Paragon Bioservices Expands Gene Therapy Manufacturing Capacity

January 23, 2018

Paragon Bioservices will build a new cGMP facility in Maryland and expand its existing cGMP facility at the University of Maryland's BioPark.

Paragon Bioservices, a biologics contract development and manufacturing organization (CDMO) for gene therapy and vaccines, announced the expansion of a new process development and cGMP manufacturing facility at a new site near Baltimore/Washington International Thurgood Marshall (BWI) Airport, in a Jan. 23, 2018 press release. A 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-ft2 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, within the next four months, to encompass an additional 10,000-ft2 of space within the BioPark.

The new, planned 150,000-ft2 facility, located in Maryland's Anne Arundel County, will include several 500-L and 2000-L 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 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 significantly from 100 to 225 employees, becoming greater Baltimore's fifth-largest biotechnology company. The company estimates that it will hire more than 200 employees for the new facility over the next three years.

Source: Paragon Bioservices