Audentes Therapeutics Announces Launch of New State-of-the-Art Internal cGMP Plasmid Manufacturing Facility
SAN FRANCISCO, April 23, 2019 /PRNewswire/ — Audentes Therapeutics, Inc. (Nasdaq: BOLD), a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases, today announced the launch of a new state-of-the-art, internal cGMP plasmid manufacturing facility in South San Francisco. This new internal capability is expected to significantly enhance a critical element of the company’s supply chain, providing high-quality nonclinical and cGMP-grade plasmids for all of its development programs.
“Four years ago, we began investing in our own industry-leading AAV manufacturing capability, which has proven to be a key competitive advantage, enabling us to rapidly progress our pipeline of promising product candidates,” stated Natalie Holles, President and Chief Operating Officer. “The addition of an internal plasmid manufacturing operation should further improve control over our supply chain, reduce costs, and significantly decrease the time it takes to advance our programs from discovery through to clinical development, and ultimately commercialization.”
Ensuring access to a reliable supply of high-quality plasmids is a critical aspect of gene therapy development. The new facility supports the company’s rapidly advancing neuromuscular pipeline including the potential commercialization of AT132 for the treatment of X-linked Myotubular Myopathy.
The plasmid manufacturing facility is the latest addition to the company’s proprietary AAV gene therapy technology platform, which consists of end-to-end internal expertise from vector construct engineering and small-scale research production to state-of the-art large-scale cGMP manufacturing. Internal process and analytical development, fill-finish, and quality control testing capabilities complete the fully-integrated approach to production and release of product candidates for clinical and commercial use. The company’s current 1,000-liter scale manufacturing operation provides sufficient capacity for global commercialization of AT132, as well as continued clinical development of pipeline programs, and the facility is sized for expansion to add an additional 8,000 liters of production capacity over time.
About Audentes Therapeutics, Inc.
Audentes Therapeutics (Nasdaq: BOLD) is a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases. We are leveraging our AAV gene therapy technology platform and proprietary manufacturing expertise to develop programs across three modalities: gene replacement, vectorized exon skipping, and vectorized RNA knockdown. Our product candidates are showing promising therapeutic profiles in clinical and preclinical studies across a range of neuromuscular diseases. Audentes is a focused, experienced and passionate team driven by the goal of improving the lives of patients.
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Forward Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, expected supply chain improvements, cost reductions and shorter research, development and commercialization timelines, expected timing for final agreement on regulatory submission pathways for AT132, potential commercialization of AT132 and sufficiency of manufacturing capacities. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the company believes that the expectations reflected in such forward-looking statements are reasonable, the company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
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