Photo credit: Heidi Ward
“We are literally at the dawn of precision biological medicine, which is going to change the way we not only treat certain diseases and what kind of therapeutics we come up with, but is going to demand a completely different approach to the manufacturing and the associated tools,” Ken Gabriel, CEO of BioForge, explained during a University of Pittsburgh webinar on Aug. 26, 2025.
Those in the Pittsburgh area who catch glimpses of the 185,000-square-foot BioForge building site in Hazelwood Green may be surprised to learn that BioForge is already up and running. BioForge was established in 2021 through the largest single grant from the Richard King Mellon Foundation to the University of Pittsburgh, $100 million, paired with $120 million provided by Pitt. While the shell of the new building, adjacent to Carnegie Mellon’s Mill 19, is up, the interior is still a construction zone. But BioForge is already operating in temporary space nearby.
That’s because Gabriel and his team did not want to wait for the building to be finished to dig in to their mission: creating innovations and breakthroughs in the manufacture of precision biologic medicines to speed their delivery, use and impact.
Gabriel began his presentation by pointing to recent and continuing news articles about the promise of precision biological medicines involving children whose lives are transformed through gene therapy.
“You can't help but be touched by these sort of developments,” he said. “They pull at the heartstrings, the toddlers that can hear their parents for the first time or live to have a productive life.” But the reality is that many such treatments are out of reach because of their costs, with some running as much as $4.5 million.
“Clearly, this is not something that is going to have an impact and be broadly accessible and available unless we tackle what is the challenge in delivering these precision medicines,” Gabriel said.
The focus of BioForge, he said, is “to create breakthroughs and innovations that make them more affordable and accessible to a greater number of people who need them.”
Currently, only a fraction of people who could benefit from these advanced treatments are getting them. “The costs aren't going to come down until there's direct and deliberate focus on the manufacture of these precision biological medicines,” Gabriel said.
The pharmaceutical industry is undergoing two major shifts, he explained. Moving from traditional small-molecule chemicals like aspirin to biologics is one. The other shift is that the move to precision medicine creates pressure on pharmaceutical manufacturing equipment and tools.
“We have to go from high-volume batch to new types of equipment that produce low volume and continuous fabrication. It's not simply moving from chemicals to biological, but a complete redo of the pharma manufacturing industry ecosystem,” he said.
To meet these challenges, BioForge is taking an innovative approach.
“This is not like your typical research center that's going to sit and work on a particular project for 10 or 15 years. This is one where there's going to be a vibrant churn of new projects coming in,” with each project given a fixed budget and time limit.
“BioForge will host, resource and support multiple projects involving a small group of people, five to 10 with diverse backgrounds in biology, life sciences, engineering and physical sciences, working together over fixed-duration, fixed-budget projects, typically from 18 to 36 months, all focused on demonstrating that breakthrough and innovation in the manufacturing,” Gabriel explained.
Some projects may succeed in a way that leads to funding of a startup while others may show that the technology is more suitable for a large pharmaceutical company, in which case the intellectual property would be licensed, Gabriel said. “But it's also important to realize that one of the ways we're structuring BioForge is to go after game-changing challenges, and if our reach is bold enough, some of these projects will give a good effort, but there won't be a successful, convincing demonstration. That's OK, we clear the decks, because we need to bring in new projects and give them a shot at the opportunity.”
Gabriel described the three projects BioForge launched in its first year and a half.
One of them involves “creating access and democratizing the access to mRNA fabrication to increase the number and diversity of design. We launched that activity, and we now have a running brokerage service that was designed to go global later this year,” he said.
The second project involved dissolvable microneedle arrays which deliver a precision skin cancer therapeutic. After 10 months, the project, in collaboration with Panther Life Sciences, completed its work at BioForge and decided to establish its manufacturing and materials section in Pittsburgh, and plans to add more than 20 employees to its team of eight over the next few years.
Gabriel counts that as a hybrid success: it’s both a startup and a licensing opportunity.
The third project, which started about five months ago, involves adeno associated virus delivery. “This is a traditional, 30-year-old technique to deliver genetic treatments, but that has had challenges in manufacturing,” Gabriel explained. “We're looking to see if we can create a general delivery platform that could get around many of the manufacturing limitations that have kept this technology from being more widely used.”
Clearly, BioForge is off to a healthy start on its goal of developing innovations in the manufacturing of precision biologic medicines, with more projects to come.
