Purpose-built for autologous CAR-T, CAR-NK, stem cell and allogeneic cell therapy workflows, our single-use bioreactor delivers a fully closed, low-shear cultivation environment that safeguards fragile therapeutic cells throughout expansion, transduction and harvest stages.
Eliminating stainless steel-associated CIP/SIP cycles and tedious cleaning validation, the disposable culture bag and entire fluid path remove cross-contamination risks completely, enabling ultra-fast batch changeover and multi-product parallel production within one cleanroom suite. Precise automated control over pH, dissolved oxygen, temperature and gentle mixing maintains stable physiological conditions, maximising viable cell yield while preserving cell phenotype and potency — core quality benchmarks for cell therapy regulatory submission.
Scalable seamlessly from lab-scale process development (mL level) through clinical trial batches to full commercial volumes, the platform complies with cGMP, ISO 13485 and 21 CFR Part 11 requirements, with full material traceability for regulatory audit readiness. Ideal for personalised small-batch patient-specific therapies and large-batch off-the-shelf cell products alike, it cuts facility capital investment, shortens production timelines and accelerates your cell therapy pipeline from bench to patient bedside.
