Primary, expanded, and engineered NK cell manufacturing — genetic design, expansion, and GMP release testing inside one organization.
Natural Killer (NK) cell therapy manufacturing expands natural killer cells — from peripheral blood, cord blood, a cell line, or iPSCs — and optionally engineers them with a chimeric antigen receptor to make CAR-NK. Unlike T cells, NK cells do not cause graft-versus-host disease, which is why almost all NK programs are allogeneic and off-the-shelf. The hard parts are expansion yield, resistance to transduction, and retaining cytotoxicity through cryopreservation.
GeneFab is a NK cell CDMO for GMP CAR-NK and primary NK manufacturing. We cover genetic circuit design, vector manufacturing, feeder-based and feeder-free expansion, cryopreservation, and GMP release testing in one organization — so expansion conditions and vector potency are tuned against each other instead of inherited from separate suppliers.
An NK program can enter with a construct in hand, a process defined, or a target and nothing else. These are the pieces we own.
CAR-NK architecture, promoter selection, and payload design from our synthetic biology group — including NK-appropriate regulatory elements and screening in primary NK cells rather than a convenient surrogate line.
Peripheral blood–derived NK, cord blood–derived NK, cell line–derived NK, and iPSC-derived NK. Each carries a different banking strategy and a different comparability burden, and we work that out before the first engineering run.
Feeder-based expansion where the yield justifies the added supply chain and testing burden, feeder-free where it does not. We will tell you which one your program actually needs, including what the feeder cell line adds to your release package.
NK cells are harder to transduce than T cells. Vector we manufacture ourselves means transduction conditions and vector potency are developed together, with non-viral options where a vector is not the right tool.
Post-thaw recovery and retained cytotoxicity are the attributes that decide whether an allogeneic NK product is viable. Formulation and cryopreservation are treated as process steps to be optimized, not an afterthought at fill.
NK programs are almost always allogeneic, so scale-up is real: one campaign has to produce many doses. Development targets expansion yield per run, consistency across scales, and the comparability package that justifies moving from development scale into GMP without repeating the clinical work.
Identity, purity, potency, and safety assays developed against the process, with core biosafety testing performed in house.
Most NK programs are allogeneic from the start. That moves banking, lot comparability, and post-thaw performance to the front of the development plan rather than the end of it.
Donor or line selection and cell banking decided up front, because every downstream comparability argument depends on it.
Feeder-based versus feeder-free chosen on what your yield and release package can carry, not on what is fashionable.
Post-thaw viability and retained cytotoxicity treated as release-relevant attributes from the first engineering run.
What sponsors ask before choosing a NK cell CDMO for a NK program.
Yes. We manufacture CAR-NK and unmodified NK cell therapies under GMP, including the vector used to engineer them. Genetic circuit design, vector manufacturing, expansion, and GMP release testing all sit in one organization.
Peripheral blood–derived NK, cord blood–derived NK, cell line–derived NK, and iPSC-derived NK. Each has different banking and comparability implications, which we work through during tech transfer.
Both approaches are available. Feeder-based expansion can deliver yield that feeder-free cannot, but it adds a cell bank, a supply chain, and testing to your release package. We assess which one your program actually needs rather than defaulting.
We manufacture the vector ourselves, so vector potency and transduction conditions are developed against each other rather than inherited from a separate supplier. Non-viral delivery is an option where a viral vector is not the right tool.
Yes. Cytotoxicity-based potency assays are developed alongside the process, together with identity, purity, and safety testing. Core biosafety tests run in house to keep GMP release timelines short.
Yes. Because NK programs are typically allogeneic and multi-dose, scale-up is a core part of the work — expansion yield per run, consistency across scales, and the comparability package that supports moving from development scale into GMP.
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.
