As it applies to the development of cell therapies, AstraZeneca’s chief of global operations, Pam Cheng, admits that the company is a “little late to join the party.”
But just because AZ has trailed other personalized medicine players in its Big Pharma sphere—including Gilead Sciences, Novartis, Bristol Myers Squibb and Johnson & Johnson—doesn’t mean it’s not an optimal time for the European pharma giant to pick up the pursuit, Cheng said.
In tandem with that goal, AZ on Monday announced the opening of its new cell therapy manufacturing site in Rockville, Maryland. The $300 million facility will employ at least 150 workers and produce clinical and potential commercial CAR-T treatments. The facility is part of AZ’s commitment to invest $3.5 billion in the U.S.
“This is pivotal. This actually brings us to a major manufacturing capacity in the U.S., which is critical to take into our clinical trials,” Craig Maxwell, AZ’s head of oncology R&D, said during a plant debut event attended by Fierce Pharma in Maryland on Monday.
“Cell therapy is special," he added. "It’s a living drug. It’s living cells. And because of that they can get into parts of the body and tissues that other drugs can’t get into and they’re really, really good at killing cells with disease.”
“Our ambition is that we’re going to leapfrog because we also have the opportunity to learn from those who’ve gone ahead of us,” Cheng said of AZ's overall cell therapy strategy at the event. “We can really in some ways shortcut through all that learning.”
Given the steep price of cell therapies, not to mention the fact that each dose is tailored to an individual patient, production of the personalized medicines has perpetually tripped up other players in the field.
With high hopes for the economy, AstraZeneca adds $2B to US investment in manufacturing, R&D
AZ's new manufacturing site is located just five miles from its sprawling R&D campus in Gaithersburg, Maryland, which employs more than 4,000 workers. Thirty miles up Interstate-270 in Frederick is the company’s largest biologics manufacturing facility, currently producing nine commercial and nine clinical treatments.
No life sciences company employs more people in Maryland than AZ, according to the state’s lieutenant governor, Aruna Miller, who was one of several state and local government officials in attendance at Monday's ribbon cutting.
Former oncology R&D chief José Baselga spurred AZ’s move to cell therapy before passing away in 2021 of the rare Creutzfeldt-Jakob disease. Soon afterward, AZ made its first major grab in the space, acquiring Neogene Therapeutics, which is taking on the challenging task of developing cell therapies for solid tumors.
In 2023, AZ followed with a $1 billion acquisition of China’s Gracell Biotechnologies and other collaborations with cell therapy specialists Quell Therapeutics, AbelZeta and Cellectis. Two months ago, meanwhile, AZ waded into the off-the-shelf cell therapy space with a $1 billion deal to gain Belgium’s EsoBiotech and its lentiviral vector platform.
With each of these deals came early-stage candidates spanning a wide range of disorders including diabetes and lupus. AZ currently has seven cell therapy programs in the clinic, led by a BCMA and CD19 dual-targeting CAR-T for multiple myeloma acquired as part of the Gracell buyout.
Additionally, much of impetus behind the partnerships was the technologies brought by the respective companies.
“What truly differentiates us is the multiple platforms that we are working on,” Cheng said Monday.
One such technology is Gracell’s FasTCAR platform, which is designed to cut manufacturing timelines and enhance T-cell fitness. AZ said it aims to eventually employ FasTCAR to develop treatments for rare diseases.
AstraZeneca brings its cell therapy ambitions to Maryland with $300M plant investment, 150 planned hires
Helping put a face on the value of personalized medicines at AZ’s event on Monday was Andrew Gordon, a lawyer from Harrisburg, Pennsylvania. Gordon is a multiple myeloma patient who was in remission and remained off treatment for seven years before it “came roaring back" in 2023.
Gordon’s relapse was a very rare form of myeloma that attacked his central nervous system.
“There is no recognized treatment planned for this type of multiple myeloma, because there simply aren’t enough people to study,” Gordon said.
In August of last year, Gordon received J&J’s multiple myeloma gene therapy Carvykti. After six weeks of close observation for side effects, Gordon returned home and resumed his daily exercise regimen.
“I’m back on my bike. I’m back in the gym,” Gordon said. “I’ve been rolling ever since.”
AstraZeneca cell therapy cell therapy manufacturing Gracell Cellectis Quell Therapeutics Manufacturing