Paragon Bioservices Expands Gene-Therapy Mfg Facility
Paragon Bioservices, a contract development and manufacturing organization (CDMO) of biopharmaceuticals and vaccines, is investing in a new process development and cGMP manufacturing facility.
Currently, the company provides process and analytical development and cGMP clinical manufacturing services from its 80,000 square-foot facility in the University of Maryland’s BioPark located in Baltimore City, Maryland. The company expects that its new 150,000 square-foot facility will include commercial manufacturing capabilities in 18 to 24 months. 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.
Paragon says its new facility will include several 500-liter and 2000-liter 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 is expected to comply with both European Medicines Agency and US Food and Drug Administration 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.
The company estimates that it will hire more than 200 employees for the new facility over the next three years.
Source: Paragon Bioservices