Towards integrated production of an influenza A vaccine candidate with MDCK suspension cells

Seasonal influenza epidemics occur both in northern and southern hemispheres every year. Despite the differences virus surface antigens virulence of seasonal subtypes, manufacturers are well-adapted to respond this periodical vaccine demand. Due decades research, development new vaccines is relatively straight forward. In similarity with ongoing coronavirus disease 2019 pandemic, manufacturing a major bottleneck for rapid supply billions doses required worldwide. particular, egg-based production would be difficult schedule shortages other high demands also have anticipated. Cell culture-based systems enable large amounts within short time frame expand significantly our options pandemics emerging viral diseases. study, we present an integrated process inactivated A based on Madin–Darby Canine Kidney (MDCK) suspension cell line cultivated chemically defined medium. Very titers 3.6 log10(HAU/100 µl) were achieved using fast-growing MDCK cells at concentrations up 9.5 × 106 cells/ml infected A/PR/8/34 H1N1 1 L stirred tank bioreactors. combination membrane-based steric-exclusion chromatography followed by pseudo-affinity sulfated cellulose membrane adsorber enabled full recovery capture step 80% polishing step. Purified particles showed homogenous size distribution mean diameter 80 nm. Based monovalent dose 15 µg hemagglutinin (single-radial immunodiffusion assay), level total protein host DNA was 58 10 ng, respectively. Furthermore, all steps can fully scaled industrial quantities commercial either or pandemic vaccines. Fast 300 per liter 4–5 days makes competitive not only cell-based processes but as well.