News & Events

Nantes, France and Geneva, Switzerland, March 9, 2026 – Naobios, a Contract Development and Manufacturing Organization (CDMO) providing bioprocess development and GMP production of clinical batches of virus-based products, and SGS (SIX:SIGN), the world’s leading testing, inspection and certification company, today announce their partnership in the manufacturing of a Respiratory Syncytial Virus (RSV) challenge agent for use in Controlled Human Infection Model (CHIM) studies conducted by SGS.

Produced under cGMP conditions, the Human Viral Challenge Agent (HVCA) is derived from a 2015 A-strain isolate that closely mirrors currently circulating RSV strains, with its realistic infection profile allowing researchers to generate robust, decision-enabling data on vaccine efficacy and immune response dynamics.

Naobios has already successfully completed the development, manufacturing and filling of several HVCAs for study use on the global market. HVCAs are used in strictly controlled clinical trials (or CHIM studies) in which healthy volunteers are intentionally given a carefully considered dose of a pathogen inoculated under rigorous ethical, regulatory and biosafety oversight to evaluate prophylactic vaccines or curative treatments.

These studies enable early and cost-efficient evaluation of RSV vaccines to prevent infection; in turn, this contributes to the accelerated development of effective and affordable vaccines against RSV.

To generate first-in-human proof-of-concept data, in October 2025 12 healthy participants were inoculated at the SGS Clinical Pharmacology Unit in Antwerp, Belgium, with the RSV A-strain challenge agent. The participants showed a 100% attack rate with mild, selfresolving pathology.

“In response to the growing use of CHIM studies, we have invested to extend our range of services, enabling us to meet the critical needs of clients worldwide,” said Eric Le Forestier, general manager of Naobios. “This partnership with SGS demonstrates that Naobios continues to be a key global player and first-choice partner for viral challenge agent manufacturing in accordance with cGMP.”

Naobios has a proven track record in HVCA, having successfully manufactured and released 36 GMP batches of HVCA – including for SARS-CoV-2, RSV and hMPV, and influenza, leveraging this innovative approach to accelerate the vaccine development process, with clinical evaluation conducted by specialized CHIM centers such as SGS.

“Controlled Human Infection Models are a powerful tool to de-risk and accelerate early vaccine development when conducted under the highest scientific, ethical and biosafety standards,” said Jelle Klein, Medical Director, SGS CPU. “Following GMP manufacturing of the RSV challenge agent by Naobios, SGS was responsible for the full clinical validation within a CHIM setting, including study design, clinical execution, safety oversight and virological assessments, enabling the generation of robust, decision-enabling data for RSV vaccine and antiviral development. The clear step-by-step approach of Naobios provided us with a solid overview on which assessments were performed, when they were
completed and what the results were. This provided us with full oversight of the process, allowing us to adjust clinical timelines based on emerging data.”

RSV is one of the world’s foremost causes of severe respiratory infections in infants, immunocompromised adults and the elderly, contributing to an estimated 64 million infections and 3.6 million hospitalizations globally each year. As health systems continue to face the burden of yearly RSV outbreaks, the need for agile development of effective vaccines and therapeutics has never been greater.

SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of 99,500 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and trusted specialized brands, including Brightsight, Bluesign, Maine Pointe and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN:SW).
www.sgs.com

Naobios is a Contract Development and Manufacturing Organization (CDMO) providing bioprocess development and offering GMP production of clinical batches of BSL2/BSL3 viral vaccines, oncolytic viruses, viral vectors and human viral challenge agents. Naobios joined the Clean Biologics group in 2019.
Having built up 20 years’ experience in bioprocess development, Naobios helps its clients to bring their drug candidates to the clinical stage as rapidly as possible – at the highest level of quality – whilst building on its technical know-how in scalable and industrial processes. With its adaptability and range of skills, the company can lead a project from the initial stages through to completion, with a motivated and dedicated team. Its highly qualified staff have the experience to deal with a wide range of viruses, as well as multiple cell substrate lines.
Naobios is based near Nantes, in Western France.