Needs
Unified donor registry: The creation of a unified donor registry that retains collections schedule will, first of all, enable donor safety by setting and implementing a standard recovery period. The registry will also retain and reference donor profiling information.
Collection and processing standardization: Standardization across apheresis and analytical sample collection is critical. For apheresis, a standardized protocol will be key for both the analysis and the scalability of cell therapies where even minor variations can have profound effects on feasibility. There is ongoing work by Blood Centers of America for standard leukopak specifications for further manufacturing. For analytical samples along the workflow, standardization of sample collection and processing will ensure that the samples collected are comparable and will yield statistically meaningful insights. Learnings can be adopted from the sample collection protocol the UK Biobank developed as well as from the work of other organizations that have built sample cohorts that were successfully validated.
Data standardization: In order to enable algorithmic analysis, data across therapies and therapy developers needs to be uniformly parametrized. In the context of BioMADE collaboration, PAT and CQA data parametrization is standardized, and those learnings can be applied to the diverse data sets within the Vein-to-Vein Data Ecosystem.
Large-scale data set: Assembly of the Vein-to-Vein Data Ecosystem will require the legal framework and federated data architecture to enable protection of competitive information, while allowing for algorithmic analysis to yield precompetitive insights about manufacturability. For the legal framework, agreements currently in place as well as those used for past collaborations can be used. For federated data architecture, CIBMTR has been building out a structure that retains data storage and ownership by therapy developers, while allowing analysis, and the lessons from CIBMTR can be leveraged for the Vein-to-Vein Data Ecosystem.