The applicability of BMM to Cohn's fractionation process for manufacturing immunoglobulin preperation was investigated from the view point of filtration characteristics such as the values of filtration-capacity (FC), and of sieving-coefficient (SC) of protein, and of the change in electrophoretic pattern (EP) according to filtration.
The filtration conditions for the intermediate products was settled so as to fit the acutual manufacturing conditions.
For the semifinal products, the dependences of FC, SC and EP on the filtration-temperature (FT), protein-concentration (PC) and the mean pore size of BMM (2rf) were evaluated.
The values of FC and SC increased when the intermediate products approached to the final one or 2rf increased or FT elevated or PC decreased.
We concluded that BMM was applicable for the liquid before dispensing into a bottle and for the supernatant-II-3.
