Why Early QC Planning Matters in Cell and Gene Therapy

Late-stage CMC setbacks often begin with early QC decisions that shape cell and gene therapy timelines, costs, and regulatory outcomes

1

Manufacturing or quality deficiencies accounted for 74% of Complete Response Letters issued by the FDA from 2020 to 2024.
2

Three high-profile cell and gene therapy programs faced delays or rejections in 2025 due to Chemistry, Manufacturing, and Control-related issues.
3

Early development decisions in gene therapy have significant downstream consequences, as emphasized by FDA guidance on CMC.
4

A cohesive QC strategy is essential, as it cannot be redesigned at each development stage without risking compliance and efficiency.
5

Geographical considerations in quality strategy are crucial, as operational habits can lead to documentation inconsistencies across regions.

1