Vaccines

Qualification and quality assurance for sterile vaccine production

For Moderna, the PBE Expert team qualified the manufacturing equipment, clean utilities and HVAC for bulk sterile mRNA vaccine production, along with quality assurance, procedure writing and risk analysis.

  • FDA
  • EMA
  • Health Canada
Two specialists in sterile garments in a laboratory

Project fact sheet

Client
Moderna
Location
Montreal, Quebec
Years
2024
Engagement
Qualification (C&Q) and quality assurance
Facility
Bulk sterile mRNA vaccine
Next project · Dakar, SenegalInstitut PasteurSince 2021, the PBE Expert team has supported Institut Pasteur de Dakar’s vaccine manufacturing program: a sterile BSL-2 plant, then the Vaccinopole.

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