A maturing, data-rich and more commercially-focused cell and gene therapy (CGT) industry is finally embracing innovative manufacturing technologies, according to the head of U.K.-based industrial software firm, Autolomous.

Early CGT manufacturing relied heavily on technologies borrowed from biologics manufacturing, systems originally built for producing therapeutic proteins rather than patient-specific therapies. As a result, production processes were often highly manual, fragmented, and operator-dependent. Indeed, in many cases, manufacturing resembled a specialized laboratory process, rather than a scalable industrial operation.

But the situation is changing, says Autolomous CEO, Alexander Seyf, who argues CGT manufacturers are embracing innovation with product quality, cost control, and scalability in mind.

“As the industry moves beyond early clinical programs and toward commercialization, manufacturers are recognizing that traditional approaches simply won’t support the scale, consistency, or economics needed long term.

“There’s now much greater focus on automation, closed processing, and digital integration to improve reproducibility, reduce contamination risk, and lower the cost of goods,” Seyf tells GEN.

Increasingly, CGT firms are opting for purpose-built technologies, he says, citing automated cell handling, closed-system processing, robotic fill-finish, and integrated single-use platforms as examples.

“The broader shift is toward what many describe as ’CGT 4.0:’ applying the principles of Industry 4.0 to cell therapy manufacturing. The aim is to move away from highly manual, artisanal production toward scalable, repeatable manufacturing that can support broader patient access,” he adds.

Data

Data is also driving the adoption of new technologies. In cell and gene therapy production, large volumes of data are collected by different instruments, software platforms, QC systems, environmental monitoring tools, and manual inputs—many of which were never designed to communicate with one another.

In such circumstances, digital technologies provide manufacturers with an infrastructure that can gather process information and ensure it is usable, traceable, and reliable, Seyf says.

“Maintaining data integrity and full chain-of-custody visibility across fragmented systems can become incredibly difficult, particularly as operations scale.

“To solve this, companies are investing heavily in integrated digital architectures that bring manufacturing and quality data together into unified environments. Standardized data models, interoperable software platforms, and automated data capture are becoming increasingly important. Cloud infrastructure also plays a key role because it allows manufacturers to aggregate and analyze data across multiple facilities in real time,” Seyf says.

A typical, modern digital cell and gene therapy manufacturing setup includes systems that manage manufacturing execution, laboratory information, quality, electronic batch records, and cloud-based data platforms.

“Together, these systems help manage scheduling, batch tracking, compliance, traceability, and quality oversight in real time,” Seyf says, adding, “Modern facilities are also increasingly using process analytical technologies and integrated sensors to monitor critical process parameters continuously, rather than relying only on end-point testing.”

“A digital CGT manufacturing system is really about connectivity and visibility across the entire process. It’s not just about replacing paper records with electronic systems—it’s about creating an environment where manufacturing equipment, quality systems, analytics, and logistics are all connected and continuously sharing data.”

Material traceability

The need to keep track of cell and gene therapy raw materials is also fueling the adoption of innovative technologies, with patient-specific therapies being a case in point.

Seyf tells GEN, “Maintaining chain-of-identity and chain-of-custody is particularly important in CGT manufacturing, especially for autologous therapies where every batch is tied to an individual patient. That requires seamless integration between manufacturing systems, analytics platforms, and logistics operations.”