Software Can Solve CGT’s Sectors Traceability Challenges
Cell and gene therapy developers should use software to help trace materials and data through the complex multi-stakeholder supply chains, manufacturing and distribution processes on which such products rely according to an industry expert. The post Software Can Solve CGT’s Sectors Traceability Challenges appeared first on GEN - Genetic Engineering and Biotechnology News .
Industrial software plays a crucial role in the cell and gene therapy (CGT) sector, particularly in ensuring precise traceability of materials from the collection site through the manufacturing plant to the patient. According to Jonathan Wofford, Chief Commercial Officer at Title21 Health Solutions, CGT manufacturing often involves fragmented and bespoke workflows, compounded by diverse collection methods, highly variable starting materials, operator techniques, and challenging logistics.
The therapy's time-sensitive nature and orchestration across various entities, such as clinical operations, manufacturing, supply chain, quality, and data management, make coordination critical, a complexity that software systems can address more effectively than traditional methods. Wofford emphasizes that the primary value of software lies in bringing control, standardization, and traceability to manual data workflows, as each handoff during CGT manufacturing presents opportunities for human error, documentation discrepancies, and compliance risks.
Software platforms can significantly enhance data traceability within the manufacturing facility through numerous features, including electronic batch records, which facilitate real-time chain-of-identity and chain-of-custody tracking. Real-time dashboards and analytics offer valuable insights into production runs, while automated warnings help identify in-process issues or data anomalies promptly.
Although advancements in technology may eventually reduce the need for manual handling in CGT processes, software systems remain an immediate solution for enhancing data accuracy, reducing manual data entry and processes, strengthening compliance controls, and driving analytics. Wofford advises CGT organizations to prioritize technologies that provide immediate operational and compliance benefits over speculative yet untested technologies like artificial intelligence-based process control systems.
While AI may contribute to predictive manufacturing and autonomous process control in the future, the most immediate value lies in targeted applications that improve efficiency, strengthen compliance, accelerate batch reviews, and generate actionable insights from complex data.
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