Same-Day Immunogenicity Turnaround: What an In-House Lab Changes

Central laboratory turnaround for multi-color flow cytometry samples typically runs five to ten business days once shipping, batching, and manual analysis queues are accounted for. For a vaccine or immunotherapy trial tracking immune response kinetics across multiple timepoints, that lag can materially affect a sponsor's ability to make adaptive decisions.

Mount Clinical Research's bioanalytical laboratory processes flow cytometry, ELISpot/FluoroSpot, ELISA, and cytokine bead array samples on-site, eliminating the shipping and batching delay entirely. Paired with FlowAutoGate™ for automated gating, a same-day flow result is realistic for many panels — sample receipt to report in under 48 hours, rather than the industry-standard week or more.

The chain-of-custody benefits compound the speed benefit. Because samples never leave the building, there is no courier handoff, no freeze-thaw risk from transit delays, and a single, continuous audit trail from collection to report — all documented under our SOP library and 21 CFR Part 11-compliant electronic data management system.

For sponsors evaluating site partners for immunology-heavy protocols, we believe this combination of in-house processing and AI-assisted analysis represents a genuinely different turnaround-time offer, not an incremental improvement on the central-lab model.