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Linearized DNA Manufacturing

Project-specific Solution

• 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 specific, 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.

PROPLUSTM PROCESS

(E. Coli Fermentation)

Plasmid will be digested directly with in process control
Compared to Process 1.0, ProPlus™ Process has

Less purification steps improve recovery rate
2~3 times of final yield
5~6 weeks manufacturing turnaround time from cell bank to batch release

PROCESS 1.0

(E. Coli Fermentation)

Separate manufacturing and QC release for plasmid and linearized DNA

suitable for long-term storage due to the stable structure of plasmid

PROSYNTM PLATFORM

(Cell-free Technology)

Simple and Rapid Manufacturing: skip cell banking process (RCA+enzyme digestion), save your time for less than 50% of traditional e.coli fermentation process
Milligram-Level GMP Product: obtain the precise quantity you need for your projects, with the assurance of GMP quality
Proprietary PowerStarry™ Primer Pool: stable structure and high universality, applicable for any restriction site, suitable for different projects

Phase-appropriete Linearized DNA Manufacturing Service

IND

Phase I

Phase II

Phase III

BLA

Commercial

BLA CMC

Linearized DNA Manufacturing

Phase-appropriete Linearized DNA Manufacturing Service

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