Audentes Therapeutics begins large-scale cGMP production runs
Audentes Therapeutics announced it has successfully initiated large-scale cGMP production runs in its new, state-of-the-art manufacturing facility. 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. 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.