Lentiviral solutions for clinical cell therapy success
Plasmid DNA you can trust from IND to commercialization
Phase-appropriate plasmids for lentiviral gene therapy—manufactured with consistency, compliance, and supply security in mind—for CMC success.
Scaling a gene-modified cell therapy program means navigating increasingly stringent regulatory expectations, evolving manufacturing demands, and a relentless need for consistency. At Phase I and beyond, the cost of error, delay, or inconsistency grows exponentially. You need a partner that can deliver plasmids and transparency at every stage and scale—without compromise.
Aldevron combines 25+ years of gene therapy manufacturing experience with unmatched scale and a deep bench of regulatory expertise.
We help CMC leaders:
- Maintain consistent plasmid supply across RUO, GMP-Source™, and cGMP
- Accelerate development with validated, scalable production
- Minimize tech transfer risk through phase-appropriate formats
- Provide compliance with FDA/EMA expectations
- Reduce cost and complexity with proven, audit-ready quality systems
Learn More About Fast Lane to the Clinic
Built-in value of working with an industry leader
| Benefits | How Aldevron delivers |
| Smooth tech transfer, no surprises in late stages | Phase-appropriate manufacturing (RUO → cGMP) |
| Reduced QC burden and fewer regulatory questions | Standardized, ready-to-order constructs |
| Secure timelines and prevent delays | On-time delivery (85%+ in 2024) |
| Clear IND/BLA path, faster response to agency requests | Regulatory engagement (15 BLAs supported) |
| Redundant capacity + long-term agreements for continuity | Supply chain security |
| Full traceability, pre-audited systems, DMFs available | Process transparency & documentation |
Scale with confidence—even mid-program
Whether you're entering Phase I or preparing for pivotal trials, Aldevron is equipped to manufacture your existing plasmid design at cGMP scale—with the quality, documentation, and delivery performance your program now demands.
Our process development and regulatory teams will support you through a smooth tech transfer and rapid scale-up, while our flexible GMP-Source™ and full cGMP platforms help you meet quality, timing, and budget expectations.
- Tech transfer for your existing plasmid — any format, any stage
- cGMP and GMP-Source options available
- Experienced with clinical-phase onboarding (100+ programs/year)
- Documentation support for process comparability and regulatory filings
- Process Performance Qualification (PPQ), you can ensure that every step of your manufacturing process meets stringent quality criteria.
- Flexible batch sizes, from <100 mg to 50+ grams, for clinical and commercial-scale needs
