       Document 0468
 DOCN  M9630468
 TI    Virus validation experiments on the production process of OCTAVI SDPlus.
 DT    9603
 AU    Biesert L; Lemon S; Suhartono H; Wang L; Rubsamen H;
       Chemotherapeutisches Forschungsinstitut Georg-Speyer-Haus,; Frankfurt am
       Main, Germany.
 SO    Blood Coagul Fibrinolysis. 1995 Jul;6 Suppl 2:S48-54. Unique Identifier
       : AIDSLINE MED/96076199
 AB    The inactivation of both transfusion-relevant and model viruses by
       modified pasteurization has been evaluated following the established
       guidelines of the European Union Committee for Proprietary Medical
       Products Ad Hoc Working Party on Biotechnology/Pharmacy. This heat
       treatment in solution for 10 h at 63 degrees C was introduced into the
       manufacturing process of OCTAVI, a very high purity factor VIII
       concentrate stabilized by von Willebrand factor. It could be
       demonstrated that both enveloped (human immunodeficiency virus, herpes
       simplex virus, pseudorabies virus) and non-enveloped viruses
       (poliovirus, coxsackievirus, hepatitis A virus) were inactivated by this
       heating step with an efficacy of greater than 4.5 log10 TCID50. The
       combination of the solvent/detergent step already used in the
       manufacture with this modified pasteurization leads to a double
       virus-inactivated factor VIII concentrate (OCTAVI SDPlus) with a viral
       safety distinctly superior to monoinactivated products.
 DE    *Antiviral Agents  Blood Banks/*STANDARDS  *Blood Donors  Blood
       Transfusion/*ADVERSE EFFECTS  Detergents  European Economic Community
       Factor VIII/*ISOLATION & PURIF  Guidelines  Heat  Human  Reproducibility
       of Results  Solvents  JOURNAL ARTICLE

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).

