Viralgen was founded with the aim of giving people with genetic diseases access to curative gene therapy.
Its founders, Asklepios BioPharmaceutical (AskBio), a leading gene therapy American pharmaceutical, and Columbus Venture Partners, a Spanish venture capital firm focused on biotech companies, saw the value in the growing trend of gene therapy. Ahead of their time, they invested in a platform for the industrial production of clinical trials and the eventual marketing of the new treatments.
In October 2017, Viralgen was established in the Gipuzkoa Science and Technology Park (in San Sebastian, Basque Country, Spain), a strategic location because of its emphasis on knowledge and talent. Two years later, in 2019, Viralgen was accredited by the Spanish Agency of Medicines and Medical Devices (Spanish: Agencia Española de Medicamentos y Productos Sanitarios – AEMPS) and given leeway to manufacture and provide cGMP (Good Manufacturing Practice) services. These regulations ensure that production and marketing meet the required standards for use in humans.
Its rapid and exponential growth establishes Viralgen as an emerging leader in the production of AAV for clinical trials. It also poses a challenge: the industrial-scale manufacturing of treatments that are currently in the clinical trial phase, and need to be subsequently put on the market.
In October 2020, Viralgen was acquired by the German multinational, Bayer. They kept the original brand, philosophy and management team, and allowed for managerial independence to ensure an optimal response to upcoming challenges.
We have completed our expansion into a new facility that will enable commercial manufacturing. The first of the 3 modules of the new facility was opened in June 2021 and it represents the first step towards increasing production capacity fivefold. The manufacturing scalability of the Pro10 (TM) platform enables a seamless transition from R&D production to commercial cGMP manufacturing.
During its first phase, this expansion represents an investment of more than 70 million euros, which will increase to 120 million euros once the next two phases are completed. The opening of the first module has resulted in the recruiting of 130 new highly-skilled employees, increasing our whole team to over 400 people by the end of 2022.
Once the three modules are finished, Viralgen’s production capacity will increase fifteenfold. This will enable the democratization of gene therapy, both in volume and speed of production, whilst decreasing manufacturing costs. As a result, Viralgen will fulfill its foundational purpose even more effectively.
The founders, AskBio and ColumbusVP, meet for the first time to pave the way for the future of gene therapy production.
In September, Viralgen launches two laboratories in the Gipuzkoa Science and Technology Park.
Facility construction concludes in September and gives way to the transfer of technology and the qualification of teams and processes.
In July, the first clinical suites were accredited by the Spanish Agency of Medicines cGMP production and marketing.
The second and third suites are accredited. Construction phase of Viralgen’s second floor begins. This will enable industrial-scale manufacturing. In October, AskBio is acquired by Bayer.
The first phase of Viralgen’s expansion is completed for module 1. It increases its capacity fivefold and allows full coverage of projects from the preclinical phase to commercial production.
The new facility has received cGMP certification for the manufacture of human medicinal products, investigational medicinal products and sterile or biological active substances by the AEMPS, a part of the EMA network. The company now operates two facilities with 7 state-of-the-art single-use suites that have up to 2,000 liters of manufacturing capacity.
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