BioNet Receives EU-GMP Certification for Pharmaceutical Quality

Strategic Insights -

BioNet, a pioneering biotechnology group, has received European Union Good Manufacturing Practice (EU-GMP) certification, a benchmark of pharmaceutical quality and compliance, to produce its acellular pertussis vaccine. This milestone underscores BioNet's 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). The EU-GMP certification confirms that BioNet's facilities, quality systems, and quality controls meet the highest international criteria.

Key Takeaways:

  • BioNet's facilities, quality systems, and quality controls meet the highest international criteria for pharmaceutical quality and compliance.
  • The EU-GMP certification was received following an inspection by the Ireland Health Products Regulatory Authority (HPRA).
  • This achievement marks a key step in the centralized regulatory review of BioNet's recombinant acellular pertussis vaccine candidate, VacPertagen, by the European Medicines Agency (EMA).
  • The EU-GMP certification is a benchmark of pharmaceutical quality and compliance, recognized internationally.
  • BioNet's pertussis vaccine is licensed under Pertagen in Asia and has been submitted under VacPertagen to EMA centralized procedure in France.
  • BioNet has a long-standing culture of excellence and commitment to provide public health authorities with innovative solutions to the global pertussis resurgence.

Statistics:

  • 25 years of experience in fostering partnerships to accelerate access to technology and increase global vaccine capability.
  • 100% compliance with the highest international criteria for pharmaceutical quality and compliance.
  • 1 EU-GMP certification received by BioNet for its acellular pertussis vaccine production facility.
  • 1 inspection by the Ireland Health Products Regulatory Authority (HPRA) was conducted before receiving the EU-GMP certification.
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Sources:

  • BioNet (Source category: Biotechnology, Pharmaceuticals, Awards and Recognitions)
  • Ireland Health Products Regulatory Authority (HPRA)