Immusoft reported progress with its Immune System Programming (ISP) ex vivo CGT platform and a Phase I/IIa program (ISP‑001) for MPS‑I, highlighting the ability to redose patients without preconditioning — a departure from AAV‑based once‑only dosing. Immusoft has Fast Track designation and is titrating doses after an initial redose administered last September. Separately, FDA’s Center for Biologics Evaluation and Research signaled steps to modernize and add flexibility to CGT chemical, manufacturing and control (CMC) expectations, aiming to reduce one‑size‑fits‑all burdens and speed clinical translation. Together, platform-level redosing advances and regulatory flexibility could lower clinical development risk and commercial barriers for CGTs by enabling repeat dosing strategies and streamlined manufacturing pathways.