"In vitro" and in animal model studies on a double virus-inactivated factor VIII concentrate
Arrighi, S.; Rossi, R.; Borri, M.G.; Lesnikov, V.; Lesnikova, M.; Franco, E.; Divizia, M.; De Santis, M.E.; Bucci, E.
Thrombosis and Haemostasis 74(3): 868-873
1995
ISSN/ISBN: 0340-6245 PMID: 8571312 Document Number: 447050
To improve the safety of plasma derived factor VIII (FVIII) concentrate, we introduced a final super heat treatment (100 degree C for 30 min) as additional virus inactivation step applied to a lyophilized, highly purified FVIII concentrate (100 IU/mg of proteins) already virus inactivated using the solvent/detergent (S/D) method during the manufacturing process. The efficiency of the super heat treatment was demonstrated in inactivating two non-lipid enveloped viruses (Hepatitis A virus and Poliovirus 1). The loss of FVIII procoagulant activity during the super heat treatment was of about 15%, estimated both by clotting and chromogenic assays. No substantial changes were observed in physical, biochemical and immunological characteristics of the heat treated FVIII concentrate in comparison with those of the FVIII before heat treatment.