Agilent - Breakthroughs in Immunotherapy- 2019 - 18

Breakthroughs in Immunotherapy

The Role of Real-Time Cell-Based In Vitro Assays
The cell therapy manufacturing process can be quite long, ranging from
several days to weeks. "Changes in cell behavior and phenotype can happen
during the process," says Dr. Roy. "Real-time assays would be very beneficial
to generate continuous feedback during that process, which would help us
verify the quality of the batch and reduce manufacturing costs."
In the R&D phase, real-time feedback is critical to understand the cell
properties that are predictive of functional potency. The real-time
measurement of these quality attributes would then ensure the production
of highly potent cells.
Researchers are still working to define which quality attributes need to be
measured to predict potency. "Some engineered cells are compared to the
wild type to make sure the desired changes took place. For CAR-T cells,
the cell's viability, surface markers, and cell killing activity are measured
to evaluate the end product. But this set of measurements does not really
indicate that these cells are going to be effective in this particular patient,"
continues Dr. Roy.
The xCELLigence Real Time Cell Analysis (RTCA) instrument by Agilent
Technologies allows for longer duration real-time assays. Real-time assays
can more accurately evaluate the biology, efficacy or potency of the product,
especially when the cell activity can be monitored over many hours or days
with multiple readouts. While endpoint assays provide valuable information,
they may fail to predict activity in vivo if the cells kill later than the measurement time.
Additionally, killing assays with high background noise may fail to identify
robust candidates for cell therapy. With the highly sensitive xCELLigence
18

| GENengnews.com

"Keep it simple. Often,
fancy ideas about a
potency assay can
be almost impossible
to establish in a
reproducible and
reliable fashion."
Mark Lowdell, Ph.D., director of Centre for
Cell, Gene & Tissue Therapeutics, Royal
Free Hospital, professor of Cell & Tissue
Therapy, University College London.

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Agilent - Breakthroughs in Immunotherapy- 2019

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