Flow Cytometry Services CRO for Immunophenotyping, Receptor Occupancy, and MRD, by MD/PhD Scientists at 20+ Year, FDA-Inspected Lab

Cell by cell readouts that bulk assays average away: which immune subsets are present and in what proportion, what sits on each cell surface, what each cell secretes or phosphorylates after stimulation, and whether your therapeutic is bound to its target. That single-cell resolution is why flow carries immunophenotyping, receptor occupancy, effector function and MRD work that no plate assay can answer.

Receptor occupancy measures how much of the target on the cell surface your drug is actually engaging at a given dose, which turns PK numbers into a mechanistic dose argument. Programs use it for dose selection, PK/PD modeling and safety margins, typically from first-in-human onward. Panels are designed around your molecule, validated fit for purpose or to GLP, and read against the same draws as your PK samples.

By treating logistics as part of the assay. Collection kits, stabilization approach, shipping lanes and time-to-stain windows are fixed during validation, not improvised per site, and acceptance criteria catch a compromised sample before it becomes a data point. Across a dozen sites it is rarely the panel that fails; it is the samples, so the method is built around the sample’s journey.

Yes. Panels validate to the rigor the data must defend: fit for purpose for exploratory endpoints, GLP and GCLP where the readout supports safety or regulatory decisions, with multi-species immunophenotyping on the preclinical side and clinical panels carried through validation, batch controls and documented gating review.

MRD panels are built for rare-event work in CLL, multiple myeloma and AML, including the post-CAR-T setting, where the question is finding a malignant cell among hundreds of thousands of healthy ones. Sensitivity is established per panel during validation, with event counts, gating strategy and acceptance criteria fixed in writing before study samples run.

Either. Sponsors arrive with a validated panel to transfer, a marker list, or only a biological question. We design or adapt the panel, select antibodies and fluorochromes around your markers, qualify it in your matrix, and document gating so the readout is reproducible run to run and reviewer to reviewer.

Yes, on two fronts: cell-mediated response to your therapeutic, and anti-CAR or anti-vector immune responses for cell and gene therapy programs, read alongside the ADA and NAb tiers that run on our ligand binding platforms. Having both under one roof means the cellular and humoral halves of the immunogenicity story come from one accession.

The molecule and mechanism, the markers or the biological question, species and matrix, roughly how many samples and sites, and the decision the data feeds. With that we return a written scope, panel approach and timeline within two business days.