ProBio Capabilities Update October 2026: Cell & Gene Therapy

Unlocking the Promise of In Vivo CAR-T: CMC Strategies for Scalable, Rapid, and Accessible Cell Therapies

In vivo CAR-T therapies have the potential to redefine cell therapy by eliminating complex ex vivo manufacturing, enabling off-the-shelf treatment, reducing costs, and accelerating patient access. However, as investment and clinical activity continue to expand, robust CMC strategies have become critical for successful development and regulatory advancement.

This presentation will examine the advantages of in vivo CAR-T platforms, including lentiviral vector (LVV) and mRNA-targeted LNP approaches, with a focus on manufacturing scalability, analytical development, formulation, quality control, and IND-enabling readiness. Drawing on ProBio's integrated development platforms, we will explore the evolving in vivo CAR-T landscape, compare leading delivery technologies, and discuss key CMC considerations including vector design, process development, scale-up, analytical characterization, formulation, quality control, and regulatory readiness.

Through comprehensive CMC solutions and platform capabilities, attendees will gain insights into how platform-enabled CMC strategies can accelerate development timelines from discovery to clinical proof-of concept, de-risk clinical translation, and unlock the full commercial and therapeutic potential of in vivo CAR-T therapies.