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
Plant 1 (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
Plant 2 (V-plant)		15,834㎡	· cGMP-compliant design and construction · Microorganism (200L, 500L, 600L and 1000L)

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  CMO Facilities Designed and constructed in compliance
  with EU-GMP and operated in compliance
  with the cGMP regulations.

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  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 The fill and finish product lines are available
  for aseptic filling with drug substance
  and final formulated bulk.

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  Analysis EuBiologics also provides quality testing services including physico
  - chemical analysis / microbiological analysis and protein analysis.