With the rise of biologics and gene therapies, viral clearance and safety testing are increasingly in demand, notes Texcell. The multimillion-dollar site will add 27,000 square feet of laboratory and office space, more than doubling Texcell’s current capacity for biosafety testing and viral clearance studies.
The facility will contain eight new independent client suites, designed to adapt to the needs of the project and the client. The suites will be stocked with mobile equipment, such as new ÄKTA pure chromatography systems and nanofiltration units. The GLP facility will offer clients the opportunity to execute scaled-down manufacturing models, or transfer work to a dedicated viral clearance team.
The completion date is expected in Q1, 2023.
The expansion is a next step in Texcell’s growth trajectory as it increases capabilities for its service lines, including customized R&D cell culture, GLP viral clearance studies, and select GMP assay capabilities for viral safety testing.
Responding to demand for gene therapies
Texcell - North America is part of the Texcell Group of global biosafety contract research organization. The new facility in Frederick has been chosen for its place at the heart of North America’s biotech hub and proximity to three airports: making it readily accessibly to both clients along the eastern seaboard of the US and around the world.
“Viral clearance and safety testing are an integral part of the development of biologics and gene therapies. This expansion will give us the opportunity to scale up our testing capabilities to meet the rising demand for these life-saving products,” said Jeff Schubert, President of Texcell – North America.
“As the number of candidate molecules in clinical pipelines continues to grow rapidly, this additional capacity permits us to provide research support to even more clients, with the hallmark devotion and expertise that our technical team has become known for.”