Linearized DNA Manufacture

Provide Optimal Solutions for Different Projects

• E. Coli Fermentation: Process 1.0 or ProPlus™ Process

• Cell-free Technology: ProSyn™ Linearized DNA

mRNA becomes to have wide applications for cancer, influenza, genetic diseases, etc. As a leading plasmid CDMO, ProBio offers three options in linearized DNA manufacturing for mRNA, aiming to help mRNA projects from preclinical to commercial stages with one-stop services.

To be specify, the plasmid from Process 1.0 and ProPlus^TM Process is still manufactured through e.coli fermentation, suitable for regular mRNA projects. However, in ProSyn^TM DNA Platform, the linearized DNA will be made through enzymatic DNA synthesis, means that clients can get small quantity of the product in fast turnaround time.

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Technical Platforms for Linearized DNA

Process 1.0

ProPlus^TM

ProSyn^TM DNA

• 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

IND CMC

GMPro^TM Grade

GMP Grade

BLA CMC

GMP Grade

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

Related Service

• GMPro^TM Plasmid Manufacturing
• Plasmid CMC for IND
• Plasmid Manufacture
• mRNA Manufacture