Bivalent rLP2086 (Trumenba®): Development of a well-characterized vaccine through commercialization
| Autor: | Sriram Srinivasan, Brad Evans, John Farley, Eric Bortell, Weiqiang Sun, Khurram Sunasara, Daniel Griffin, Michele Bailey Piatchek, Scott Cook, Katherine Arch-Douglas, John Cundy |
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| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Process management Breakthrough therapy Drug Industry Computer science Meningococcal Vaccines Vaccine Production Meningitis Meningococcal Neisseria meningitidis Serogroup B Commercialization 03 medical and health sciences 0302 clinical medicine Humans 030212 general & internal medicine License Antigens Bacterial General Veterinary General Immunology and Microbiology Operating model Public Health Environmental and Occupational Health United States 030104 developmental biology Infectious Diseases Problem identification Meningococcal meningitis Molecular Medicine Accelerated approval |
| Zdroj: | Vaccine. 36(22) |
| ISSN: | 1873-2518 |
| Popis: | 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 development work helped facilitate the accelerated approval of the Biologic License Application for the well-characterized vaccine bivalent rLP2086 (Trumenba®, Pfizer Inc) in 2014 under Breakthrough Therapy Designation. Bivalent rLP2086 contains two rLP2086 antigens and is licensed for the prevention of meningococcal meningitis disease caused by Neisseria meningitidis serogroup B in individuals 10-25years of age in the United States. This paper discusses the development of the manufacturing process of the two antigens for the purpose of making it amenable to any manufacturing facility. For the journey to commercialization, the operating model used to manage this highly accelerated program led to a framework that ensured "right the first time" execution, robust process characterization, and proactive process monitoring. This framework enabled quick problem identification and proactive resolutions, resulting in a robust control strategy for the commercial process. |
| Databáze: | OpenAIRE |
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