SUMMARIA, LOUIS,ROTH, NATHAN,BERHE, ABERASH,EVEN, MARK
申请号：
CA2330389
公开号：
CA2330389C
申请日:
1999.02.26
申请国别(地区):
CA
年份:
2012
代理人:
摘要：
A method using diafiltration to prepare a blood product is described. Themethod removes contaminating plasma proteins from whole blood or bloodproducts. Diafiltration may be used on paraformaldehyde-fixed platelets toremove formaldehyde to undetectable levels, and to suspend the platelets intoa formulation buffer suitable for subsequent treatment, such aslyophilization. The manufacturing procedure can be divided into three steps, afirst diafiltration, fixation, preferably with paraformaldehyde, and a seconddiafiltration. In the first step, plasma proteins are removed from fresh orstored platelets or blood cells. The technique is gentle to prevent theactivation and aggregation of the platelets. Fixation stabilizes the plateletsto withstand freezing, lyophilization and subsequent reconstitution, and alsoprovides a viral and bacterial reduction. The second diafiltration removes theparaformaldehyde to indetectable levels, and suspends the platelets or bloodcells into a formulation buffer for subsequent lyophilization.
