Paragon expansion to address ‘deficit in gene therapy CDMO capacity’

The CDMO says it is building a 150,000 square-foot biomanufacturing facility in Maryland in preparation for a double-digit growth in the gene therapy space.

Paragon Bioservices’ facility in Baltimore, US will make clinical batches of gene therapies for customers by the fourth quarter 2014, with commercial manufacturing capabilities offered in the next two years.

According to CEO Pete Buzy, “the growing need for broad gene therapy manufacturing capacity from its current and future client base,” has driven the expansion, financials of which he did not divulge.

“There's also a significant deficit in gene therapy CDMO capacity that will mostly grow over the next three to five years,” he told Biopharma-Reporter. “Paragon believes the space will increase by double digits in the foreseeable future.”

While the plant will be equipped with several 500L and 2000L single-use bioreactors, Buzy said many of the contract development and organisation’s (CDMO) clients are in the orphan disease or rare disease markets, which will not require such large capacity.

“Paragon is using a variety of vendors, and the selection is based on what best fits the needs of its clients and their processes,” Buzy said, though did not name specific vendors.

Buzy added the facility’s location, near to Baltimore/Washington International Thurgood Marshall (BWI) Airport, is a critical advantage as time is critical for patients who receive personalised therapies.