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Technical Platforms for Linearized DNA

Process 1.0

Plasmid
Plasmid construction
Fermentation
Harvest
Lysis
Purification
QC release
Linearized DNA
Enzyme digestion
Chromatographic purification
Concentration
Sterile filtration
Formulation
QC release

ProPlusTM

Linearized DNA
Plasmid construction
Fermentation
Harvest
Lysis

Capture

QC release
Formulation
Sterile filtration
Concentration
Chromatographic purification
Enzyme digestion

ProSynTM DNA

ProSynTM DNA
Rolling-circle
amplification (RCA)
Enzyme
digestion
Chromatographic
purification
UF/DF
Sterile
filtration
Formulation
QC release
  • Process 1.0

    • High density fermentation
    • Three-step purification
    • Plasmid manufacturing and QC release
    • Linearized DNA manufacturing and QC release
  • ProPlus™ Process

    • High density fermentation
    • Compared to Process 1.0
    • Less purification steps, improving recovery rate
    • Final yield increases 2~3 times
    • No change for QC standard
  • ProSyn™ Linearized DNA

    • RCA + enzyme digestion (non cell bank)
    • 10-6~10-7 low error rate
    • PowerStarry™ Primer Pool: stable structure and high universality

Linearized DNA Service

IND
Phase I
Phase II
Phase III
BLA
Commercial
FDA/EMA IND Ready CMC
ProSyn™ Linearized DNA CMC
Process 1.0
ProPlusTM
ProSyn™ Linearized DNA
Plasmid CMC
Linearized DNA CMC
Linearized DNA CMC
Linearized DNA CMC
Vector Construction
Engineering Run (Optional)
Vector Construction
Vector Construction
Cell Bank
Pilot Scale Production
Cell Bank
Process Development
Pilot Scale Production
Stability Test
Pilot Scale Production
Pilot Scale Production
Stability Test
IND Documentation
Stability Test
Stability Test
IND Documentation
IND Documentation
Fast CMC
ProSyn™ Linearized DNA CMC
Process 1.0
ProPlusTM
ProSyn™ Linearized DNA
Plasmid CMC
Linearized DNA CMC
Linearized DNA CMC
Linearized DNA CMC
Vector Construction
Demo Run
Vector Construction
Vector Construction
Cell Bank
Project Specific Qualification
Cell Bank
Process Development
Demo Run
Pilot Scale Production
Demo Run
Project Specific Qualification
Project Specific Qualification
Stability Test
Project Specific Qualification
Pilot Scale Production
Pilot Scale Production
IND Documentation
Pilot Scale Production
Stability Test
Stability Test
Stability Test
IND Documentation
IND Documentation

Tech. Driven Linearized DNA Platform

  • >10 global IND approvals (US, CN, JP, KR, ID, AE, etc.)
  • Robust manufacturing process: multiple batches from mg to g
  • Three manufacturing options: provide optimal solutions
  • ProSyn™ Linearized DNA: get small quantity GMP product in fast turnaround time

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