News & Events
Clean Mails – December 2022
Naobios, your partner in the production of Human Viral Challenge Agents
Nantes, France, 1st December 2022 – Naobios today announces its investment in the manufacturing of Human Viral Challenge Agents.
Human Viral Challenge Agents: a new modality for clinical studies
Human Viral Challenge Agent (HVCA) is a new modality which is used in a strictly controlled clinical trial to test a prophylactic vaccine or curative treatment. Controlled Human Infection Models (CHIM) are used in several countries such as the USA, the UK or Belgium. Manufacturing regulations for challenge agents differ however, depending on the country, ranging from GMP grade to non-medicinal product.
In response of a growing need, Naobios has invested to extend its current range of services and is now proud to offer challenge agent 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.
Meeting the most stringent guidelines regarding challenge agents
To meet the expectations of the most stringent regulations, Naobios regulatory approach regarding the manufacturing of the challenge agents is to be as close as possible to the GMP requirements and perform a risk-analysis for any technical gap identified.
Naobios is uniquely suited for the manufacturing of Human Viral Challenge Agents: it is a GMP-certified Pharmaceutical Establishment by the French Regulatory Agency ANSM, it has BSL2 and BSL3 manufacturing suites, and a broad experience in bioprocess development and clinical manufacturing of a wide range of viral vectors on many cell lines. Naobios can also perform the full range of analytical testing in-house required for challenge agents and with the support of Clean Cells, its sister company.
Naobios is already producing Human Viral Challenge Agents for an undisclosed CRO, which is a world leader in Controlled Human Infection Models (CHIM).