Autolus' Stevenage, UK site will manufacture clinical products for global commercial supply, effective as of March 18, 2024, followed by a GMP inspection by the Medicines and Healthcare products Regulatory Agency (MHRA) in February 2024.
The site will focus on manufacturing autologous chimeric antigen receptor (CAR) T-cell therapies.
“Autolus has secured from the MHRA a Manufacturer’s Importation Authorization (MIA) together with the accompanying GMP certificate,” a spokesperson for Autolus told BioProcess Insider.
“This enables the global export of obe-cel to any licensed market. We anticipate a PLI (Pre-License Inspection) by the US Food and Drug Administration (FDA). Beyond this Autolus is considering follow-on indication for obe-cel in both oncology and auto-immune disorders. Further, Autolus is pursuing additional indications in their pipeline.”
Primarily the site will focus on the production of obe-cel for ALL patients. Obe-cel is a CD19 CAR-T cell investigational therapy designed with a fast target binding off-rate to minimize excessive activation of the programmed T cells.
Additionally, Autolus is focused on first securing marketing approvals for obe-cel in the US, UK and EU (all in progress) and will pursue further licensing opportunities as appropriate.
The spokesperson confirmed that the FDA has accepted Autolus’ Biologics License Application (BLA) for obe-cel for patients with relapsed/refractory (r/r) Adult B-Cell ALL. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of November 16, 2024.
“Autolus expects to file a marketing authorization application (MAA) to the European Medicines Agency (EMA) in the first half of 2024 and an MAA to MHRA in the second half of 2024.”
The advanced therapy medicinal products (ATMP) facility based in Stevenage is 30 minutes North of London and is the manufacturing headquarters of Autolus. According to the firm, the facility can produce over 2000 commercial CAR-T patient batches per year.
The 70,000 square-foot facility includes clean rooms, quality check (QC) laboratories, training labs, warehouses and administrative space.
“Located in the golden triangle between London, Oxford and Cambridge the facility is also ideally located to attract key biotech talent resources with a staff of 300 already based at the Stevenage site. Our pipeline indications are also on this platform thus allowing us to use this same facility for eventual launch on future products,” said the spokesperson.
The facility uses Miltenyi’s Prodigy Bioreactor platform. Autolus and Miltenyi partnered in 2018 to supply and support instruments, reagents and disposables for the manufacture of Autolus’ programmed T cell therapies.
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