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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
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)