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

Lifu Xiao; Sagar Shelake; Maria Ozerova; Karin M Balss; Ketan Amin; Amos Tsai

doi:10.1016/j.xphs.2021.08.005

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

J Pharm Sci. 2021 Dec;110(12):3786-3793. doi: 10.1016/j.xphs.2021.08.005. Epub 2021 Aug 6.

Authors

Lifu Xiao¹, Sagar Shelake², Maria Ozerova², Karin M Balss³, Ketan Amin², Amos Tsai²

Affiliations

¹ Large Molecule Drug Product Development, Biotherapeutics Development, Janssen Research & Development LLC, Spring House, PA 19477, USA. Electronic address: [email protected].
² Large Molecule Drug Product Development, Biotherapeutics Development, Janssen Research & Development LLC, Spring House, PA 19477, USA.
³ Advanced Technology Center of Excellence, Janssen Supply Chain, Spring House, PA 19477, USA.

PMID: 34364901
DOI: 10.1016/j.xphs.2021.08.005

Abstract

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.

Keywords: Apoptosis markers; Cell therapy; Cryopreservation; Drug product characterization; Flow cytometry; Raman spectroscopy.

MeSH terms

Apoptosis
Cell Death
Cell- and Tissue-Based Therapy
Pharmaceutical Preparations*
Pilot Projects
Spectrum Analysis, Raman* / methods
T-Lymphocytes

Substances

Pharmaceutical Preparations