Audentes Therapeutics launched a new South San Francisco-based internal cGMP plasmid manufacturing facility which, the company says, is expected to significantly enhance a critical element of its supply chain, i.e., provide high-quality nonclinical and cGMP-grade plasmids for all of its development programs.
Andentes is an AAV-based genetic medicines company focused on developing and commercializing products for serious rare neuromuscular diseases, such as AT132 for the treatment of X-linked Myotubular Myopathy.
“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 COO. “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.”
The plasmid manufacturing facility is the latest addition to the company’s proprietary AAV gene therapy technology platform, which consists of internal expertise from vector construct engineering and small-scale research production to large-scale cGMP manufacturing, according to Holles. 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, she adds.
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, notes Holles.