CGT manufacturing progress is often slowed by fragmented data environments, inconsistent documentation practices, and limited mechanisms for standardized data sharing across institutions. These gaps create obstacles that prevent teams from fully understanding sources of variability, identifying process optimization opportunities, and harmonizing manufacturing practices at scale. As part of the Act for Hope initiative, our manufacturing workstream has taken an early but meaningful step toward addressing these barriers by developing an initial digitized process development (PD) database. This resource aggregates non-clinical, de-identified CAR-T manufacturing data from three participating institutions, creating a shared foundation for transparency and collaborative learning.

Although this first version represents a baseline dataset rather than a statistically robust or fully comprehensive resource, it serves as a clear demonstration that multi-center, standardized PD data sharing is both feasible and operationally achievable. Establishing common data structures, aligning on critical process parameters, and implementing harmonized data collection workflows required close coordination among sites, yet these efforts have produced a functional, scalable proof of concept.

The value of this initial accomplishment extends well beyond the dataset itself. By showing that institutions can contribute comparable data into a unified digital system without compromising confidentiality or operational integrity, the project lays essential groundwork for future expansion. As more centers contribute and data volumes increase, this shared platform will enable deeper analytics, richer benchmarking, and more sophisticated modeling to support evidence-based process optimization. Ultimately, this collaborative, data-driven approach has the potential to accelerate development timelines, enhance manufacturing consistency, and support the long-term vision of more efficient, scalable CGT production.