DiNAQOR Establishes New GMP Manufacturing Facility in Zurich
PFÄFFIKON, Switzerland, Jan. 11, 2021 /PRNewswire/ -- DiNAQOR, a gene therapy platform company, today announced that it will establish its own GMP manufacturing capabilities with a new facility in the Bio-Technopark Schlieren-Zürich. This state-of-the-art 1200 sqm (13,000 sq. ft) GMP facility will produce adeno-associated virus (AAV)-based gene therapies and is co-located with DiNAQOR's Research & Development (R&D) facility.
"Establishing DiNAQOR's own gene therapy manufacturing capabilities positions us for the successful development of our in-house pipeline of novel genetic treatments for the failing heart," said Eduard Ayuso, D.V.M., Ph.D., Chief Technology Officer at DiNAQOR. "By building our new GMP facility alongside our R&D facility, DiNAQOR will have R&D, Process and Analytical Development, Quality Control and GMP capabilities in the same location, enabling rapid internal collaboration and innovation to accelerate our pipeline advancement toward and through the clinic."
The new 1200 sqm manufacturing facility will be in addition to DiNAQOR's R&D facility at Bio-Technopark, more than doubling the Company's current space there. The R&D facility supports the design and production of viral vectors suitable for in vitro and in vivo R&D applications, and also enables testing of innovative solutions in vectorology and manufacturing. The new GMP facility will be dedicated to establishing a GMP-compatible process in the Process Development labs and provide on-site tech transfer for GMP manufacturing of viral vectors at 500L scale. It will be designed to produce clinical-grade material up to Phase 3 development of DiNAQOR's pipeline. The GMP facility is anticipated to be ready in the second half of 2022, at which point the combined Bio-Technopark facilities will accommodate more than 50 DiNAQOR employees.
"Co-locating our new GMP facility gives DiNAQOR full control of vector supply, from R&D through clinical trials, and supports tech transfer, a critical step for successful manufacturing and a key competitive advantage. By having our teams together, we will be able to optimize novel processes, quality, and scale, ultimately reducing the time to bring our gene therapy solutions to patients," said Hanns Erle, Ph.D., Chief Product Officer & Head of Global Supply at DiNAQOR. "We are grateful for Bio-Technopark's support enabling DiNAQOR's expansion in the same location."
Founded in 2019, DiNAQOR is a global gene therapy platform company focused on advancing novel solutions for patients suffering from heart disease. The company is headquartered in Pfäffikon, Switzerland, with additional presence in London, England and Hamburg, Germany. For more information visit www.dinaqor.com.
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