Manufacturing a patient-specific therapy is as much a logistical challenge as a scientific and technical one. In theory, digital technology can manage the complex supply chains on which such products rely. But industry must invest in the infrastructure needed to track materials from the bedside to the plant and back.

Terry Church, PhD, professor in the department of regulatory and clinical sciences at the University of Southern California, is convinced of the benefits of digital supply chains, particularly for cell and gene therapy developers.

“Digital technologies are a priority area of investment for many cell and gene therapy companies, however not many have made the switch to full digitization. This is mostly due to infrastructure issues,” he says. “Equipment used in the manufacture process of cell and gene therapy may be incompatible or not designed for digital systems. The investment cost to make changes to the equipment and shipping practices can be quite expensive.

Church and colleagues examined the logistical challenges involved in producing cell and gene therapies for trials in a recent study. And the key finding was that industry is moving in a digital direction.

“There are barcoding and 3D QR code systems that allow for easy tracking of cell and gene products, which function from collection to distribution to track and monitor progress throughout the supply chain,” Church tells GEN. “They provide valuable data on quality, movement speed, and delays to name a few. These systems will continue to become more advanced as time progresses.”

Shipping considerations

Shipping is also a challenge, according to Church, who points out that any delays at port can impact the viability of cell and gene therapies.

“Among the biggest challenges are import and export issues as each country has its own unique system and logistics must be closely monitored for any exceptions,” he points out. “Many of these products need to be kept at a consistent temperature to remain viable and the longer a container remains in customs the more chances it has to fluctuate below optimal thresholds.”

Again, digital technologies can address import export issues. However, says Church, regulators will need to move away from established systems and embrace digitization.

“Global regulatory mechanisms vary widely in terms of guidance and regulations surrounding cell and gene therapy. In some instances, there have been clear and calculated decisions to maintain traditional and legacy systems of paper and barcode scanner,” he continues.”

Despite this, Church is confident that eventually digital systems will come to dominate.

“I do think in the not-so-distant future, however, that these antiquated paper systems will need to give way to more sophisticated digital platforms that help optimize the process from collection to distribution,” he predicts.

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