Low pH formulation of whole IgG antivenom: Impact on quality, safety, neutralizing potency and viral inactivation

Silvia Solano, Álvaro Segura, Guillermo León, José María Gutiérrez, Thierry Burnouf

研究成果: 雜誌貢獻文章同行評審

16 引文 斯高帕斯(Scopus)

摘要

Low pH treatment improves the tolerance to intravenous infusion, the stability, and the viral safety of various therapeutic immunoglobulins G preparations, but has never been evaluated for horse plasma-derived antivenoms. We have studied the impact of low pH formulation on the quality, safety, stability, potency and viral inactivation of a whole IgG antivenom used to treat viperid snake bite envenoming. Horse plasma-derived whole immunoglobulins purified by caprylic acid were incubated for 24 h at low pH in the presence of 4% sorbitol, then sterile-filtered and stored liquid at 2-8 °C. Appearance, aggregates, purity, safety tests in mice, venom antibody titre, and neutralization potency tests were controlled. Low pH treatment did not affect the physico-chemical characteristics, safety and potency of antivenom for at least 6 months of storage, but a major increase in aggregates was observed. In vitro antibody titre and in vivo neutralizing potency were maintained. There were ≥ 5.5 log inactivation of Herpes Simplex Virus-1, an enveloped virus, but no significant inactivation of the non-enveloped Poliovirus type 3. Low pH treatment appears feasible to improve the viral safety of antivenoms without affecting the neutralization potency. The possibility to formulate antivenoms at low pH requires further investigations to avoid formation of aggregates.
原文英語
頁(從 - 到)129-133
頁數5
期刊Biologicals
40
發行號2
DOIs
出版狀態已發佈 - 3月 2012
對外發佈

ASJC Scopus subject areas

  • 生物技術
  • 應用微生物與生物技術
  • 生物工程
  • 一般免疫學和微生物學
  • 藥理

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