Viral Safety of Plasma-derived Blood Products. I. Efficiency of Virus Inactivation/Elimination during Manufacturing Process of Monoclonal Antibody-purified Freeze-Dried Coagulation Factor VIII Concentrate(CROSS EIGHT M).

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  • 血しょう分画製剤の安全性に関する検討　　Ｉ．　モノクローナル抗体精製乾燥濃縮人血液凝固第ＶＩＩＩ因子製剤（クロスエイトＭ）の製造工程におけるウイルスの不活化／除去効果について
  • I. Efficiency of Virus Inactivation/Elimination during Manufacturing Process of Monoclonal Antibody-purified Freeze-Dried Coagulation Factor VIII Concentrate (CROSS EIGHT M<sup>®</sup>)
  • I. モノクローナル抗体精製乾燥濃縮人血液凝固第VIII因子製剤 (クロスエイトM<sup>®</sup>) の製造工程におけるウイルスの不活化/除去効果について

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CROSS EIGHT M® is a monoclonal antibody-purified factor VIII concentrate produced by the Japanese Red Cross from donated blood plasma. During its manufacture, viruses are expected to be inactivated and eliminated by either solvent/detergent (S/D) treatment or both immunoaffinity and anion exchange chromatography.<br>To validate virus inactivation/elimination during the manufacture of CROSS EIGHT M®, the amount of virus spiked in the manufacturing materials was measured before and after treatment, and the efficiency of virus clearance was calculated for each step. The viruses used were as follows: sindbis virus (SIN), vesicular stomatitis virus (VSV), human immunodeficiency virus type 1 (HIV-1), hepatitis B virus (HBV) and herpes simplex virus type 1(HSV-1) as enveloped viruses; and hepatitis A virus (HAV) and polio virus (Polio V) as non-enveloped viruses.<br>The result shows that enveloped viruses were effectively inactivated to below detection level after S/D treatment with logarithmic reduction values (LRVs) of 5.6 in SIN, >4.4 in VSV, >5.2 in HSV-1 and >4.9 in HIV-1. In contrast, non-enveloped viruses were not inactivated by S/D treatment. Using the immunoaffinity chromatography process, both enveloped and non-enveloped viruses were eliminated with the LRVs of >3.1 in polio V, >5.4 in VSV, >4.4 in SIN, 4.5 in HAV and 5.4 in HBV. LRVs with anion exchange chromatography varied among viruses, from 0 in HAV to 1.9 in Polio V, depending on the condition of the viral particles.

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Details 詳細情報について

  • CRID
    1390282679885442816
  • NII Article ID
    130003706998
  • DOI
    10.3925/jjtc1958.45.349
  • ISSN
    18838383
    05461448
  • Text Lang
    ja
  • Data Source
    • JaLC
    • Crossref
    • CiNii Articles
  • Abstract License Flag
    Disallowed

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