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One-Stop mRNA Vaccine Solution for IND Filing - in as Little as 5 Months
5-Month One-stop Solution for IND Filing
Plasmid
Linearized DNA
IVT-mRNA
mRNA-LNP
mRNA Vaccine Manufacturing Process
1
2
3
4
Proprietary PowerS™-
T7 RNA Polymerase, VCE, 2´-O-Methyltransferase
PolyAssure Strain
Proprietary IntegraBone
Nanoparticle component:
Cholesterol, phospholipids,
PEG derivatives, cationic lipids
Uncapped
mRNA
Capped
mRNA
Chromatographic
Purification
Enzymatic capping
UF/DF
Microfluidic mixing
mRNA & buffer
T7 RNA Polymerase
Capped
mRNA
cap analog
Co-transcriptional capping
1.0 Process
Plasmid
Linearized DNA
TM
IVT-mRNA
mRNA-LNP
ProPlus Process
Linearized DNA (Plasmid as in Process Control)
mRNA Plasmid Platform
mRNA&LNP Platform
IVT-mRNA: enzymatic and
Proprietary PowerS™-PolyAssure
co-transcriptional capping
strain and IntegraBone ensure
One-stop Solution
for IND Filing
poly(A) integrity
LNP encapsulation:
Process 1.0 and ProPlusTM process:
5-Month
microfluidic technology
provide best solution for clients
mRNA QC: comprehensive, in-house,
700+ clinical batches
compliant with the requirement for
30+ IND clearances
global filings
(US, China, Japan, Korea, etc.)
1st BLA & commercial project in China
4mRNA IND Clearances (US & China)
ProBio Service Overview – from Plasmid to mRNA
Phase
I
Phase
II
Phase
III
IND
BLA
Commercial
GMP Grade
Plasmid &
PreCMC Grade
IND CMC
IND CMC
GMP-Principle* Grade
GMP Grade
BLA PC/PV
BLA PC/PV
Linearized DNA
IVT-mRNA
Pro Grade
GMP Grade
GMP Grade
GMP Grade
mRNA-LNP
*2 choices in GMP-Principle grade: IND Pro for FDA & EMA; GMProTM for NMPA(China), FDA & EMA
ProBioCDMO.com
+1-732-885-9188
Accelerating Ideas. Delivering Impact.
Plasmid ProPlusTM Process
ProPlusTM process has
Less plasmid purification steps (in process
control instead of full QC release)
Optimized linearized DNA purification
Advantage
Improve recovery rate, reduce product loss
Shorter turnaround time: as fast as 2 weeks
ProPlus™ process for low copy plasmid;
Process 1.0 for high copy plasmid
Process 1.0
ProPlus Process
Recovery Rate
Yield
IVT-mRNA Platform
10
8
100%
80%
60%
40%
20%
0%
Suitable for mRNA with different lengths
6
1K-10K
Two capping methods (co-transcriptional
4
2
0
and enzymatic capping methods): capping
efficiency >90%, up to 99%
1.2K
2K
3.5K
mRNA-LNP Platform
100%
80%
60%
40%
Universal LNP platform with
excellent critical quality attributes
Encapsulation efficiency up to 99.7%
20%
0%