Research Of M007 Photochemical Virucidal Treatment On Plasma Virus Inactivation

In order to find the best irradiation device for M-007 photochemical virus inactivation for plasma,three different light sources were selected and their effect of virus inactivation and impact on coagulation factorâ…§in plasma were tested.They are Red LED sources,fluorescence lamp and White LED sources.The photosensitizer M-007,which had been designed and synthesized all by IBT of CAMS itself,was a new derivative of phenothiazine dye Methylene Blue that had been applied in virus inactivation for plasma in Europe for years.And,M007 had encouraging data in virus inactivation for red blood cell.In this experiment,it was Red LED sources that took least time to achieve 6 log of virus inactivation and,reserved most functionality of coagulation factorâ…§,which was the most sensitive one of plasma components.So, Red LED sources were selected for further exploration.To evaluate the new optimized method(M-007 plus Red LED) for virus inactivation of plasma,more experiments were conducted.The loss of other important coagulation factors,such as Fâ…§:C,Fâ…¤:C,Fbg:C, ATâ…¢were assayed,as well as the residual levels ofα₂-M in plasma.The residual activity or levels were 85.8±7.9%,87.66±10.78%, 80.29±2.92%,87.07±9.41%and 72.89±2.40%respectively.And the concentration of clottable fibrinogen in processed plasma was 72.98±8.49%,while the changes of APTT and PT were also studied and discussed.The levels of Anti-HBs in processed FFP were 86.37±25.12% compared with FFP,which were assayed by IRMA(immunoradiometric assay).At the same time,it was proven that there was no formation of new antigen in treated plasma by Native-PAGE of native and processed plasma and by double immunodiffusion.Conclusion:The method of M007 plus Red LED for virus inactivation established in this research does not affect the activity of major proteins in plasma significantly when it achieves sufficient virus reduction.Its clinical application is being expected.