Tumor-infiltrating lymphocyte and engineered B cell manufacturing — isolation and enrichment, expansion, payload delivery, and GMP release testing in one organization.
Tumor-Infiltrating Lymphocyte (TIL) therapy manufacturing recovers tumor-infiltrating lymphocytes from a resected tumor fragment, selects for tumor-reactive cells, and expands them rapidly into a dose — no genetic engineering strictly required. Engineered B cell therapy instead isolates and activates B cells and delivers a payload so the cells secrete a therapeutic protein or present an antigen. Both begin from starting material that is far less standardized than a leukapheresis bag.
GeneFab is a CDMO for GMP Tumor-Infiltrating Lymphocytes (TILs) and engineered B cell manufacturing. We handle tumor fragment receipt and dissociation, rapid expansion, B cell isolation and payload delivery, formulation, and GMP release testing — with the process designed around real starting-material variability rather than an idealized specification.
TIL and engineered B cell programs sit on the same lymphocyte backbone with different front ends. These are the pieces we own.
Tumor fragments, resected tissue, leukapheresis, and isolated PBMCs. Incoming material specifications, chain of identity, and chain of custody are defined during tech transfer, before the first engineering run.
Initial outgrowth from fragment through rapid expansion, with the variability handling that TIL manufacturing requires. Process robustness across donors is the design target.
B cell isolation and activation strategies matched to the program's payload approach — secreted protein, antigen presentation, or engineered receptor.
Genetic circuit design from our synthetic biology group, with vector we manufacture ourselves and non-viral delivery where a vector is not the right tool.
Closed wash, concentration, and cryopreservation into the final container, with post-thaw viability and function treated as release-relevant attributes.
Identity, purity, potency, and safety assays developed against the process, with core biosafety testing performed in house.
You cannot specify your way out of a tumor fragment. The only way to get a consistent product from inconsistent starting material is to design the process for the variability from the beginning.
Incoming material specifications and acceptance criteria defined before engineering runs, not after a failed batch.
Process conditions developed across the material variability you will actually see in the clinic.
Potency and phenotype assays that stay meaningful when the starting material moves.
What sponsors ask before choosing a TIL CDMO for a TIL and B cell program.
Yes. We manufacture tumor-infiltrating lymphocyte products under GMP, from tumor fragment receipt and dissociation through rapid expansion, formulation, and release.
Yes. Fragment receipt, dissociation, chain of identity, and material acceptance criteria are defined during tech transfer, and the process is developed against the variability you will actually see.
Yes. B cell isolation, activation, and payload delivery for secreted-protein, antigen-presenting, and engineered-receptor strategies, including the vector or non-viral delivery used to engineer them.
Yes. Genetic circuit design, vector manufacturing, and cell processing sit in one organization, so delivery and cell process are developed against each other rather than transferred between vendors.
Yes. Identity, purity, potency, and safety assays are developed alongside the process, and GMP sterility, mycoplasma, endotoxin, and identity testing run in house.
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.
