Pharmaceutical Business review

Audentes Therapeutics to build gene therapy manufacturing facility in North Carolina

Architectural rendering of Audentes Therapeutics new gene therapy manufacturing facility planned in Sanford, North Carolina (Credit: Business Wire)

The company will invest around $109m to develop the 135,000ft² gene therapy manufacturing facility.

North Carolina Governor Roy Cooper said: “With our powerhouse research centres and highly-skilled workforce, biotech pioneers recognise North Carolina’s role as a leader in the life sciences.

“Lee County is a perfect fit for Audentes as they seek to become a global leader in genetic medicines.”

Audentes plans to complete the initial phase of the capital investment on the new facility in around 18 months.

The company will complete the remaining investment in two additional planned expansion phases.

Slated to begin operations in 2021, the new gene therapy manufacturing facility is expected to create more than 200 new jobs in Lee County.

Audentes Therapeutics president and CEO Natalie Holles said: “Our investment in large-scale manufacturing has always been a cornerstone of our strategy to develop and ultimately deliver our important genetic medicines to patients as rapidly as possible.

“This new facility in Sanford will support the next phase of our growth as we establish a robust, global supply chain and expand our therapeutic and geographic scope as a part of the Astellas group of companies.”

In December 2019, Astellas Pharma agreed to acquire Audentes Therapeutics for a total equity value of around $3bn.

Audentes Therapeutics, a major AAV-based genetic medicines company, is involved in the development and commercialisation of advanced gene therapies to treat serious rare neuromuscular diseases.

The company uses its AAV gene therapy technology platform and advanced manufacturing expertise to develop programmes across three modalities: gene replacement, vectorised exon skipping and vectorised RNA knockdown.