Thermo Fisher Scientific and Charles River Laboratories are joining Multiply Labs’ robotic cell therapy manufacturing consortium, which also includes UCSF and Cytiva. The goal of the multi-disciplinary consortium is to develop and validate a cGMP-compliant robotic manufacturing system capable of manufacturing gene modified cell therapies at industrial scale.
The consortium believes automation of advanced living drugs is an industry-defining technology with broad implications for the whole cell therapy field. It claims traditional manufacturing workflows hinder the industry’s ability to develop cell therapies at scale, increasing manufacturing costs and limiting their accessibility. The consortium intends to demonstrate robotic technology can be deployed in clinical and commercial applications.
Robotics development activities are coordinated by Multiply Labs, while the cell manufacturing process is overseen by UCSF through a sponsored research agreement.
“This unprecedented alliance brings together the global leaders in cell therapy manufacturing technologies, with the common goal of pioneering the deployment of robotic technology and achieving truly industrial scale,” said Fred Parietti, PhD, co-founder and CEO of Multiply Labs. “We are very excited to combine Multiply Labs’ cutting-edge expertise in cloud-controlled robotics with the GMP-ready, market-leading instrumentation technologies by Cytiva, Thermo Fisher and Charles River.”
Thermo Fisher’s Heracell VIOS incubators are used to provide active airflow control, HEPA filtration, and integrated humidity and CO2 control in cell therapy manufacturing. Within the Consortium, the company is collaborating with Multiply Labs on automating the operation of the incubators. The companies aim to demonstrate fully automated incubation and gene delivery processes, where every step of the manufacturing procedure is managed by cloud-controlled robotic systems.
“With a legacy of supplying the top 50 biopharma companies and focused investments in cell and gene therapy, Thermo Fisher is committed to helping developers accelerate their cell therapy programs,” said Betty Woo, VP and General Manager of cell and gene therapy at Thermo Fisher Scientific. “By contributing our proven GMP capabilities, we will help move the whole sector forward to serve patients who need life-saving cell therapies.”
Charles River’s Celsis rapid microbial detection and Endosafe endotoxin testing are platforms for sterility testing of cell therapy products. Celsis’ rapid microbial detection platform can enable final release testing of cell therapy products in as little as three days, the company claims. The Endosafe Nexgen-PTS is a point-of-use handheld spectrophotometer for real-time endotoxin testing. Charles River is collaborating with Multiply Labs on the automation of these quality control testing processes.
“Charles River is excited about participating in the Multiply Labs consortium,” said Matthew Hewitt, PhD, Executive Director, Scientific Services Cell and Gene Therapy, Charles River. “The result of developing a closed, automated, scalable cell therapy manufacturing platform will lower manufacturing costs, decrease process failures, and increase patient access to potentially curative therapies. We’re proud of the role our quality control platforms will have in ensuring the safety of cell therapies prior to patient dosing.”