In recent years, cellular therapy has surged into the spotlight as a frontier of modern medicine. Treatments that harness living cells—whether stem cells, engineered immune cells or regenerative cell products—offer enormous promise. But with this promise comes tremendous responsibility: ensuring every unit is tracked, every treatment is safe and every patient receives precisely what is intended. That’s where the ISBT 128 labelling system steps in—and its relevance to cellular therapy is deeper than you might think.
Cellular Therapy’s Unique Challenge
Unlike conventional pharmaceuticals, cellular therapy products are derived from living donors or autologous systems, may undergo complex processing, and often carry stringent requirements for traceability and regulatory compliance. The nature of these products means the risk of mislabelling, mis-identification or lost traceability presents a very real patient-safety concern.
A system designed for these complexities must deliver globally unique identifiers, standardized product terminology and consistent format across institutions and countries. Without that, a therapy product harvested in one facility could arrive at another with ambiguity around donor, product code, processing history or handling conditions.
What ISBT 128 Brings to the Table
ISBT 128 is an international standard for labelling, coding and identification of medical products of human origin—including cellular therapy. According to the International Council for Commonality in Blood Banking Automation (ICCBBA), it is the framework by which donation identifiers, product codes, bar-codes and data structures are defined so that information travels unambiguously.
In the context of cellular-therapy products, ISBT 128 enables:
- Unique donation numbering that prevents duplication of identifiers.
- Standardized product description codes (so “CAR‐T cell product type A” is defined the same way everywhere).
- Bar-coding and machine-readable labels that reduce transcription errors.
- Global interoperability—products moving across borders maintain accurate information.
In essence, ISBT 128 converts the intricate ecosystem of cellular therapies into an organised, trackable flow of products from donors through processing, release and administration.
Why Adoption Matters in Cellular Therapy
Implementing ISBT 128 in a cellular therapy facility is more than regulatory box-checking—it addresses real risks and operational pain points. As one expert summary puts it: the field’s growth makes standardised labelling critical because “variations in licensing requirements, language differences and local practice… increase the risk of error.”
From an operational standpoint:
- Traceability: A labelling system based on ISBT 128 allows backward (and forward) tracking of a product’s journey, including donor, processing site, batch or division, and final recipient.
- Efficiency: When labels are consistent and machine-readable, processing times shorten, errors shrink and staff can focus on value-add tasks instead of manual reconciliation.
- Compliance & Accreditation: Accreditation bodies like Foundation for the Accreditation of Cellular Therapy (FACT) and regulatory agencies increasingly require or expect ISBT 128 labelling for cellular therapy products.
- Global scale: For programmes that harvest cells in one country, process in another and deliver in a third, a standard like ISBT 128 ensures the information stays intact across systems and countries.
To fully realise these benefits, facilities must integrate ISBT 128 standards into their workflows and systems. That often calls for custom software development—tailored solutions that embed ISBT 128 data structures, label-generation modules, scanning/verification logic, and integration with laboratory information systems (LIS) or enterprise resource planning (ERP) tools.
For example, a facility might build a module that:
- Generates an ISBT 128 compliant label the moment a harvest is logged
- Prints bar codes and human-readable text in the correct layout referenced in ST-004 (“Standard Labeling of Cellular Therapy Products”).
- Interfaces with the donor database, processing records, and shipping system so the downstream data flows seamlessly
- Triggers alerts if a scanned label doesn’t match expected identifiers, reducing mismatch risk
When the software is designed with your workflow in mind—rather than relying solely on off-the-shelf systems—your facility gains precision, speed and compliance in one package.
Key Steps to Implementation
- Gap Assessment – Review current labelling, tracking and software infrastructure to determine how far you are from full ISBT 128 compliance.
- Define Workflow – Map your entire cell therapy product lifecycle: donation → processing → storage → release → administration. Identify where labels are created, scanned or archived.
- Label Specification – Consult ISBT documents like ST-004 and ST-018 to define label layout, code structures and bar-code symbology.
- Software Integration – Engage developers (or internal IT) to build or customise software that supports ISBT 128 data structures, integrates with your LIS/ERP and handles real-time scanning/verification.
- Training & Validation – Ensure staff understand label meaning, scanning routines and exception handling. Run validation to confirm labels meet standard and work in practice.
- Continuous Monitoring – After rollout, monitor for errors, mis-scans or traceability gaps and iterate the system accordingly.
Conclusion
In the evolving arena of cellular therapy, one of the strongest allies you have is standardisation. The ISBT 128 labelling system provides the backbone for safe, traceable, efficient product handling—from harvest to patient infusion. Adopting it isn’t just a best practice—it’s becoming essential. And when you combine ISBT 128 compliance with thoughtfully engineered software—customized to the unique demands of your laboratory or manufacturing facility—you equip your operation to deliver advanced therapies with precision, confidence and accountability.
For the teams pioneering the future of cellular treatment, implementing ISBT 128 is the smart route to rigorous quality and sustainable growth.
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