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- Farley, John, et al. Show all 11 Authors
- Vaccine 2018 v.36 no.22 pp. 3180-3189
- Neisseria meningitidis; antigens; clinical trials; commercialization; manufacturing; meningitis; models; process monitoring; serotypes; therapeutics; vaccines; United States
- ... The phrase “Process is the Product” is often applied to biologics, including multicomponent vaccines composed of complex components that evade complete characterization. Vaccine production processes must be defined and locked early in the development cycle to ensure consistent quality of the vaccine throughout scale-up, clinical studies, and commercialization. This approach of front-loading the de ...