Development of a pandemic H5N1 influenza vaccine using MDCK suspension cells: A scalable and efficient production platform

/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.