Controlling the entire cell therapy production process—from material receipt to product release—is “essential,” according to AstraZeneca, which says its new $300 million manufacturing facility will be central to its CAR T business.
The Anglo-Swedish drug firm opened the plant in Rockville, MD, this month, describing it as its first, fully owned and operated cell therapy facility in the United States.
A spokeswoman told GEN, “The Rockville facility will be central to AstraZeneca’s production of next-generation cell therapies, including CAR-T therapies.
“It will handle critical aspects of the manufacturing and testing processes, from receipt of patient cells through culturing and formulation, ensuring the high-quality production of these therapies.”
The facility will support the U.S. market. However, in time, it will likely play a role in global supply, the spokeswoman explained.
“Given the sensitive nature of cell therapies and the materials involved, the facility will focus on meeting U.S. demand initially, but there is potential for the facility to support other markets, depending on regulatory and logistical considerations.”
She went on to say AstraZeneca will adjust capacity to meet demand, adding, “The investment is part of a broader $3.5 billion commitment to U.S. research and manufacturing.”
Essential control
Process control was a major investment driver, according to the spokeswoman, who underlined the benefits of being able to make these potentially curative, sensitive therapies in-house.
“The complex and personalized nature of CAR T and other cell therapies means that having total control of the manufacturing supply chain is essential. These therapies involve highly specialized, patient-specific processes, and even minor variations in manufacturing could significantly affect the therapy’s efficacy and safety.
“By controlling the entire production process, AstraZeneca ensures that each therapy is made to the highest standards, improving outcomes for patients and mitigating the risk of errors or delays in the supply chain,” she added.
The approach contrasts with AstraZeneca’s previous strategy, which involved third-party producers.
“Prior to the opening of the Rockville facility, AstraZeneca did partner with contract development and manufacturing organizations for some aspects of cell therapy production. However, with the new facility, AstraZeneca is transitioning to in-house manufacturing to have greater control over production and enhance its ability to innovate in the rapidly evolving cell therapy space,” the spokeswoman said.
Technology
For facility and technology design, AstraZeneca leveraged relationships with suppliers as well as expertise gained through the 2023 acquisition of Neogene Therapeutics, a Netherlands-based developer of T-cell therapies.
“AstraZeneca’s relationships with companies like Quell, AbelZeta, Cellectis, and Neogene have provided invaluable insights into the design and development of the Rockville facility.
“These partnerships have informed the company’s approach to optimizing cell therapy production technologies, ensuring that the facility is equipped with the latest, most advanced tools and systems to support the development of cutting-edge therapies,” the spokeswoman said.
She added that the facility will incorporate innovative manufacturing technologies—including automation—to streamline and enhance production. In addition, AI and advanced data analytics may also be used to optimize production processes and improve manufacturing efficiency.
