One standard. Every batch.
Six checkpoints, each documented and temperature-controlled — the complete path a single lot takes from reception to your door.
Reception
Source material is logged, inspected and matched against its chain-of-origin documentation before it enters cGMP culture — qualified operators, environmental monitoring, a complete batch record for every run.
- — Ethically sourced tissue, fully documented chain of origin
- — Environmental monitoring throughout the culture cycle
- — Batch record archived for every expansion run
Cytometry
Every lot is profiled by multicolor flow cytometry against the identity and purity markers that define its cell type — the same panel that ships inside your Certificate of Analysis.
- — Flow-cytometry identity and purity panel per lot
- — NTA and tetraspanin ELISA for extracellular vesicles
- — Results cross-checked before advancing to QC
Quality control
Viability, sterility and endotoxin levels are tested against pharmacopeial limits. Cellular products are held to a ≥ 95% viability threshold before anything can move forward.
- — Viability assay, ≥ 95% threshold for cellular products
- — Sterility and endotoxin screening against pharmacopeial limits
- — HPLC / mass-spec verification for peptides
Release with COA
A signed Certificate of Analysis is issued per lot, documenting every identity, viability, sterility and potency result before the batch is cleared for shipment.
- — Signed, lot-specific Certificate of Analysis
- — Downloadable from an approved professional account
- — No lot ships without a completed, signed COA
Cold chain
Each package ships in a qualified thermal container with gel packs and phase-change material. An in-package data logger records temperature every minute — no exceptions.
- — Qualified thermal container, gel packs and phase-change material
- — Data logger records temperature every minute, handed over with the product
- — Priority routes, 24–48 h across the US, Mexico and major LATAM cities
Application & follow-up
For cellular therapies, our own medical team performs or guides the application in-clinic. A written protocol, an onboarding call and structured follow-up are included — never just a box on a doorstep.
- — PDF clinical protocol with dosing, route and safety flags
- — Onboarding call and direct medical line throughout the protocol
- — In-clinic application by our medical team where the protocol requires it
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.