Regulatory status, stated plainly.
Which filings exist, what they cover, and what a sponsor can actually reference. If a document is missing from this page, ask for it — the answer is usually "here it is".
Six things an auditor will ask about.
Each of them is answered before the question is finished — because the system was built for CGT customers, not adapted from a general chemical catalogue.
ISO 13485:2016
The medical-device quality management system applied to reagent manufacture — design control, risk management and traceability from raw material to release.
ISO 9001
Company-wide quality management covering the R&D, production and commercial processes around the ISO 13485 scope.
GMP cleanroom
3,200 m² R&D and production base with a GMP-level clean workshop for bead, protein and medium manufacture.
Two Type II DMFs
DMF 038124 (ActSep® CD3/CD28 beads) and DMF 038820 (anti-human CD28 mAb), referenceable by sponsors in an IND.
Analytical release testing
Identity, purity and activity testing per lot: SDS-PAGE, SEC-HPLC, endotoxin, residual host-cell protein and cell-based potency where applicable.
Audit support
Audit data packages delivered for more than 30 customers, plus on-site and remote inspection hosting.
Drug Master File status
A Type II DMF is a closed reference: the sponsor cites the file in their IND and we provide a letter of authorisation. The content stays confidential to the agency.
| DMF number | Type | Product covered | Status |
|---|---|---|---|
| 038124 | Type II | ActSep® CD3/CD28 Separation & Activation Magnetic Beads | On file |
| 038820 | Type II | Anti-Human CD28 Monoclonal Antibody | On file |
Additional Type II filings are on record for the anti-human CD3 monoclonal antibody, recombinant human IL-7 (GMP-TL506) and recombinant human IL-15. File numbers are released to customers on request.
Status reflects the position published on tlbiotechnology.com. Confirm current status with our regulatory team before citing a file in a submission.
What arrives with the box
Documentation is released per lot, not per catalogue number. That distinction matters during a comparability exercise.
Traceability end to end
Raw-material sourcing, in-process controls and release testing are recorded against the lot number that appears on your COA, so a deviation investigation can be answered from the batch record.
- Animal-origin-free where the product claims it
- Lot-level retention samples held for the shelf life
- Cold-chain packaging validated for destination
- Change notification under quality agreement
