How we help you power through the challenges of in vivo CAR-T development
Balancing in vivo potency and safety
Achieve targeted, durable CAR expression while limiting off-target toxicity and immune reactions
Complex formulation and conjugation
Combine genetic payloads with delivery systems deliver precise control
Expanded analytical requirements
Advanced bioanalytical methods are used to characterize both vector and formulation attributes
Cross-modality GMP scale-up
End-to-end solutions manage viral vector or RNA-LNP production, formulation, and fill/finish
New regulatory questions
CMC submissions in this area face especially strict standards, requiring flawless quality, safety, and clinical alignment
How we know what you need
Commercial track record of mRNA vaccines and viral vectors for
ex vivo CAR-T
Supporting multiple in vivo CAR-T programs, including clinical manufacturing
Fully integrated development and manufacturing
Decades of GMP experience in cell
and gene therapies
For Viral Vectors, you need Lonza
Technical expert guidance for emerging in vivo CAR-T programs
- Proven track record across ex vivo and in vivo CAR-T programs
- Deep expertise across multiple vector types, including LVV, AAV, and adenoviral
Proven platforms for high-yield viral vector scale-up
- Proven, scalable AAV and LVV platform with strong, consistent performance
- Demonstrated high yields across multiple Genes of Interest (GOIs)
Advanced analytics for complex viral vector characterization
- Detects process inefficiencies and drives optimization
- Orthogonal assays ensure confident viral vector characterization
Experienced and reliable commercial-scale manufacturing
- Delivery of 200+ cGMP viral vector batches per year for late-stage and commercial programs
End-to-end regulatory and CMC support for a rapidly evolving field
- Robust global quality and regulatory infrastructure
Proven end-to-end supports for process development, tech transfers, GMP manufacturing, and pre-license inspection readiness
FDA-approved Houston site for commercial viral vector production
For mRNA, you need Lonza
Process scale-up for complex in vivo modalities
- Advanced targeted LNP programs to cGMP
- Experience gained with commercial mRNA/LNP manufacturing
Multiple payload encapsulation
- Established process for the transition from early process development to GMP manufacturing
- Support of multiple RNA payloads across in vivo applications
Deep characterization
- Analytical platform supporting novel RNA-LNPs formulations including advanced immunogenicity testing capabilities
- Early process characterization to build a robust and scalable process
Pioneering in vivo CAR-T/gene editing
- Early cGMP execution experience in in vivo CAR-T
- Expertise to de-risk and accelerate first-to-clinic programs
Check out our recent webinar looking at the critical factors shaping the development of complex RNA-based CAR-T therapies.
We cover quality requirements, delivery challenges, and innovative process design from linker selection and LNP encapsulation to analytical hurdles.
Learn about strategies for development through IND, overcoming scale-up challenges, and ensuring reproducibility for next-generation in vivo CAR-T treatments.
Let’s supercharge your in vivo CAR-T program
Tell us about your program and how we can help you bring in vivo CAR-T therapies to your patients.
