Cytokine Release Syndrome (CRS) is a critical safety concern in the development of therapeutic antibodies and cell therapies. Sailybio provides comprehensive in vitro CRS assessment services to evaluate the cytokine release profile of your drug candidates using human PBMC-based assays, supporting preclinical safety evaluation and IND submissions.
CRS assessment evaluates the potential of therapeutic antibodies, bispecific T-cell engagers (BiTEs), and CAR-T/CAR-NK products to induce excessive cytokine release upon interaction with immune cells. This in vitro assay is a regulatory expectation for immunomodulatory biotherapeutics and provides critical data for clinical risk mitigation strategies.
Sailybio's CRS assay utilizes healthy donor PBMCs (or enriched immune cell populations) incubated with your test article across a range of concentrations. Cytokine levels in culture supernatants are quantified using multiplex bead-based arrays and/or ELISA, providing a comprehensive cytokine release profile.
Discuss your test article, study objectives, and regulatory requirements. Our scientific team designs a customized CRS assay protocol including donor selection, concentration range, time points, and cytokine panel.
Select donor-matched PBMCs from our biobank based on your study requirements. Cryopreserved PBMCs are thawed and rested; fresh PBMCs can be arranged for time-sensitive studies.
PBMCs are plated with test article at multiple concentrations. Both plate-bound and soluble formats can be evaluated. Cultures are incubated and supernatants collected at designated time points.
Supernatants are analyzed using multiplex cytokine detection platforms. All assays are performed with standard curves and quality controls.
Comprehensive data analysis including dose-response curves, time-course kinetics, donor-to-donor variability, and statistical comparison with controls. Full study report delivered with raw data.
| Study Report | Comprehensive report including protocol, raw data, analysis, and conclusions |
|---|---|
| Raw Data | All instrument output files (Luminex/ELISA/MSD) provided electronically |
| Dose-Response Curves | Graphical representation of cytokine release vs. concentration for each donor |
| Time-Course Data | Cytokine kinetics over 24h / 48h / 72h for each test condition |
| Statistical Analysis | Donor variability analysis and comparison with positive/negative controls |
| QA Documentation | Chain of custody, equipment calibration records, and SOP compliance documentation |
Pricing depends on donor count, cytokine panel size, and assay format. Contact our scientific team for a tailored proposal within 24 hours.
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