Paragon Bioservices Expands Production Campus in Baltimore, Maryland
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 & 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,” he said. The new planned 150,000 square-foot facility, located in Maryland's Anne Arundel County, will facilitate Paragon's continued rapid growth, which has increased significantly within the past several years.
As part of its commitment to delivering to the expectations of its clients, 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.
"We are pleased to support the tremendous growth of Paragon Bioservices, which has doubled its number of employees over the last few years and is now poised to expand its manufacturing operations and add over 200 new jobs," said Governor Larry Hogan. "This new location will enable the company to take their work with gene therapy to the next level, and we are excited to help them continue to grow in Maryland."
"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," Mr. Buzy concluded.
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