iPSC manufacturing, engineering, and differentiation at scale — from protocol transfer through GMP lots that stay consistent as volumes grow.
Induced Pluripotent Stem Cell (iPSC) manufacturing reprograms somatic cells into induced pluripotent stem cells, banks and characterizes them under GMP, optionally engineers the line, then differentiates it into a therapeutic lineage such as iPSC-derived NK, T, or macrophage cells.
GeneFab is an iPSC CDMO for GMP iPSC manufacturing and scale-up. We transfer and optimize differentiation protocols, drive yield and purity per run as volumes increase, engineer lines at the pluripotent stage so every differentiated lot inherits the edit, bank the line under GMP, and run the comparability and GMP release testing that allogeneic programs demand.
iPSC programs enter with a research line, a GMP-intent line, or a differentiation protocol that needs to make real lots. These are the pieces we own.
Differentiation is where an iPSC platform scales. Development targets yield and purity per run, consistency as volumes increase, and the comparability package that supports a scale change without invalidating earlier lots.
Engineering, Master, and Working cell banks manufactured and characterized under GMP, with the documentation package regulators will ask for.
Engineering at the iPSC stage so every differentiated lot inherits the edit. Genetic circuit design from our synthetic biology group, with promoter and regulatory element selection appropriate to the target lineage.
Differentiation protocol transfer, optimization, and scale into therapeutically relevant lineages, with the purity and residual-undifferentiated-cell questions handled explicitly.
Lot-to-lot comparability across differentiated batches, and the characterization package that supports a change to the bank, the protocol, or the scale.
Closed wash, concentration, and cryopreservation into the final container, with post-thaw viability and lineage identity treated as release-relevant.
Identity, purity, potency, and safety assays developed against the process, with core biosafety testing performed in house.
Most iPSC programs can make a lot. Fewer can make the tenth lot at three times the volume and prove it is the same product. That gap is a process and comparability problem, and it is the one we work on first.
Differentiation yield and purity per run held as volumes increase, with cost of goods per dose modelled rather than discovered.
Edits made at the iPSC stage so every differentiated lot inherits them, with screening before commitment.
Scale-change comparability designed up front, so a volume increase does not invalidate the lots behind your clinical data.
What sponsors ask before choosing an iPSC CDMO.
Yes. We manufacture and characterize Engineering, Master, and Working iPSC banks under GMP, including identity, sterility, mycoplasma, adventitious agent, and genomic stability testing.
Yes. We transfer, optimize, and scale differentiation protocols into therapeutically relevant lineages, and develop the purity and lineage identity analytics alongside the process.
Yes. Engineering at the iPSC stage means every differentiated lot inherits the edit. Our synthetic biology group supports genetic circuit design and lineage-appropriate promoter selection, and we manufacture the vector.
Control of residual undifferentiated cells is treated as a defined process and analytical objective, with the assay developed alongside the differentiation process rather than after it.
Yes. Comparability is designed as an exercise up front — across banks, differentiated lots, protocol changes, and scale changes — rather than assembled retrospectively.
Yes. Differentiation is where an iPSC platform scales, so development targets yield and purity per run, consistency as volume increases, and the comparability package that supports a scale change without invalidating earlier lots.
A technical exchange under CDA, then a gap assessment of your line, protocol, and analytics, a tech transfer plan, and engineering runs before GMP. Requesting a quote starts that conversation.
