In the classic Bill Murray comedy Groundhog Day, the main character is stuck reliving the same day—again and again. Biotech startups often face a similar fate when they sprint to first-in-human trials without planning for the realities of large-scale manufacturing. “Many times, researchers rush to get their product tested in humans with processes that are not suitable for later-stage GMP manufacturing or commercial production,” says Landmark Bio CEO Ran Zheng. “Along the way, they have to change the product and the process, and often have to repeat clinical trials, which is very costly. Our goal is to help them incorporate the requirements for GMP and commercial manufacturing early on, so they can engineer out those repeated studies and accelerate the development.”
Landmark Bio was founded to address such challenges related to the development and manufacture of cell and gene therapies. While many academic spinouts and small biotechs push forward rapidly to the clinic, they sometimes overlook the practicalities of manufacturability and scalability. Landmark Bio, by contrast, was architected to gather the expertise to guide these innovators from the outset, helping sponsors avoid repeated work and smoothing the path toward clinical trials and, eventually, commercial readiness.
Designing with the future in mind
“You don’t need a fully commercial process on day one, but you do need to design with the future in mind,” Zheng says. “Otherwise you’ll end up spending more time, more money, and risking the entire program down the line.” This principle of early planning—“end-in-mind” thinking—sits at the core of Landmark Bio’s approach. “Cell and gene therapy is a very exciting space,” she continues. “The potential impact these types of therapies can make on patients—it’s incredibly rewarding. It’s also very challenging, but that’s what makes it fun. We’re helping guide these new therapies from a single academic discovery to something that can reach people around the world.”
A cold start
When it launched, the company itself was “very much a cold start—no facility, no team.” Zheng remembers the moment she signed on: “I’d worked at small startups, but never in a situation where it was literally an empty shell—no team, no labs, no processes. It was an incredible growth opportunity. We had to define everything from hiring practices to how we’d lay out the cleanrooms. It was a chance to build a culture from the ground up.” In fact, “at the time, I didn’t even know what ‘cold start’ meant.” But while many upstarts fumble the transition from lab to real-world application, Landmark Bio quickly found its footing, thanks in part to its pedigree. Born from a cross-sector initiative led by Harvard’s Alan Garber, Ph.D.—then provost, now university president—and backed by prominent research hospitals, the company could assemble seasoned talent and a requisite infrastructure from the outset. That high-profile collaboration enabled Landmark Bio to help sidestep the very re-engineering pitfalls that cell and gene therapy developers should avoid.
Landmark Bio’s 44,000-square-foot Watertown facility, opened in 2022, represents a leap in advanced therapy infrastructure. Housed in a retrofitted WWII-era Army ballistic research building, the site features eight cleanrooms for cell therapies, mRNA production, viral vectors, and lipid nanoparticles, alongside fill-finish capabilities. “When I first walked in, it was surreal—this big empty building that once was used for ballistic research,” Zheng recalls. “There was so much potential there. We had to map out how labs and GMP suites would flow. It was like turning a piece of Boston history into a launchpad for 21st-century therapies.”
Proximity to world-class hospitals
Location also plays a crucial role. Being close to world-class hospitals like Mass General Brigham, Dana-Farber, and Boston Children’s is crucial, especially for autologous cell therapies. Having that patient–clinic–manufacturing loop all within a few miles is vital. Beyond the logistics, proximity to major academic centers helps Landmark Bio expedite the handoff from lab bench to trial.
Zheng was drawn to Landmark Bio precisely because of its “unprecedented” cross-sector roots. “I was at Orchard Therapeutics, an ex vivo gene therapy company, where we faced early challenges in manufacturing. Seeing a collaboration between academia and industry that focused on solving these bottlenecks was a great opportunity.”
The company’s public-benefit LLC structure, anchored by partners like Mass General Brigham, Dana-Farber, and Boston Children’s, was also a compelling factor. “We’re not just another CMO,” Zheng says. “Being a public-benefit organization means every decision has to pass the test: ‘Does this help the ecosystem at large? Does it serve patients?’ That’s the lens we always look through.”
“Cell and gene therapy is a very exciting space,” Zheng said. “The potential impact this type of therapies can be made on patients, it’s incredibly rewarding.”
Filed Under: Biotech, Cell & gene therapy, Regulatory affairs
