Funding drives viral challenge agent development forward

CDMO Naobios, a provider of bioprocess development and GMP production of clinical batches of virus-based products, has plans to manufacture a human viral challenge agent for evaluating the effectiveness of vaccines in preventing infections. With the support of a $1.87M (€1.7M) grant from the Bill & Melinda Gates Foundation, this approach will also accelerate the vaccine development process in support of vaccine development.

The viral challenge agent, an Omicron variant SARS-CoV-2 virus manufactured by Naobios for the foundation, will be used to conduct a Controlled Human Infection Model (CHIM) study. The aim is to support the development of low-cost effective mucosal vaccines to stop respiratory virus transmission, which, with greater breadth, can be deployed to outbreak areas, typically in Low-to-Middle Income Countries (LMICs), to prevent widespread infection.

The manufacture of Naobios’ viral challenge agent will be followed by stability testing for a period of three years.

“Naobios is excited to receive support from the Bill & Melinda Gates Foundation in its drive to accelerate the development and commercialisation of novel vaccines and the sustainable manufacture of existing vaccines,” said Eric Le Forestier, general manager of the French company.  “With our experienced team, BSL3 suite and track record in successfully manufacturing several viral strains of challenge agents, we look forward to delivering on this project.”

CHIM studies are increasingly used in several countries such as the US, the UK, the Netherlands and Belgium to investigate all aspects of the course of an infection. In response to this growing need Naobios, situated in Saint Herblain, has invested in extending its current range of services; the company can now offer viral challenge agent manufacturing according to the principles of GMP. It supplies the development and manufacturing of viral challenge agents to global markets.

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