The most important role of industrial software for the cell and gene therapy sector is the ability to precisely trace materials from collection site through the plant and back to the patient. So says Jonathan Wofford, CCO at Phoenix, Arizona software developer, Title21 Health Solutions, who told GEN, “CGT manufacturing typically involves fragmented, bespoke workflows.
“The complexity is compounded by several variables, including diverse collection methods and protocols, highly variable starting materials, operator techniques, and challenging logistics. Therapies are time-sensitive and orchestration between collection centers, manufacturing facilities, and treatment centers is critical.
“As a result, CGT manufacturing requires coordination across a complex ecosystem that includes clinical operations, manufacturing, supply chain, quality, and data management, unlike mature and standardized mAb production processes.”
And this is where software makes its biggest, if somewhat underacknowledged, impact, according to Wofford.
“The primary value of software systems is not replacing or automating manufacturing processes, but rather bringing control, standardization, and traceability of manual data workflows,” he pointed out. “CGT manufacturing is variable and typically involves multiple changes in custody…each handoff creates opportunities for human error, documentation discrepancies, and compliance risk.”
Traceability in the plant
Software can also enhance the traceability of data within the manufacturing facility.
“Software platforms can help bring quality control and standardization to data entry and workflow management manufacturing through multiple features,” he continued, using electronic batch records as an example. “Industrial software system can also facilitate real-time chain-of-identity and chain-of-custody tracking, with live dashboards and analytics capabilities to drive enhanced insights into production runs, as well as real-time automated warnings for in-process issues or data values.”
The ability to trace materials and data in the plant is always going to be important, even if technology advances allow CGT process developers reduce the requirement for manual handling.
“Adoption of closed-system manufacturing may increase over time. However, today, software systems remain a more immediate solution for improving data accuracy, reducing manual data entry and processes, strengthening compliance controls, and driving analytics,” said Wofford, noting that this is where the emerging cell and gene therapy industry should focus its efforts rather than on promising yet untested technologies like artificial intelligence (AI) based process control systems.
“CGT organizations should be prioritizing technologies that can deliver meaningful and measurable operational and compliance benefits now,” he emphasized. “In the not-too-distant future, AI will likely contribute to predictive manufacturing and autonomous process control. But the greatest value today lies in targeted applications that improve efficiency, strengthen compliance, accelerate batch reviews, and generate actionable insights from complex data.”
