Abstract
Background aims
In-process monitoring and control of biomanufacturing workflows remains a significant
challenge in the development, production, and application of cell therapies. New process
analytical technologies must be developed to identify and control the critical process
parameters that govern ex vivo cell growth and differentiation to ensure consistent and predictable safety, efficacy,
and potency of clinical products.
Methods
This study demonstrates a new platform for at-line intracellular analysis of T-cells.
Untargeted mass spectrometry analyses via the platform are correlated to conventional
methods of T-cell assessment.
Results
Spectral markers and metabolic pathways correlated with T-cell activation and differentiation
are detected at early time points via rapid, label-free metabolic measurements from
a minimal number of cells as enabled by the platform. This is achieved while reducing
the analytical time and resources as compared to conventional methods of T-cell assessment.
Conclusions
In addition to opportunities for fundamental insight into the dynamics of T-cell processes,
this work highlights the potential of in-process monitoring and dynamic feedback control
strategies via metabolic modulation to drive T-cell activation, proliferation, and
differentiation throughout biomanufacturing.
Key Words
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Article info
Publication history
Published online: April 13, 2023
Accepted:
March 20,
2023
Received:
December 21,
2022
Publication stage
In Press Corrected ProofIdentification
Copyright
© 2023 International Society for Cell & Gene Therapy. Published by Elsevier Inc. All rights reserved.
