Identity
Each product is confirmed to be what its specification says it is.
The Standard
The standard behind every 1CELL product.
Seven requirements every product meets before it reaches a clinic — and the records that prove it.
Characterization
Defining markers and parameters are measured for every lot.
Quality
Sourced from cGMP production and released against specification.
Documentation
Every lot is released with a lot-specific Certificate of Analysis.
Traceability
Every vial links back to its lot, its source and its custody record.
Preservation
Storage and transport follow each product's requirements.
Delivery
Handoff to the clinic is coordinated, documented and confirmed.
See the documentation
The records that accompany each lot.
Quality
Quality starts at the source.
1CELL works with production under cGMP conditions, and every lot is released against its specification before it moves.
- cGMP production with documented procedures
- Release against specification, lot by lot
- Sterility and endotoxin testing, where applicable
- Viability thresholds for cell products
cGMP
Testing
What is tested, by product type.
Exact tests and acceptance criteria are listed on each lot's Certificate of Analysis.
Cell therapies
MSC · NK · Muse
- Identity and purity markers (flow cytometry)
- Viability
- Sterility and endotoxin
- Cell count per dose
Exosomes
Extracellular vesicles
- Particle concentration and size (NTA)
- Tetraspanins CD9, CD63, CD81
- Sterility and endotoxin, where applicable
Peptides
1CELL Longevity
- Purity by HPLC
- Identity by mass spectrometry
- Endotoxin
Traceability
Every vial has a complete history.
If a vial is in your clinic, you can know where it came from, when it was released and how it travelled.
- Lot numberLinks each vial to its production run
- SourceThe laboratory and source material
- Release and specificationWhen and against what it was released
- Certificate of AnalysisThe results for that lot
- Custody and temperature recordEvery handoff until receipt
Preservation
Conditions set by the product.
From controlled refrigeration to frozen or cryogenic storage, conditions are set for each product and maintained through transport.
- Controlled refrigeration
- Frozen storage
- Cryopreservation and nitrogen-based transport, when required
- Monitoring in transit
Documentation
Documentation you can verify.
Verified professionals can request a sample COA and the documentation for every lot they receive.
Sample COA
The Certificate of Analysis released with each lot.
Available on requestProduct characterization
Identity and purity markers measured for each lot.
Per lotBatch documentation
Source, release date and specification of the lot.
Per lotTemperature monitoring
The shipment's temperature record in transit.
Per shipmentChain of custody
Every handoff, from release to receipt at the clinic.
Per shipment