Forge Biologics outlined how gene-therapy process development is shifting from “can we make it” to “can we make it consistently,” emphasizing seamless integration across early- and late-stage manufacturing. In its view, high-throughput scale-down models and explicit critical process parameter and critical quality attribute work are necessary to reduce late-stage failure risk. The company also described early and continuous stakeholder alignment to manage regulatory and commercialization expectations, particularly for AAV workflows where manufacturing robustness is a major determinant of schedule. The message reflects ongoing industry pressure to improve manufacturing predictability for CGT programs, where timelines and batch consistency directly affect trial starts and patient access.