Accelerate Your Next In Vivo CAR-T Program

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

From commercial ex vivo CAR-T to in vivo viral vector excellence

Successful CAR-T programs depend on reliable viral vector platforms that deliver high yield and consistent performance. Our proven expertise spans LVV, AAV, and adenoviral systems, enabling efficient scale-up for both ex vivo and in vivo applications.

With demonstrated success across multiple Genes of Interest (GOIs), we combine advanced analytics and orthogonal assays to ensure precise characterization and optimization of complex viral vectors, reducing variability and accelerating timelines.

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

RNA and LNP manufacturing expertise in vivo CAR-T and gene editing applications

Complex in vivo modalities demand robust processes and deep expertise. We offer proven scale-up strategies for mRNA and advanced targeted LNP programs, backed by experience in commercial manufacturing.

Our platforms support multiple RNA payloads and encapsulation approaches, ensuring flexibility for diverse therapeutic applications.

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