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Paragon to Build Second GMP Mfg. Facility

Expands collaboration in manufacturing design and operation with Sarepta Therapeutics

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By: Tim Wright

Editor-in-Chief, Contract Pharma

On the heels of its acquisition by Catalent, Paragon Bioservices, the biologics contract development and manufacturing organization (CDMO), is forming a wide-ranging partnership in gene therapy manufacturing with Sarepta Therapeutics. The two companies will seek to establish additional dedicated facilities for manufacturing Sarepta’s gene therapy candidates.
 
Prior to the news, Catalent unveiled its intent to acquire Paragon for $1.2 billion. With the future support of Catalent and the opening of its new, state-of-the-art commercial manufacturing center near the Baltimore-Washington International Airport, Paragon is positioned to advance 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 needs of gene therapy products.
 
Sarepta has developed proprietary manufacturing capabilities for the development, scale-up and purification of its gene therapy candidates for clinical development and commercialization.
 
“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 Pete Buzy, president and chief executive officer, Paragon. “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 take viral vector manufacturing to the next level. The partners will explore the potential for a joint venture in manufacturing new gene therapy candidates in a dedicated facility.
 
Douglas S. Ingram, president and chief executive officer, Sarepta, said, “We are excited to begin work on this new venture with Paragon and ultimately Catalent. Sarepta has had a long and fruitful relationship with both Paragon and Catalent, one of Sarepta’s current PMO drug manufacturers, and we are particularly pleased to expand our relationship with both companies. Catalent is a well-resourced innovator with an outstanding reputation for operational excellence, product quality, and reliable supply. By making our expertise available to Paragon and Catalent, we can ensure the success of our own manufacturing programs and explore potentially new and enhanced techniques to drive innovation in gene therapy manufacturing.”
 
“The unmatched expertise of both Paragon and Sarepta in developing and overseeing the manufacture of potentially transformative gene therapy technologies will be a tremendous asset to Catalent,” said John Chiminski, chief executive officer, Catalent. “We are delighted to have this opportunity to work together with Sarepta in this high-growth and life-saving field of medicine.”

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