Viralgen has opened a cGMP production facility in San Sebastian, Spain. Credits: Bayer.
The facility is used for producing clinical and commercial-grade recombinant adeno-associated virus (rAAV) products. Credit: Bayer.
The San Sebastian facility will increase Viralgen’s production capacity by 15 times. Credits: Viralgen.

In June 2021, Spanish contract development and manufacturing organisation (CDMO) Viralgen Vector Core (Viralgen)  opened the first module of its new manufacturing facility in San Sebastian, Spain, in June 2021. The company invested €70m ($85.4m) in the development of the module.

The new facility is used for the production of clinical and commercial recombinant adeno-associated virus (rAAV) vectors, using the Pro10 cell line, for gene therapies. It is certified as complying with good manufacturing practice (cGMP) standards.

With the addition of the new facility, Viralgen now operates two facilities with seven state-of-the-art single-use suites in San Sebastian. These facilities have a combined manufacturing capacity of up to 2,000l.

In January 2023, the company’s San Sebastian facilities were cGMP-certified for the manufacturing of human medicinal products, investigational medicinal products, and sterile or biological active substances following an inspection by the Spanish Agency for Medicines and Medical Devices (AEMPS), which is a part of the European Medicines Agency (EMA). The certification has tripled Viralgen’s production capacity.

Location of Viralgen’s cGMP manufacturing facility

The new facility is located at Viralgen’s existing site in the Gipuzkoa Science and Technology Park in San Sebastian, Basque Country, Spain.

Details of Viralgen’s network expansion

The San Sebastian facility is a part of Viralgen’s expansion drive to enable greater commercial manufacturing. The first of the facility’s three modules was opened in June 2021 and had recruited 130 new employees by the end of 2022.

The completion of the three modules will increase Viralgen’s production capacity by 15 times and require an investment of around €120m ($129.9m).

Viralgen’s cGMP manufacturing facility in Spain

Viralgen’s cGMP facility is equipped with three independent state-of-the-art quality control labs and commercial manufacturing suites, which feature 500l and 2,000l single-use bioreactors. The facility has performed seven successful runs at its maximum scale of 2,000l.

An area of around 300,000ft² was added in the first module of the facility’s expansion for manufacturing clinical and commercial-grade rAAV product. The company aims to create additional space for manufacturing, science, and technology (MSAT) and analytical development at the facility by the end of the first quarter of 2023.

Viralgen’s existing cGMP capacity in San Sebastian contains three independent state-of-the-art commercial manufacturing suites, which cover more than 1,800m² in total. The manufacturing suites made the facility capable of continuously producing three different products at the same time.

The San Sebastian facility has 50l bioreactors for production and to support research and toxicology for either toxicology or biodistribution studies, as well as 50l, 250l and 500l single-use stirred-tank bioreactors. These bioreactors have a total AAV production capacity of 1,250l for suspension cell culture.

The facility also features in-house quality control labs for critical release assays.

Details of Viralgen’s manufacturing process

Viralgen’s manufacturing platform utilises proprietary Pro10, an HEK293-based suspension cell line technology, which allows large scale and higher yields of AAV manufacturing. Cultured in an animal-derived, component-free, suspension-adapted cell culture, the Pro10 cell line is capable of producing all serotypes and chimeric forms of rAAV.

The company’s upstream process is plasmid-based triple transfection that utilises up to 2,000l single-use stirred-tank bioreactors.

After expansion, Pro10 cells are co-transfected with the transgene plasmid, a plasmid containing pAAVrep2capX, and a helper plasmid containing the VA-RNA, E2A, and E4 helper genes of the adenovirus serotype.

The optimised RepCap and Helper plasmids are then used as part of its platform for upstream manufacturing.

Marketing commentary on Viralgen

Founded in 2017, Viralgen specialises in developing, validating and producing AAV gene therapies. The company is a subsidiary of Asklepios BioPharmaceutical (AskBio) and a part of the Bayer group.

As a fully-integrated CDMO, Viralgen provides a wide range of products and services, including process, analytical development, stability studies, and fill and finish, for all rAAV serotypes.

Since 2019, the company has manufactured more than 135 batches of clinical and pre-clinical material and has received approval for more than 24 investigational new drug applications (INDs).