Gene Therapy Data Pipelines from Bench to Clinical Review
Holding
Gene therapy data pipelines should be built as evidence systems. They must connect assay result, batch, vector, construct, patient or sample context, and manufacturing step without losing reviewability.
Authority
FDA gene therapy guidance emphasizes chemistry, manufacturing, controls, and clinical considerations. The software implication is that CMC and clinical evidence cannot be managed as disconnected spreadsheets when the product depends on biological process control.
Issue
The failure mode is fragmented evidence. Potency, identity, purity, safety, sequencing, release testing, and clinical response may live in separate systems. When those records cannot be joined, teams struggle to explain variability or support a regulatory review narrative.
Resolution
The pipeline should preserve batch identity, assay method version, sample chain, acceptance criteria, deviations, vector attributes, and clinical linkage. Data models should distinguish exploratory analysis from controlled release evidence.
Evidence Package
The record should include assay metadata, chain-of-custody events, batch genealogy, method versions, QC exceptions, deviation records, analysis scripts, validation reports, and review signoff. Gene therapy data systems should make the biological product's history computable and auditable.