Facility Overview
OmniParticles
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.
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.
Drug Substance GMP Facility
GMP Manufacturing Plant
GMP Production Area
Analysis Area
Equipment Area
QC Area
Drug Product GMP Facility
Aseptic Filling Area
Compounding Area
Sterility Testing Area
Material Transfer & Sterilization Area
