Date: 2016-11-29
Type of information: Opening of new premises
Compound:
Company: Audentes Therapeutics (USA - CA)
Therapeutic area: Rare diseases - Genetic diseases
Type agreement:
Action mechanism:
Disease:
Details: * On November 29, 2016, Audentes Therapeutics announced it has successfully initiated large-scale cGMP (current Good Manufacturing Practice) 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. 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 FDA 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.
Financial terms:
Latest news:
