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배양공정

삼성바이오로직스는 동물세포 배양을 기반으로 하는 임상 및 상업제품의 생산이 가능한 최신식 cGMP 설비를 갖추고 있습니다. 특히 다목적의 배양기(Versatile Bioreactors), 배지조제 탱크(HTST 사용가능), CIP 시스템은 교차 오염이 최소화하도록 설계되었습니다.

  • 중력 흐름을 기반으로 디자인된 설비
  • 연속적 전력 공급이 가능한 유틸리티
  • 특정제품 전용 독립된 플라스크 배양 시설
  • 배양기 :
    유가식 배양, 관류(Perfusion) 배양(N-1스텝, 3공장)
    다양한 첨가 라인, 다양한 범위의 스파징(Sparging)
    Single Use 배양기 / Stainless Steel 배양기(N-4 스텝)
  • 배지 조제 탱크(Media Prep. Tanks) :
    단시간 고온 멸균 처리가 가능한 설비(HTST) 구비
    독립적으로 분리된 배지 조제 구역
  • 세포회수 :
    Large Area Depth Filter 시스템, Hybrid-depth(1공장), 장비 이중화(원심분리기, Harvest Pool 탱크 등)
배양공정 사진 1 배양공정 사진 2
  • 배양공정 사진 1
  • 배양공정 사진 2
배양공정의 항목으로는 division, Plant 1, Plant 2, CMP, Plant 3 등 이 있습니다.
Plant 1 Plant 2 CMP Plant 3
Type Mammalian Mammalian Mammalian Mammalian
Total Capacity 30,000 L 150,000 L 2,000 L 180,000 L
Production Scale 5,000L (x 6) Three Trains 15,000L (x 10) Five Trains 1,000L (x 2) 15,000L (x 12) Six Trains
Bioreactor Type Stainless Steel Stainless Steel Stainless Steel Stainless Steel
Development Stage cGMP late clinical & commercial cGMP late clinical & commercial cGMP clinical cGMP late clinical & commercial
Plant Specifications
  • Shaker or Magnetic Stirring Flask Culture
  • Hybrid Depth Filtration System (POD, Typical Lenticular)
  • Cultivation Type: Fed-Batch
  • Shaker or Magnetic Stirring Flask Culture
  • Lenticular Depth Filtration System
  • Cultivation Type: Fed-Batch
-
  • Shaker or Magnetic Stirring Flask Culture
  • Lenticular Depth Filtration System
  • Cultivation Type: Fed-Batch, Perfusion
Operational Q3 2013 Q1 2016 2H 2016
Regulatory Compliance Global HA including FDA, EMA, PMDA, MFDS
배양공정의 항목으로는 Plant 1, Type, Total Capacity, Production Scale, Bioreactor Type, Development Stage, Development Stage, Plant Specification, Operational, Regulatory Compliance 등 이 있습니다.
Plant 1
Type Mammalian
Total
Capacity
30,000 L
Production
Scale
5,000L (x 6) Three Trains
Bioreactor
Type
Single use/Stainless Steel
Development
Stage
cGMP late clinical & commercial
Plant
Specification
  • Shaker or Magnetic Stirring Flask Culture
  • Hybrid Depth Filtration System (POD, Typical Lenticular)
  • Cultivation Type: Fed-Batch
Operational Q3 2013
Regulatory
Compliance
Global HA including FDA, EMA, PMDA, MFDS
배양공정의 항목으로는 Plant 2, Type, Total Capacity, Production Scale, Bioreactor Type, Development Stage, Plant Specification, Operational, Regulatory Compliance 등 이 있습니다.
Plant 2
Type Mammalian
Total
Capacity
150,000 L
Production
Scale
15,000L (x 10) Five Trains
Bioreactor
Type
Single use/Stainless Steel
Development
Stage
cGMP late clinical & commercial
Plant
Specification
  • Shaker or Magnetic Stirring Flask Culture
  • Lenticular Depth Filtration System
  • Cultivation Type: Fed-Batch
Operational Q1 2016
Regulatory
Compliance
Global HA including FDA, EMA, PMDA, MFDS
배양공정의 항목으로는 CMP, Type, Total Capacity, Production Scale, Bioreactor Type, Development Stage, Plant Specification, Operational, Regulatory Compliance 등 이 있습니다.
CMP
Type Mammalian
Total
Capacity
2,000 L
Production
Scale
1,000L (x 2)
Bioreactor
Type
Single use/Stainless Steel
Development
Stage
cGMP clinical
Plant
Specification
-
Operational 2H 2016
Regulatory
Compliance
Global HA including FDA, EMA, PMDA, MFDS
배양공정의 항목으로는 Plant 3, Type, Total Capacity, Production Scale, Bioreactor Type, Development Stage, Plant Specification, Operational, Regulatory Compliance 등 이 있습니다.
Plant 3
Type Mammalian
Total
Capacity
180,000 L
Production
Scale
15,000L (x 12) Six Trains
Bioreactor
Type
Single use/Stainless Steel
Development
Stage
cGMP late clinical & commercial
Plant
Specification
  • Shaker or Magnetic Stirring Flask Culture
  • Lenticular Depth Filtration System
  • Cultivation Type: Fed-Batch, Perfusion
Operational
Regulatory
Compliance
Global HA including FDA, EMA, PMDA, MFDS