Downstream Process - Continuous Purification
System-c - PAK System for Continuous Biopharmaceutical Purification
The PAK System is an advanced platform specifically designed for the continuous purification of biopharmaceuticals, such as monoclonal antibodies. This single-use platform performs four unit operations: diafiltration, chromatography, viral inactivation, and inline concentration. It automates flow and mass rates for purifying up to 500 L of cell culture daily. The system utilizes four control schemes: mass flow control, flow kit vessel level control, dual column vessel level control, and high-low level control. This ensures constant product levels, prevents overflow, and reduces process volumes by as much as 100-fold compared to batch methods. The PAK System allows significant reductions in capital expenditures, offering a 50% lower cost compared to traditional batch setups. The automation is compliant with CFR21 part11, using the PurSyncTM automation package. The setup is efficient due to its single-use, flow kit assembly, making it ideal for rapid deployment in various bioprocessing environments.
