The Spanish company based in San Sebastian, VIRALGEN Vector Core, which specializes in the production of viral vectors for gene therapy, will manufacture the COVID-19 vaccine being developed by Mass General Brigham (MGB), a Harvard-affiliated hospital system, which is leading a consortium of organizations to manufacture this vaccine for use in clinical trials and subsequent commercialization. VIRALGEN will be the only participant in that consortium from outside the United States.

As published by MGB  through its associated entities: the Massachusetts Eye and Ear and the Massachusetts General Hospital, the vaccine for COVID-19 will be developed by three companies that will carry out the production and scale-up worldwide. These companies will be VIRALGEN, Aldevron in North Dakota and Catalent in New Jersey. The experimental vaccine uses Adeno-associated Viruses (AAV) to deliver and express the S (spike) gene of the SARS-Cov-2 virus to create an immune response.

One important aspect of the vaccine is that it can leverage the extensive and established AAV industry that currently supports dozens of gene therapy products and programs. The expertise, capacity, and capabilities in terms of manufacturing that these companies offer will help to reach the goal of a widely distributed vaccine.

This collaboration is the result of VIRALGEN's technological expertise and production capacity. The company has licensed the technology Pro10™, developed by Askbio, which allows the production of large volumes of adeno-associated viruses in a reduced time and with the versatility to adapt to variations that may occur with the virus that causes COVID-19.

The MGB Consortium has chosen VIRALGEN as its partner for the manufacture of the vaccine because of the versatility and production capacity that the technology Pro10™ provides, which are key aspects to achieve the volume necessary to meet the demand for the vaccine, thus impacting on an affordable production cost and the ability to reach a greater number of people.

"VIRALGEN will enable us to start the production of the vaccine with scalable processes and in the volume that can make the difference to solve the problem of mass access to it" explained Luk H. Vandenberghe, PhD, Director of the Grousbeck Gene Therapy Center at Massachusetts Eye and Ear and Associate Professor of Ophthalmology at Harvard Medical School.

VIRALGEN is pleased to participate in such a large project. In this sense, it is worth mentioning that the company has recently announced the opening of a new manufacturing facility also located in the Science and Technology Park of Gipuzkoa, (Miramón), for which it has the support of all the Basque and financing institutions led by Santander Bank, which will mean an investment of more than 50 million euros. This new facility will have the capacity to supply the growing gene therapy market, complementing the production for clinical trials already underway at the VIRALGEN facility opened in September 2018 in San Sebastian. This new infrastructure, which is expected to start operations at the end of 2021, will be one of the most modern plants in Europe for the production of gene therapy treatments and will create more than 200 direct high-level jobs. With the start-up of this infrastructure, VIRALGEN will have sufficient capacity to produce this vaccine on a large scale.

Javier García, VIRALGEN's CEO has said that "the participation in this project is an exciting challenge, for which we have the support of the Institutions of the Basque Country and the collaboration of the Spanish Agency of the Medicine and Health Products. This project is the result of the work and talent of all the staff of VIRALGEN who have made a commitment to make a difference in the lives of others through their professional activity".

According to the Basque Government's Regional Minister for Economic Development and Infrastructure, Arantxa Tapia, "we have decided to actively participate in this initiative as it is in line with our commitment to R+D, but above all because of the opportunity that is opening up for its subsequent local production, through VIRALGEN. This crisis has taught us many things, including the importance of being well equipped with the necessary essentials and that careful planning is key. The opportunity to have this local production available in the Basque Country would mean major health, social and business progress, to which we will continue to be very attentive at all times as an institution. We are part of a high level chain of collaboration, Mass General Brigham (MGB), a Harvard-affiliated hospital system, through the Massachusetts Eye and Ear and the Massachusetts General Hospital and with companies such as VIRALGEN, Aldevron and Catalent, and we are confident that it will succeed for the good of society".

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