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DNA Vaccine & Drug Platform
Plasmid DS/DP One-stop Solution for DNA
Vaccine & DNA Drug
Partner with ProBio to Achieve The Next Milestone
DNA vaccines & DNA drug are often considered third-generation vaccines, which operate by transfecting engineered
plasmid DNA onto cells in order to induce an immunological response. The plasmid DNA, encoding immunogenic antigens,
can be produced in E.coli.
ProBio is one of the pioneers in manufacturing GMP plasmid DNA at a large-scale, providing plasmid DNA from preclinical
to clinical trials and commercialization.We have also a accumulated experience in process and analytical development
which allows us to support clients in attaining IND approvals.
Target gene
Plasmid
Formulation
DNA
or
High density
fermentation
High concentration
of purified DNA
Purification
EFFICIENT AND FLEXIBLE ONE-STOP CELL
Screening &
Construction
Upstream
Process
Downstream
Fill & Finish
Process
•
•
Proprietary high-
•
Animal source
free, antibiotics
free
•
•
Disposable
purification
equipment
•
•
Automatic aseptic
isolator filling
Aseptic filling
performing
PowerSTM -DNA
+
strain with up to 3g/L
fermentation yield
Automatic
pyrolysis system
ProBio Service Overview - Plasmid DS/DP
Phase
Phase
Phase
IND
BLA
I
II
III
Commercial
GMP Grade
Plasmid
DS/DP
PreCMC Grade
IND CMC
GMP Grade
GMP Grade
PC/PV
ProBioCDMO.com
+1-732-885-9188
Accelerating Ideas. Delivering Impact.
Technology Advantages
Robust Plasmid Manufacturing Process
Scale-up
Robust and scalable: 5L-10L-30L-50L
avg. 1.5 g/L
Fermentation yield
Impurity removal: HCD < 0.1%
.
5L
50L
Superior DNA Vaccine & DNA Drug Manufacturing Process
Continuous Improvement on Upstream & Downstream Process
Optimization
Fermentation Yield After Optimization (up to 3g/L)
Recovery Rate (up to 50%)
Before Optimization After Optimization
Before Optimization After Optimization
Fill & Finish
15+ years of aseptic filling experience
100% Weighing & Environmental
Monitoring System
Workshop: automatic aseptic isolator filling line