Linearized DNA Manufacture

• Leading Linearized DNA Platform

• Two manufacturing options: provide optimal solutions

As mRNA technology is widely used in the prevention and treatment of various diseases including cancer, influenza, genetic diseases, etc., the demand for production from template plasmids to mRNA has also increased rapidly. As a leading plasmid CDMO, GenScript ProBio can provide customers with one-stop services for plasmids and linearized DNA from preclinical to commercial stages.

GenScript ProBio's linearized DNA platform has two sets of mature production processes, which provide optimal solutions with various enzymes according to different projects. At present, GenScript ProBio has assisted many global customers to obtain IND approvals and produced multiple batches of clinical samples.

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Technical Platforms for Linearized DNA

Process 1.0

ProPlus^TM

• High copy plasmid: process 1.0

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

• Low copy plasmid: ProPlus^TM

  • High density fermentation
  • Less purification steps, improving recovery rate
  • Final yield increases 2~3 times
  • No change for QC standard

Linearized DNA Service

IND

Phase I

Phase II

Phase III

BLA

Commercial

IND CMC

GMPro^TM Grade

GMP Grade

BLA CMC

GMP Grade

Plasmid Manufacturing

Tech. Driven Platform for Plasmid as mRNA Template

• >10 global IND approvals (US, CN, JP, KR, ID, AE, etc.)
• Robust manufacturing process: multiple batches at scales of 100L~150L
• Ploy (A) Length from 70bp to150bp
• Two manufacturing options: provide optimal solutions

Related Service

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