Flow cytometric assays for identity, safety and potency of cellular therapies

Cellular therapeutics are a fast‐growing, highly innovative area of medicine. This field encompasses well‐established immune therapies for infection and cancer, as well as newer cell therapies aimed at regenerating diseased tissue. Flow cytometry is arguably the most important tool in the developmen...

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Bibliographic Details
Published in:Cytometry. Part B, Clinical cytometry Clinical cytometry, 2018-09, Vol.94 (5), p.725-735
Main Authors: Campbell, John D.M., Fraser, Alasdair R.
Format: Article
Language:English
Subjects:
Assaying
Cancer
Cell culture
Cell therapy
Cellular manufacture
cellular therapy
Drug development
Flow cytometry
good manufacturing practice
Lymphocytes
Lymphocytes T
manufacturing
Medical innovations
Monocytes
phenotype
potency
Quality control
Raw materials
release criteria
sequential gating
Viability
vital dyes
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Summary:Cellular therapeutics are a fast‐growing, highly innovative area of medicine. This field encompasses well‐established immune therapies for infection and cancer, as well as newer cell therapies aimed at regenerating diseased tissue. Flow cytometry is arguably the most important tool in the development of advanced cellular therapeutics and plays a role in many aspects of manufacturing. Quality control of raw materials, assessing rates of cellular growth during complex in vitro culture processes, differentiation status, as well as final product characterization, viability, and product stability are all essential data to be collected and documented. This requires robust and validated flow cytometric analysis. In this review, we discuss flow cytometer set up; design and use of assays to maintain quality control in cell processing, and the building of a robust set of release criteria. The use of flow cytometric assays as surrogates of functional assays to allow comparison and release of cellular products for clinical use are reviewed with reference to monocyte‐derived and T cell products.
ISSN:1552-4949
1552-4957
DOI:10.1002/cyto.b.21735