The Role of Digital Infrastructure in Scaling CGT Manufacturing
As an increasing number of cell and gene therapies advance toward commercial scale, the industry is coming to understand that digital systems are not optional. Electronic batch records, standardized parameter capture, and interoperable data platforms are becoming essential tools that help manufacturing teams reduce manual variability and build confidence in regulatory compliance. These digital-first approaches are more than a nice-to-have; they are foundational enablers of scale.
In a mature, digital manufacturing environment, every aspect of the production process is captured, tracked, and analyzed in real time. Rather than relying on paper logs or fragmented spreadsheets, teams use electronic batch records to ensure that key process steps are recorded consistently and accurately. Parameter capture is standardized across sites, meaning that critical inputs such as temperature, gas flow, media composition, and timing are logged in a structured and comparable way. These data points flow into interoperable platforms that integrate information across systems, connecting upstream development, manufacturing, quality control, and supply chain.
This unified digital infrastructure helps to drive down risk. By minimizing manual interventions and eliminating transcription errors, it reduces variability between runs and between facilities. It also supports audit-readiness, because data trails are automatically retained and can be readily reviewed. Regulatory bodies are more likely to trust a manufacturing process that is underpinned by rigorous, digitized, and transparent records.
Perhaps most importantly, digital systems unlock the scalability that will be required for commercial production. As the volume of therapies grows, so too does the need to coordinate large-scale production, scale out capacity, and maintain consistency across multiple geographies. Digital-first manufacturing environments make that possible. They provide the visibility, the traceability, and the analytical power to replicate processes reliably, optimize yields, and accelerate delivery to patients. In short, embracing these technologies is a critical step in realising the full potential of advanced therapies.
