This fully automated integrated chromatography system is engineered exclusively for end-to-end downstream purification of monoclonal antibodies (mAbs), covering capture, intermediate purification, polishing, virus filtration and buffer exchange unit operations in a unified platform.
All wetted flow paths adopt sanitary 316L stainless steel or biocompatible PEEK material, supporting automated CIP and SIP cycles, fully compliant with cGMP, data integrity and E&L evaluation requirements for biopharmaceutical production. High-precision low-pulsation diaphragm pumps, multi-channel gradient elution control, online UV, conductivity, pH and column pressure real-time monitoring deliver stable flow rate and precise gradient programming, guaranteeing consistent binding, elution and impurity removal performance batch after batch.
Controlled by dedicated industrial automation software following ISA-88 standards, the system stores customizable purification methods, executes unattended full-cycle running, automatically collects fraction peaks, records complete electronic batch records and generates full audit trails for FDA, EMA and NMPA regulatory submission. Built-in pressure interlocks, column overload protection and leak detection effectively safeguard chromatography resins and expensive antibody products.
Modular skid-mounted layout supports seamless inline connection with centrifuge depth filtration and virus inactivation units. It flexibly scales from pilot process development to full commercial manufacturing lines, drastically reducing manual intervention, lowering product loss, improving antibody purity and yield, and serving as the core purification workstation for industrial-scale mAb drug commercial production.
