Cell processing, cell-therapy and protein manufacturing, and biopharma product development
Before assuming the role of executive director last year, Seefeldt had been on staff as a protein chemist since the facility launched at the Gates Center for Regenerative Medicine on the CU Anschutz Medical Campus in Aurora in 2015.
The seed was planted in 2013 when academics focusing on CAR T-cell cancer therapy at CU Anschutz needed biomanufacturing services for their own research. Now spanning 20,000 square feet, the current Good Manufacturing Practice (cGMP) facility employs a hybrid model where it manufactures for internal use at CU Anschutz's hospitals and labs as well as taking on contract manufacturing from external clients.
"That's what drove those internal programs we manage to support," says Seefeldt. "We do external work with biotechnology companies and internal work for the University of Colorado," says Seefeldt. "We've got two of Terry Fry's CAR T programs in the clinic, and we're managing those trials, and with that hybrid business model, we work with companies like Nkarta."
The business model -- which is in place at only a few other institutions in the country -- was the brainchild of Dr. Dennis Roop, director of the Gates Center for Regenerative Medicine, says Seefeldt, as a resource to recruit top talent to the campus "to translate their early-stage molecules" into therapies for clinical trials.
"We needed a GMP facility to do that, so we could keep up with the likes of Baylor and Stanford and Mayo," says Seefeldt. "We really got a two-year head start on other institutions that were thinking about trying to do this, because we were already doing construction projects and putting in cleanroom filters and all of the things you would need for a GMP facility when everyone else was in planning mode."
There's a fiscal need to offer services to both internal and external clients, he adds. "Because the University of Colorado does not have the endowment of a Stanford or a MIT, that's why we've always ran with a hybrid business model, working with external companies for a portion of our business and then using that to subsidize internal University of Colorado projects. It's a challenging business model but yet a very rewarding one, in that we have to dot our i's, cross our t's, we have to make money to pay for our head count. There's a definite financial piece to what we do -- we can't just live off of grants, for lack of a better description. But then at the same time, we take that capital we pull in from the external biotechnology companies to make our systems better, then use that to support early-stage development work to get more drugs into the clinic."
Ultimately, the hybrid model "is a differentiator," says Seefeldt. "There are very few institutions -- around 10 or so -- that can do this in a sustainable, high-throughput way. . . . We're punching a little bit above our weight. We're hanging out with Stanford and Baylor and Mayo and Memorial Sloan Kettering."
The recent contract with California-based Nkarta to manufacture therapeutic natural killer (NK) cells for clinical trials is just one of many external contracts that has driven growth. That side of the business has surged, increasing from about two production runs a month in 2020 to six in 2021, as the facility's staff jumped from 35 in late 2020 to more than 50 in late 2021.
The growth has been driven largely by manufacturing microbial proteins and cell therapies, "often with a custom run for a given patient," for external clients, notes Seefeldt.
The facility's product development services have also been well-received. "We understand our niche in the world, especially as a mission-based facility, is to really help some of the little guys, for lack of a better description," says Seefeldt. The focus is on startups "that have a good idea but need more development effort to get ready to go into a Phase 1 clinical trial. We don't mind that early-stage development work to help get them going."
Adds Charles Hickey, the facility's director of finance and operations: "They are literally producing a miracle upstairs, and it's walked across the street, and that miracle is delivered to someone pretty much every month. It's pretty powerful that it's all happening on campus."
Challenges: "Hiring," says Seefeldt. "It's not the classic problem that maybe other industries are going through, like the restaurant business. Our compensation's where it needs to be , and I think we offer a really compelling job. At the end of the day, just going through the logistics of hiring 20 people within a university setting is challenging."
He adds, "We pull a lot of people from the Midwest. I think that's been the secret to our success. It's so hard to pull from the coasts, but it is pretty easy to pull from the Midwest, find talented people and get them to Colorado."
Opportunities: Seefeldt says he sees a lot of opportunity to increase the amount of work the facility does internally with the University of Colorado, UCHealth, Children's Hospital Colorado, and other entities on campus.
"It's taken a while to get the internal side going, not to the fault of anyone," says Seefeldt. "It takes a lot to get the infrastructure in palace to be able to handle some of these CAR T clinical trials on campus, where you're both managing the clinical trial with the FDA, doing the manufacturing at the Gates Biomanufacturing Facility, and then you are administering that product over at the hospitals. Setting up those relationships takes some time."
The first internal patient was treated about a year ago as part of the initial CAR T-cell cancer therapy clinical trial led by Dr. Michael Verneris on the CU Anschutz campus. That patient, Heather Pidcoke, is now in total remission.
"In the meantime, we've been using this external business model with biotechnology companies to keep the lights on," says Seefeldt.
Needs: "A lot of it's really around our personnel and our staffing," says Seefeldt. "We have a great mission-based facility with a number-one goal of improving patients' outcomes and lives, and we get to do that while solving challenging technical problems in an early-stage development kind of way. Those don't always go hand in hand. Oftentimes, the pharmaceuticals that are getting injected into someone from a commercial setting, that's a very locked-down manufacturing process. There's not a lot of flexibility and not a lot of problem-solving going on, there's a lot of execution. In contrast, we get to try to do both here because we get to see the potency of these drugs in a Phase 1 setting. . . . Because these cell therapies are so therapeutically powerful, we also get to see really good outcomes in the Phase 1 space, like complete remission in things of that sort."