Nucleus Biologics’ expansion efforts are paying off

BIOTECH: Firm Inks New Supply Agreement with CBM

Rancho Bernardo-based Nucleus Biologics’ recent moves to expand cell media manufacturing are already paying off.

On March 7, Nucleus and its spin off company Stoic Bio announced a supply agreement with the Center for Breakthrough Medicines (CBM), a leading contract development and manufacturing organization (CDMO) in the cell and gene therapy space.

The agreement makes Nucleus Biologics the preferred supplier of cell culture media – the liquid material cells used in cell therapies grow in outside the body – and other critical biological solutions for CBM.

“We are proud to partner with CBM as their company culture facilities, and services make them uniquely positioned to support the cell and gene therapy development community,” said David Sheehan, CEO of both Nucleus Biologics and Stoic Bio.

Part of CBM’s “unique position” is the company’s headquarters in Philadelphia and its adjacency to the University of Pennsylvania, which was where the first successful CAR-T transfusions were done and is “one of the biggest biotech clusters for gene and cell therapies in U.S.,” Sheehan said, adding that the agreement will “open the Northeast corridor for us.”

High-Quality Supply Chain

Sheehan credits the new agreement with CBM to Nucleus’ recent focus on building out a “self-reliant” supply chain that also ensures high standards.

In August of last year, Nucleus’ cell manufacturing process was granted ISO 13485 certification – considered the industry standard for quality management systems regulating medical devices and related services.

“We’re operating at a pretty high standard and trying to create leadership in the industry,” Sheehan said. “We’re big innovators but we also have to be leaders of quality.”

In September, Nucleus expanded its capacity to be a leader in quality when it cut the ribbon on a 20,000-square-foot building in Rancho Bernardo that includes four liquid clean rooms and two powder clean rooms built to ISO 7 specifications for cell media manufacturing.

“Were going to have over 2 million liters a year of liquid media manufacturing capacity here once all the new clean rooms are fully functional,” Sheehan said. “We’ve been anticipating that this customer and this industry were going to take off. Now that we have the capacity this will bring a fair amount of new business.”

Once the relationship with CBM “gets up and going,” Sheehan added, it will result in contracts for “hundreds of different media formulations” worth “millions of dollars in new business.”

Krakatoa Collaboration

In addition to the agreement for Nucleus to be CBM’s preferred supplier, CBM will also be one of the first adopters of Nucleus Biologics spin-out company Stoic Bio’s bioreactor-scale Krakatoa system. Krakatoa is the first point-of-use media manufacturing system in the world. The system reconstitutes powdered media formulations into liquid media, adding cost savings in shipping and reducing carbon emissions by 65%.

“CBM saw that this was the future of media manufacturing and wanted to be involved in not only buying existing units we sell, but also being involved in the bioreactor-scale Krakatoa systems,” Sheehan said. “This collaboration will leverage enabling, innovative technology to assist therapy developers from discovery to commercialization.”

The existing lab bench version of the Krakatoa systems that CBM had purchased produce 500 milliliters of media at a time. The bioreactor-scale system that CBM has also been involved in the development of will be able to make 100 liters of media, Sheehan said.

“Our recent collaboration with Nucleus has demonstrated the critical role cell culture media can have in both the manufacturing of cell therapies and its clinical efficacy,” said Matthew Farabaugh, chief financial officer at CBM. “This agreement strengthens our relationship and secures an integral part of the supply chain that allows us to get these lifesaving treatments to patients faster.”