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Hum Vaccin Immunother
. 2026 Dec 31;22(1):2679784.
doi: 10.1080/21645515.2026.2679784. Epub 2026 Jun 8.
Development of a pandemic H5N1 influenza vaccine using MDCK suspension cells: A scalable and efficient production platform
Shaobo Zhang 1 , Meihao Wang 2 , Dongwu Jin 2 , Jiayou Zhang 3 , Jiamin Wang 1 , Zhongren Ma 1 , Jinliang Yang 1
Affiliations
The persistent threat of H5N1 avian influenza pandemics necessitates the development of rapid and scalable vaccine manufacturing platforms as alternatives to traditional egg-based systems. We established a complete process for manufacturing an inactivated H5N1 vaccine using serum-free MDCK suspension cells, incorporating cell-line screening, systematic optimization of infection parameters, and scale-up in a bioreactor. High-titer virus propagation (1:1024 HA titer; 10.07 log10CCID50/mL) was achieved in a 75 L bioreactor within 48 h. A purification process employing ultrafiltration and two-step chromatography effectively reduced host cell protein and DNA to 2.20 µg/mL and 3.92 ng/mL, respectively. In a preliminary immunogenicity assessment, two immunizations with a 15 µg dose induced 100% seroconversion (geometric mean titer GMT = 183). This work demonstrates a scalable and efficient cell-based production platform for generating high-quality H5N1 vaccines, offering a promising strategy for pandemic preparedness.
Keywords: H5N1; MDCK suspension cells; immunogenicity; influenza vaccine; process optimization; virus purification.
. 2026 Dec 31;22(1):2679784.
doi: 10.1080/21645515.2026.2679784. Epub 2026 Jun 8.
Development of a pandemic H5N1 influenza vaccine using MDCK suspension cells: A scalable and efficient production platform
Shaobo Zhang 1 , Meihao Wang 2 , Dongwu Jin 2 , Jiayou Zhang 3 , Jiamin Wang 1 , Zhongren Ma 1 , Jinliang Yang 1
Affiliations
- PMID: 42258627
- DOI: 10.1080/21645515.2026.2679784
The persistent threat of H5N1 avian influenza pandemics necessitates the development of rapid and scalable vaccine manufacturing platforms as alternatives to traditional egg-based systems. We established a complete process for manufacturing an inactivated H5N1 vaccine using serum-free MDCK suspension cells, incorporating cell-line screening, systematic optimization of infection parameters, and scale-up in a bioreactor. High-titer virus propagation (1:1024 HA titer; 10.07 log10CCID50/mL) was achieved in a 75 L bioreactor within 48 h. A purification process employing ultrafiltration and two-step chromatography effectively reduced host cell protein and DNA to 2.20 µg/mL and 3.92 ng/mL, respectively. In a preliminary immunogenicity assessment, two immunizations with a 15 µg dose induced 100% seroconversion (geometric mean titer GMT = 183). This work demonstrates a scalable and efficient cell-based production platform for generating high-quality H5N1 vaccines, offering a promising strategy for pandemic preparedness.
Keywords: H5N1; MDCK suspension cells; immunogenicity; influenza vaccine; process optimization; virus purification.