.org/10.1016/j.xphs.2021.08.005DOI Listing

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