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Bivalent rLP2086 (Trumenba®): Development of a well-characterized vaccine through commercialization.

Abstract：

: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.

journal_name

Vaccine

journal_title

Vaccine

authors

Sunasara K,Cundy J,Srinivasan S,Evans B,Sun W,Cook S,Bortell E,Farley J,Griffin D,Bailey Piatchek M,Arch-Douglas K

doi

10.1016/j.vaccine.2017.03.100

subject

Has Abstract

pub_date

2018-05-24 00:00:00

pages

3180-3189

issue

22

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(17)30474-7

journal_volume

36

pub_type

杂志文章

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