Proven Plasmid DNA, Viral Vector, and CAR-T Production Platforms
Streamline Your Cell and Gene Therapy Supply
eXpDNA™ Plasmid Production Platform
Fine-tuned by successfully supporting vaccine and advanced therapy developers with the manufacture and release of more than 200 High Quality (HQ) and GMP plasmid DNA batches to date, the eXpDNA™ plasmid development and manufacturing platform employs a robust plug-and-play screening toolbox for tackling challenging plasmids, fit-for-purpose production facilities, on-hand materials, and in-house analytics.
Expedited Timelines
- Immediate slot and materials availability
- Extensive in-house testing powerhouse
- 5+ weeks for HQ and 10+ weeks for GMP from initiation to release
Integrated CDMO
- 20+ years of plasmid DNA and viral vector CDMO experience
- 30+ years of biologics testing expertise
- Experience with various complex plasmids
Operational Excellence
- 20+ years regulatory track record
- 100+ HQ and 120+ GMP batches
- >95% successfully released plasmid batches
"This collaboration brings us closer to accomplishing our goal to develop potentially transformative therapies for ciliopathies. We are excited to leverage Charles River's expertise in plasmid DNA production to help drive our work forward."
Victor Hernandez, Co-Founder and CSO, Axovia
nAAVigation® AAV Production Platform
With decades of AAV CDMO expertise, the nAAVigation® AAV production platform is based on a proprietary high-productivity HEK293 suspension cell line that is amenable to clients' scale-up and serotype needs.
Utilizing an optimized single-use upstream approach coupled with robust downstream purification processes, nAAVigation® significantly shortens the timeline to GMP by over 50% compared to traditional development methods.
Production Speed
- Fast-tracked plasmid DNA supply and expedited process confirmation
- 100% in-house analytics
- Templated documentation and on-hand materials
Predictability
- Standardized materials
- Royalty-free, proprietary, optimized technologies
- Reliable scale-up path to GMP and clinic
Track Record
- 20+ years of integrated plasmid and viral vector CDMO experience
- 30+ years of biologics testing expertise
- 10+ years of AAV production experience across five different serotypes
"By collaborating with Charles River, we are one step closer to beginning clinical trials to ensure our therapeutic for Stargardt's Disease (STGD) is safe and efficacious for patients. We trust the team’s decades of success developing, producing, and reliably delivering plasmid DNA and look forward to expanding treatment options for this patient population."
Nina Kotsopoulou, PhD, CTO, AAVantgarde
Lentivation™ LVV Production Platform
Reinforced by decades of viral vector CDMO experience, Lentivation™ enables a cost-effective and reliable path to GMP in less than seven months by integrating the three pillars of plasmid manufacture, viral vector production, and testing under one roof.
Lentivation™ has the capability to cut a gene or gene-modified cell therapy program timeline to GMP by 60% versus traditional manufacturing processes.
Streamlined Supply
- Fast-tracked plasmid DNA supply and expedited process confirmation
- 100% in-house analytics
- Templated documentation and on-hand materials
Reliability
- Standardized materials
- Royalty-free, proprietary, optimized technologies
- Predictable scale-up path to GMP and clinic
Experience
- 20+ years of integrated plasmid and viral vector CDMO experience
- 30+ years of biologics testing expertise
- GMP manufacturing experience across different serotypes
"We value this new partnership with Charles River, a standout in biopharmaceutical services. In the near term, this collaboration will accelerate the Gates Institute CAR-T programs with their plasmid and lentiviral vector production. Looking ahead to our long-term collaboration, we remain committed to advancing patient impact more broadly."
Terry Fry, MD, Executive Director, Gates Institute
Cell Therapy Flex Platform
Integrating standardized processes with pre-validated platforms and protocols, the Cell Therapy Flex Platform shortens development timelines from months to weeks, while reducing costs and improving quality outcomes.
With off-the-shelf solutions that provide faster knowledge transfer and process crossover to reduce bottlenecks and speed development, the Flex Platform is ready to use for preclinical drug development through manufacturing and commercialization to accelerate your autologous CAR-T or TCR-T cell therapy development.
Key Benefits
- Proven acceleration of development timelines
- Flexibility with product and quality attributes
- Lower overhead cost
- Improved drug product quality
- Process and analytical optimizations
- Regulatory compliance readiness
- Streamlined tech transfer and GMP preparation
"Manufacturing of gene therapies is highly complex and product quality is of paramount importance. We have the utmost confidence in Charles River to manufacture for VGX-0111 as we work toward our goal to bring treatment for those suffering from dry-AMD."
William Pedranti, CEO, Visgenx
The Benefits of Proven Cell and Gene Therapy Platforms
- Integration: A true concept to cure cell and gene therapy portfolio
- Speed: Supply chain simplification with industry-leading timelines
- Experience: Decades of production track record backed up by regulatory fluency
- Predictability: Standardized materials and a reliable path to GMP and beyond