LVV Plasmid CMC to GMP
From CMC to commercial-scale validation, ProBio’s CMC to GMP services help ensure lentiviral vector plasmid quality, consistency, and regulatory compliance, reducing development risk and accelerating your path to market.
Accelerate Your Path from Plasmid CMC with Global GMP Expertise
Proven Experience
In plasmid development and manufacturing with:
- 40+ IIT plasmid projects delivered
- 90+ global IND clearances achieved
- 800+ plasmid clinical batches manufactured
- Agency-specific CMC strategies supporting FDA, EMA, PMDA, MFDS, NMPA, TGA and other submissions
Fast Turnaround Time
- Early clinical plasmid manufacturing: conditional release in as fast as 2 weeks
- Late-stage and commercial plasmid manufacturing: batch release in as little as 5 weeks
- IND-enabling CMC support: cell banking to pilot-scale production in 2+ months
Ready to Use,
Reliable Technologies
- Ready-to-use LentiHelper™ plasmid platform to help accelerate development
- Guaranteed plasmid quantity and quality
- Global supply chain resilience with dual GMP sites in the US and China, local sourcing and regulatory support and dedicated project management and technical experts
IND-enabling CMC from Cell Banking to Pilot Scale Production Release –
in as Fast as 2 Months
Cell Banking
- Research Cell Bank
- Primary Cell Bank
- Master Cell Bank
- Working Cell Bank
Process Development
- Upstream PD
- Downstream PD
- Formulation Study
- Verification Run
Analytical Development
- Method Development
- Method Qualification
- Project Specific Qualification
Plasmid Manufacturing
- PreCMC Plasmid Manufacturing
- GMP-Principle Plasmid Manufacturing
- GMP Plasmid Manufacturing
Stability Study
- Long-term Stability
- Accelerate Stability
- Influencing Factor Stability
IND Documentation
- CTD Format
Resources
FLYER
GMP Plasmid Manufacturing
Whether you’re working on a gene therapy, cell therapy, DNA vaccine or mRNA vaccine, it starts with high-quality DNA.
FLYER
Cell Therapy: 6-month One-Stop Solution for IND Filing
Discover an integrated solution from plasmid to LVV, at high quality and speed.
FLYER
GMP Viral Vector Manufacturing
Your programs are important, and your time is valuable. ProBio is a responsive and reliable CDMO partner of viral vector for pre-clinical, clinical and commercial use.
WHITE
PAPER
Design of Targeting Lentiviral Vectors and Their Producer Cells for in Vivo CAR-T
Learn about successful LVV design, manufacturing, and downstream application for in vivo CAR-T.
Frequently Asked Questions