Paragon Bioservices is expanding a new process development and cGMP manufacturing facility. Growing need for broad gene therapy manufacturing capacity from its current and future client base is driving the company’s investment in this new facility, which the company expects will include commercial manufacturing capabilities in 18 to 24 months.

The company currently provides full process and analytical development and cGMP clinical manufacturing services from its 80,000 square-foot facility in the University of Maryland’s BioPark. Paragon’s current cGMP facilities, which include mammalian, microbial and virus suites, as well as automated aseptic fill-finish capabilities, will also be expanded to encompass an additional 10,000-square-feet of space within the BioPark.

“The expansion of our biopharmaceutical manufacturing capabilities via our new site, including the ability for commercial manufacturing, is a key strategic initiative for Paragon,” said Pete Buzy, president and chief executive officer. “This expansion is in response to the company’s current world-class client base requesting additional pre-clinical and commercial capacity. We look forward to partnering with our clients and bringing lifesaving gene therapy medicines to the clinic and beyond for patients in need.”

The new 150,000 square-foot facility will include several 500L and 2000L single-use bioreactors for clinical trial and eventually commercial material production, as well as additional research laboratory space for process optimization and scale up. Similar to Paragon’s current facility in the BioPark, the new facility will comply with both European Medicines Agency (EMA) and U.S. Food and Drug Administration FDA manufacturing requirements for biopharmaceutical manufacturing. Initial GMP capabilities are expected to be up and running at this new facility, including capacity for Phase I and Phase II clinical manufacturing, in the fourth quarter of 2018.