Chaozhong Zou
In vivo CAR-T therapies are gaining momentum, with early clinical data showing encouraging efficacy. However, key challenges remain, including improving targeting precision, persistence, toxicity management, and optimizing delivery platforms—particularly the choice between viral vectors and RNA-based approaches.
For ex vivo immunotherapies, innovations such as multi-targeting constructs, inducible on/off switches, and armored cell designs are advancing, especially in solid tumors. Still, reducing manufacturing cost and complexity remains a critical priority.
Reliance on CDMO partnerships is increasing significantly, as sponsors seek flexible capacity, specialized expertise, and regulatory support. At the same time, decentralized and point-of-care manufacturing models are emerging as transformative solutions, particularly for autologous therapies and rare diseases, though broader regulatory alignment is needed.
Ultimately, success in CGT will depend on integrated ecosystems that combine therapeutic innovation with agile, distributed manufacturing and strong external collaboration.
