Evidence map›Paper›PMID 42180585›Full record

ArticleInternational journal of pharmaceutics: X2026

A versatile and GMP-compliant bead-based IFN-γ potency assay for standardized quality control and release testing of CAR-T cell drug products.

Robin Dennebos, Macarena González-Corrales, Maria Lysandrou, Nienke A M Smit, Yuzhu Qi, Tom van Meerten, Jos G W Kosterink, Gerwin Huls, Harm-Jan Lourens, Bahez Gareb and 1 more

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Article in International journal of pharmaceutics: X, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Robin DennebosDepartment of Hematology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Macarena González-CorralesDepartment of Hematology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Maria LysandrouDepartment of Hematology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Nienke A M SmitDepartment of Hematology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Yuzhu QiDepartment of Hematology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Tom van MeertenDepartment of Hematology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Jos G W KosterinkDepartment of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Gerwin HulsDepartment of Hematology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Harm-Jan LourensDepartment of Hematology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Bahez GarebDepartment of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Edwin BremerDepartment of Hematology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Potency is a critical specification for CAR-T cells and is typically determined by co-culture of CAR-T cells with target cell lines. However, cell line heterogeneity hampers standardization and can lead to analytical variation impacting potency test results. Further, both the assay and cell line maintenance are labor, time, and resource intensive. Here, we developed and validated a versatile, fully standardized, and GMP-compliant CAR-T cell potency assay. This assay utilizes antigen-loaded beads instead of target cell lines and was fully validated for CD19 and qualified for CD7 and HER2 CAR-T cells. Incubation of streptavidin beads with recombinant biotinylated antigen yielded a dose-dependent bead loading. Subsequent incubation of CAR-T cells with increasing amounts of antigen-loaded beads yielded a dose-dependent secretion of IFN-γ, whereas non-loaded or MOCK antigen-loaded beads did not significantly trigger IFN-γ secretion. Notably, as assessed for CD19 CAR-T cells, cryopreserved CAR-T cells yielded lower potency than fresh CAR-T cells and potency results correlated with the total amount of CAR-T cells in the test sample. Therefore, the assay was fully standardized using a fixed amount of 50 k CAR-T cells per test, a fixed amount of antigen loaded onto the beads (1 pg/bead), and a fixed amount of 500 k antigen-loaded beads. A quantitative and statistically substantiated potency threshold for batch release was established for fresh as well as cryopreserved CAR-T cell drug products This fully standardized assay protocol and validation strategy provides a facile potency assay for CAR-T cell drug products that can be implemented for essentially any antigen of interest.

Indexed as

CAR-T cellsGood manufacturing practices (GMP)IFN-γ releasePotency assayQuality control testing

Identifiers

PMID42180585
PMCPMC13195360

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.