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Cell Culture

Samsung BioLogics possesses advanced cGMP facilities that can provide clinical and commercial products based on mammalian cell culture. Our Versatile Bioreactors, Media Prep Tanks (HTST available), and CIP Systems are made with minimum cross-contamination design.

  • Facility Design based on Gravity Flow
  • Plant utility committed to providing constant power supply
  • Separate Flask Culture Suites (Made for Specific Products)
  • Bioreactor:
    Fed-Batch, Perfusion (N-1 Step, Plant#3),
    Various Addition Lines, Wide range of Sparging
    Single use/Stainless Steel bioreactor at N-4 step
  • Media Prep Tanks:
    HTST (High Temperature Short Time) Capability,
    Segregated Special Media Prep Area
  • Harvest:
    Large Depth Filter Area, Hybrid-depth (Plant#1),
    Dual Equipment (Centrifuge, Harvest Pool, etc.)
Cell Culture Photo 1 Cell Culture Photo 2
  • Cell Culture Photo 1
  • Cell Culture Photo 2
Cell Culture Facility Specifications items include division, Plant 1, Plant 2, CMP, Plant 3 and so on.
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
Cell Culture Facility Specifications items include Plant 1, Type, Total Capacity, Production Scale, Bioreactor Type, Development Stage, Plant Specifications, Operational, Regulatory Compliance, and so on.
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
Specifications
  • 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
Cell Culture Facility Specifications items include Plant 2, Type, Total Capacity, Production Scale, Bioreactor Type, Development Stage, Plant Specifications, Operational, Regulatory Compliance, and so on.
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
Specifications
  • 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
Cell Culture Facility Specifications items include CMP, Type, Total Capacity, Production Scale, Bioreactor Type, Development Stage, Plant Specifications, Operational, Regulatory Compliance, and so on.
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
Specifications
-
Operational 2H 2016
Regulatory
Compliance
Global HA including FDA, EMA, PMDA, MFDS
Cell Culture Facility Specifications items include Plant 3, Type, Total Capacity, Production Scale, Bioreactor Type, Development Stage, Plant Specifications, Operational, Regulatory Compliance, and so on.
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
Specifications
  • 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