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Viralgen increases its manufacturing capacity with the opening of a new facility for commercial production

June 30, 2021

San Sebastian / Donostia. 30/06/21. Viralgen, the first company in Spain to specialize in the production of AAV gene therapy, celebrates the opening of a significant expansion of their manufacturing capability in the Basque Country today. The inauguration was attended by the President of the Basque Government, Iñigo Urkullu, and the Minister of Science and Innovation, Pedro Duque.

Viralgen has been serving the rapidly expanding gene therapy market with its robust AAV manufacturing platform since 2018, supporting customers in preclinical through phase 2. Viralgen’s new facility, located in the same technology park as Viralgen’s existing manufacturing footprint, expands capacity more than 5-fold and enables full support of customer projects from early pre-clinical through to commercial scale. Equipment validation and facility certification activities will continue throughout 2021 with the first commercial-grade 2,000L batches released by mid-2022. This expansion has been designed in compliance with the most advanced sustainability standards regarding energy use, waste management, and water consumption It represents more than €70M investment for its first phase and will reach €120M when the next two buildings are completed. The new commercial facility will bring 130 additional highly qualified new jobs to Viralgen which should represent a team of over 250 people in 2022.

Viralgen’s Pro10™ AAV platform, licensed from AskBio, offers fast, scalable, and robust manufacturing. This unique approach empowers customers to leverage decades of process development and optimization, as well as regulatory support to accelerate development and de-risk clinical and commercial product supply, and enables broader access to life-saving gene therapy treatments for patients around the world.

Viralgen was formed in 2017 as a joint venture between AskBio and Columbus Venture Partners, based on the production technology developed by co-founder Dr. Richard Jude Samulski. Viralgen was acquired by Bayer upon closing of the acquisition of Asklepios BioPharmaceutical Inc. (AskBio) in 2020.

Javier García, CEO of Viralgen, was very positive in his remarks when announcing the expansion today. “We will be positioned as a world CDMO leader in the field of AAV gene therapy. Production is a real bottleneck in the market, and we will offer a full service at a very competitive cost of goods to our partners. This will highly benefit patients around the world who are in need of gene therapy products,” says Mr. Garcia. “It is also good news for San Sebastian, as it consolidates a major CDMO operation that has the potential to become an innovation hub for biotechnology and life sciences in Europe and in the world.”

Additionally, Javier García has also highlighted the “valuable support that Viralgen has received from public institutions (City Council, Provincial Council, and Basque Government) to continue developing the company’s key capabilities” and has committed to continue to collaborate with the regional authorities in the field of biotechnology, in order to make Viralgen “an even more potent company in the international sector.”

Wolfram Carius, Executive Vice President for Cell & Gene Therapies at Bayer, has highlighted the importance and impact of Viralgen on the economies of the Basque Country and of Spain, and he is enthusiastic in his support of the commitment of Viralgen to the community where it resides. “Viralgen is going to play a key role in the development of Bayer’s growing cell and gene therapy business and help many companies to bring their ideas successfully to market,” he says. Bayer’s Executive Vice President has highlighted Viralgen’s experience in the development and manufacturing of gene therapies, knowledge that is not easily found in industry. “The compliance with cGMP guidelines and the product quality are essential in the manufacturing process in order to guarantee the safety and efficacy of these very specialized medicines. Here Viralgen brings key expertise.”

“Demand for safe, reliable gene therapy manufacturing capabilities is growing as more companies enter the gene therapy space,” said Sheila Mikhail, Co-Founder and CEO of AskBio. “Viralgen plays a critical role to AskBio and the industry by providing safe, reliable AAV vectors for clinical and commercial use, and this expansion allows the highly skilled Viralgen team to maximize those efforts.”

Iñigo Urkullu has pointed out that what "just over a thousand days ago" was a commitment to the future of the Basque Country is today a model of success and an example for other companies. In this time of pandemic "we have redoubled our public-private commitment to scientific research and the Biosciences-Health sector," has said Urkullu. The lehendakari has recognized both the work of Viralgen and its professional team and its contribution to consolidating a biotechnological ecosystem with a great future and international projection.

The Minister of Science and Innovation, Pedro Duque, has highlighted the role of this new plant in "improving the lives" of "patients, who will benefit from the therapies that Viralgen will help to produce in greater quantities." In the same way, Duque has affirmed that the rest of society also has "much to celebrate" since "generating wealth with scientific discoveries must be part of our social commitment." In this sense, the minister has reminded that "technology transfer policies have been increased, with a 42% increase in CDTI funding." These funds, he has explained, "will allow us to continue supporting promising projects, as the CDTI did at the beginning of Viralgen through the Innvierte Program."

If you want to read the news in Spanish, click here.

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