BioForge project officially approved for construction

Kinsey Casey, Pitt’s associate vice chancellor for economic development in the health sciences, believes the biomanufacturing industry is still in its “clunky desktop computer stage.” 

Pitt’s BioForge project aims to bring it closer to the “iPhone” stage and make Pittsburgh a center for the greater bioeconomy.

The Pittsburgh Planning Commission officially approved construction plans for Pitt’s BioForge Manufacturing Center on Sept. 29. The BioForge is located on the Hazelwood Green site, which is also the home of Carnegie Mellon University’s Manufacturing Futures Institute at Mill 19 and is the center of Pitt’s proposed “Bio Valley.”

The BioForge will bring new cell and gene therapies to patients and the healthcare industry with specialized labs and biomanufacturing technologies. 

Casey said until the BioForge is built, there is no facility in Pittsburgh that can manufacture enough gene and cell therapies for clinical trials. Instead, they have had to take their work to contract manufacturing organizations whenever necessary.

“And you basically don’t know what happens after that,” Casey said. “They sort of have their process. You give them what you need, they try to manufacture it, sometimes it works. Sometimes it fails. But it’s somewhere else. And so to have that ability to have it here is incredibly helpful for them.”

Building the BioForge manufacturing center in Pittsburgh will help doctors and researchers at Pitt, like Dr. Leah Byrne, translate and commercialize their research. Byrne is an assistant professor of ophthalmology at Pitt’s School of Medicine whose lab works to develop gene therapy for retinal disease.

“The manufacturing is a huge part of successfully translating therapies into the clinic,” Byrne said.

Though there are many biomanufacturing facilities in the United States, Byrne said it’s still not enough to meet the demands and needs of people and companies around the country.

“Biomanufacturing is still a major bottleneck for gene therapies,” Byrne said. “It’s still quite common for there to be a yearlong or even a multi-year waiting period to get your drug manufactured. There is still a major unmet need in the field right now for biomanufacturing.”

Additionally, not all manufacturing centers have institutes attached to them to collaborate with in the way that BioForge is linked to Pitt.

“We think in Pittsburgh we have a lot of uniqueness, both in Pitt’s brilliant life sciences faculty and the research that they’re doing, and also this manufacturing institute will partner with Carnegie Mellon and their expertise in AI and robotics,” Casey said.

The BioForge is a big draw for graduate students and postdoctoral fellows who are interested in Byrne’s Pittsburgh gene therapy bootcamp, a nine-week course that will cover new developments in gene therapy. According to the Byrne lab’s website, this includes “gene delivery, genome editing, optogenetics and ethical considerations.”

“It’s an opportunity to bring all these people from very diverse backgrounds up to speed on what is cutting edge in the field of gene therapy,” Byrne said. “It’s an opportunity to educate them about potential career paths in the field of gene therapy.”

Anna Kessler, a junior natural sciences major, hopes to become a genetic counselor in the future and thinks the BioForge could be a good opportunity for students like her to gain experience in manufacturing gene and cell therapy. However, she also expressed some concerns about potential projects.

“There are a lot of ethical concerns about gene therapies and gene editing and stuff like that, that we discussed in some of my classes,” Kessler said. “So I think it definitely could be a little controversial. It will be interesting to see what kind of specific treatments and certain therapies they develop.”

Pitt’s partner company in the BioForge project is ElevateBio. Casey said they’re not just a traditional manufacturing organization, they also provide end-to-end services while other companies don’t.

“They really work with the researchers on how to best manufacture. How would this work better? How can we do it differently so that it’ll be successful every time?” Casey said. “It’s really exciting for our faculty.”

Casey said partnering with the industry in this way will also help Pitt recruit more faculty who are looking to translate and commercialize their work and provide opportunities for undergraduate students to observe biomanufacturing.

“If you are an undergrad and you’re interested in cell and gene therapy manufacturing, when the BioForge is built you could actually go down and see it, and see how it works and understand it to learn about it,” Casey said.

Byrne thinks the new BioForge will facilitate the growth of the biotech industry.

“Gene therapy is really taking off here in Pittsburgh and in general, there’s a lot of momentum and movement right now in biotech,” Byrne said. “And I really think Pittsburgh is gonna be a center for not just biotechnology, but for gene therapy in the future.”