Adherent and suspension LVV from development scale through GMP —
manufactured in the same organization that runs your cell process.
Lentiviral vector (LVV) manufacturing produces a replication-incompetent, HIV-1–derived vector that integrates a therapeutic gene into the genome of a target cell. LVV is the dominant delivery platform for ex-vivo cell therapy — CAR-T, CAR-NK, and CD34+ gene therapy — because it transduces dividing and non-dividing cells and gives durable expression. Production runs in adherent or suspension formats, followed by clarification, concentration, purification, fill, and release testing.
GeneFab is a lentiviral vector CDMO manufacturing GMP LVV in both adherent and suspension formats — process development, scale-up, purification, fill, and release. Because we also run the cell process, vector potency is developed against the actual target cell type rather than against a titre assay in isolation, which removes a tech transfer, a comparability exercise, and a schedule dependency.
A vector program can enter with a construct in hand, a research-grade process, or a GMP process needing transfer. These are the pieces we own.
Payload architecture, promoter selection, and regulatory element design from our synthetic biology group, with screening in the primary cell type the vector will target.
Adherent LVV production for development and early clinical supply, where flexibility matters more than scale and speed to first material is the priority.
Suspension LVV production and scale-up for programs whose demand outgrows adherent formats, with the process comparability work that the switch requires.
Clarification, concentration, and purification developed for the impurity profile your cell process and clinical protocol can tolerate — including residual plasmid and host cell material.
Fill into the final container with stability treated as a program deliverable, so vector supply is scheduled against clinical demand instead of hoped for.
Physical and infectious titre, identity, purity, and safety testing developed against the process, with core biosafety tests performed in house.
A vector lot with an impressive titre that transduces your cells poorly has cost you money and time. The only number that matters is how the drug product performs — which is why the vector and the cells are developed together here.
Vector potency developed against the actual cell type and process, not against a titre assay in isolation.
Vector and cell process under one quality system removes a tech transfer, a comparability exercise, and a schedule dependency.
Vector supply planned against clinical demand, with stability data to back the plan.
What sponsors ask before choosing a lentiviral vector CDMO.
Yes. We manufacture LVV under GMP in both adherent and suspension formats, covering process development, scale-up, purification, fill, and release testing.
Yes, and that is the point. Vector and cell process are developed against each other in one organization, which removes a transfer, a comparability exercise, and a schedule dependency on someone else's queue.
It depends on your demand profile and stage. Adherent gets you to first material faster with more flexibility; suspension carries larger demand. We will also run the comparability work if you need to switch later.
Yes. Tech transfer is run as a discipline rather than a document handoff, starting with a gap assessment of the incoming process and analytics.
Physical and infectious titre, identity, purity, and safety testing, with GMP sterility, mycoplasma, endotoxin, replication-competent, and residual impurity testing. Core biosafety tests run in house.
A technical exchange under CDA, then a gap assessment of your construct, process, and analytics, a transfer plan, and engineering runs before GMP. Requesting a quote starts that conversation.
