SAN FRANCISCO– Multiply Labs, a robotics company developing industry-leading automated manufacturing systems to produce individualized drugs, today announced that Cytotherapy, the official journal of the International Society for Cell & Gene Therapy (ISCT), published a peer-reviewed research article focused on the performance of its proof-of-concept robotic system developed alongside a group of leading cell therapy organizations.
The paper, “Development of a robotic cluster for automated and scalable cell therapy manufacturing,” found that during the expansion phase of T cells-based therapy, Multiply Labs’ robotic system can automate an existing manual process while maintaining statistical equivalence on all critical process parameters. Additionally, estimates based on industry data show that this technology can reduce the cost of typical GMP-level cell therapy manufacturing processes by approximately 70%, on a per-product basis.
Currently, the development and manufacturing of cell therapies are exorbitantly expensive, hindering broad access to life-saving treatments. In fact, as much as 50% of manufacturing costs stem from labor-intensive manual processes and a shortage of skilled workers. This peer-reviewed paper highlights that by using Multiply Labs’ innovative approach, automated cell therapy manufacturing has the potential to significantly reduce costs while ensuring statistically equivalent outcomes to manual processes in terms of cell yields, viability, and phenotype.
A key advantage of Multiply Labs’ robotic technology is its compatibility with leading cell therapy manufacturing instruments. The data in this study shows that it is possible to automate an existing cell expansion protocol without significantly changing the process or impacting product characteristics. The data also demonstrates how Multiply Labs’ robotic approach reduces the number of human errors, which are the most significant cause of contamination, and enables the manufacturing of sterile products even in a non-classified environment.
“This peer-reviewed scientific data, an industry-first focused specifically on the potential of robotics in cell therapy, proves the ability of our automation technology to not only replicate a manual cell expansion process with equivalent results, but also to increase quality and to substantially reduce costs,” said Fred Parietti, Ph.D., Co-founder and CEO of Multiply Labs. “This independent, scientific and reproducible validation of our approach marks a significant milestone, bringing us and our partners closer to making cell therapies available to more patients than ever before.”
While robotics and automation are common approaches to reducing labor costs in other industries, it is more challenging in the biotech field as changing instruments or processes in FDA-approved therapeutics manufacturing requires regulatory resubmissions and lengthy comparability studies. This is why Multiply Labs’ unique approach focuses on robotic systems that can operate market-leading GMP instruments from multiple different vendors which are already extensively deployed for cell and gene therapy manufacturing. This technology is designed to enable plug-and-play-like capabilities, faster automation timelines, and fewer regulatory barriers.