After a relatively quiet stretch, Aspen Neuroscience is rolling out a major upgrade to its in-house manufacturing. The project will support production for Aspen’s autologous cell therapy studies and future capacity needs for the company’s personalized medicines.
The new 22,000-square-foot facility near Aspen's headquarters in the Torrey Pines neighborhood of San Diego will specialize in the production of induced pluripotent stem cell (iPSC)-derived cell therapies. Specifically, the plant will be designed for production and testing of Aspen’s iPSC cell therapy candidate ANPD001, which the company is trialing in Parkinson’s disease, Aspen said in a release.
Aspen is embarking upon the manufacturing expansion after dosing the first patient with ANPD001 in its phase 1/2a ASPIRO trial in April. Prior to this, privately held Aspen had already been cranking out its patient-specific drug using in-house production and quality control units, the company said Tuesday.
The project includes a new 14,000-square-foot facility housing 3,000 square feet of controlled manufacturing space. That section of the plant will include three qualified production suites, QC labs, warehouses and offices. Aspen has also locked down 8,000 square feet of expansion space for future manufacturing suites, QC labs and additional process automation.
Aspen did not say how much it’s investing in the new project.
The new plant builds on an existing 500 square feet of manufacturing and lab space at Aspen’s San Diego home base, where the company processes patient skin biopsies and carries out research and process development activities.
Aside from clinical cell therapy supply, Aspen says it has laid out a broader goal for “further industrialization of autologous cell therapy manufacturing” as well as plans to automate, close processes and increase throughput.
Aspen’s manufacturing platform leverages a small sample of a patient’s own skill cells, which are subsequently reprogrammed to iPSCs tailored to the individual before differentiation into their final cell type for therapeutic delivery.
For ANPD001 specifically, the patient’s iPSCs are converted into bespoke dopaminergic neuronal precursor cells for treatment of Parkinson’s, according to Aspen. Before implantation back into the patient, the cells are assessed at several stages of the production process using Aspen’s genomic tests and machine-learning-based bioinformatics tools, the company explained.
Over the last couple of years, Aspen has primarily busied itself working on its ASPIRO study and pitching its unique cell therapy approach at conferences and in medical journals.
The biotech in 2022 reeled in a $147.5 million series B funding round co-led by Alphabet spinout GV, LYFE Capital and Revelation Partners. At the time, the company also enticed new investors like Newton Investment Management, EDBI, LifeForce Capital, Mirae Asset Capital and others.
The cash infusion supplied Aspen with the funding needed to support its studies of ANPD001, which won a fast-track designation from the FDA last October.
Following initial dosing in April, Aspen finished dosing the first cohort in its ASPIRO study late last month.