Human Viral Challenge Agents
Human Viral Challenge Agents:
We can support you with cGMP HVCA manufacturing for your CHIM study
Human Viral Challenge Agent (HVCA) is a new modality which is used in a strictly controlled clinical trial to test prophylactic vaccines or curative treatments.
Controlled Human Infectious Models (CHIM) are already used in several countries such as the USA, the UK or Belgium.
Naobios extends its current service portfolio and proudly offers HVCA manufacturing to the biotech and pharmaceutical industry as well as to academic institutions and agencies like Bill and Melinda Gates Foundation, CEPI, WHO, and others.
GMP manufacturing
Naobios is uniquely suited for the manufactuing of Human Viral Challenge Agents :
- GMP-certified as a Pharmaceutical Establishment by the French Regulatory Agency ANSM,
- BSL2 and BSL3 manufacturing suites,
- Broad experience in bioprocess development and clinical manufacturing of a wide range of viral vectors on many cell lines,
- Full range of analytical testing in-house and with the support of Clean Cells.
Naobios regulatory approach is to manufacture HVCA following as close as possible the GMP requirements – performing risk-analysis for any technical gap identified.
CHIM Studies : How it works ?
With extensive quality control methods, and an experienced team, Naobios supplies safe, pure, and potent Human Viral Challenge Agents.
In this short video, discover the key steps of a CHIM study and how Naobios can support you for your HVCA manufacturing.
Please reach out to the team for additional information !