SK biotek Continuous Process Technology

A world leader in the development of custom cGMP Chemical Manufacturing of APIs and Intermediate by Continuous Flow Process.  With state-of-art manufacturing facilities, the capability to manufacture APIs and, Intermediates, plus the ability to scale up from kilos to multi-ton for global leading pharmaceutical companies.

SK biotek is the leading supplier of late-phase and commercial pharmaceutical materials using Continuous Flow Processing. Continuous Flow Processing has many advantages over traditional batch processes; it is not just greener, highly efficient, cost-effective, and regulatory support; but also has the capability to conduct low-temperature reactions, hazardous reactions (Azide/Hydrogen Peroxide, etc.), catalytic reactions, and other extreme chemistries not possible by batch processing.

Continuous Process Manufacturing Offers

  • Improvement in the degree of purity achieved and/or higher process yield
  • Avoids cryogenic process steps
  • Simplifies process scale-up
  • Achieves a higher process stability
  • Enables safe operation of reactions otherwise not possible in batch mode
  • Improves levels of process control through Quality by Design (QbD) approaches, combining improved process economics versus batch operations

Our Expert Equipment and Capabilities

  • Continuous Process Development and Optimization
  • Organic / Analytical Chemists and Chemical Engineers / Organic Chemists
  • New Synthetic Route Design for Continuous Process
  • Process Validation / Method Validation
  • Integration of Batch and Continuous Process
  • Fixed Bed Catalyst Reaction and Micro-Reactor Technology

Continuous Flow Process in SKBT

Tubular & Fixed Bed Reactor

Cryogenic Reaction

  • Halogen-Metal Exchange
  • Alkynylation
  • Enolate Chemistry

Hazardous Reaction

  • H2O2 Oxidation
  • Azide Chemistry
    Curtius rearrangement, Tetrazole, Triazole synthesis

Catalysis (Homogeneous)

  • Enantioselective Hydrogenation
  • Enantioselective Reductive Amination

Catalysis (Heterogeneous)

  • Het. Catalyst Technology
    Design, screening and manufacturing
  • Hydrogenation
    Rosenmund reduction, Lactam reduction

Continuous Process Development Equipment in R&D

Key Equipment in R&D

  • Process development instrument
  • General and batch process development
  • RC1, DSC, Multi-max, Opti-Max, Easy-Max, FBRM, Autoclave, Jet-mill, Multi-reactors, Microscope, Easy-sampler
  • Continuous process development
  • Low temperature Continuous Tubular Reactors
Material Flow Rate No. of Units Max Pressure Min Temperature
Lab 316LSS 30ml/min 3 5 atm -60°C
Bench & Pilot 316LSS + H/C 250ml/min 2 5 atm -80°C
  • High Temperature Continuous Tubular Reactors
Material Flow Rate No. of Units Max Pressure Min Temperature
Lab 316LSS 20ml/min 3 70 atm 200°C
Pilot 316LSS + H/C 200ml/min 1 70 atm 230°C
  • Continuous Fixed Bed Reactors
Catalyst Volume No. of Units Max Pressure Max Temperature
Mini 5 ~ 20ml 9 100 atm 650°C
Bench S 100 ~ 300ml 1 250 atm 650°C
Bench L 300 ~ 500ml 1 250 atm 650°C
  • Continuous workup equipment: Continuous distillation(SPD), Continuous extractor, Continuous crystallization
  • Analytical instrument
  • NMR, ICP-R, LC-R, GC-R, HS-GC, UPLC, HPLC, CAD, GC, XRD

Scale-up of Continuous Catalytic Reaction

4-Stage Evaluation System: Lab Bench Pilot Commercial Plant

Lab

  • Continuous (High P)
  • Batch (Autoclave)

Bench

  • Continuous (High P)
  • Series reactor system

Pilot (250atm)

  • Reactor 20 L, max. 400°C

Commercial Plant (120atm)

  • Reactor 220 L, max. ~200°C

Commercial Plant (330atm)

  • Reactor 450 L, max. ~170°C

Scale-up of Continuous Tubular Reaction

Lab

  • Material: 316LSS
  • Flow rate: 30ml/min
  • Scale: ~ hundreds of grams

Pilot (Low temperature)

  • Material: 316LSS + H/C
  • Flow rate: 250ml/min
  • Scale: ~ tens of kilograms

Pilot (High temperature)

  • Material: 316LSS + H/C
  • Flow rate: 200ml/min
  • Scale: ~ tens of kilograms

Commercial (Low temperature)

  • Material: 316LSS/ Flow rate: 1L/min
  • Japanese PMDA (2013) & US FDA (2014) approved
  • Currently producing over 30MT/year
  • Production Capacity: 4 MT/month

Continuous Tubular Reaction System

Low Temperature Continuous Reaction System
(Daejeon)

  • Operation Range : -80°C ~ +20°C
  • Controlled and Monitored by PLC System
  • Lithiation with Butyl-Li, Hex-Li
  • 2 Set, 316LSS, + Hastelloy-C , In-line Mixer
  • Production Capacity: 4 MT/month

Continuous Oxidation Reaction System
(Daejeon)

  • Oxidation with 50% H2O2
  • 1 Set, Hastelloy-C, Tubular Reactor
  • Production Capacity: 3MT/month

Low Temperature Continuous Reaction System
(Sejong Plant)

  • Operation Range : -80°C ~ +20°C
  • Controlled and Monitored by PLC System
  • Lithiation with Butyl-Li, Hex-Li
  • 2 Set, 316LSS + Hastelloy-C, In-line Mixer
  • Production Capacity: 4 MT/month

Low Temperature Continuous
Reactor (Daejeon)

Continuous Oxidation Reactor
(Daejeon)

Low Temperature Continuous
Reactor (Sejong Plant)

Low Temperature Continuous
Reactor (Sejong Plant)

Continuous Workup Equipment

High Vacuum Distillation Equipment

  • Hybrid SPD(Daejeon)
    • Operating Condition : 50~250°C , < 0.1mbar Capacity : 15 kg/hr
    • 316LSS, 110L*2ea,

Hybrid SPD
(Daejeon)

Pilot Plant

Low Temperature Continuous Reaction System

  • Movable-type
  • – 80°C ~ +20°C

Packed Bed Column Reactor for Continuous Catalytic Reaction

  • 20 L * 1 EA
  • 200 bar, 400°C

Pilot Scale Low Temp.
Continuous Reaction System
(Movable-type)

Pilot scale Packed Bed
Column Reactor

Pilot Scale High Temp.
Continuous Reaction System

Contact Us Today

For Business Development & Marketing Enquires contact: info@skpharmteco.com
For Recruitment Enquiries contact: careersireland@skbiotek.ie
For Media and General Enquiries contact: info@skpharmteco.com

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