The cell types and delivery platforms we manufacture under GMP every day — and what each one actually demands of a manufacturing partner.
Cell and gene therapy manufacturing is the process of turning living cells into a dosed, released drug product: engineering the cells with a genetic payload, expanding them under GMP conditions, formulating and cryopreserving them, and proving through analytical testing that each lot is what the protocol says it is. Because the product is alive, the process largely defines it — which is why the choice of manufacturing partner shapes the program itself.
GeneFab is a GMP cell & gene therapy CDMO. We manufacture CAR-T, TCR-T, γδ-T, NK and CAR-NK, regulatory T cell, TIL, engineered B cell, iPSC-derived, CD34+ hematopoietic, mesenchymal stromal, and macrophage therapies, using lentiviral, retroviral, and non-viral gene delivery. Synthetic biology and genetic circuit design, vector manufacturing, cell processing, and core biosafety testing sit in one organization, so a program is not split across vendors and re-transferred at every stage.
Every cell type brings its own failure modes — starting-material variability, differentiation control, phenotype drift, potency measurement. These are the ones we have GMP-ready processes for.
Autologous and allogeneic CAR-T, TCR-T, and gamma-delta (γδ) T cell programs — genetic circuit design, transduction, closed expansion, and release testing.
Tumor-infiltrating lymphocytes and engineered B cells — TIL programs from tumor fragment through rapid expansion, and B cell programs for secreted-protein and antigen-presenting strategies.
Primary and expanded NK programs, including donor-derived and engineered NK, with feeder-based and feeder-free expansion strategies.
Treg isolation, expansion, and engineering for tolerance and autoimmune programs, where purity and stability are the central attributes.
iPSC banking, differentiation into therapeutically relevant lineages, and the comparability work allogeneic programs demand.
CD34+ selection, transduction, and formulation for ex-vivo gene therapy in hematopoietic programs.
MSC expansion from tissue-derived starting material, engineered or unmodified, with potency assays matched to mechanism.
Monocyte-derived macrophage programs, including CAR-macrophage, with the differentiation and transduction challenges that come with them.
How the payload gets in. We manufacture the vector ourselves, so delivery and cell process are developed against each other.
Adherent and suspension LVV from development scale to GMP, manufactured in the same organization that runs your cell process.
Gamma-retroviral vector production and packaging cell line work for programs built on retroviral integration.
mRNA and lipid nanoparticles, where a viral vector is not the right approach.
The expensive part of a cell therapy program is rarely a single unit operation. It is the seams between them — every transfer, every comparability exercise, every schedule dependency on someone else's queue. We removed the seams.
Genetic circuits and promoters are screened in the cell type they will be used in, not in a convenient surrogate line.
Vector potency and transduction conditions are tuned together instead of inherited from a separate supplier.
GMP-compliant sterility, mycoplasma, endotoxin, and identity testing run under our own roof, so release does not wait in an external queue.
The questions sponsors ask before the first technical call.
T cells (CAR-T, TCR-T, and gamma-delta T cells), tumor-infiltrating lymphocytes, engineered B cells, NK cells, regulatory T cells, iPSC and iPSC-derived cells, mesenchymal stromal cells, hematopoietic stem cells and CD34+ cells, and macrophages and monocytes.
Lentiviral vector and gamma-retroviral vector, plus non-viral delivery including mRNA and lipid nanoparticles, electroporation, and transposon-based integration.
Yes. Genetic circuit design with synthetic biology, viral vector manufacturing, cell processing, and core biosafety testing all sit inside one organization — so vector and cell process are developed against each other instead of being transferred between vendors.
Yes. Autologous programs from patient-derived starting material, and allogeneic programs built on healthy-donor or iPSC-derived cells — including the cell banking and lot-to-lot comparability work allogeneic development requires.
Often, yes. The unit operations behind most engineered cell therapies overlap substantially. Send us the process you have and we'll tell you honestly whether we're the right partner for it.
