Story perspectives

FDA Delays Highlight Need for Better Gene Therapy Planning

8/22/2025

Summary

Story summary

Recent FDA rejections and delays in cell and gene therapy reveal significant barriers in chemical, manufacturing, and controls (CMC).
Experts stress the importance of early CMC planning, particularly in facility readiness and process scalability.
Key early development choices, like cell sourcing and vector selection, affect product performance and manufacturability.
Increasing regulatory demands for advanced therapy manufacturing may be addressed through standardization and digital platform advancements.

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Story summary

Recent FDA rejections and delays in cell and gene therapy reveal significant barriers in chemical, manufacturing, and controls (CMC).
Experts stress the importance of early CMC planning, particularly in facility readiness and process scalability.
Key early development choices, like cell sourcing and vector selection, affect product performance and manufacturability.
Increasing regulatory demands for advanced therapy manufacturing may be addressed through standardization and digital platform advancements.