At OmniParticles, our facilities are designed to support the entire development journey, from early-stage research to GMP-compliant manufacturing and sterile fill-finish. Our Seoul site houses a GMP drug substance manufacturing plant and a purpose-built sterile drug product suite aligned with the current EU GMP Annex 1.

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Key features of our facility include:

   • Two Manufacturing Suites : A GMP drug substance production plant and a purpose-built sterile drug product suite for aseptic fill-finish, covering all stages from R&D to GMP-level production.

   • Sterile Fill-Finish Environment : Grade A filling in open RABS (oRABS) within a Grade B classified background, with a fully single-use product-contact train and 0.2 µm sterilizing filtration with PUPSIT, aligned with the current EU GMP Annex 1.

   • Analytical Equipment : DLS, TEM, zeta-potential, HPLC (including SEC mode, triple detector) and ICP-MS for characterization and quality control.

   • Regulatory Readiness : Comprehensive GMP standard operating procedures and documentation to support compliance with global regulations.

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