The FDA’s Center for Biologics Evaluation and Research announced steps to modernize and provide flexibility in chemical, manufacturing and control expectations for cell and gene therapies (CGTs), signaling a regulatory tilt toward modality‑specific, risk‑based approaches. Separately, Asimov licensed its LV Edge Packaging lentiviral production line to AGC Biologics, enabling single‑plasmid transfection workflows that reduce GMP plasmid needs and simplify vector manufacturing. AGC plans to offer the packaging system at its Milan Cell & Gene Center of Excellence. Taken together, the announcements point to an industry shift: regulators easing rigid, one‑size‑fits‑all requirements while CDMOs adopt technologies that cut complexity and supply‑chain risk. Developers of CGTs said the twin moves could reduce cost and speed clinical manufacturing scale‑up.