Polyclonal and antigen-specific regulatory T cell manufacturing — isolation, expansion, engineering, and GMP release testing inside one organization.
Regulatory T cell (Treg) therapy manufacturing isolates the suppressive CD4+ Treg subset, expands it without losing lineage identity, and — for CAR-Treg and antigen-specific products — engineers it to home to a defined target. Tregs are used to induce tolerance in autoimmunity and transplant rather than to kill. Because contaminating conventional T cells would work against the therapy, purity and phenotype stability are the attributes that define the product.
GeneFab is a Treg CDMO for GMP regulatory T cell manufacturing. We cover isolation and purity strategy, expansion for retained suppressive function, CAR-Treg genetic circuit design and vector manufacturing, and the identity, purity, and suppression-based potency assays a Treg release package requires — developed alongside the process, with core biosafety testing in house.
Tolerance and autoimmune programs enter at different points — polyclonal, antigen-specific, or engineered. These are the pieces we own.
Treg isolation from leukapheresis or PBMCs with a purity target set by the clinical protocol, not by convenience. The isolation strategy and the purity assay are developed together, because one without the other proves nothing.
Expansion conditions chosen for retained suppressive function and phenotype stability, not for cell count alone. Stability through expansion, formulation, and freeze is tracked as a product attribute.
CAR-Treg and antigen-specific Treg architecture from our synthetic biology group, with promoter and regulatory element selection appropriate to the Treg lineage and screening in primary Tregs.
Vector we manufacture ourselves, so vector potency and transduction conditions are tuned against a cell type that tolerates handling poorly.
Closed wash, concentration, and cryopreservation into the final container, with post-thaw phenotype and function treated as release-relevant.
A Treg release package has to prove identity, purity, and suppressive function. All three are developed against the process, with core biosafety testing in house.
For most cell therapies, potency is the hard assay. For Tregs, purity and stability are just as hard — and just as decisive. We treat them as first-class development problems.
Selection strategy set against the purity your protocol needs, with the assay to prove it built at the same time.
Expansion conditions chosen for retained phenotype and suppressive function, not cell count alone.
Suppression-based potency assay development alongside the process, not bolted on before release.
What sponsors ask before choosing a Treg CDMO for a Treg program.
Yes. We manufacture polyclonal, antigen-specific, and engineered CAR-Treg products under GMP, including the vector used to engineer them.
Isolation strategy and the purity assay are developed together, with a purity target set by the clinical protocol. Control of contaminating conventional T cells is a defined process objective, not a hope.
Yes. Suppressive function assays are developed alongside the process, together with identity, purity, and safety testing.
Yes. Our synthetic biology group supports CAR-Treg genetic circuit architecture and lineage-appropriate promoter selection, and we manufacture the vector that delivers it.
Stability is tracked as a product attribute through expansion, formulation, and cryopreservation, with post-thaw phenotype and function included in the development plan rather than discovered at release.
A technical exchange under CDA, then a gap assessment of your process and analytics, a tech transfer plan, and engineering runs before GMP. Requesting a quote starts that conversation.
