Three years ago a coalition of life science leaders at local universities, hospitals, and companies who were worried about a growing biomanufacturing backlog hatched a bold plan to take matters into their own hands.
A boom in cell and gene therapy startups — many spun out of academic labs — and a dearth of facilities equipped to turn their ideas into tangible medicines was delaying the ability of companies to test cutting-edge medicines in clinical trials.
Harvard, MIT, a real estate firm, two life science companies, and four local hospitals considered the growing waitlist a problem, so they pitched in $75 million to launch a new cell and gene therapy manufacturing firm called Landmark Bio, which is celebrating the opening of its 44,000 square-foot facility in Watertown on Thursday. The city is emerging as a small biotech hub as companies looking to escape the sky-high rents in Cambridge move elsewhere.
Landmark has about 60 employees pulled from across the drug industry and plans to expand to more than 100 in coming years. The company caters to helping small startups figure out how to make their experimental therapies reliably, consistently, and in big enough quantities to use in clinical trials.
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“We are set up to be the extension of their team,” Landmark chief executive Ran Zheng said during a tour of the facility. “Their strength is on the scientific idea and what the product looks like. Our strength is how to make it.”
Zheng was formerly chief technical officer for the British biotech Orchard Therapeutics. Working from Orchard’s offices in California, Zheng helped establish the manufacturing network for the firm’s gene therapies, including Libmeldy, which is approved in Europe for the treatment of a rare and often lethal childhood disease.
Landmark’s origins date to 2017 when leaders at Harvard University realized how many academic scientists were working on cell and gene therapies and forming startups based on their work. Although these groups had brilliant ideas for novel medicines, and had sometimes even tested them in animals, they often had no experience scaling up production of the therapies for testing in humans.
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Although contract manufacturing organizations exist to help biotech companies make their medicines, the wait times remain long. Perhaps more importantly, many of these therapies are so different from anything that’s come before, that manufacturing organizations don’t always know how to make them. Landmark was conceived as a solution to those issues.
“We can shorten that line and shorten the time,” said Kevin Casey, a former public affairs and communications leader at Harvard who was involved in the early ideation of the company and now serves as one of its strategic advisers. He views Landmark as a “concierge service” for startups that need help working out the inevitable kinks that arise when first trying to make experimental medicines.
Dr. Alan M. Garber, the provost of Harvard University and chairman of Landmark’s board of directors, said in a statement that the company “enables groundbreaking ideas from our laboratories to be transformed into life-changing therapies.”
Landmark was initially envisioned as a nonprofit, but ultimately took the form of a for-profit public benefit company when Alexandria Real Estate Equities, the lab equipment firm Cytiva, and the drug manufacturing powerhouse Fujifilm Diosynth Biotechnologies contributed to Landmark’s initial funding. Leaders from those three companies and MIT provost Cynthia Barnhart are also on Landmark’s board of directors.
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Four local hospitals — Beth Israel Deaconess Medical Center, Boston Children’s Hospital, Mass General Brigham, and the Dana-Farber Cancer Institute — contributed to Landmark’s founding as well.
Although Landmark was formed with the intention of helping local startups advance their programs, Zheng expects her firm’s clients will come from many places. “We got our first clients before we even had a sign on our door,” she said, but she wouldn’t disclose any specific groups that Landmark is working with.
Gregg Nyberg, Landmark’s chief technology officer, said the company is already helping biotech startups with an early stage of manufacturing called process development. It’s the pharmaceutical equivalent of converting grandma’s heirloom recipe into something that can be consistently made in larger quantities, he said.
Making sure that the therapies are made the same way for every patient is a particularly important part of what Landmark hopes to do. The firm’s process development labs are open, and eight cleanrooms designed for making clinical-grade drugs should be fully operational in 2023.
The Cambridge-based nonprofit LabCentral recently opened a new lab and manufacturing facility in Kendall Square where startups can rent private and shared lab spaces for figuring out how to start making their therapies. But the site is only equipped for preclinical manufacturing. “We could see graduates of LabCentral becoming clients of Landmark Bio,” Casey said.
Landmark’s founders looked in many neighborhoods when deciding where to base the firm’s operations. They ultimately decided that Kendall Square — the epicenter of Boston’s biotech industry — was too pricey, Casey said.
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The company settled on a space at 300 North Beacon St. in the Arsenal on the Charles in Watertown. The location’s cheaper lease and easier access to shipping made it an attractive option for a manufacturing center, Casey said.
Ryan Cross can be reached at ryan.cross@globe.com. Follow him on Twitter @RLCscienceboss.