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Thromb Haemost 1995; 74(03): 868-873
DOI: 10.1055/s-0038-1649839
Original Article
Clinical Studies
Schattauer GmbH Stuttgart

“In vitro” and in Animal Model Studies on a Double Virus- Inactivated Factor VIII Concentrate

Silvana Arrighi
The SCLAVO SpA, R/D Haemoderivatives, Siena, Italy
,
Roberta Rossi
The SCLAVO SpA, R/D Haemoderivatives, Siena, Italy
,
Maria Giuseppina Borri
The SCLAVO SpA, R/D Haemoderivatives, Siena, Italy
,
Vladimir Lesnikov
1   The Institute of Exp. Med., R.A.M.S., St. Petersburg, Russia
,
Marina Lesnikov
1   The Institute of Exp. Med., R.A.M.S., St. Petersburg, Russia
,
Elena Franco
2   The Dept. Public Health, Tor Vergata University, Rome, Italy
,
Maurizio Divizia
2   The Dept. Public Health, Tor Vergata University, Rome, Italy
,
Maria Elena De Santis
3   The AIMA Derivati, St. Rufina, Rieti, Italy
,
Enzo Bucci
3   The AIMA Derivati, St. Rufina, Rieti, Italy
› Author Affiliations
Further Information

Publication History

Received 22 September 1994

Accepted after resubmission 02 May 1995

Publication Date:
09 July 2018 (online)

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Summary

To improve the safety of plasma derived factor VIII (FVIII) concentrate, we introduced a final super heat treatment (100° 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 (SID) 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.

 

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