Paragon Bioservices, a biologics contract development and manufacturing organization (CDMO) with expertise in gene therapy and next-generation vaccines that recently opened a manufacturing facility in Northern Anne Arundel County, will be exploring the formation of a wide-ranging partnership in gene therapy manufacturing with Sarepta Therapeutics, a precision genetic medicine innovator for rare diseases. The two gene therapy leaders will seek to establish additional dedicated facilities for manufacturing Sarepta’s gene therapy candidates.
Earlier, Catalent Pharma Solutions, a global diversified provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, announced its agreement to acquire Paragon. With the future support of Catalent and the opening of its new, state-of-the-art commercial manufacturing center in Harmans, near BWI Thurgood Marshall Airport, Paragon is positioned to advance life-saving gene therapy products, including Sarepta’s Duchenne muscular dystrophy (DMD) gene therapy candidate.
The new large-scale production campus – now combined with a recently-leased second building, which will be built out for commercial GMP manufacturing – has the potential for more than 425,000 square feet of manufacturing space upon completion of construction. The facility will offer individualized manufacturing suites specially designed to handle the unique needs of gene therapy products.
“With the recent grand opening of our new manufacturing facility, the expansion of our relationship with Sarepta and the anticipated transaction with Catalent, Paragon is positioned to be the premier leader in gene therapy manufacturing,” said Paragon President and CEO Pete Buzy. “Paragon’s level of expertise and experience in this area is unparalleled. That, together with our high caliber partners and customers, will allow us to meet the manufacturing demands of the double-digit growth in the gene therapy market.”
Paragon and Sarepta will use their respective strengths in gene therapy manufacturing, as well as the related development techniques including bioanalytics, to pursue new avenues in viral vector manufacturing. The partners will explore the potential for a joint venture in manufacturing new gene therapy candidates in the dedicated facility.