WebJSTOR Home WebJan 1, 2010 · The recommendations were most recently incorporated into a draft Guidance from FDA/CBER: “Draft Guidance for Industry: Characterization and Qualification …
Inactivation of viral antigens for vaccine preparation with particular ...
WebThe inactivation rates with binary ethylenimine prepared apart from the virus suspension in dilute sodium hydroxide with either 2-bromoethylamine hydrobromide or 2-chlorethylamine hydrochloride were higher than with pure ethylenimine. ... Application of binary ethylenimine in the preparation of foot-and-mouth disease vaccines considerably ... WebBinary ethylenimine (BEI) has been widely used as a virucide to inactivate viruses. For regulatory exclusion of a select agent, the United States Federal Select Agent Program (FSAP) requires an inactivation procedure that renders a select agent non-viable but allows the select agent to retain antigenic characteristics for future use must be validated, and … churchill group logo
Binary Ethylenimine Inactivated Japanese Encephalitis
WebJul 23, 2024 · The starting strains were obtained using ultraviolet (UV) irradiation and binary ethylenimine treatment followed by preparation of protoplasts, UV irradiation inactivation, multi-cell fusion, and fusion of the inactivated protoplasts to produce positive colonies. After two rounds of genome shuffling and the 96-PH method, six l-valine high ... WebApr 7, 2024 · To inactivate the clarified viruses, 3 mM binary-ethylenimine (Sigma-Aldrich, St. Louis, MO, USA) was added, and the mixture was incubated in a shaking incubator for 24 h at 26 °C . The inactivated viruses were treated with a final concentration of 7.5% polyethylene glycol 6000 (Sigma-Aldrich) and 0.5 M NaCl (Sigma-Aldrich) for 16 h at 4 °C. WebDec 2, 2024 · In this experimental study, cell mediated immune response and protective efficacy of binary ethylenimine (BEI) inactivated Montanide ™ ISA 206 adjuvanted pentavalent (BTV-1, 2, 10, 16 and 23) vaccine was evaluated in sheep and direct challenge with homologous BTV serotypes in their respective group. churchill group holdings