Made Scientific acquires cell therapy facility in Pennsylvania, US

The company said programmes could be onboarded at the facility immediately, rather than after a construction and qualification period, with the site intended to support clinical and commercial supply from 2027.

It has completed 145 good manufacturing practice (GMP) manufacturing batches across various autologous and allogeneic cell therapy programmes, including chimeric antigen receptor T-cell (CAR-T) and B-cell therapies.

The facility is designed for large-scale, end-to-end cell therapy production and includes eight Grade B/C cleanrooms, a Grade C ballroom, and a Grade B fill-finish suite.

It also features on-site quality control and analytical testing laboratories, high-bay warehousing, and 30,000ft² of expansion space. Plans allow for the construction of eight additional ballrooms to support future growth.

The facility can manufacture starting material, drug substance, and drug product using both customised processes and platform technology transfers.

Planned upgrades include scalable 3D bioreactor platforms of up to 200L, advanced cell harvest equipment, automated fill-finish, and lyophilisation capacity.

The site’s integration into Made Scientific’s network expands its overall footprint to 145,000ft² along the US East Coast, with 15 qualified GMP suites and development and quality control laboratories across both the new and existing Princeton facility.

The company expects the Princeton site to undergo a US Food and Drug Administration (FDA) pre-licensure inspection in early 2027, followed by the East Norriton facility.

Made Scientific chairman and CEO Syed Husain said: “The acquisition of an operational facility with an experienced manufacturing team represents a significant advance in our ability to support clients from clinical to commercial.

“Sponsors advancing therapies toward approval require manufacturing capacity that is available when their programmes reach it.

“It is also the next step in a manufacturing network we are building deliberately and for the long term, with a strategic shareholder that has backed Made Scientific since 2022.”

Made Scientific is a contract development and manufacturing organisation focused on autologous and allogeneic cell therapy products, operating facilities in New Jersey and Pennsylvania.

In November 2025, Made Scientific and Cellergy Therapeutics formed a manufacturing partnership to advance the latter’s CLG-001 mitochondrial therapy toward first-in-human studies.

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