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GMP Plasmid Manufacturing
GMP Plasmid Manufacturing
ProBio Provide High-quality Plasmid
Whether you’re working on a gene therapy, cell therapy, DNA vaccine or mRNA vaccine, it starts with a
high-quality DNA, ProBio will be your partner that supports you from small-scale, pre-clinical work through
clinical trials, and eventually at commercial scale with phase-appropriate quality grades, analytics, and
regulatory support.
Capacity
Plasmid DNA
ProBio has proven experience from IND to BLA of plasmid DNA
projects
Viral Vector (LVV, AAV and RVV etc.)
mRNA vaccine
DNA vaccine
Our state-of-the-art, GMP, multi-production line facility is
specially designed to enable your cell and gene therapy
GMP cleanroom suites at Grade B and C
TFF Systems: Repligen KR2i for 10L scale; AKTA Readyflux and
AKTA Readyflux XL
CRISPR gene editing
Chromatography Systems: AKTA Pilot 600R and AKTA Ready
Gradient Extended
Automated fill & finish capabilities; performed in Grade A
qualified environments
GMP suites specifically designed for maximum productivity and
efficient production
Capability
Regardless of the number of constructs, you can count on
reliable plasmid DNA for pre-clinical, clinical and commercial
uses. Our platform includes supercoiled and linearized DNA
Integrated One-stop CDMO Solution: IIT to Commercial
Manufacturing
Clinical Trial
Phase
Commerialization
BLA/NDA
IIT/IND
Phase
Phase
PreCMC Grade
IIT
CMC Study
IND Filling
GMP-Principle Grade
GMP Grade
Late Clinical Phase
Commercialization
Early Clinical Phase
Off-the-shelf LentiHelperTM (MF25552) and AAssistVTM (MF29497)
Plasmids with FDA DMF Registration
High Fermentation Yield - Up to 3 g/L
High Supercoiled Ratio: 98%
IEC%: 98%
ProBioCDMO.com
+1-732-885-9188
Accelerating Ideas. Delivering Impact.
Accelerate Your Breakthrough with The Timelines You Need
and The Quantities You Can Count On
Week
2
4
6
8
10
12
GMProTM Plasmid Mfg.
ProBio
ProBio
Market Timeline
From strain construction to conditional release
GMPPlasmid Mfg.
Market Timeline
From GMP mfg. to batch release
90+ 30+
3
GLOBAL IND CLEARANCES
IND CLEARANCES FOR DNA
DRUG
mRNA PLASMID GLOBAL
IND CLEARANCES
700+
30+
1
GMP BATCHES
EMERGENCY USE
PLASMID IIT PROJECTS
AUTHORIZATION (EUA)
GMP Plasmid Facility
China,
Zhenjiang
USA,
Hopewell