LYON, 29-Oct-2025 — /EuropaWire/ — BioNet today announced it has received European Union Good Manufacturing Practice (EU-GMP) certification, an internationally recognized benchmark of pharmaceutical quality and compliance, to produce its acellular pertussis vaccine.

“This milestone underscores BioNet’s resolute dedication to world-class manufacturing standards and marks a key step in the ongoing centralized regulatory review of its recombinant acellular pertussis vaccine candidate, VacPertagen, by the European Medicines Agency (EMA).” said Philippe Guillot-Chêne, CEO, BioNet in Europe.

The EU-GMP certification confirms that BioNet’s facilities, quality systems and quality controls meet the highest international criteria.

“The certificate was received following the inspection of BioNet production site by the Ireland Health Products Regulatory Authority (HPRA).” added Dario Cresci, Director Quality. “This achievement reflects BioNet’s long-standing culture of excellence and commitment to provide public health authorities with innovative solutions to the global pertussis resurgence.”

About BioNet
BioNet is a pioneering biotechnology group that specialises in the development of next-generation vaccines. Leveraging its expertise in translational research and its GMP production facilities, BioNet is today the leading global manufacturer of recombinant pertussis vaccines. For 25 years, BioNet has fostered multiple partnerships to accelerate access to technology and to increase and expand global vaccine capability.

BioNet’s pertussis vaccine is licensed under Pertagen® tradename in Asia and has been submitted under VacPertagen name to EMA centralized procedure by BioNet in France.

SOURCE: EuropaWire