CMO service

Sustainable Growth of
STgen Bio

+

Well trained
manpower

+

Liter of cell
capacity a)

+

Clinical projects
(KR, JP, EU, US) b)

+

Commercial products
(KR, JP) c)

  • a - Plan to expand facility to 9,000L (2023 Q3)
  • b - Biosimilar: 10; New Biologics: 1 (DS: 4, DP: 7)
  • c - Biosimilar: 3; New Biologics: 1 (DS: 1, DP: 3)
  • Regulatory Approvals

  • Regulatory compliance track records with approval by health authorities including Japan PMDA, Turkey MoH, and Korea MFDS
  • EU QP audits for investigational medicinal products
  • Pre-approval inspection by FDA and EMA (planned in 2023)
  • 0%