The cell therapy field has undergone rapid expansion in the last decade, driven by numerous accomplishments in chimeric antigen receptor (CAR) T-cell therapies for lymphomas and leukemias.
The research and development of these life-saving treatments begins with starting material obtained from a healthy donor: a source for peripheral blood mononuclear cells (PBMCs).
Starting material cell populations can be homogenous—like isolated immune cell subsets or apheresis products—or heterogenous—such as leukocyte reduction system (LRS) cones, whole blood, or plasma-suspended buffy coats.
Heterogenous cell populations pose the risk of red blood cell (RBC) contamination, which can adversely impact downstream cell cultures.
While the initial cost of this heterogeneous starting material is typically lower than its purified counterparts, are these upfront savings maintained throughout the research and development process?
Sources of contamination
RBC contamination can arise from various sources. For example, manual isolation of the PBMC layer from whole blood employing density gradient media necessitates a deft operator, completely trained with established standard operating procedures (SOPs). However, differences in the patient initial material may still produce a thin PBMC layer, potentially elevating the risk of contamination.
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Even partially fractionated sources of PBMCs, like LRS cones, have demonstrated significant RBC contamination (often as many as 6x1010 RBCs per cone).
Further methods, such as RBC lysis buffers and washing steps, can minimize the risk of contamination from heterogeneous starting materials. However, these techniques add to the total labor and reagent costs.
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