Astellas celebrates the opening of its new large-scale gene therapy manufacturing facility in North Carolina – PharmaLive

“Our new manufacturing facility symbolizes our company’s continued dedication to advancing new, life-changing gene therapies for patients with serious diseases and significant unmet need, as well as our commitment to the Sanford community,” said Mathew Plecher, Ph.D., senior vice president and division head of gene therapy research and technical operations at Astellas Gene Therapies. “This state-of-the-art facility leverages our existing manufacturing network in Tsukuba, Japanand South of San Francisco, California, and will serve as a major driver of our pipeline, partnerships and technology. This new facility is a key enabler in our mission to develop safe, effective and transformative gene therapies as quickly as possible. As such, from Sanford manufacturing capabilities will allow us to produce materials for multiple programs in parallel rather than in sequence and provide commercial scale manufacturing capability for all future approved therapies. This is critical to rapidly advancing our programs and driving Astellas’ next phase of growth.

Through the expansion of Astellas’ integrated global manufacturing infrastructure, the company is striving to increase manufacturing capabilities and achieve greater scalability and better pricing for gene therapies. The Sanford enables continuous learning and effective knowledge sharing, which helps improve the pace and efficiency of drug development. The 135,000 square foot stand-alone facility will be Good Manufacturing Practices (GMP) compliant and is designed to provide clinical and commercial scale manufacturing capabilities for Astellas’ AAV gene therapy pipeline. From the company $100 million the investment will also support global supply chain needs and internal quality control testing, as well as create more than 200 jobs through 2026. The new facility at 6074 Enterprise Park Drive joins the vibrant community of biopharmaceutical research and manufacturing facility based in Lee County.

“Sanford, North Carolina is a prime location for Astellas Gene Therapies to expand its manufacturing operations,” said Governor Roy Cooper. “Our state’s skilled workforce, leading academic institutions, and healthy business environment provide all the resources they need to drive innovation and continued success. »

With the creation of the Astellas Gene Therapies Center of Excellence following the 2020 acquisition of Audentes Therapeutics Inc., Astellas is a leader in the field of genetic medicines, working alongside its world-class partners to build a portfolio of potentially life-changing gene therapies. Astellas strives to identify, develop and deliver transformative therapies to patients with genetic diseases who currently have few or no effective treatment options.

About Astellas

Astellas Pharma Inc. is a pharmaceutical company with operations in more than 70 countries around the world. We promote the focus area approach which is designed to identify opportunities for the continued creation of new medicines to treat diseases with high unmet medical need by focusing on biology and modality. Additionally, we are also looking beyond our core purpose of Rx to create Rx+^® healthcare solutions that combine our expertise and knowledge with state-of-the-art technology in different areas from external partners. Through these efforts, Astellas is at the forefront of change in healthcare to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence that develops genetic medicines that have the potential to bring transformative value to patients. Based on an innovative scientific approach and industry-leading in-house manufacturing capability and expertise, we are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy and vectored RNA knockdown and we will also advance other Astellas gene therapy programs to clinical investigation. We are based at San Franciscowith manufacturing and laboratory facilities at South of San Francisco and SanfordCN

Cautionary Notes

In this press release, statements made regarding current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. These factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations relating to pharmaceutical markets, (ii) exchange rate fluctuations, (iii) delays in the launch of new products, (iv) Astellas’ inability to effectively market existing and new products, (v) Astellas’ inability to continue to effectively research and develop customer-accepted products in highly competitive markets, and (vi) violations of Astellas’ intellectual property rights by third parties.

Information about pharmaceutical products (including products under development) that is included in this press release is not intended to constitute advertising or medical advice.

Source: PR Newswire