Gene therapy manufacturer Viralgen relies on RLT technology from WOLF
The Spanish pharmaceutical biotechnology company Viralgen relies on WOLF air handling technology for the air conditioning of its new laboratory and research areas. In the state-of-the-art clean rooms, gene therapeutics for rare and ultrarare diseases are developed, produced and bottled in 250-to-2000-liter bioreactors.
Viralgen, a subsidiary of AskBio and an independent affiliate of the Bayer Group, was founded in Spain in 2017 and has set itself the goal of bringing life-saving gene therapeutics to market worldwide faster and at a lower cost, for the benefit of human health and well-being.
To this end, Viralgen in San Sebastian has been investing in laboratory and production space for the clinical and commercial production of gene therapeutics since 2017, which will cover almost 300,000 square meters in the future.
Located in the Gipuzcoa´s Science and Technology Park, the company has been licensed for the commercial production of recombinant adeno-associated viruses (rAAV) since 2022. The clean rooms have been certified by the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) as compliant with cGMP (certified good manufacturing practices) for batches of gene therapeutics up to 2,000 litres.
MSAT, R&D clean rooms and ACE laboratory
Around €10 million were invested during 2023 - 2024, in the state-of-the-art labs. This demonstrates Viralgen’s commitment to scientific advancement and health improvement.
MSAT (Manufacturing Science And Technology) ensures that the manufacturing processes for biological products are robust, efficient, and compliant with regulatory standards. This plays a crucial role by combining initial process development with GMP manufacturing activities for Adeno-associated Virus (AAV) production in advanced therapies. All MSAT equipment used to support commercialization activities is specifically qualified for MSAT purposes and operated by highly experienced and trained scientists.
Viralgen has been producing clinically tested gene therapeutics for the international market since 2019, which are exported worldwide.
WOLF clean room ventilation technology
For this highly sensitive research, production and analysis environment, the investors were looking for an efficient and reliable clean room ventilation system and a manufacturer that could offer not only precise technology but also excellent service. The choice fell on the air handling solutions from WOLF in Mainburg (Germany).
In addition to the hygienic design of the systems, their integrated control is essential for reliable operation that is precisely tailored to demand. The ventilation technology is easy for staff to operate, and maintenance work is simple to carry out.
A total of 19 weatherproof KG Top air handling units with enthalpy heat exchangers, installed outside, condition the supply air brought into the building.
They are also equipped with mixing valves and water-bearing heating and cooling coils for temperature control. An F9 filter is used to achieve sterility.
In the individual building sections, 24 CEH high pressure fan coil units distribute the conditioned and germ-free supply air with little draft.
For the prescribed heat recovery according to Eco design ERP 2018, two flat WOLF CFL-WRG 32 with a plate heat exchanger were installed in the false ceiling. The hygienic air quality is also ensured here with an F9 filter.
‘Designing air handling units for clean rooms is one of the most complex tasks that professionals in this field can face,’ says Julián Pradillo, national head of engineering and technical management at the WOLF Ibérica Business Unit Climate and Ventilation. ‘This project reflects our clean room equipment. We are proud to have fulfilled our commitment to commission state-of-the-art, durable and reliable ventilation systems that are made in Germany and fit perfectly.’
World's largest production plant for adenoviruses
Viralgen's further growth is already taken care of, because in addition to the existing production and laboratory space, two additional building modules provide the possibility for expansion. They will be put into operation when production is ramped up further, as expected in the next few years.
This will increase the capacity of what is already the world's largest production facility for adenoviruses fifteenfold.
“This will democratize access to gene therapy in terms of both volume and production speed, while also reducing manufacturing costs,” says Jimmy Vanhove, CEO of Viralgen, explaining the benefits of this investment for patients with genetic rare and ultrarare diseases.
Gene therapy Around 400 million people worldwide suffer from rare and or ultrarare diseases, and only 5 percent of the 7,000 identified rare chronic diseases have an approved treatment. About half of all rare diseases mainly affect infants and children. The effort required to develop these gene transfer therapies is correspondingly high. These treatments can save a patient's life and improve their quality of life. |