Sarcouncil Journal of Internal Medicine and Public Health

Abstract: Labeling in cell and gene therapy (CGT) manufacturing occupies a unique operational position that has no direct parallel in conventional pharmaceutical production. Because CGT products are biologically variable, frequently patient-specific, and characterized by critical quality attributes that are determined only after manufacturing is complete, the sequential logic that governs traditional labeling workflows—wherein product characteristics are known before a label is applied—cannot be assumed. Regulatory frameworks governing advanced therapy medicinal products (ATMPs), including the applicable provisions of 21 CFR Part 1271 and EudraLex Volume 4 Annex 2, establish functional requirements for product identification and traceability without prescribing the structural architecture through which those requirements must be fulfilled. This regulatory flexibility has, in practice, allowed legacy practices such as two-stage labeling to persist in environments where digital manufacturing infrastructure has materially changed the operational conditions that originally justified them. The biological basis of late-stage data generation in CGT—rooted in the variability of living cellular starting materials, the complexity of gene transfer processes, and the post-manufacturing nature of release testing—makes deferred label completion an intrinsic feature of these manufacturing workflows rather than a procedural anomaly. Alternatives, including just-in-time labeling and minimal-label architectures grounded in digital traceability, offer operationally sound and regulatorily consistent responses to this challenge. A transition toward data-centric labeling models, in which the physical label functions as an identity anchor and validated digital systems carry the authoritative attribute record, represents the most coherent path forward for scalable, safe, and compliant CGT manufacturing.