Scaling Cell And Gene Therapies: Crossing The Inflection Point

By Mike Paglia, Chief Technology Officer, ElevateBio

The field of cell and gene therapy has reached a pivotal moment where scientific possibilities outpace current manufacturing capabilities. Although transformative treatments are emerging for rare and difficult‑to‑treat diseases, their accessibility remains limited by how they are designed and produced. The article outlines how progress now depends on eliminating the traditional divide between therapeutic development and manufacturing. Instead of siloed workflows, an integrated ecosystem is needed—one where process development, analytical sciences, quality control, and manufacturing operate in parallel to reduce delays and improve reliability.

A key theme is the importance of designing therapies with manufacturability in mind from the earliest stages. Embedding process development scientists directly into therapeutic design ensures real‑time feedback loops, enabling more compact constructs, optimized delivery systems, and seamless scalability from small‑scale models to full cGMP manufacturing. This integrated approach supports significantly higher batch success rates and accelerates the transition from scientific concept to patient‑ready therapy, positioning the field to meet growing global demand.