Global mRNA Plasmid DNA and Linearized DNA Clearances
Our Services
We provide rapid, flexible, and cost‑effective plasmid DNA (pDNA) preparation services for messenger RNA (mRNA) applications, delivering
high‑quality material from Investigator Initiated Trials (IIT) to full commercial scale.
Phase Appropriate mRNA Plasmid Preparation Support
IIT
IND
Phase I
Phase II
Phase III
BLA/NDA
Commercial
IIT/IND
- Over 90 global plasmid IND clearances
- Over 30 global mRNA plasmid DNA and linearized DNA clearances
- Over 40 plasmid IIT projects delivered
Clinical Phases
- Proven track record of over 700 plasmid clinical batches
- Gene to GMPro™: 4+ weeks for PCV mRNA clinical sample
BLA/Commercial
- 2 EUA/BLA
- GMP workshop pass in BLA PAI in Indonesia
- Multiple active BLA projects
Plasmid IIT Projects Delivered
Clinical Plasmid Batches Produced
EUA/BLA Approvals
Resources
WHITE
PAPER
PAPER
Challenges and Solutions in the Poly(A) Control for Plasmid and mRNA
Learn about how consistent control strategies ensure poly(A) length and purity, from upstream plasmid to downstream production.
FLYER
ProSyn™ Linearized DNA Using Cell-free Technology
Discover an accelerated cell-free approach with ProSyn™ Linearized DNA, using enzymatic DNA synthesis through rolling circle amplification (RCA).
FLYER
GMP Plasmid Manufacturing
Read how high-quality plasmid manufacturing is the backbone of your advanced therapies: gene therapy, cell therapy, DNA vaccine or mRNA vaccine, and more.
FLYER
Manufacturing Plasmids for mRNA Vaccines
Learn about an integrated and accelerated one-stop CDMO solution for IND filing: design, manufacturing, and downstream application for mRNA vaccines.
Frequently Asked Questions