Traceable biology
cGMP manufacturing, flow-cytometry characterization and a third-party COA archived for every lot.
Why 1CELL
The standard, on every vial.
Nothing ships without documentation, a clinical plan and a validated temperature record. This page covers exactly how — from the cleanroom to the Certificate of Analysis in your inbox.
Unbroken cold chain
2–8 °C from culture to clinic, with a digital logger on every shipment. Out-of-range lots are rejected.
Real medical guidance
A clinical protocol ships with every order, and a dedicated medical team guides application and follow-up.
Independently verified
Every lot is tested by a third-party laboratory, not just released on internal QA. The result ships with the product, not just on request.
0Biological families
0COA per batch
0Medical support
≤0Cold chain
Quality control
One standard. Every batch.
Five checkpoints, run in order, before a single vial is released for shipment.
- 01
Reception
Source material is logged, inspected and matched against its chain-of-origin documentation before it enters the lab.
- 02
Cytometry
Flow cytometry confirms the surface-marker profile that defines each cell type — and rules out cross-contamination between lots.
- 03
Quality control
Viability, sterility and endotoxin are tested against pharmacopeial limits — cellular products are held to a ≥ 95% viability threshold.
- 04
Release with COA
A signed Certificate of Analysis is issued per lot, documenting every result above before the batch is cleared for shipment.
- 05
Cold chain
The released lot enters validated 2–8 °C packaging with a digital logger — and never leaves that range until it reaches you.
Documentation
What ships in a Certificate of Analysis.
A COA is a signed, independent record — not a marketing sheet. Every 1CELL shipment includes one, tied to a specific lot number.
4.2 °C · in range
Logistics
Never leaving
Never leaving
2–8 °C.
Every shipment carries a digital temperature logger, monitored 24/7. Out-of-range readings automatically reject the lot — so the biology you order is the biology you receive.
Professional access
Join the 1CELL physician network.
License validation, institutional pricing and dedicated scientific support. Held to one standard.
License verification within 24 h · Per-batch evidence, no noise.