BioNet Advances Pertussis Vaccine Agenda with EU-GMP Approval, Clinical Collaborations, and New Research Links

BioNet’s Manufacturing Accreditation Aligns with Growing International Efforts to Reinforce Pertussis Vaccine Supply

• BioNet earns EU-GMP certification for its acellular pertussis vaccine, confirming compliance with EU manufacturing and quality standards.
• Inspection by Ireland’s HPRA supports EMA review of BioNet’s recombinant vaccine candidate VacPertagen.
• Partnerships expanding: MoU with Indonesia’s Bio Farma to accelerate TdaP vaccine access across ASEAN.
• Innovation recognized: BioNet named BARDA Patch Forward Prize winner for its mRNA microneedle vaccine platform.
• Clinical progress: Reduced-dose recombinant pertussis vaccine under study with Chulalongkorn University.
• Global engagement: Participation at APS-MCV 2025 underscores BioNet’s regional leadership in vaccine development.

(NEWS) LYON, 29-Oct-2025 — /EuropaWire/ — BioNet has announced via EuropaWire that it has received European Union Good Manufacturing Practice (EU-GMP) certification, a key international benchmark confirming that its facilities and quality systems meet the stringent standards required for pharmaceutical manufacturing within the EU. The certification allows BioNet to produce its acellular pertussis vaccine in compliance with the European Union’s high-level quality and safety requirements.

The approval follows an inspection conducted by Ireland’s Health Products Regulatory Authority (HPRA), which verified that BioNet’s production site adheres to the EU’s strict criteria for manufacturing excellence and regulatory compliance. This achievement marks a significant step in the company’s ongoing efforts to gain European Medicines Agency (EMA) approval for its recombinant acellular pertussis vaccine candidate, known as VacPertagen.

Philippe Guillot-Chêne, BioNet’s CEO for Europe

Philippe Guillot-Chêne, BioNet’s CEO for Europe, described the certification as an important milestone demonstrating the company’s commitment to world-class manufacturing standards. He noted that the recognition supports the ongoing centralized regulatory review of VacPertagen by the EMA, potentially paving the way for broader European market access.

Dario Cresci, BioNet’s Director of Quality, highlighted the inspection’s positive outcome as a reflection of the company’s culture of excellence and dedication to providing public health authorities with reliable and innovative solutions to tackle the resurgence of pertussis globally.

BioNet, which has specialized in vaccine research and production for more than 25 years, is recognized as a leader in recombinant pertussis vaccine development. The company’s pertussis vaccine is already licensed and distributed in Asia under the brand name Pertagen® and has now been submitted under the VacPertagen name for EMA’s centralized evaluation process.

The EU-GMP certification not only underscores BioNet’s technical capabilities but also reinforces its role in supporting global immunization initiatives amid renewed concern over whooping cough outbreaks.

Advances in Pertussis Vaccine Research and Maternal Immunization

BioNet’s EU-GMP certification comes at a pivotal time for pertussis research and public health efforts worldwide. Recent scientific studies and expert reviews across Europe and the United States underscore the need for next-generation pertussis vaccines—particularly those using recombinant and genetically detoxified components like BioNet’s VacPertagen—to improve long-term protection and address resurgent outbreaks.

A growing body of evidence supports the superior quality of immune responses elicited by genetically detoxified pertussis toxin-containing vaccines compared to older, chemically detoxified formulations. In a study published on PubMed Central, researchers examined antibody avidity—the strength with which antibodies bind to the pertussis toxin—in pregnant women vaccinated during pregnancy. The results showed that those receiving recombinant, genetically detoxified acellular pertussis vaccines produced antibodies with significantly higher avidity, both in mothers and in their infants at birth and at two months of age. The findings suggest that these newer recombinant formulations, even at lower antigen concentrations, can generate equal or superior immune protection compared to conventional vaccines, highlighting the potential of genetic detoxification technologies in advancing maternal and infant immunization.

Complementing these findings, a European expert review published in Expert Review of Vaccines called for urgent improvements in pertussis vaccination strategies during pregnancy. The review noted that maternal immunization remains the most effective way to protect newborns—over 90% effective in preventing infant hospitalizations due to pertussis—yet uptake rates across Europe remain below optimal levels. It also emphasized that current Tdap vaccines were not originally designed for pregnancy and include unnecessary antigens such as tetanus and diphtheria. The experts advocated for the development of pertussis-only recombinant vaccines, which could improve vaccine acceptance, reduce side effects, and enhance long-lasting protection for infants. The review’s conclusions align closely with BioNet’s ongoing work to develop recombinant acellular pertussis vaccines specifically suited for global immunization programs.

Across the Atlantic, new research from The University of Texas at Austin has deepened the scientific understanding of pertussis immunity and how vaccines can be improved. Published in the Proceedings of the National Academy of Sciences, the study identified two key antibodies, hu11E6 and hu1B7, that neutralize pertussis toxin by blocking its binding and entry into human cells. Using advanced cryo-electron microscopy, the researchers mapped the exact epitopes—target sites on the toxin—where these antibodies attach. These discoveries could inform the design of future vaccines that more effectively train the immune system to target the most vulnerable parts of the toxin. According to lead researcher Professor Jennifer Maynard, incorporating these insights into recombinant vaccine design could strengthen immune responses, extend protection duration, and ultimately help re-establish herd immunity against the disease.

The study also highlighted the continuing global threat of pertussis, which has resurged following declines in vaccination rates during the COVID-19 pandemic. In 2024, outbreaks in regions including the U.S., Australia, and Europe led to sharp rises in infant hospitalizations. Public health experts attribute these trends to gaps in maternal immunization, waning immunity from current vaccines, and vaccine hesitancy. Researchers, including co-author Annalee W. Nguyen, stressed that prevention through maternal vaccination remains the most effective strategy to protect infants too young to be vaccinated, reinforcing the vital importance of sustained immunization efforts.

Together, these studies paint a clear picture: innovative recombinant vaccines like BioNet’s VacPertagen, bolstered by robust manufacturing standards and scientific validation, may represent the next critical step in preventing pertussis worldwide—particularly for vulnerable infants.

Recent Developments Strengthen BioNet’s Global Vaccine Leadership

BioNet’s recent EU-GMP certification for its acellular pertussis vaccine adds to a growing list of strategic milestones achieved by the Franco-Thai biotechnology group in 2025, underscoring its expanding influence across vaccine innovation, global partnerships, and clinical research.

Earlier this year, BioNet was selected as a Concept Stage winner of the U.S. Biomedical Advanced Research and Development Authority (BARDA) Patch Forward Prize, in collaboration with LTS Lohmann Therapie-Systeme AG. The $50 million initiative, part of BARDA’s Project NextGen, seeks to accelerate microneedle patch technologies for mRNA vaccines against influenza and COVID-19. BioNet and LTS received $2 million to advance their innovative vaccine delivery platform, which combines BioNet’s proprietary mRNA technology with LTS’s dissolvable microneedle patches. This system improves stability, accessibility, and potential self-administration — key elements in strengthening pandemic preparedness and global health resilience. “This recognition from BARDA underscores the transformative potential of BioNet’s mRNA vaccine platform,” said Bill Cadwallader, Vice President of Business Operations (North America), emphasizing the company’s agility in producing mRNA vaccines within days for research and clinical use.

Building on this success, BioNet entered into a strategic Memorandum of Understanding (MoU) with Indonesia’s state-owned PT Bio Farma (Persero) to co-develop and distribute a combined TdaP (tetanus, diphtheria, and recombinant acellular pertussis) vaccine across ASEAN countries. The partnership, signed during French President Emmanuel Macron’s state visit to Indonesia, combines BioNet’s proprietary recombinant pertussis antigens with Bio Farma’s extensive production capabilities and regulatory reach. The collaboration aims to reduce vaccine introduction timelines in the region from over a decade to less than five years, reinforcing regional vaccine self-sufficiency and accelerating equitable access. “By aligning our strengths, BioNet and Bio Farma are helping to build a stronger regional health ecosystem,” said Philippe Guillot-Chêne, CEO of BioNet Europe.

In parallel, BioNet continues to engage with the scientific community through forums such as the Asia-Pacific Summit on Medical and Clinical Vaccinology (APS-MCV 2025) in Taipei, where it will showcase new findings in bacterial vaccine innovation. The session “Pertussis Vaccine: A Story of Old & New,” presented by Assoc. Prof. Tawee Chotpitayasunondh, M.D., will highlight BioNet’s advancements in recombinant pertussis vaccine technology and its potential to counteract the ongoing resurgence of whooping cough across the region.

Further demonstrating its commitment to advancing public health through clinical innovation, BioNet is collaborating with Chulalongkorn University’s Faculty of Medicine on a clinical study evaluating a reduced-dose recombinant acellular pertussis vaccine. The new formulation lowers the antigen dose from 5 µg to 2 µg while maintaining equivalent immune protection. This breakthrough aims to make vaccination more affordable and accessible, particularly for pregnant women, adolescents, and adults with underlying health conditions, contributing to broader immunization coverage in Thailand and beyond.

Together, these developments reflect BioNet’s expanding global footprint and sustained leadership in vaccine innovation — from pioneering recombinant and mRNA technologies to building regional partnerships that enhance resilience and equity in global immunization efforts.