Automated cell manufacturing company Mytos has signed an agreement with Aspen Neuroscience, a clinical-stage private company focused on autologous regenerative medicine, to automate the manufacture of autologous dopaminergic neuronal precursor cells (DANPCs) for ANPD001, Aspen’s investigational cell therapy program for Parkinson’s disease.
Under the terms of the agreement, Aspen will integrate Mytos’ iDEM automated cell technology into its 22,000-square-foot manufacturing facility in Torrey Pines, CA. The iDEM technology combines fluidics, advanced imaging, and mechanical movement and control to support the production of specific human cell types. According to Mytos, the system will enable Aspen scientists to manage multiple batches simultaneously with a smaller cleanroom footprint, minimizing the need for extensive hiring, training, and facility expansions as manufacturing scales out.
Aspen’s DANPCs, which replace lost dopamine-producing neurons in the brain, are differentiated from induced pluripotent stem cells derived from each patient’s skin cells. As of last year, the company said that it had dosed its first cohort of patients as part of a Phase I/IIa clinical trial of ANPD001.
Mytos’ instrumentation and software platform technology “have the potential to close and automate an important step of our process, and thereby significantly reduce labor and increase production capacity,” said Thorsten Gorba, PhD, vp of process development at Aspen Neuroscience. “We are confident that, alongside our bioinformatics and enabling technologies, the integration of the Mytos iDEM platform will streamline and elevate the automation of patient-specific DANPC production.”
Aspen is one of several companies in the last year looking to Mytos’ technology to automate the process of growing cells for use in the regenerative medicine space, Ali Afshar, Mytos CEO and co-founder, told GEN. His company has spent the last few years building an automated platform for differentiating iPSCs into neurons and other cell types, that is simple to use with minimal training. A single operator can learn all they need to run the system in about an hour compared to months with a manual workflow.
The two-part iDEM platform automates the process of coating, seeding, feeding, passaging, and imaging cells, reducing the risk of inconsistencies and contamination that plague manual workflows. Besides the physical hardware where the cells are grown, the company also provides all the consumables including reagents and flasks needed to grow and sustain the cells for weeks or months depending on the type of cell. Customers also have software for tracking and storing data throughout the growing process. That data is stored in the cloud and readily accessible to users. Once the cells are ready for harvest, the system sends an alert.
Afshar said that the company will share details of additional manufacturing deals over the course of the year. Part of what makes the platform attractive is its ability to address the failure rate associated with manual workflows. For therapy manufacturers, “that failure rate needs to come way down, closer to what they would expect when manufacturing a traditional drug,” Afshar said.
Additionally, installing a Mytos system can reduce the costs associated with running high-grade clean rooms needed for manufacturing as these can be expensive to build, run, and scale over time. “With a Mytos platform, they can use two-and-half times less [space] than a really expensive clean room,” he said. Since each box has a small physical footprint, manufacturers can easily add systems to their existing fleet to rapidly scale up cell production.
Afshar expects the demand for the Mytos platform to grow in the coming months, particularly from companies manufacturing stem cell therapies for neurodegenerative diseases like Parkinson’s disease but also spinal cord injuries and dry age-related macular degeneration where cells are damaged or lost. The platform can be used to manufacture stem cells for both autologous therapies, which use the patient’s stem cells in the treatment, and allogeneic therapies, which are not personalized for a single patient. “We’ve seen big breakthroughs where these treatments have started to work. Mytos has doubled down on trying to help those companies scale as fast as they can and get to more patients as quickly as possible,” he said.
