News & Events

Clean Mails – February 2024

Extending biomanufacturing capacity for human challenge studies

Human challenge studies represent an exciting new modality to accelerate vaccine development by reproducing viral infection in a strictly controlled clinical environment. Using Controlled Human Infection Models (CHIM), the objective is to test prophylactic or curative options and gain valuable insights into a virus’ behavior in humans, thus tackling existing or emerging health threats.

Backed by a $1.87M (€1.7M) grant from the Bill & Melinda Gates Foundation, Naobios is proud to announce the extension of biomanufacturing capacities to generate viral agents  for human challenge studies (or human viral challenge agents – HVCA), providing the support to this growing evaluation strategy.

The context of human challenge trials

Already implemented in many countries (such as the UK, the USA, Belgium and the Netherlands), human challenge studies involve the careful selection of volunteers, a controlled environment of testing and monitoring, and strains of viral challenge agents meeting the highest quality standards. To tackle ethical challenges and ensure safety, the material must be produced using proven bioprocesses and undergo extensive characterization before entering challenge studies.

Bringing cGMP experience to HVCA manufacturing

As a lead CDMO, Naobios has developed a broad expertise for the bioprocess development, biomanufacturing and QC testing of viruses used for viral vaccination, gene therapy and oncolytic virus therapy.

With the knowledge accumulated about virus manufacturing in a cGMP framework, Naobios’ approach to supply HVCA for human challenge trials is to have a cGMP approach to challenge agents production, while using a risk-analysis strategy for any technical gap encountered. This ensures that the highest regulatory standards are met to produce HVCA and use them in human challenge studies worldwide.

With extensive quality control methods, and an experienced team, Naobios supplies safe, pure, and potent HVCA to the biopharmaceutical industry, academic institutions, Clinical Research Organisations, foundations, and international organizations (CEPI, WHO, etc.). Our BSL-2 and BSL-3 laboratories provide an invaluable environment to produce strains of all relevant biosafety levels for all types of human challenge studies.

Track-record and anticipated developments

As the trusted partner of the world leader in Controlled Human Infection Models (CHIM), Naobios has already built a track-record of cGMP HVCA manufacturing. With the trust of the Bill & Melinda Gates Foundation, Naobios is looking at expanding its biomanufacturing capacity for human challenge trials to confirm its position as world leader in HVCA manufacturing.

As part of the Clean Biologics group, Naobios is part of a network of bioprocess and analytical development experts, able to support any regulatory development and provide the safest material for human challenge studies.