Audentes Therapeutics announces initiation of large-scale cGMP production at its gene therapy manufacturing facility.

Audentes Therapeutics, Inc., a biotechnology company focused on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases, announced it has successfully initiated large-scale cGMP (current Good Manufacturing Practice) production runs in its new, state-of-the-art manufacturing facility.

“The establishment of large-scale internal manufacturing is a key strategic milestone for Audentes,” Matthew R. Patterson, president and chief executive officer, said. “We began this effort in 2015 with the goal of retaining full control over costs, timelines and intellectual property associated with manufacturing our products. With the initiation of cGMP runs, we have translated this vision into a reality and taken a significant step toward achieving our mission of providing transformative therapies for patients.”

The facility’s initial cGMP production suite includes two 500-liter bioreactors for use with the company’s proprietary serum-free suspension cell culture-based production system. This represents capacity to meet the material requirements for the clinical trials of the company’s current product candidates.

Planned future expansions will provide increased capacity to support both commercial manufacture and clinical supply for new development programs. In addition, Audentes has established robust in-house process and analytical development operations to ensure the long-term scalability and quality of its manufacturing operations. 

The plant has been designed and commissioned as a multi-product facility intended to support commercial licensure by both the U.S. Food and Drug Administration and European Medicines Agency. The company intends to initiate clinical trials for two of its products, AT132 for X-Linked Myotubular Myopathy and AT342 for Crigler-Najjar Syndrome, in 2017 with material manufactured in this facility.

(Source: PR Newswire)