Andelyn Biosciences Inc. has opened its huge biotech manufacturing facility in Columbus, but is in need of a new CEO to run it.
The 250,000-square-foot commercial-scale manufacturing facility for the genetic material and delivery viruses needed for gene therapy is "ready for client production," the spinoff from Nationwide Children's Hospital announced in a LinkedIn post last week.
Andelyn's facility is bigger than the 185,000 square feet projected in 2020. The outer shell was built with the capacity to finish additional lab space inside.
Meanwhile, Mayo Pujols, recruited as CEO from pharmaceutical company Novartis in 2020, left in July for a publicly traded gene therapy development company that is adding in-house manufacturing capabilities, according to a news release and regulatory filings. Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) hired Pujols as chief technical officer and executive vice president.
Officials from both companies were not immediately available for comment. Andelyn does not list a current CEO on the leadership page of its website.
Construction started two years ago on Andelyn's facility off Lane Avenue and Carmack Road, the first private development within Ohio State University's west campus Innovation District. The $200 million facility was financed by Children's and an investment from biotech equipment maker Pall Corp., a subsidiary of Danaher Corp.
The private, for-profit Andelyn produces precisely engineered genetic material and the non-virulent viruses that deliver snippets of DNA to cells, correcting genes responsible for rare and often lethal inherited conditions. A single treatment takes trillions of viruses; something so tiny needs a building so large to house vat-like bioreactors in cleanrooms.
The field of regenerative medicine struggles with a severe production shortage. Grove City-based Forge Biologics, which this month raised $90 million in venture capital, has a growing roster of research and pharmaceutical clients for its manufacturing facility, and is readying some of the largest-ever bioreactor equipment used for this purpose.
Andelyn spun out of Nationwide Children's Hospital, which about 15 years ago invested its first $2 million in equipment to manufacture genetic material for research purposes, leading to FDA approval of the first systemic gene therapy for a fatal inherited disease.
Andelyn took ever-larger space in the Wexner Research Institute during construction, so the move frees cleanroom space for other researchers at the pediatric hospital.
The company had 185 employees as of September 2021, when it also added a research lab in Dublin.
Pujols aimed to place Andelyn at "the forefront of innovation" in the fast-growing gene therapy field, working alongside clients to improve yields and quality in biotech production.
Rocket in a news release on his hiring cited his manufacturing experience with companies including Novartis and Celgene, as well as his leadership at Andelyn. The company is working toward regulatory approval for a gene therapy for a fatal condition called Danon Disease.
“Rocket’s progress moving four gene therapy programs to clinical proof of concept and achieving the primary endpoint for two of them in a short time is remarkable,” Pujols said in the release. “Additionally, its forward-looking approach to in-house (delivery virus) manufacturing will help ensure patients with rare genetic disorders, like Danon Disease, have reliable access to quality therapies for which there are currently no other viable options. I’m grateful and excited to join this passionate group of visionaries."
