The contract development and manufacturing organization (CDMO) said the new facility, located in the same technology park as its existing manufacturing footprint, increases capacity more than five-fold and now allows it to fully support 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, it added.
Viralgen was created in 2017 as a joint venture between AskBio and Columbus Venture Partners, in response to the unmet need for manufacturing of gene therapies. It was acquired by Bayer upon closing of the acquisition of AskBio in 2020.
The CDMO specializes in the production of recombinant adeno-associated viral (rAAV) vectors. Its original production unit in San Sebastian was set up to provide flexibility for customers using rAAV, as it manufacture from small R&D batches to 500L clinical GMP batches.
Addressing AAV vector supply bottleneck
Viralgen said the first phase of the development is costing €70m (US$83m), with total costs of the project estimated to reach €120m (US$142m) when the next two buildings are completed.
When fully realized the new plant will be the largest AAV vector manufacturing plant in the world. The initiative will see 130 new jobs being created, bringing total headcount at Viralgen to over 250 employees in 2022.
Javier García, CEO of Viralgen, said the manufacturing expansion project will help address the global viral vector shortage.
Many gene therapies are based on the use of a vector to deliver the genetic payload to the target location. The vectors of choice for most of today’s gene therapies are adeno-associated viruses (AAV), while they are also being used in COVID-19 vaccines. However, AAV production is struggling to keep up with demand.
The project, said the chief executive, 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.”