Ysaline Roland | Head of Bioprocess Department
NAOBIOS

Day 2 (21st October) @ 11:30

Considerations on the development and manufacturing qualities of Human Viral Challenge Agents (HVCA)

Human Viral Challenge Agents (HVCA) are a new modality used in strictly controlled clinical trials to test prophylactic vaccines or curative treatments in human infection studies (also known as Controlled Human Infection Models (CHIM) studies). These studies are experimental trials in which healthy human volunteers are deliberately exposed to a pathogen, called “the challenge agent”. As the infectious organisms are inoculated to healthy humans, the development and manufacturing processes of a challenge agent must ensure the highest level of quality in order to guarantee participant safety, trial reproducibility and product efficacy. For this reason, Naobios has opted to follow the strict GMP requirements for the manufacturing of these HVCA. 

Naobios is offering its expertise on the development and manufacturing of human viral challenge agents to CROs and consortia composed of academic laboratories, biotechnology and pharmaceutical companies. Based on case studies, find out how developing and manufacturing a challenge agent is a complex task and what are the key points to consider making your project a success. 

Session led by: Clean Biologics Group

Ysaline Roland, Head of Bioprocess Department, NAOBIOS

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Ysaline Roland / Considerations on the development and manufacturing qualities of Human Viral Challenge Agents (HVCA)

Ysaline Roland, Head of Bioprocess Department,
NAOBIOS

Ysaline ROLAND, MSc, Head of Bioprocess Department at Naobios, since december 2025, is in charge of planning and execution of process development and clinical manufacturing activities for virus-based products at lab, pilot and manufacturing scale. Previously she was Head of Production. Thanks to...

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