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IND-enabling tLVV for In vivo CAR-T

In vivo CAR-T One-stop Solution  
RNA-tLNP IND-enabling CMC  
RNA-tLNP Workflow  
Antibody  
Reduction  
Purification  
Purification  
Sterile  
Filtration  
Fill &  
Finish  
RNA-tLNP  
(Conjugation)  
Purification  
IVT-mRNA  
IVT-circRNA  
RNA-LNP  
（Encapsulation）  
RNA-tLNP Integrated Solution  
IVT-mRNA  
RNA-tLNP  
Antibody  
Successfully delivered  
Co-transcriptional/enzymatic capping  
Capping efficiency > 90%  
Crude yield up to 10g/L  
LNP surface modification efficiency: > 95%.  
Conjugation based on -SH&-Mal, Click  
chemistry and post insertion  
Comparable encapsulation efficiency after  
conjugation  
Comprehensive quality analytical platform  
Multiple tLNP-based IND-enabling CMC  
and IIT project expereinces  
multiple types of antibody  
fragments (Fab, scFv, VHH)  
Flexible GMP manufacturing  
scale — minimum batch size  
as low as 50 L  
IVT-circRNA  
Proprietary circulation design technology  
Circulation efficiency up to 75%  
Purity > 85%  
g-level GMP-grade tLNP production track  
records  
ProBio RNA-tLNP Platform  
Comparable encapsulation efficiency  
after conjugation  
LNP surface modification efficiency: > 95%  
100  
90  
80  
70  
60  
50  
40  
30  
20  
10  
1M  
100k  
10k  
1k  
1M  
100k  
10k  
1k  
P1 3919/95.3%RNA-tLNP  
P2 195/4.7%  
P1 35/0.6%  
P2 5612/99.4%  
RNA-LNP  
100  
10  
100  
10  
1
1
1
100 1k 10k 100k 1M  
Pro Vir10
1
10 100 1k 10k 100k 1M  
Clinical GMP Viral Vector  
SS-A  
0
Pro Vir
RNA-LNP  
RNA-tLNP1 RNA-tLNP2 RNA-tLNP3  
SS-A  
ProBioCDMO.com  
+1-732-885-9188  
cdmo.us@probiocdmo.com  
Accelerating Ideas. Delivering Impact.  
LVV DP Workflow (Serum-free Suspension Manufacturing  
Process)  
Fill &  
Finish  
Cell  
Thawing  
Cell  
Expansion  
Nuclease  
Treatment  
Purification &  
Concentration  
Sterile  
Filtration  
LVV Drug  
Product  
Transfection  
Clarification  
Formulation  
Suspension Cell Line  
Plasmid Packaging System  
Upstream Process  
Downstream Process  
Serum-free suspension  
production process  
High titer and scale-up to 200L  
Upstream process development  
Downstream process  
development  
Formulation study: screen  
Proprietary cell line, no IP  
issue  
Transfer plasmid  
Envelope plasmid  
Helper plasmids  
Flexible commercial  
licensing model  
different buffers  
FDA DMF registration  
In-house, Comprehensive LVV DP Analytical Platform  
MOA (Mechanism  
Critical Quality Attributes (CQA)  
Analytical Methods  
of Action)  
According to regulatory  
requirement, items like  
visible particles, container  
content, particulate matter,  
particle size, etc. are needed  
Specific quality standards for  
particulate matter and  
endotoxin based on LVV as  
drug product  
Comprehensive Mechanism  
of Action (MOA) biological  
activity analytical methods  
Appearance  
Ratio of F/P titer  
qPCR  
ddPCR  
Intracellular  
gene analysis  
Visible particulates  
pH  
Residual nuclease  
Residual host cell protein  
Residual host cell DNA  
Western Blot  
ELISA  
Flow cytometry  
Osmolality  
Expression  
analysis  
Container content  
Particulate matter  
Particle size  
Residual plasmid  
Residual Host Transfer Gene (SV40)  
Residual Host Transfer Gene (E1A)  
Reporter gene-based assay  
Cell Proliferation assay  
NGS-based gene editing assay  
Cell cytotoxicity assay  
Target gene sequence  
of lentiviral vector (GOI)  
Residual Host Cell DNA Fragment  
(≥200bp)  
Functional  
assay  
Functional titer  
Sterility  
p24 protein concentration Endotoxin  
LVV DP Project Experience  
Multi-project experience  
In vivo CAR-T  
Ongoing projects  
Phase II clinical  
stage (fastest)  
NMPA & FDA IND  
clearances  
Virus-like  
particles (VLPs)