Establishment of nanofiltration process model for intravenous human immunoglobulin

Objective To optimize the experimental conditions and construct nanofiltration process model for intravenous human immunoglobulin (IVIG). Methods Factors affecting nanofiltration efficiency, including pre-filter, protein concentration, pH, with/without stabilizer, were analyzed and nanofiltration process model parameters were optimized with orthogonal test. Results The pre-filter system with better filtration load was selected. The nanofiltration efficiency was influenced significantly by pH, but not by protein concentration in low concentration range, or by stabilizer. The optimal area ratio of pre-filter to nano membrane was 1∶1. Under optimized conditions, the maximal load of nanofiltration was 13.6 kg/m2. Conclusion Optimization of the pre-filter and nanofiltration process model parameters for IVIG can increase the filtration capacity and decrease nanofiltration cost. Key words: Immunoglobulins, intravenous; Viruses; Nanofiltration