DURHAM – Isolere Bio, a Duke University, female-led spinout focused on “reimagining the manufacturing of complex therapeutics,” has landed $7 million in seed funding from lead investor Northpond Ventures.

It’s now getting ready to scale.

“We are thrilled to be teaming up with a top-tier, science-driven investor who believes in and shares our mission of delivering technologies for a healthier and safer world,” said Kelli Luginbuhl, Ph.D., Isolere’s founder and CEO.

The funding will support “development, scaleup, and commercialization” of its most advanced purification technology platform.

Kelli Luginbuhl, Ph.D., Isolere’s founder and CEO

It’s currently focused on developing this technology for the manufacturing of antibodies and adeno-associated virus (AAV). The goal is to develop a “low-cost, high throughput, and scalable purification platform.”

“With this new funding, we will be able to grow our team, diversify product development, and robustly demonstrate how our technology solves major biomanufacturing problems from the lab bench to commercial scale,” Luginbuhl said.

‘Simplify and streamline’

Founded in 2017, Isolere Bio is developing next-generation biomanufacturing technologies to “simplify and streamline” purification, improving global access to important drugs. It builds upon phase separating materials invented in the Chilkoti Laboratory at Duke University.

Luginbuhl founded the startup with Ashutosh Chilkoti, Ph.D., and Joe McMahon (former CEO of contract manufacturer KBI Biopharma).

The emergence of cell and gene therapies has led to the development of “incredibly promising yet complex molecules,” the founders say.

Poor manufacturability, however, creates high costs and limits their clinical impact. Isolere’s “IsoTag” technology aims to combat that.

For those not in the know, viral vectors are tools designed to deliver genetic material into cells.

The company said its purification platform improves viral vector yields by “at least 50 percent, and productivity by 5-10 times.”

The company is beginning with AAVs — what it calls the “go-to” platform for gene delivery — in the treatment of various diseases, “accounting for nearly 40 percent of the viral vector market.”

The company says financing will fund platform expansion to other viral vectors critical to cell therapy, along with mRNA, which it believes will experience continued growth “due to the success of COVID-19 vaccines.”

Scaling quickly

The company is also hiring – “talented scientists and engineers” — to add to its team to support these new applications.

Early supporters of Isolere’s technology include the National Institutes of Health (NIH) and the National Science Foundation (NSF), which provided initial small business grants, as well as the North Carolina Biotech Center.

“Northpond is honored to collaborate with Isolere and contribute this seed financing,” said Adam Wieschhaus, Ph.D., CFA, director at Northpond Ventures. He will join Isolere’s Board of Directors.

“Isolere’s technology represents a step change in how gene therapies will be manufactured. We are privileged to collaborate with this incredibly talented team in developing highly accessible and scalable solutions for gene therapy manufacturing.”