Agilent - Breakthroughs in Immunotherapy- 2019 - 16

Breakthroughs in Immunotherapy

When designing a potency assay for cell therapy manufacturing, the
first step is to define potency in the context of the specific therapy.
"Keep it simple. Often, fancy ideas about a potency assay can be
almost impossible to establish in a reproducible and reliable fashion,"
states Mark Lowdell, Ph.D., director of Centre for Cell, Gene & Tissue
Therapeutics, Royal Free Hospital, professor of Cell & Tissue Therapy,
University College London.
"In the context of manufacturing, maintaining a balance between
mimicking the human disease, complexity, and cost is critical," adds
Krishnendu Roy, Ph.D., director, Center for ImmunoEngineering, Georgia
Institute of Technology.
Currently, a potency assay for CAR-T cells could simply measure the
expression of the desired CAR on the cell surface. However, it should
be noted that this does not directly measure function; and there is no
proof that the tumor cells expressing the relevant antigen for the CAR
will be killed. If the projected activity in vivo is not taken into account,
this type of potency may not be sufficiently predictive.
In a UK clinical trial Dr. Lowdell is involved with, a bank of allogeneic
mesenchymal stromal cells (MSCs) is being transduced to express
tumour necrosis factor (TNF)-related apoptosis inducing ligand (TRAIL).
Engineered MSCs expressing TRAIL may be used as an efficient form of
cell therapy due to the MSC's non-immunogenic nature and ability to infiltrate the tumor microenvironment. To meet quality control standards, the
product is tested based on the proportion of cells that express TRAIL and
by the amount of TRAIL expressed by the positive cells.
16

| GENengnews.com

"In the context of
manufacturing,
maintaining a
balance between
mimicking the
human disease,
complexity, and cost
is critical."
Krishnendu Roy, Ph.D., director,
Center for ImmunoEngineering,
Georgia Institute of Technology.

http://www.GENengnews.com

Agilent - Breakthroughs in Immunotherapy- 2019

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