BioNet Advances Pertussis Vaccine Agenda with EU-GMP Approval, Clinical Collaborations, and New Research Links
Nov 5, 10:20am
BioNet has recently made significant strides in its pertussis (whooping cough) vaccine agenda, marked by several key achievements:
1. EU-GMP Certification
BioNet received European Union Good Manufacturing Practice (EU-GMP) certification for its acellular pertussis vaccine. This certification is a globally recognized benchmark for pharmaceutical quality and compliance, enabling BioNet to produce its vaccine to the highest international standards. The certification also supports the ongoing review of BioNet’s recombinant pertussis vaccine candidate, VacPertagen, by the European Medicines Agency (EMA).
2. Clinical Collaborations
BioNet is collaborating with Chulalongkorn University’s Faculty of Medicine on a clinical study evaluating a reduced-dose recombinant acellular pertussis vaccine, aiming to address the resurgence of whooping cough in the region.
The company has also signed a strategic Memorandum of Understanding (MoU) with Indonesia’s Bio Farma to expand access to TdaP (tetanus, diphtheria, and acellular recombinant pertussis) vaccines in ASEAN, leveraging BioNet’s recombinant technology and Bio Farma’s manufacturing capabilities.
BioNet’s vaccine, Pertagen®, is already marketed in Asia and is part of Thailand’s maternal immunization program. The vaccine is also under regulatory evaluation in Europe and Australia.
3. New Research and Regulatory Milestones
BioNet’s recombinant pertussis vaccine has been submitted to the EMA for centralized approval, with clinical trials demonstrating its safety, immunogenicity, and antibody persistence in adults, adolescents, pregnant women, and the elderly.
The company’s proprietary genetically detoxified pertussis toxin (PTgen) technology has shown superior immune response compared to leading marketed vaccines, positioning BioNet’s vaccine as a best-in-class option for pertussis prevention.
BioNet was also 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, further validating its innovative approach.
4. Addressing Global Health Challenges
The EU-GMP certification and ongoing research are particularly timely, as pertussis cases are surging globally, with over 60,000 reported in Europe alone. BioNet’s advancements are seen as crucial in supporting global immunization initiatives and improving protection against whooping cough, especially among vulnerable populations.
Would you like more details on any specific aspect of BioNet’s pertussis vaccine developments?
Nov 5, 10:21am
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