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Purification

Samsung BioLogics’ cGMP Drug Substance Downstream Purification consists of two facilities with the newest equipment for cGMP operations, including chromatography (e.g., affinity, ion-exchange, multi-modal), viral filtration, ultrafiltration / diafiltration (UF/DF), and formulation and bulk filling operations. Both facilities consist of physically segregated pre-viral and post-viral suites designed for maximum flexibility and minimum turnover time.

Each downstream facility can be adjusted to accommodate all customer process needs. All purification facilities are classified as Grade C or higher. The design minimizes opportunities for cross-contamination with physically segregated pre-viral and post-viral suites containing equipment dedicated to cleaning areas and a Grade B bulk fill room. Three separate column packing suites support optimization of production cadence. The high-capacity buffer preparation suites are designed for temperature control and contain hold tank sizes to handle buffer preparations up to 15,000 L. The downstream suites are equipped with chromatography skids, columns, UF/DF skids, virus filtration skids, and Grade A (laminar flow booth) bulk filling capacity as well as product pool vessel capacities from 200 L to 15,000 L to handle a wide range of pool volumes and high protein titers. Our purification process is supported by industry leading automation solutions.

All processes are cGMP-compliant and meet the regulations of U.S. FDA, EMA and local authorities. Samsung BioLogics' dedication to quality and optimal services is visible in everything we do, from small-scale clinical trials to large-scale commercial productions.

  • Facility design based on gravity flow
  • Plant dedicated utility committed to providing constant power supply
  • Chromatography:
    Affinity, Ion Exchange, Hydrophobic, Multi-modal
    Columns range : 0.8m to 1.8m in diameter
    Automation controls integrated with MCS
    Columns to accommodate all range of sizes
  • Dedicated equipment for Pre-Viral and Post-Viral areas for cross-contamination control
    COP and glassware parts washers
    Autoclaves
    Utility station with CIP and SIP capabilities for portable equipment
    CIP and SIP capabilities for all production equipment
  • VF Operation:
    Fully automated
    Hybrid design to accommodate any configuration
  • UFDF Operation:
    Fully automated
  • In line and off line Recirc vessel capability
  • Bulk Fill
  • Dedicated Grade B/A space
Purification img 1 Purification img 2
  • Purification img 1
  • Purification img 2
Purification 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
Equipment
  • Chromatography Skids, Columns
  • UF/DF, VF Skids
  • Product Vessels
  • Buffer Prep. / Hold Vessels
  • CIP Systems
  • SIP full capacity
  • COP/GWD Cabinets, Autoclaves
  • Chromatography Skids, Columns
  • UF/DF, VF Skids
  • Product Vessels
  • Buffer Prep. / Hold Vessels
  • CIP Systems
  • SIP full capacity
  • COP/GWD Cabinets, Autoclaves
  • Chromatography Skids, Columns
  • Hybrid UF/DF skids
  • Single use VF skid
  • Product Pool Containers
  • Buffer Prep. / Hold Containers
  • Autoclaves
  • GWD
  • Chromatography Skids, Columns
  • UF/DF, VF Skids
  • Product Vessels
  • Buffer Prep. / Hold Vessels
  • CIP Systems
  • SIP full capacity
  • COP/GWD Cabinets, Autoclaves
Capacity/Capability
  • Small to large scale
  • Closed sampling
  • Chemical additions
  • Temp control 2-37℃
  • Class B/A Bulk Fill
  • Portable Equip stations
  • Cryo Freezing Tank/Bag/Bottle
  • Large Scale
  • Closed sampling
  • Chemical additions
  • Temp control 2-37℃
  • Class B/A Bulk Fill
  • Portable Equip stations
  • Cryo Freezing Tank/Bag/Bottle
  • Chemical additions
  • Temp Control 2-37 ℃
  • Class B/A Bulk Fill
  • 2 Purification Suites
  • Large Scale
  • Closed sampling
  • Chemical additions
  • Temp control 2-37℃
  • Class B/A Bulk Fill
  • Portable Equip stations
  • 2 Purification Suites
  • Cryo Freezing Tank/Bag/Bottle
Development Stage cGMP late clinical & commercial cGMP late clinical & commercial cGMP Clinical cGMP late clinical & commercial
Operational Q3 2013 Q1 2016 2H 2016
Regulatory Compliance Global HA including FDA, EMA, PMDA, MFDS
Purification Specifications items include Plant 1, Type, Equipment, Capacity/Capability, Development Stage, Operational, Regulatory Compliance, and so on.
Plant 1
Type Mammalian
Equipment
  • Chromatography Skids, Columns
  • UF/DF, VF Skids
  • Product Vessels
  • Buffer Prep. / Hold Vessels
  • CIP Systems
  • SIP full capacity
  • COP/GWD Cabinets, Autoclaves
Capacity/Capability
  • Small to large scale
  • Closed sampling
  • Chemical additions
  • Temp control 2-37℃
  • Class B/A Bulk Fill
  • Portable Equip stations
  • Cryo Freezing Tank/Bag/Bottle
Development Stage cGMP late clinical & commercial
Operational Q3 2013
Regulatory Compliance Global HA including FDA, EMA, PMDA, MFDS
Purification Specifications items include Plant 2, Type, Equipment, Capacity/Capability, Development Stage, Operational, Regulatory Compliance, and so on.
Plant 2
Type Mammalian
Equipment
  • Chromatography Skids, Columns
  • UF/DF, VF Skids
  • Product Vessels
  • Buffer Prep. / Hold Vessels
  • CIP Systems
  • SIP full capacity
  • COP/GWD Cabinets, Autoclaves
Capacity/Capability
  • Large Scale
  • Closed sampling
  • Chemical additions
  • Temp control 2-37℃
  • Class B/A Bulk Fill
  • Portable Equip stations
  • Cryo Freezing Tank/Bag/Bottle
Development Stage cGMP late clinical & commercial
Operational Q1 2016
Regulatory Compliance Global HA including FDA, EMA, PMDA, MFDS
Purification Specifications items include CMP, Type, Equipment, Capacity/Capability, Development Stage, Operational, Regulatory Compliance, and so on.
CMP
Type Mammalian
Equipment
  • Chromatography Skids, Columns
  • Hybrid UF/DF skids
  • Single use VF skid
  • Product Pool Containers
  • Buffer Prep. / Hold Containers
  • Autoclaves
  • GWD
Capacity/Capability
  • Chemical additions
  • Temp Control 2-37℃
  • Class B/A Bulk Fill
  • 2 Purification Suites
Development Stage cGMP Clinical
Operational 2H 2016
Regulatory Compliance Global HA including FDA, EMA, PMDA, MFDS
Purification Specifications items include Plant 3, Type, Equipment, Capacity/Capability, Development Stage, Operational, Regulatory Compliance, and so on.
Plant 3
Type Mammalian
Equipment
  • Chromatography Skids, Columns
  • UF/DF, VF Skids
  • Product Vessels
  • Buffer Prep. / Hold Vessels
  • CIP Systems
  • SIP full capacity
  • COP/GWD Cabinets, Autoclaves
Capacity/Capability
  • Large Scale
  • Closed sampling
  • Chemical additions
  • Temp control 2-37℃
  • Class B/A Bulk Fill
  • Portable Equip stations
  • 2 Purification Suites
  • Cryo Freezing Tank/Bag/Bottle
Development Stage cGMP late clinical & commercial
Operational
Regulatory Compliance Global HA including FDA, EMA, PMDA, MFDS