Potency testing for a recombinant protein vaccine early in clinical development: Lessons from the Schistosoma mansoni Tetraspanin 2 vaccine

Potency testing for a recombinant protein vaccine early in clinical development: Lessons from the Schistosoma mansoni Tetraspanin 2 vaccine

Introduction: As a primary stability-indicating parameter, potency should be strategically evaluated during each phase of vaccine development. Herein, we present potency testing during the early clinical development of the Schistosoma mansoni (Sm) Tetraspanin-2 vaccine formulated on Alhydrogel (Sm-T...

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Bibliographic Details
Main Authors: Guangzhao Li, Lara Hoeweler, Brian Keegan, Jin Peng, Larissa Scholte, Peter Hotez, Maria Elena Bottazzi, David Diemert, Jeffrey Bethony
Format: Article
Language:English
Published: Elsevier 2021-08-01
Series:Vaccine: X
Subjects:
Vaccine
Potency
Compliance approach
Least-squares regression
Control charting
Bootstrap modeling
Online Access:http://www.sciencedirect.com/science/article/pii/S2590136221000176

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http://www.sciencedirect.com/science/article/pii/S2590136221000176

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