This fully skid-mounted industrial chromatography system is engineered for large-scale target biomolecule capture, intermediate purification and polishing isolation in biopharmaceutical downstream workflows, applicable to monoclonal antibodies, recombinant proteins, viral vectors, vaccine bulk fluids and other biologic products.
The entire fluid contact path adopts electropolished 316L stainless steel or biocompatible PEEK tubing with seamless orbital welding, passing full E&L qualification and supporting automated CIP and SIP cycles, fully aligned with global cGMP requirements. Equipped with high-stability low-pulsation process pumps, multi-channel gradient elution modules, plus real-time online monitoring of UV absorbance, conductivity, pH and column pressure, the system delivers precise flow rate and gradient programming to guarantee consistent separation efficiency and batch repeatability.
Automated control architecture complies with ISA-88 batch standards, enabling recipe storage, unattended full-cycle execution, automatic peak fraction collection, electronic batch record generation and complete audit trails, which greatly simplifies validation work for FDA, EMA and NMPA regulatory submissions. Built-in column overpressure protection, leakage interlock and low-resin-loss design effectively safeguard expensive chromatography media and target products.
Integrated compact skid structure completes factory FAT testing before delivery, shortening on-site installation and commissioning cycles. It can be seamlessly docked with upstream clarification, ultrafiltration systems and plant MES/LIMS platforms, flexibly covering pilot process transfer to full commercial-scale continuous production, serving as the core isolation unit for modern large-scale biopharmaceutical manufacturing lines.
