Immusoft reported it achieved redosing with its ex vivo Immune System Programming (ISP) platform and advanced ISP‑001 into Phase I/IIa for MPS‑I; the company emphasized redosing’s potential to permit repeated dosing regimens, align with payer models and tailor therapy over time. Immusoft previously received FDA Fast Track designation. Concurrently, the FDA’s Center for Biologics Evaluation and Research announced flexibility and modernization steps for CGT chemical, manufacturing and control (CMC) requirements, signaling a regulatory willingness to adapt oversight to modality‑specific realities. The agency described leveraging experience with CGTs to allow targeted, risk‑based approaches rather than one‑size‑fits‑all rules. Taken together, clinical proof of redosing and CBER’s guidance indicate a shift toward more pragmatic development and manufacturing pathways for CGTs—changes that could lower barriers to iterative dosing strategies and commercial models for advanced therapies.