Evaluation of the chromatographic procedure for the preparation of a high-purity C1-esterase inhibitor concentrate from cryosupernatant plasma.

This report is an analysis of the parameters involved in the preparation of a C1-esterase inhibitor concentrate. We investigated ways to improve the purification by finding the optimal pH, ionic strength, and quantity of chromatographic media to use at each step. The optimisation of the process gave a greater than two-fold increase in both yield and purity over published methods. The product retained more than 50% activity upon dry heat-treatment at 80 degrees C for 72 h, and the yield of the heat-treated product was 180 I.U./kg of plasma.