Stem cell lines and related biomaterials
A new venture of AlloSource, Essent Biologics is on a mission to empower medical researchers.
"For the past decade, AlloSource has developed this core expertise and knowledge around deriving primary cells from deceased allogeneic donors," says Stone. "When I came to AlloSource [in 2017], I asked a very basic question: 'What are we doing with all these cells that come from our donors?' . . . There was a gap there. We had access to donors, and we weren't really utilizing that aspect of the donor in new markets."
Such cells represent a valuable resource for R&D in regenerative medicine and a means to "honor the gift of donation in a different way," he adds. The 2021 launch of Essent Biologics is the culmination of that line of thought.
Stone says the decision to spin the startup off is rooted in regulations. As a tissue bank certified by the American Association of Tissue Banks (AATB), AlloSource "has its own regulatory challenges and processes," says Stone. "We are not going to be AATB-certified. We are driving more towards what we're calling 210, 211 compliance for [Current] Good Manufacturing Practices, and that's going to be governed around more of a pharmacological space, so we have a little bit different of a hurdle in the regulatory market, and to do that, we have to have different manufacturing and process controls."
Essent was in stealth mode as it developed its manufacturing processes until February 2021, and plans to launch production in May. "Right now, we're going through our internal validation runs of our final processes to essentially validate what will be in the vial . . . so we can have a consistent quality product out there," says Stone. "We have a pretty hefty validation hurdle that we have to pass before we consider ourselves ready for market."
At that point, Essent will start shipping its products: lines of stem cells as well a scaffold, which is "a collagen-based product for tissue engineering," says Stone. "We will have an actual inventory of those products for the market."
The end biomaterial -- "vials of prominent cell lines derived from deceased donors" -- represents a "game changer in the market," says Stone. "The real value proposition for Essent Biologics is our history and connection to AlloSource."
Essent currently rents 3,000 square feet of space from AlloSource in Centennial. "Right now, it is a separate clean room environment with separate processing controls," says Stone, noting that Essent could need more space as soon as 2023. The plan is to maintain R&D where it is now and possibly scale manufacturing elsewhere.
To isolate stem cells, Essent's employees take fat or other tissue from a donor and process it with different reagents in a clean room. "All the extra cellular material, the other cell lines, the core lipids are all washed away, and you're left with the living, healthy primary cell that is ultimately going to be used in research," explains Stone. "Our isolation process and technique is a trade secret. . . . The big difference here is the access to incoming donor material."
The isolated primary cells are cryo-preserved in vials containing at least 1 million cells. "We have the opportunity then to expand each one of those vials -- different passages, different doublings -- to where we can ultimately get to billions of cells from one donor."
The research community can use the material for a broad range of studies. Stone highlights some prominent possibilities. "One of them is taking our adipose-derived mesenchymal stem cells. . . . They're activating those stem cells in a very specific way. . . . They are then in turn making a therapeutic treatment for antibiotic-resistant infections. They're working their way toward a human clinical study to begin in the latter half of this year using our materials."
For another customer, Essent is combining stem cells with demineralized bone matrix into a feedstock for 3D bioprinting. "What the organization is ultimately driving toward is custom 3D-printed jaws for soldiers who had catastrophic injuries to the face," says Stone.
Stone says Essent has been in touch with the team who found injecting stem cells into the spinal column of patients with catastrophic injuries had regenerative effects. "We were actually in contact with those researchers because we feel we should be able to provide the same stem cells from healthy donors," says Stone. Using Essent's lines instead of cells from the patient, he adds, "Our hope is that we would have a better outcome."
These examples are just the beginning: There is a vast white space in front of Essent. "I always try to remind the team that we're not limited in where this can go," says Stone. "We're only limited by the creativity of ourselves and our partners. Some of the applications and indications that are out there and coming to market today are changing lives and saving lives, but what's really powerful is that there is no loss of researchers who are trying to cure the next incurable disease. To be able to provide a really stable product to ultimately facilitate that research and to help them go faster is what should drive us every day."
Challenges: "Prioritization," says Stone. "Because regenerative medicine and tissue engineering is so vast and there are so many researchers out there and we have access to so many donors -- which means we can pick from hundreds of different cell lines -- we need to be very focused on how and what we choose to bring to market to optimize our potential, the donor's potential, and ultimately the patient's potential."
Opportunities: Regenerative medicine is a big opportunity, but Essent's mission is about more than dollars. "It's going to impact patients' lives, and that's why we're in business," says Stone.
The company's Origin Sample -- flash-frozen tissue offered as a companion to the stem cells -- "allows the researchers to go to a deeper level of understanding their process," says Stone. "To me, the biggest product that's going to drive our success is that Origin Sample, and ultimately what that is is access to the donor."
Needs: Capital. "Right now, we are a 100 percent owned subsidiary of AlloSource, which is a 501(c)(3) nonprofit tissue bank," says Stone. "One of their biggest expenditures this year is the funding of Essent Biologics. Going forward, we need to become self-sufficient. . . . We can do that by driving product success in the market or we can go out there and do rounds of fundraising as well." The latter strategy would involve a flip to for-profit status.
Name recognition is another need, he adds. "People don't know us, so we have a whole reputation and knowledge base in the market that we have to build."