“Paragon is one of the few gene therapy manufact
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Posted On: 06/11/2019 12:16:01 PM
“Paragon is one of the few gene therapy manufacturers that has the expertise to develop and successfully manufacture complex biotherapeutics using commercially-scalable processes,” said Pete Buzy, Paragon Bioservices President and CEO.
Paragon, one of Baltimore’s largest biotechnology companies, employs a team of 300+ at two locations in Maryland. Paragon is constructing a new, world-class, 151,000 square-foot, GMP gene therapy biomanufacturing facility, which will be online in February 2019 and is located in Anne Arundel County. It will include several 500L and 2000L single-use bioreactors for clinical trial and commercial material production. Paragon also has facilities at the University of Maryland, Baltimore (UMB) BioPark where the Company currently provides full process, analytical development, and cGMP clinical manufacturing services from its approximately 100,000 square-foot facility. The BioPark facility complies with both European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) early-phase manufacturing requirements for biopharmaceutical manufacturing. The newly constructed facility is being built to comply with these regulations, as well.
The Catalent announcement, which is subject to customary closing conditions, comes on the heels of the grand opening of Paragon’s state-of-the-art 200,000-square-foot GMP gene therapy biomanufacturing facility in Anne Arundel County (Md.).
http://www.umbiopark.com/news-events/news/357...ip-paragon
Paragon, one of Baltimore’s largest biotechnology companies, employs a team of 300+ at two locations in Maryland. Paragon is constructing a new, world-class, 151,000 square-foot, GMP gene therapy biomanufacturing facility, which will be online in February 2019 and is located in Anne Arundel County. It will include several 500L and 2000L single-use bioreactors for clinical trial and commercial material production. Paragon also has facilities at the University of Maryland, Baltimore (UMB) BioPark where the Company currently provides full process, analytical development, and cGMP clinical manufacturing services from its approximately 100,000 square-foot facility. The BioPark facility complies with both European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) early-phase manufacturing requirements for biopharmaceutical manufacturing. The newly constructed facility is being built to comply with these regulations, as well.
The Catalent announcement, which is subject to customary closing conditions, comes on the heels of the grand opening of Paragon’s state-of-the-art 200,000-square-foot GMP gene therapy biomanufacturing facility in Anne Arundel County (Md.).
http://www.umbiopark.com/news-events/news/357...ip-paragon
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