Autologous and allogeneic CAR-T, TCR-T, and γδ T cell manufacturing —
genetic circuit design, vector, cell process, and release testing inside one organization.
T cell therapy manufacturing takes a patient's or a donor's T cells, introduces a chimeric antigen receptor (CAR) or engineered T cell receptor (TCR) — usually by lentiviral or retroviral transduction — then activates, expands, formulates, and cryopreserves them under GMP. Autologous programs run one batch per patient; allogeneic programs, including most gamma-delta (γδ) T cell products, are banked from healthy donors and released as multi-dose lots.
GeneFab is a CAR-T CDMO covering the whole of that sequence. We manufacture autologous and allogeneic CAR-T, TCR-T, and γδ T cell therapies — genetic circuit design, lentiviral vector, selection and activation, closed expansion, formulation, and GMP release testing — inside one organization, so the construct is designed for the vector, the vector is made for the cell process, and release testing is developed alongside the process rather than after it.
Whether the program is autologous or allogeneic, it can enter at any point — construct in hand, process defined, or nothing but a target. These are the pieces we own, in the order they usually happen.
CAR and TCR genetic circuit architecture, promoter selection, and payload design handled by our synthetic biology group — including cell-specific promoters and regulatory elements developed in house for T cell programs.
Fresh or cryopreserved leukapheresis, isolated PBMCs, or pre-selected T cell fractions. Incoming material specifications, chain of identity, and chain of custody are defined during tech transfer, before the first engineering run.
T cell isolation and activation strategies matched to the program's target phenotype, followed by transduction using vector we manufacture ourselves — so vector potency and process conditions are tuned together instead of inherited.
Closed and functionally closed expansion, wash, concentration, and cryopreservation into the final container. Process development focuses on the attributes the clinical protocol actually depends on — phenotype, viability, and dose consistency.
Autologous T cell programs scale out, not up: the challenge is running many small, patient-specific batches reproducibly rather than one large one. Process development focuses on robustness across variable starting material, closing the process, and shortening the make span so slot capacity is not the constraint on your trial.
Identity, purity, potency, and safety assays developed against the process, with core biosafety testing performed in house.
An integrated GMP project team — process, analytical, QA, and program management in one group — carries the process from engineering runs into GMP manufacturing with a single accountable point of contact.
The unit operations are largely shared. What changes is how batches are structured, how cells are banked, and what the release package has to prove.
Single-patient batches, tight chain of identity, and a schedule built around apheresis slots and clinical demand. Process robustness across variable starting material is the central problem, and it is the one we design for.
Healthy-donor or iPSC-derived starting material, banked and scaled into multi-dose lots. Cell banking, editing strategy, and comparability across lots move to the front of the development plan.
What sponsors ask before choosing a CAR-T CDMO for a T cell program.
Yes. We support autologous CAR-T and TCR-T programs from patient-derived starting material, and allogeneic programs built on healthy-donor or iPSC-derived T cells. The unit operations are shared; what differs is batch architecture, cell banking strategy, and the release testing package.
Yes. We manufacture lentiviral vector in both adherent and suspension formats and manufacture the T cell drug product in the same organization. Vector and cell process are developed against each other rather than handed between vendors — which removes a transfer, a comparability exercise, and a schedule dependency.
Fresh or cryopreserved leukapheresis material, isolated PBMCs, and previously selected T cell fractions. We review incoming material specifications and chain-of-identity requirements during tech transfer and confirm the selection and activation strategy before the first engineering run.
Yes. TCR-T programs follow the same manufacturing backbone, with additional attention to genetic circuit design, endogenous TCR handling, and potency assay development. Our synthetic biology group supports genetic circuit architecture and promoter selection for both.
Yes. γδ T cells are a subset of T cells and run on the same manufacturing backbone. What changes is the isolation and expansion strategy, the phenotype and purity targets, and the fact that most γδ programs are allogeneic and off-the-shelf rather than patient-specific.
Yes. Identity, purity, potency, and safety assays are developed alongside the process, and core biosafety tests — sterility, mycoplasma, endotoxin, and identity — are run in house to keep release timelines short.
Yes. Autologous programs scale out rather than up, so development focuses on reproducibility across variable starting material, closing the process, and shortening the make span. For allogeneic programs we develop genuine scale-up into multi-dose lots.
Programs typically begin with a technical exchange under CDA, followed by a gap assessment of your existing process and analytics, a tech transfer plan, and engineering runs before GMP. Requesting a quote is what starts that conversation.
