The Lab
- Manufacturing & Quality
Five stages, one chain of custody.
Every vial in your clinic was sourced, characterized, packaged, and shipped through this pipeline. We control all five stages — no third-party fill, no white-label.
01
ISO 20387 · donor consent · COA
Sourcing
Donor screening, raw-material qualification, certificate-of-origin on every input. CellGenic operates under appropriate regulatory frameworks with full compliance, including IND pathways where applicable for products like exosomes.
02
cGMP-certified · ISO 7
Lab
ISO Class 7 cleanroom. Cell expansion, vesicle isolation, peptide synthesis under one roof.
03
USP <71> · USP <85> · NanoSight
QC / Compliance
Sterility, endotoxin, mycoplasma, identity, potency. Every batch. COA shipped with product. Quality and testing standards verified per batch.
04
Lyo · −80°C cryo · cold chain
Packaging
Lyophilized or cryo-preserved as the protocol requires. Tamper-evident, batch-stamped.
05
GDP · 72-hour SLA
Shipping
Validated cold-chain to four countries. Temperature logger in every box. Signature on receipt.