Small Digital Steps, Big Hopes for Gene Therapy Manufacturing

Gene therapy producers test data tools and intensified processes to improve viral vector quality and scale

29 Jul 2025

Selective adoption of digital tools is beginning to shape viral vector production as a small group of gene therapy manufacturers tests data-led methods and intensified processes to improve reliability. The activity remains limited, but it signals how producers are searching for practical responses to long-running issues in yield, quality control and scale.

Viralgen has been one of the earliest movers. The company has reported using dashboards, mathematical models and digital-twin style simulations to identify points in its process where variability can slow output. By organising and analysing production data more systematically, Viralgen aims to reduce uncertainty and improve oversight of steps where small fluctuations can affect performance.

Landmark Bio has also begun work on process intensification. The group recently partnered with ChromaTan under a grant aimed at refining purification and other difficult stages. While the project does not yet involve public deployment of digital twins or dashboards, it reflects wider interest in technologies that could streamline upstream and downstream operations.

Academic researchers are pursuing similar lines. A team at University College London has examined digital-twin methodologies for biologics and advanced therapies, offering early analytical frameworks that could, over time, support commercial manufacturing.

Regulators continue to focus on well-characterised processes and strong quality systems rather than specific digital tools. Even so, specialists note that data-driven methods may help manufacturers meet existing expectations more efficiently as gene therapy pipelines expand.

Challenges remain, including validation demands, training requirements and the risk of new errors if tools are adopted without careful integration. But gradual progress from early industrial pilots and academic studies may inform more structured approaches in future.

With gene therapy development gaining pace, even modest analytical gains or intensified processes could influence how steadily viral vectors are produced. Current trends point to incremental, evidence-based steps rather than rapid transformation.