eubiologics

CRMO

Contract R&D and Manufacturing Organization
Speed up development & market launching by specialized CRMO Service

Service Overview

Production Facilities

The EuBiologics Production facilities are designed and established in compliance with EU-GMPs, and managed and operated by the quality assurance system under
the cGMP regulations and guidelines.
These facilities consisting of a culture room, a fermentation room, a harvest room and a purification room have been strictly operated to maintain optimal conditions
to maximize production efficiency and product stability.

Plant Overview

Facilities Facilities Total Area Features
C-Plant
Plant 1 (C-Plant)
C-Plant 3,734㎡ · EU GMP-compliant design and construction
· Microorganism (100L and 600L),
Animal Cell (30L, 100L, 200L and 1000L) and Fill-Finish facilities
V-Plant
Plant 2 (V-plant)
V-Plant 15,834㎡ · cGMP-compliant design and construction
· Microorganism (200L, 500L, 600L and 1000L)
  • CMO Facilities
    CMO Facilities Designed and constructed in compliance
    with EU-GMP and operated in compliance
    with the cGMP regulations.
  • Production Facilities
    Production Facilities Consist of animal cell culture,
    microorganism fermentation
    and purification suites that are strictly
    operated to maintain optimal conditions
    to maximize work efficiency and product stability.
  • Fill and Finish Facilities
    Fill and Finish Facilities The fill and finish product lines are available
    for aseptic filling with drug substance
    and final formulated bulk.
  • Analysis
    Analysis EuBiologics also provides quality testing services including physico
    - chemical analysis / microbiological analysis and protein analysis.