Cell and gene therapy (CGT) manufacturing is approaching a turning point, with developers and manufacturers facing increasing pressure related to labor, costs, and speed-to-market. Industry leaders said on April 8 that automation, digitization, and greater collaboration are becoming essential to meet growing demand.
The need for scalable production methods is pressing as current CGT processes remain labor-intensive, expensive, and slow. Single batches can cost over $500,000 to produce. There are also not enough skilled biologists worldwide to support this sector. Edwin Stone, CEO of Cellular Origins, said the repetitive nature of some tasks leads to high staff turnover while human involvement increases the risk of contamination or error in sterile environments.
"Robotics and automation can be a solution," Stone said. Stuart Lowe, head of Advanced Therapies at TTP, described how much of today’s equipment still relies on handwritten notes or USB sticks for data collection. The industry is working to digitize these legacy systems so they can connect with centralized manufacturing dashboards.
Jason Jones, head of global business development at Cellular Origins, called the current scalability challenge "quite insurmountable" under old frameworks. He explained that boosting annual product capacity significantly while maintaining regulatory standards requires more advanced technology but changing hardware entirely is costly and may force companies into lengthy revalidation processes. Lowe said many firms prefer incremental upgrades over complete system replacements.
Companies like Cellular Origins have developed robotic digital platforms aimed at standardizing production across different systems through automation. Machine learning tools can analyze collected data for safety signals or mechanical faults; artificial intelligence may help correct errors in real time or suggest improvements during production runs according to Jones and Miguel Forte, president of the International Society for Cell & Gene Therapy (ISCT).
Alexander Seyf, founder and CEO of Autolomous—which provides integrated supply chain software—said scalability will be crucial if CGT manufacturing is to keep pace with patient needs globally.
Seyf emphasized that broad collaboration among all stakeholders—including manufacturers, device companies, therapy developers—and increased partnerships across sectors are vital for advancing both therapeutics and manufacturing capabilities. Jones highlighted ongoing co-development projects between Cellular Origins and companies such as Fresenius, Cytiva,and Thermo Fisher Scientific; discussions are also underway with contract research organizations like Charles River Laboratories.
As partnerships grow across sponsors,blood centers,and academic institutions,Seyf noted they enable consideration of the full patient journey from start to finish.Jones agreed,saying such collaborations help design therapies accessible on a global scale.
