Optimization of preparation process for subunit influenza vaccine bulk solution
10.13200/j.cnki.cjb.004687
- VernacularTitle:亚单位流感疫苗原液制备工艺的优化
- Author:
Hongbin WU
1
Author Information
1. Jiangsu Huatai Vaccine Engineering Technology Research Co., Ltd., Taizhou 225300, Jiangsu Province, China
- Publication Type:Journal Article
- Keywords:
Subunit influenza vaccine;
Influenza virus;
Process optimization;
Ultrafiltration concentration;
Lysis
- From:
Chinese Journal of Biologicals
2026;39(04):481-485+493
- CountryChina
- Language:Chinese
-
Abstract:
Objective To optimize the preparation process of subunit influenza vaccine bulk solution, and provide reference for improving the virus titer, efficacy and safety of quadrivalent subunit influenza vaccine.MethodsThe inoculation and culture conditions(dilution factor, culture time, culture temperature), ultrafiltration concentration factor, and virus lysis conditions(lysis time, lysis temperature, sucrose concentration) for four types of influenza viruses(H1N1, H3N2, BY, BV)were optimized, and the effects of the above key influencing parameters on influenza virus proliferation were investigated.ResultsThe optimal dilution factors of the viruses were 10~(-3)-10~(-6)(inoculation concentration: 2. 0-5. 0 lgEID_(50)). The most suitable culture time was 48 h for influenza A H1N1 and H3N2 strains, and 60 h for influenza B BY and BV strains, with33 ℃ identified as the optimal temperature for all subtypes. The average protein recovery rate reached 84% after 20-fold ultrafiltration concentration. Triton N-101 achieved optimal lysis efficiency at a final concentration of 1. 0%, with an optimal lysis duration of 4 h. The optimal sucrose density range for collecting antigens was 10%-20%.ConclusionThrough the process optimization study of the subunit influenza vaccine, the vaccine has higher antigen purity and fewer impurities, which further improves the quality of the vaccine bulk solution while demonstrating significant immunogenicity and safety advantages.
