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Fill & Finish

Samsung BioLogics is equipped with a novel, state-of-the-art Fill and Finish facility with aseptic filling, lyophilizers with automated loading and unloading, and capping integrated within a Restricted Access Barrier System (RABS). All processes are cGMP compliant and are validated to meet customer and regulatory requirements. Samsung BioLogics’ dedication to quality and optimal services is visible in everything we do, from small-scale clinical trials to large-scale commercial production.

Samsung's drug product facility is designed to meet
all FDA and EU Annex 1 requirements for Sterile Drug Product Manufacturing

Samsung Biologics is preparing development services for all formulations, ranging from liquid formulations to freeze-dried formulations. Additionally, we provide optimized type formulations while securing stability and effectiveness for the customer within the time they need. We are also fulfilling customer satisfaction through development service that considers even the permitted articles following the relevant formulations.

Formulation Development

  • fomulation photo 1
  • fomulation photo 2
  • fomulation photo 1
  • fomulation photo 2
Formulation Screening system
Formulation
Screening system
Core equipment
  • Formulation Development dedicate Lab.
  • BSC (Bio safety Cabinet)
  • DLS (Dynamic Light Scattering)
  • DSC (Differential Scanning Calorimeter)
  • HPLC (High-Performance Liquid Chromatography)
  • Manual vial filling system (peristaltic type)
Specialized Capability
  • Biopharmaceuticals
  • Monoclonal antibodies
  • Fusion proteins
  • Bispecific antibodies
  • Packaging (Vials and Pre-filled syringe selection)
  • Proteins
  • Peptides
  • Formulation process optimization based on QbD
Formulation Screening system
Formulation
Screening system
Core equipment
  • Formulation Development dedicate Lab.
  • BSC (Bio safety Cabinet)
  • DLS (Dynamic Light Scattering)
  • DSC (Differential Scanning Calorimeter)
  • HPLC (High-Performance Liquid Chromatography)
  • Manual vial filling system (peristaltic type)
Specialized Capability
  • Biopharmaceuticals
  • Monoclonal antibodies
  • Fusion proteins
  • Bispecific antibodies
  • Packaging (Vials and Pre-filled syringe selection)
  • Proteins
  • Peptides
  • Formulation process optimization based on QbD

Thawing

Freeze and Thaw System Specifications items include Freeze and Thaw System, and so on.
Freeze and Thaw System
Equipment
  • Freeze/Thaw skid for cryovessels
  • Freeze/Thaw skid for cryobags
Capacity/Capability
  • Controlled freezing and thawing
  • Max. capacity: 1 tank per station
  • Temperature Range : -70℃ to 40℃
Freeze and Thaw System Specifications items include Freeze and Thaw System, and so on.
Freeze and Thaw System
Equipment
  • Freeze/Thaw skid for cryovessels
  • Freeze/Thaw skid for cryobags
Capacity/Capability
  • Controlled freezing and thawing
  • Max. capacity: 1 tank per station
  • Temperature Range : -70℃ to 40℃
  • Thaw and Formulation Photo 1
  • Thaw and Formulation Photo 2
  • Thaw and Formulation Photo 1
  • Thaw and Formulation Photo 2

Formulation

Excipient Preparation & Formulation Specifications items include Plant 1, Plant 2, and so on.
Plant 1
Equipment
  • Excipient and Formulation Vessels
Capacity/Capability
  • Excipient Vessel Capacity: 20L to 3,000L
  • Formulation Vessel Capacity: 20L to 1,500L
  • pH and temperature control
  • Weight control
  • CIP/SIP of Excipient and Formulation Vessels
  • Single Use Solutions Capabilities
Plant 2
Equipment
  • Excipient and Formulation Vessels
Capacity/Capability
  • Excipient Vessel Capacity: 200L to 2,000L
  • Formulation Vessel Capacity: 200L to 2,500L
  • pH and temperature control
  • Weight control
  • CIP/SIP of Excipient and Formulation Vessels
  • Single Use Solutions Capabilities
Excipient Preparation & Formulation Specifications items include Plant 1, and so on.
Plant 1
Equipment
  • Excipient and Formulation Vessels
Capacity/Capability
  • Excipient Vessel Capacity: 20L to 3,000L
  • Formulation Vessel Capacity: 20L to 1,500L
  • pH and temperature control
  • Weight control
  • CIP/SIP of Excipient and Formulation Vessels
  • Single Use Solutions Capabilities
Plant 2
Equipment
  • Excipient and Formulation Vessels
Capacity/Capability
  • Excipient Vessel Capacity: 200L to 2,000L
  • Formulation Vessel Capacity: 200L to 2,500L
  • pH and temperature control
  • Weight control
  • CIP/SIP of Excipient and Formulation Vessels
  • Single Use Solutions Capabilities

Vial Preparation and Filling

Vial Preparation and Filling Photo 1 Vial Preparation and Filling Photo 2
  • Vial Preparation and Filling Photo 1
  • Vial Preparation and Filling Photo 2
Vial filling Specifications items include Plant 1, Plant 2, and so on.
Plant 1
Equipment
  • Washing, Depyrogenation, Vial Filling
  • Stoppering, Capping, Transfer to Lyo
Capacity/Capability
  • Active RABS
  • Filling Rate : up to 12,000 vials/hr (up to 20cc vial)
  • Filling Operation range : 0.1 ~ 100ml
  • Pump types: Piston and Peristaltic
  • CIP/SIP of Vial Filling Machine
  • 1mL to 100mL vial size
  • GRADE A Over Sealing
  • Adaptable process to include single use or fixed systems
Plant 2
Equipment
  • Washing, Depyrogenation, Vial Filling
  • Stoppering, Capping
Capacity/Capability
  • Active RABS, Piston & Peristatic Pump
  • Max. capacity : 300vials / min (based on 10ml vial)
  • Filling Operation Range: 0.1ml to 100ml
  • 100% Weight Check System
  • CIP/SIP of Vial Filling Machine
  • GRADE A Over Sealing
  • Adaptable process to include single use or fixed systems
Vial filling Specifications items include Plant 1, Plant 2, and so on.
Plant 1
Equipment
  • Washing, Depyrogenation, Vial Filling
  • Stoppering, Capping, Transfer to Lyo
Capacity/Capability
  • Active RABS
  • Filling Rate : up to 12,000 vials/hr (up to 20cc vial)
  • Filling Operation range : 0.1 ~ 100ml
  • Pump types: Piston and Peristaltic
  • CIP/SIP of Vial Filling Machine
  • 1mL to 100mL vial size
  • GRADE A Over Sealing
  • Adaptable process to include single use or fixed systems
Plant 2
Equipment
  • Washing, Depyrogenation, Vial Filling
  • Stoppering, Capping
Capacity/Capability
  • Active RABS, Piston & Peristatic Pump
  • Max. capacity : 300vials / min (based on 10ml vial)
  • Filling Operation Range: 0.1ml to 100ml
  • 100% Weight Check System
  • CIP/SIP of Vial Filling Machine
  • GRADE A Over Sealing
  • Adaptable process to include single use or fixed systems

Inspection

  • Thaw and Formulation Photo 1
  • Thaw and Formulation Photo 2
  • Inspection Photo 1
  • Inspection Photo 2
Inspection Specifications items include Manual Inspection, Automated Inspection, and so on.
Manual Inspection
Equipment
  • Manual inspection booths
Capacity/Capability
  • Comprehensive Visual Inspection Program
  • Operators' manual inspection qualification
  • Product Type: Labeler and Lyophilized
  • Defect Classification Library developed for all product types
Automated Inspection
Equipment
  • Automated inspection line
Capacity/Capability
  • Line Speed: 12,000 vials/hr (20R vial)
  • Uses Charge Coupled Device (CCD) camera system to identify vial defects, product defects, closure defects, etc.
Inspection Specifications items include Manual Inspection, Automated Inspection (or Leak Detection), and so on.
Manual Inspection
Equipment
  • Manual inspection booths
Capacity/Capability
  • Comprehensive Visual Inspection Program
  • Operators' manual inspection qualification
  • Product Type: Labeler and Lyophilized
  • Defect Classification Library developed for all product types
Automated Inspection (or Leak Detection)
Equipment
  • Automated inspection line
Capacity/Capability
  • Line Speed: 12,000 vials/hr (30mm dia. vial)
  • Uses Charge Coupled Device (CCD) camera system to identify vial defects, product defects, closure defects, etc

Packaging

Packaging Photo
Packaging Specifications items include Packaging, and so on.
Packaging
Equipment
  • Automated packaging Line
Capacity/Capability
  • Line Speed: 18,000 vials/hr (30mm diameter vial)
  • Pakaging Type: Labeler, Cartoner, Overwrapper
  • Laser Carton Print System
  • Automatic weight check unit between cartoner and overwrapper
Packaging Specifications items include Packaging, and so on.
Packaging
Equipment
  • Automated packaging Line
Capacity/Capability
  • Line Speed: 18,000 vials/hr (30mm diameter vial)
  • Pakaging Type: Labeler, Cartoner, Overwrapper
  • Laser Carton Print System
  • Automatic weight check unit between cartoner and overwrapper