Cell therapy manufacturing software from apheresis to infusion
Chain of identity and custody, closed-system processing, expansion, cryopreservation, and release coordination for autologous and allogeneic products, with every step on the batch record.
THE PROBLEM
An autologous cell therapy batch is one patient, one product, and a vein-to-vein clock that does not stop. Chain of identity has to be proven at every handoff, from apheresis receipt through selection, activation, expansion, formulation, freeze, and release, and a single break is a lost dose.
Manufacturing execution and QC release happen in parallel under time pressure, and most systems handle one or the other. The batch record is on paper or in a generic MES, the release tests are in a LIMS, and the COI trail is in a third place. Reconciling three systems takes time this batch does not have.
Labbit runs the batch record and the release tests on the same platform. Patient-lot identity is enforced at every scan, instrument runs from Prodigy and Sepax attach to the batch, expansion trends update daily, and release tests aggregate against the infusion date. Orca Bio manufactures on Labbit.
PRE-CONFIGURED WORKFLOWS
Built visually in BPMN, adapted to your lab, and changed without a vendor release.
Instruments and platforms
How does Labbit enforce chain of identity?
Patient identity is bound to the lot at apheresis receipt and verified at every custody transfer by scan, with DIN and ISBT 128 support. A mismatch blocks the step.
Does Labbit integrate with CliniMACS Prodigy and Sepax?
Yes. Instrument run files and recovery metrics from Miltenyi Prodigy, Cytiva Sepax, and similar closed systems attach to the batch record.
Can Labbit coordinate release testing against short timelines?
Yes. Sterility, mycoplasma, potency, and VCN results aggregate in real time against the planned infusion date, with rolling release status.
Is Labbit GMP and Part 11 compliant for cell therapy?
Yes. Electronic batch records with enforced step order, electronic signatures, deviation capture, and full genealogy from apheresis to infusion.
SEE IT ON YOUR ASSAYS
Bring an assay your team runs today. We’ll show you how it’s configured, executed, and reviewed.