Chain of Identity — whose cell is this?
In the autologous cell business, confirming that patient and cell match matters as much as temperature control. OCELLBIO links the entire process — patient identifier, collecting institution, collection date and time, specimen type, manufacturing batch, storage location, release time, administering institution and the final recipient — into a single identification system.
Patient numbers and cell numbers are double-checked, barcode-based receipt and release with audit trail are applied, and personal data is stored separately from cell data.
Chain of Custody — who handed over, and when?
We record the responsible party and timestamp at every step: hospital handover, courier receipt, arrival at the manufacturing facility, manufacturing and storage, arrival at the hub, hospital release and final receipt by the clinical team. In the event of an incident, temperature excursion or recall, it is immediately clear what happened and where.
Quality documentation
We review and retain the quality documents issued by the manufacturing facility and relay them to partner clinics. Records are retained for 10 years from the final supply date as required by regulation.
- Certificate of Analysis (COA)
- Sterility test results
- Endotoxin and mycoplasma results
- Cell count and viability
- Surface markers and passage information
- Freezing and thawing conditions
- Transport temperature records
- Batch release certificate
Operating principles
Fresh specimens are shipped directly from the hospital to the manufacturing facility wherever possible, without routing through the hub. Every additional stop increases transport time, temperature excursion risk, cell yield loss and the chance of specimen mix-up.
The hub handles sealed cells only; no thawing, washing, aliquoting, mixing or relabeling is performed.
This website is intended to introduce OCELLBIO's business. OCELLBIO Inc. was incorporated in August 2026 and is currently building out its headquarters facility; the facility and equipment specifications shown are design-stage figures and will be finalized during construction and verification. Culture, quality testing and batch release of clinical-grade cells are performed by manufacturing facilities licensed under the applicable regulations, while OCELLBIO is responsible for the storage, logistics and quality documentation of cells handled in sealed condition. Specific terms of cooperation are provided on request.