Paragon Bioservices announces the expansion of a new process development and cGMP manufacturing facility located near Baltimore/Washington International Thurgood Marshall (BWI) Airport. 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 for a large and diverse, global customer base from its 80,000 square-foot facility in the University of Maryland's BioPark located in Baltimore City. 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 CEO. "Paragon is one of the few gene therapy manufacturers that has the expertise to develop and successfully manufacture complex biotherapeutics using commercially-scalable processes. We have become a center of excellence for both gene therapy and novel vaccine manufacturing and are trusted by top biopharmaceutical companies."
The new planned 150,000 square-foot facility, located in Maryland's Anne Arundel County, will facilitate Paragon's continued growth. Paragon's new 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.
Within three years, Paragon's workforce has grown from 100 to 225 employees. The company estimates that it will hire more than 200 employees for the new facility over the next three years.