Document 0640
 DOCN  M9460640
 TI    Validation of virus inactivation and removal for the manufacturing
       procedure of two immunoglobulins and a 5% serum protein solution treated
       with beta-propiolactone.
 DT    9404
 AU    Dichtelmuller H; Rudnick D; Breuer B; Ganshirt KH; Biotest Pharma GmbH,
       Dreieich, Germany.
 SO    Biologicals. 1993 Sep;21(3):259-68. Unique Identifier : AIDSLINE
       MED/94161952
 AB    Intravenous immunoglobulins and serum protein solutions are manufactured
       from human plasma pools of healthy, screened donors. A step-by-step
       validation of virus removal and/or inactivation was performed for the
       manufacturing process, which includes cold ethanol fractionation,
       beta-propiolactone (beta-PL) treatment, UV irradiation, thermal
       inactivation and other chemical and physical purification steps. The
       total viral clearance factors achieved for the entire manufacturing
       process were by several magnitudes greater than the potential virus load
       of current plasma pools. Human immunodeficiency virus 1 (HIV-1)
       infectivity was reduced by > 13.4 log for 7S immunoglobulin, > 15.3 log
       for IGM enriched immunoglobulin and > 16 log for a 5% serum protein
       solution. In addition, high clearance rate for a broad spectrum of model
       viruses was demonstrated for all three blood derivatives being > 23.2 to
       > 27.8 log for pseudo rabies virus (PSR), > 12.3 to > 22.6 log for
       vesicular stomatitis virus (VSV) and 6.9-10.6 log for simian virus 40
       (SV40). For the beta-propiolactone inactivation step Hepatitis C model
       viruses, e.g. equine arteritis virus (EAV) and bovine viral diarrhoea
       virus (BVDV) were also investigated.
 DE    Blood/*MICROBIOLOGY  Blood Proteins/*ISOLATION & PURIF  Cells, Cultured
       Cold  Drug Contamination  Human  IgG/ISOLATION & PURIF  IgM/ISOLATION &
       PURIF  Immunoglobulins/*ISOLATION & PURIF  Propiolactone/*PHARMACOLOGY
       Viruses/*DRUG EFFECTS  JOURNAL ARTICLE

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