This integrated continuous perfusion system is tailored for high-density long-duration mammalian cell retention and supernatant harvesting in biopharmaceutical upstream processes, extensively deployed for mAbs, viral vectors, recombinant proteins and novel biotherapeutics manufacturing.
Equipped with reliable in-tangential flow or alternating tangential flow cell retention modules, the system intercepts viable cells and retains them inside the bioreactor, while continuously discharging cell-free product-containing supernatant to downstream purification lines. Independent closed-loop control loops precisely regulate transmembrane pressure, crossflow velocity and backflush cycles to mitigate membrane fouling, enabling stable weeks-long uninterrupted perfusion runs and sustaining ultra-high viable cell density.
Sanitary process flow path uses electropolished 316L stainless steel, supporting automated CIP/SIP cycles and full E&L qualification, fully aligned with cGMP standards. The unified automation platform complies with ISA-88 batch specifications, allows customizable perfusion feeding schemes, real-time DO/pH/temperature co-regulation, automatic medium replenishment and waste discharge. All process parameters, equipment actions and fraction collection records are automatically archived with immutable audit trails, meeting data integrity requirements for global regulatory reviews.
Compared with traditional fed-batch culture, this system drastically boosts volumetric productivity, cuts culture medium consumption and shrinks required bioreactor footprint. The skid-integrated design enables factory FAT pre-testing, fast on-site hookup and seamless inline linkage with bioreactors, chromatography and clarification equipment. It supports seamless scale-up from process development to full commercial continuous biomanufacturing, helping biotech enterprises shorten production cycles and lower overall manufacturing costs.
