Strengthening cGMP capabilities for microbiology and immunology clinical research in South America
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Design to Implementation Study for Development and Patient Validation of Paper-Based Toehold Switch Diagnostics
Published on: June 17, 2022
Susan M Bueno1, Pablo A González1, Alexis M Kalergis2
1Millennium Institute on Immunology and Immunotherapy, Facultad de Ciencias Biológicas, Pontificia Universidad Católica de Chile, Santiago, Chile.
Abstract:
In South America, few countries can produce vaccines and biologics for clinical research under current good manufacturing practices (cGMP), which is a significant barrier to translating applied microbiology and immunology research into clinical trials, as well as further licensing and commercialization. In this comment, we offer a perspective on the relevance of enhancing cGMP production capacities for clinical trials in addressing specific epidemiological challenges in South America.
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