|Audentes Therapeutics Announces Initiation of Large-scale cGMP Production at its Gene Therapy 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
For more information regarding Audentes, please visit www.audentestx.com.
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