Engineered and unmodified mesenchymal stromal cell manufacturing —
tissue-derived expansion, banking, and GMP release testing inside one organization.
Mesenchymal stromal cell (MSC) therapy manufacturing isolates MSCs from bone marrow, adipose, umbilical cord, or placental tissue, banks them, and expands them adherently into a dose — engineered or unmodified. MSCs act largely through immunomodulatory and secretory mechanisms rather than by engrafting, which is why their defining manufacturing challenge is not scale but demonstrating potency against the proposed mechanism.
GeneFab is an MSC CDMO for GMP mesenchymal stromal cell manufacturing. We cover tissue-derived isolation, GMP Master and Working cell banking, bounded adherent expansion, engineering and secreted-payload genetic circuit design where the program calls for it, and mechanism-matched potency assay development alongside GMP release testing.
MSC programs enter with a tissue source, a bank, or an expansion process. These are the pieces we own.
Bone marrow, adipose, umbilical cord, and placental sources. Donor selection and banking strategy are decided up front, because every comparability argument downstream depends on them.
Adherent expansion through to scaled formats, with passage number, phenotype drift, and senescence treated as bounded process parameters rather than emergent surprises.
Where the program calls for it, genetic circuit design from our synthetic biology group with vector we manufacture ourselves — including secreted-payload strategies.
A potency assay built against the proposed mechanism — immunomodulatory, secretory, or regenerative — rather than a proliferation readout that proves nothing about the clinical hypothesis.
Closed wash, concentration, and cryopreservation into the final container, with post-thaw viability and retained function treated as release-relevant.
MSC doses are large, so scale-up is the defining commercial question. Development targets yield per run and cost of goods per dose while holding passage number, phenotype, and potency inside their defined limits — because scale that costs you potency is not scale.
Identity, purity, potency, and safety assays developed against the process, with core biosafety testing performed in house.
An MSC product that expands beautifully and cannot demonstrate mechanism is not a product. The potency assay is the first conversation we have, not the last.
The potency assay is designed against your clinical hypothesis, then the process is developed to preserve what it measures.
Passage number, phenotype, and senescence held inside defined process limits rather than discovered at scale.
Donor-to-donor comparability planned at the banking stage, where it is still cheap to address.
What sponsors ask before choosing a MSC CDMO for a MSC program.
Yes. We manufacture engineered and unmodified MSC products under GMP, from tissue-derived starting material through banking, expansion, formulation, and release.
Bone marrow, adipose, umbilical cord, and placental sources. Donor selection and banking strategy are addressed up front because downstream comparability depends on them.
Yes, and we consider it the central analytical problem. The assay is built against the proposed mechanism — immunomodulatory, secretory, or regenerative — alongside process development.
Yes. Where the program calls for it, our synthetic biology group supports genetic circuit design including secreted-payload strategies, and we manufacture the vector or use non-viral delivery.
Passage number, phenotype, and senescence are treated as bounded process parameters with defined limits, characterized during development rather than discovered at scale.
Yes. MSC doses are large, so scale-up is central. We develop yield per run and cost of goods per dose while holding passage number, phenotype, and potency inside defined limits, with comparability planned around any scale change.
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.
