Viralgen Receives cGMP Certification to Produce Commercial-Grade rAAV Product at New Facility in San Sebastian, Spain
— Certification Triples Viralgen’s Capacity and Positions the Company as a Global CDMO Leader —
— The New Facility Operates 50 to 2,000 Liter Single-Use Bioreactors and Manufactures Clinical and Commercial-Grade rAAV Vectors Using Pro10™, the Leading Cell Line on the Market —
SAN SEBASTIAN, Spain, Jan. 09, 2023 (GLOBE NEWSWIRE) — Viralgen Vector Core (Viralgen), an independent subsidiary of Asklepios BioPharmaceutical, Inc. (AskBio), and a member of the Bayer Global Group of Companies, has received Certification of Good certified manufacturing practices (cGMP) for the manufacture of human medicinal products, investigational medicinal products and sterile or biological active substances. This certification was granted following a successful inspection by the Spanish Agency for Medicines and Medical Devices (AEMPS), which is part of the European Medicines Agency (EMA) network. The company now operates two facilities in San Sebastian, Spain, with seven state-of-the-art single-use suites with a manufacturing capacity of up to 2,000 litres, making it one of the world’s leading development and contract manufacturing (CDMO).
Viralgen now holds a license for the commercial manufacture of recombinant adeno-associated virus (rAAV) gene therapies up to 2,000 liters and has completed seven successful trials at this maximum scale. This first phase of the expansion of the new facility, which added 300,000 square feet of clinical and commercial rAAV manufacturing, is now complete. The new facility currently has three state-of-the-art independent quality control laboratories and commercial manufacturing suites with 500 and 2000 liter single-use bioreactors. Viralgen plans to open additional manufacturing, science and technology (MSAT) and analytical development space in the same facility in late Q1 2023.
“As a fully integrated CDMO, we offer a continuum of products and services, including process, analytical development, stability studies, and fill-and-finish for all types of rAAV serotypes,” said Jimmy. Vanhove, CEO of Viralgen. “It can significantly shorten time to market, help predict cost of goods, and reduce wait times for patients who are out of options and hoping for breakthrough treatments.”
With this approval, Viralgen expands its ability to partner with rAAV customers who are initiating Phase III studies and seeking approvals to commercialize their products. This builds on the company achieving its milestone of 2022, which was the manufacture of over 135 batches of clinical and preclinical material, and the completion of over 24 INDs since its inception in 2019.
“With this certification, we have three times the rAAV production capacity that we had before. This reinforces our position as a global leader in the CDMO rAAV field,” said Javier García, Co-Founder and Chairman of the Board of Viralgen. “We are now able to manufacture at the largest scale in the industry and deliver Phase III and commercial products to our global customers.”
Viralgen was created in 2017 to address the unmet need for manufacturing gene therapies, with the goal of helping expand access to these lifesaving therapies worldwide. Viralgen specializes in the production of rAAV vectors and has built an optimized facility that maximizes the throughput and efficiency of the proprietary suspension manufacturing platform based on Pro10™, enabling yields, scalability and speed to market at the forefront of the industry. Viralgen is a fully integrated company, providing research, cGMP and commercial grade materials from 250 to 2000 liters, including process development, formulation and filling.
Viralgen, an independent contract development and manufacturing organization (CDMO), was founded in 2017 as a joint venture between AskBio and Columbus Venture Partners (a Spain-based venture capital firm). As one of the world’s leading cGMP-certified AAV manufacturers, Viralgen utilizes suspension manufacturing platform based on Pro10™, a technology licensed from AskBio and developed by co-founder R. Jude Samulski, PhD, at the University of North Carolina. Pro10™ is believed to increase the scalability, performance and accuracy of AAV therapies. Located in Spain, in the Science and Technology Park of Gipuzkoa, Viralgen produces AAV gene therapy treatments for pharmaceutical and biotechnology companies with the aim of accelerating the delivery of new treatments that can improve the lives of patients.
The company’s clinical facilities have four cGMP manufacturing suites, with 250 and 500 liter bioreactors. In 2020, Viralgen expanded within the Science Park by constructing a new building to increase its manufacturing capacity. The new space includes three additional cGMP suites with a manufacturing capacity of 2,000 liters each.
Viralgen has more than 420 employees, three-quarters of whom hold advanced degrees. This talented workforce supports a range of core capabilities in quality assurance, quality control, analytical development, and process development, all of which are essential to shortening time to market and supporting customers through the process. regulatory.
For more information, visit viralgenvc.com.
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