Consortium plans to build cell manufacturing facility
Group includes Harvard, MIT, top hospitals, several firms
A STAR-STUDDED CAST of local academic, business, and hospital institutions is uniting to spend $50 million on an independent, nonprofit cell-manufacturing facility in the Greater Boston area that is expected to bring revolutionary biomedical treatments to market much faster.
The founding partners include Harvard, MIT, GE Healthcare Life Sciences, Fujifilm Diosynth Biotechnologies, and Alexandria Real Estate Equities. The other participants are five of the region’s top hospitals — Massachusetts General, Brigham and Women’s, Dana-Farber Cancer Institute, Boston Children’s, and Beth Israel Deaconess– along with MilliporeSigma and the Commonwealth of Massachusetts.
The goal is to plug a gap in the medical research ecosystem and move promising therapies from the lab bench to manufacturing and patient testing far more quickly. The proposed facility, which is expected to employ 40 people initially and open toward the end of 2021, will occupy 30,000 to 40,000 square feet in an existing building. The facility will provide assistance to researchers trying to bring an idea to term, as well as special labs for cell experimentation and labs for manufacturing. Hospital partners will assist in finding patients who might qualify for early-stage clinical trials.
“We view this facility as an opportunity to build upon the great strength that this region already has in the life sciences and to help position this region to be even more effective in the future,” said Alan Garber, the provost at Harvard.
“These therapies equip a patient’s own immune cells to recognize, target, and destroy cancer cells. To do this, the patient’s cells are collected, modified, and re-introduced into their body – a complex procedure currently available to only a small number of people,” according to a press release issued by the consortium. “With major innovations underway, this fast-moving area of science is set to expand the pool of patients who will respond to immunotherapies and other emerging medicines. But there is a bottleneck in the discovery pipeline. Manufacturing backlogs are slowing the production of cells that are essential to research, holding up the availability of new treatments headed for the clinic.”
Officials say a researcher with a promising therapy currently can wait 18 months to 2 years for access to a cell manufacturing facility, which is basically a series of clean rooms where highly skilled workers tweak the makeup of a cell and then figure out ways to produce that reconfigured cell in volume. (For a diagram of how cell manufacturing at the proposed facility would work, click here.)
The focus initially will be on cell and gene therapies. One cell therapy that has shown promise is called CAR-T, where a patient’s own T cells are modified to identify and attack cancer cells in the blood. Researchers are also looking at using a patient’s immune system to treat diseases like Type 1 diabetes or tapping adult stem cells to repair joint tissue. (For a graphic of how CAR-T cell therapy works, click here.)
“The science is evolving so fast and new therapies are evolving so fast that nobody really can take those new ideas and make them viable globally,” said Emmanuel Ligner, the CEO and president of GE Healthcare Life Sciences of Boston. “It’s about putting resources together. It’s about cooperation.”
In addition to its manufacturing capability, the proposed facility will offer assistance to researchers trying to work out kinks in a therapy and help train cell manufacturers. Applicants seeking to use the facility will be selected by a scientific advisory board. Researchers affiliated with participating institutions will get preference, but officials said anybody with a promising idea would be considered.
“While there are many commercial contract manufacturing organizations, shared lab spaces, and even small manufacturing spaces at universities and hospitals in the US, this is a first-of-its-kind facility in three respects,” the consortium’s press release said. “First, for its intention to produce both cell and viral vector products within a single physical space. Second, for its unique partnerships between industry, academia, and leading area hospitals. Finally, for its partners’ aspirations to provide services to researchers and start-ups that will advance this new area of medicine through collaboration.”
Krystyn Van Vliet, associate provost at MIT and a professor of materials science and engineering and biological engineering, said the manufacturing facility is badly needed.
Van Vliet said Harvard, MIT, and the area’s research hospitals will continue to compete on developing new kinds of treatments. But she said when those treatments start moving toward the clinical testing stage the institutions can cooperate on cell manufacturing.
“You cannot do that alone,” she said. “It’s definitely a cooperitition.”Harvard is developing a new research campus in Allston, and the cell manufacturing facility would seem to be a perfect fit. But Harvard officials said no buildings in the research campus would be open in time to meet the cell manufacturing facility’s timetable.
“If this facility is successful, as I’m confident it will be, it opens the door for many more initiatives of this kind,” Garber said.