The facility is designed to address what its founders call a “bottleneck” by helping researchers turn their ideas into therapeutics.
A new hub for gene and cell therapy opened Thursday outside Boston, with the aim of giving lab space and manufacturing assistance to researchers developing the complex medicines.
The facility, known as Landmark Bio and based in Watertown, Mass., was born out of an unusual and broad alliance between Harvard University, MIT, and a variety of hospitals and biotech companies in the region. It was first announced in 2019, initially called the “Center for Advanced Biological Innovation and Manufacturing” and meant to address what its founders call a “bottleneck” in turning gene and cell therapy research into drug prospects.
Genetic medicines are difficult and expensive to manufacture, requiring production capabilities that most research institutions don’t have. The lack of access to those materials, like the viral delivery tools that support many gene therapies, can stall promising early-stage research projects before they turn into programs that can be tested in clinical trials and developed by biotechnology startups.
Landmark, armed with $75 million in funding, is one of the entities emerging to help fill the gap. The company began retrofitting a 44,000-square-foot facility last year that’s meant to help with all aspects of genetic medicine research and production.
Among the amenities in the facility, for example, are lab space for translational research and eight cleanrooms for cell therapies, genome editing, as well as delivery tools like viral vectors and lipid nanoparticle production. It also provides drug development and regulatory consulting services, according to a Thursday company announcement.
The company is run by Ran Zheng, a former Amgen and Genzyme executive, and employs 60 people, with plans to expand to more than 100 in the coming years.
Zheng called Landmark a “one-stop solution” for startups that need support in manufacturing and testing.
“We’re very different from an incubator,” Zheng said in an interview with BioPharma Dive. “Our collaborators come here and they want to develop a therapeutic product, so we work with them on how that product will look, what pathways to explore and how processes need to be fully developed to make the product.”
The demand was clear even as the company was building its facility – the company had its first customer “even before we put a sign on the door,” she said.
Landmark isn’t alone in seeking to help fuel gene and cell therapy research around Boston. Elevate Bio, a Cambridge-based startup, has raised nearly $1 billion from private investors and partnered with multiple biotech companies and institutions. The company’s “BaseCamp” facility similarly provides research and development support as well as manufacturing help for cell and gene therapy startups.
Landmark is different, however. It’s a public benefit limited liability corporation, meaning it is a for-profit company that commits to working for social good. In doing so, it commits to publishing statements for anyone to see – a measure of accountability and transparency – about its mission and how it is responsibly and sustainably operating.
The cross-sector partnership sets it apart from others with the goal of accelerating innovation in the life sciences industry, Zheng said.
Other institutions involved with Landmark’s founding include Fujifilm Diosynth Biotechnologies, Cytiva, Alexandria Real Estate Equities, Beth Israel Deaconess Medical Center, Boston Children’s Hospital, Massachusetts General Hospital and the Dana-Farber Cancer Institute.
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Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more.
The regulator could soon approve medicines from Apellis, Gilead and GSK, and decide whether to pull a controversial preterm birth drug from the market.
Gene therapies could help treat many ultra-rare diseases. But they may not get developed if drugmakers can’t build a sustainable business around them, CBER director Peter Marks said at a conference.
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Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more.
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Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more.
Get the free daily newsletter read by industry experts
Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more.
The regulator could soon approve medicines from Apellis, Gilead and GSK, and decide whether to pull a controversial preterm birth drug from the market.
Gene therapies could help treat many ultra-rare diseases. But they may not get developed if drugmakers can’t build a sustainable business around them, CBER director Peter Marks said at a conference.
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Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more.
