Flyer
Optimized Solutions for Linearized DNA
Linearized DNA
ProBio Provides High-quality Linearized DNA
Linearized DNA has wide application in advanced therapy. ProBio can be your partner that supports you with either
small-scale or large-scale manufacturing service from preclinical through clinical trials, and eventually at commercial
stage with phase-appropriate quality grades, analytics, and regulatory support.
Capacity
Linearized DNA
ProBio has proven experience from IND to BLA
Process 1.0 (e.coli fermentation)
Our state-of-the-art, GMP, multi-production line facility is specially
designed to enable your advanced therapy
ProPlusTM Process (e.coli fermentation)
ProSynTM DNA (cell-free technology)
E.coli fermentation (Process 1.0 & ProPlusTM Process)
√
GMP Grade: up to 300L upon request
Cell-free technology (ProSynTM Linearized DNA)
0.5mg ~ 25mg
GMP suites specifically designed for efficient production
√
Capability
ProBio offers three options in linearized DNA manufacturing, aiming to
accelerate projects from preclinical to commercial stages.
Integrated One-stop CDMO Solution: IIT to Commercial
Manufacturing
Clinical Trial
Phase
Commerialization
BLA/NDA
IIT/IND
Phase
Phase
PreCMC Grade CMC Study
GMP-Principle Grade
GMP Grade
Late Clinical Phase
Commercialization
IIT
IND Filling
Early Clinical Phase
One Batch Linearized DNA Manufacturing
Week
1
2
3
Process 1.0
ProPlusTM Process
ProSynTM Linearized DNA
ProBioCDMO.com
+1-732-885-9188
Accelerating Ideas. Delivering Impact.
Technical Platforms for Linearized DNA
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
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
2+ weeks manufacturing turnaround time from strain construction to conditional release
ProSynTM Linearized DNA (Cell-free Technology)
Simple and Rapid Manufacturing: skip cell banking process (RCA+enzyme digestion), save your
time compared to 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