The in vivo revolution in CAR-T therapy medicinal products: challenges and regulatory prospects - PubMed
4 hours ago
- #regulatory challenges
- #CAR-T therapy
- #in vivo
- In vivo CAR-T therapy offers a simplified, scalable, and more accessible alternative to ex vivo CAR-T therapy.
- Challenges include off-target effects, immunogenicity, and quality control concerns.
- Regulatory strategies need to be adaptive and involve early engagement and international coordination.