Cellares, the contract drugmaker known for its cell therapy factory-in-a-box, will expand its operations to Europe after inking a long-term lease for manufacturing and office space in the Netherlands.
The deal secures real estate for Cellares to construct a so-called Integrated Development and Manufacturing Organization (IDMO) smart factory at Leiden Bio Science Park in the Dutch city of Leiden, the company said in a Jan. 12 press release.
The lease spans roughly 105,000 square feet of lab and office space within Leiden's Nexus building, a new life sciences facility that is expected to come online in 2026's first quarter. Once the building is up and running, Cellares says it plans to complete a phased fit-out process to prepare the site and anticipates settling in there "later in 2026."
In addition to bolstering dedicated regional capacity, the new facility will double as Cellares' European headquarters, the company added.
The site will support automated cell therapy manufacturing programs for both European and global partners and will feature the company’s fully automated Cell Shuttle production platform and Cell Q quality control systems, Cellares explained Monday.
The company did not disclose how much it is paying for the lease or fit-out process at the site.
“Cell therapies are manufactured to order for each patient, and the work is time-sensitive, which makes on-continent capacity a practical requirement for European programs,” Fabian Gerlinghaus, Cellares’ co-founder and chief executive, said in a statement. “A European hub gives partners a local supply path while keeping control consistent across geographies through a single automated standard.”
Cellares, which touts itself as the industry's first IDMO, earned a coveted distinction last April when the FDA blessed its Cell Shuttle platform with an advanced manufacturing technology (AMT) designation.
To qualify for AMT designation, a company must present a manufacturing approach that incorporates a new technology or uses an established technology in a novel way to substantially improve the production process for a drug while maintaining or enhancing its qualities, according to FDA guidance.
That designation came almost a year after the Cell Shuttle system earned a current good manufacturing (cGMP) seal of approval. Cellares' manufacturing unit is about the size of a truck and includes the technology needed to complete an end-to-end cell therapy production run in a single piece of equipment.
Aside from the upcoming Leiden hub, Cellares currently operates production sites in New Jersey and San Francisco, and the company is also developing an additional smart facility in Japan.