GMP Manufacturing facilities

  • 4 GMP Fermentation suites (80-2200L)
  • 3 GMP Purification suites
  • 1 GMP 0.2 μm filtration suite
  • Classified clean rooms
  • Full traceability
  • QA and QP release

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Regulatory

All GMP material is produced in accordance to FDA 21 CFR Part 210 & 211, EU 2003/94/EC, Eudralex Vol 4, and relevant ICH; the regulatory requirements for sterile injectable products intended for human clinical trials and commercialization.

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