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LVV Drug Product One-Stop Solution

• NMPA & FDA IND Clearances

• Suspension Platform

• Comprehensive and In-house LVV DP Analytical Platform

Ex vivo CAR-T, with highly personalized, requires cell extraction, gene modification, and reinfusion-a time-consuming and costly process that limits patient access. in vivo CAR-T has attracted attention as a potential alternative to expand ex vivo CAR-T treatments, showing great potential in simplifying the treatment process and meeting unmet clinical needs.

The current mainstream delivery technologies for in vivo CAR-T including lentiviral vector (LVV) and antibody conjugated lipid nanoparticle (RNA-tLNP). ProBio has established two technology platforms (LVV and RNA-tLNP), providing one-stop solutions for two different mechanisms.

In vivo Lentiviral Vector Workflow

Cell
Thawing

Cell
Expansion

Transfection

Nuclease Treatment

Clarification

Purification &
Concentration

Formulation

Sterile
Filtration

Fill &
Finish

LVV Drug
Product

Suspension Cell Line

Proprietary cell line, no IP issue
Flexible commercial licensing model
FDA DMF registration

Plasmid Packaging System

Transfer plasmid
GagPol plasmid, Rev plasmid, VSV-G mutant plasmid, etc.

Stable and Scalable Suspension Platform

High titer and scale-up to 200L
Upstream and downstream process development to improve yield and product purity
Formulation study

Comprehensive and In-house Analytical Platform

Specific quality standards for particulate matter, endotoxin and critical impurities based on LVV as drug product
Comprehensive Mechanism of Action (MOA) biological activity analytical methods

Streamline your LVV development with our one-stop solution covering process development,analytical development, suspension GMP manufacturing, and stability testing. Our comprehensive services support regulatory filings and ensure a seamless transition from preclinical to commercial phases.

In vivo Lentiviral Vector Platform Advantages

Multi-project experience

In vivo CART
Virus-like particles (VLPs)

NMPA & FDA IND clearances
>5 in vivo lentiviral vector program, and fastest in clinical phase 2