Evaluation of effectiveness of solvent-detergent viral in activation in the manufacture of intravenous human immunoglobulin G in a model of virus diarrhea — mucosal disease of cattle

A V Kaz’yanin; Казьянин Александр Викторович; N V Zubkova; Зубкова Наталия Васильевна; I V Krasilnikov; Красильников Игорь Викторович; A K Lobastova; Лобастова Алла Константиновна; V V Anastasiev; Анастасиев Валентин Васильевич; A M Nikolaeva; Николаева Алла Максимовна; T I Glotova; Глотова Татьяна Ивановна; O V Kungurtseva; Кунгурцева Ольга Владимировна; A G Glotov; Глотов Александр Гаврилович

Evaluation of effectiveness of solvent-detergent viral in activation in the manufacture of intravenous human immunoglobulin G in a model of virus diarrhea — mucosal disease of cattle

Authors: Kaz’yanin AV¹, Zubkova NV², Krasilnikov IV³, Lobastova AK³, Anastasiev VV², Nikolaeva AM⁴, Glotova TI⁵, Kungurtseva OV⁵, Glotov AG⁵
Affiliations:
1. Federal budgetary institute “Perm State Pharmaceutical Academy”
2. FSUC “SIC Microgen” of MH RF Nizhniy-Novgorod Affiliate “ImBio”
3. FSUC “SIC Microgen” of MH RF
4. FSUC “SIC Microgen” of MH RF Perm Affiliate «Biomed»
5. Institute of Experimentally Veterinary Medicine of Siberia and Far East
Issue: No 4 (2013)
Pages: 24-30
Section: Articles
URL: https://journals.rudn.ru/medicine/article/view/3357

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Abstract

In model experiments using in vitro virus diarrhea — mucosal disease in cattle (bovine VD-MDC) studied the effectiveness of solvent-detergent (SD) virus inactivation used in the production of intravenous human immunoglobulin G (IgG). Optimized conditions for SD processing of immunoglobulin: the final concentration of tributylphosphate (TBP) 0.3% 0.2% sodium cholate, process temperature of 30 ± 1 °C to 36 ± 1 °C, incubation time 6 hours. The level of reduction of VD-MDC in the processing of the drug in these conditions was more than 6 log 10 TCD 50/ml.

Keywords

immunoglobulin, viral safety, solvent-detergent (SD) treatment, reduction of viruses, validation

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Vol 29, No 1 (2025)

Evaluation of effectiveness of solvent-detergent viral in activation in the manufacture of intravenous human immunoglobulin G in a model of virus diarrhea — mucosal disease of cattle

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Abstract

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About the authors

A V Kaz’yanin

N V Zubkova

I V Krasilnikov

A K Lobastova

V V Anastasiev

A M Nikolaeva

T I Glotova

O V Kungurtseva

A G Glotov

References

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