Pete Buzy, Paragon Bioservices president and CEO told us the company is expanding to meet a growing need from its current and future client base.
"The expansion of our biopharmaceutical manufacturing capabilities via our new site, including the ability for commercial manufacturing, is a key strategic initiative for Paragon," he said.
"There's also a significant deficit in gene therapy CDMO capacity that will mostly grow over the next three to five years," Buzy explained, adding, "Paragon believes the space will increase by double digits in the foreseeable future."
The facility will feature research laboratory space for process optimization and scale up as well as several 500L and 2000L single-use bioreactors for Phase I and Phase II clinical manufacturing by the fourth quarter of 2018.
Commercial material production capabilities will be available in the next 18 to 24 months according to the biologics contract development and manufacturing organization (CDMO).
The facility – which will comply with both European Medicines Agency (EMA) and US Food and Drug Administration (FDA) manufacturing requirements for biopharmaceutical manufacturing – will be located in Maryland’s Anne Arundel County, near Baltimore/Washington International Thurgood Marshall (BWI) Airport.
Over the past three years, the company’s workforce has grown from 100 to 225 employees. Moving forward three years, it expects to hire more than 200 employees for the new facility.
Paragon is also expanding its current cGMP facilities to include an additional 10,000-square-feet of space within the University of Maryland’s BioPark located in Baltimore City.