- Naobios, Nuvonis, and EVI have partnered with the Inno4Vac consortium to develop a GMP-compliant Human Viral Challenge Agent for influenza A(H3N2).
- The project aims to support Controlled Human Infection Model studies and improve the effectiveness of seasonal influenza vaccines.
Naobios, a contract development and manufacturing organisation (CDMO), has partnered with biotechnology company Nuvonis and the European Vaccine Initiative (EVI) to develop an influenza A(H3N2) Human Viral Challenge Agent. The collaboration forms part of the Inno4Vac consortium, which focuses on advancing new vaccine development models.
The initiative responds to the ongoing need for faster and more efficient influenza vaccine development. It will support the creation of a Controlled Human Infection Model (CHIM) for influenza A(H3N2), which exposes healthy adult volunteers to a well-characterised virus under clinical conditions to generate data on vaccine protection and immune responses.
Naobios will lead GMP production of the Human Viral Challenge Agent using Nuvonis’s GMP Vero Working Cell Bank. This approach removes the need for additional cell bank development and accelerates the manufacturing process. Vero cells are widely recognised by regulatory authorities, including the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), as a reliable substrate for vaccine production.
Christina Nicolodi, CEO of Nuvonis, said: “Our GMP Vero Working Cell Bank will play a crucial role in accelerating the GMP manufacturing process by eliminating the need for time-consuming cell bank production and reducing the associated risks and costs.”
Naobios has previously delivered more than 30 GMP batches of Human Viral Challenge Agents, including a Respiratory Syncytial Virus (RSV) challenge agent in collaboration with Inno4Vac. The new influenza project reinforces its long-standing partnership with EVI and expands its role in supporting innovative vaccine development.
