BioNet Achieves EU-GMP Certification for its Pertussis Vaccine

BioNet Achieves EU-GMP Certification for its Pertussis Vaccine

(IN BRIEF) BioNet has achieved European Union Good Manufacturing Practice (EU-GMP) certification, a key international standard that validates its facilities and processes for producing high-quality pharmaceuticals. This certification, granted after inspection by Ireland’s Health Products Regulatory Authority (HPRA), allows BioNet to manufacture its acellular pertussis vaccine in compliance with stringent EU standards. The milestone supports the ongoing centralized review of its recombinant acellular pertussis vaccine candidate, VacPertagen, by the European Medicines Agency (EMA). BioNet, a global leader in recombinant pertussis vaccines, has been advancing vaccine innovation for 25 years and continues to collaborate with global partners to enhance access and manufacturing capacity. Its pertussis vaccine is already marketed in Asia under the name Pertagen® and is now under regulatory evaluation in Europe as VacPertagen.

(PRESS RELEASE) 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.

Media contact:

Mr Philippe Guillot-Chêne, BioNet, France.
Tel: +33 4 81 49 46 00
info@bionet.one
www.bionet.one

Website:

Logo:

BioNet logo

FAQs about BioNet’s EU-GMP Certification and VacPertagen Vaccine

1. What is EU-GMP certification and why is it important for BioNet?
EU-GMP (European Union Good Manufacturing Practice) certification is an internationally recognized standard ensuring that pharmaceutical products are consistently produced and controlled according to high-quality standards. For BioNet, this certification confirms that its manufacturing processes, facilities, and quality systems meet the strict criteria required for producing vaccines in the European market.

2. Which regulatory body conducted BioNet’s inspection for EU-GMP compliance?
The inspection was conducted by the Health Products Regulatory Authority (HPRA) of Ireland, which verified that BioNet’s production site adheres to the EU’s stringent quality and manufacturing requirements.

3. What vaccine does BioNet produce under this certification?
BioNet produces an acellular pertussis vaccine—a next-generation vaccine designed to protect against whooping cough. The vaccine has been developed using recombinant technology to ensure high efficacy and safety standards.

4. What is VacPertagen and how is it related to BioNet’s existing vaccine?
VacPertagen is the name under which BioNet’s recombinant acellular pertussis vaccine has been submitted for centralized regulatory review by the European Medicines Agency (EMA). The same vaccine is already licensed and marketed in Asia under the brand name Pertagen®.

5. How does this certification benefit BioNet’s global operations?
With EU-GMP certification, BioNet strengthens its position as a global leader in vaccine manufacturing. It enables the company to expand its reach into European markets, reinforces its reputation for quality, and supports its mission to provide innovative solutions to combat the resurgence of pertussis worldwide.

6. What does this milestone mean for public health?
The certification and EMA review signify progress toward making BioNet’s advanced pertussis vaccine more widely available. This could improve global protection against whooping cough, a disease that has been resurging in several parts of the world.

7. How long has BioNet been active in vaccine development?
BioNet has over 25 years of experience in vaccine research, development, and production, collaborating with global partners to accelerate technology access and strengthen vaccine manufacturing capabilities worldwide.

SOURCE: BioNet