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Removal and inactivation of human immunodeficiency virus (HIV-1) by cold ethanol fractionation and pasteurization during the manufacturing of albumin and immunoglobulins from human plasma

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Abstract

Viral safety is a prerequisite for manufacturing clinical albumin and immunoglobulins from human plasma pools. This study was designed to evaluate the efficacy of cold ethanol fractionation and pasteurization (60°C heat treatment for 10 h) for the removal inactivation of human immunodeficiency virus type 1 (HIV-1) during the manufacturing of albumin and immunoglobulins. Samples from the relevant stages of the production process were spiked with HIV-1, and the amount of virus in each fraction was quantified by the 50% tissue culture infectious dose (TCID50). Both fraction IV fractionation and pasteurization steps during albumin processing were robust and effective in inactivating HIV-1, titers of which were reduced from an initial 8.5 log10 TCID50 to undetectable levels. The log reduction factors achieved were ≥4.5 and ≥6.5, respectively. In addition, fraction III fractionation and pasteurization during immunoglobulins processing were robust and effective in eliminating HIV-1. HIV-1 titers were reduced from an initial 7.3 log10 TCID50 to undetectable levels. The log reduction factors achieved in this case were ≥4.9 and ≥5.3, respectively. These results indicate that the process investigated for the production of albumin and immunoglobulins have sufficient HIV-1 reducing capacity to achieve a high margin of safety.

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Authors and Affiliations

  1. Technical Operations Service, Greencross Plasma Derivatives Corp., 227-3 Kugal-Ri, Kiheung-Eup, 449-900, Yongin City, Kyunggi-Do, Korea

    In Seop Kim, Ho Gueon Eo, Chong E. Chang & Soungmin Lee

  2. GreenCross Vaccine Corp., 227-3 Kugal-Ri, Kiheung-Eup, 449-900, Yongin City, Kyunggi-Do, Korea

    Chan Woo Park

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  1. In Seop Kim
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  2. Ho Gueon Eo
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  3. Chan Woo Park
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  4. Chong E. Chang
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  5. Soungmin Lee
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Correspondence to In Seop Kim.

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Kim, I.S., Eo, H.G., Park, C.W. et al. Removal and inactivation of human immunodeficiency virus (HIV-1) by cold ethanol fractionation and pasteurization during the manufacturing of albumin and immunoglobulins from human plasma. Biotechnol. Bioprocess Eng. 6, 25–30 (2001). https://doi.org/10.1007/BF02942246

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  • DOI: https://doi.org/10.1007/BF02942246

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