A GMP facility equipped with bioreactors of up to 2,000 L will be the first commercial gene therapy production site in Spain, says CDMO Viralgen.

Contract development and manufacturing organization (CDMO) Viralgen will invest upwards of €50 million ($55 million) at its site at the Miramon Technology Park in San Sebastian, Spain to add capacity for gene therapy manufacturing services.

“We have a cGMP facility up and running that will have three production rooms by Q1 2020,” CEO Javier García told this publication. “We are expanding our capacity to include a commercial manufacturing facility that will be operational between Q2 and Q3 2022.”

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The commercial facility will house nine cleanrooms with a capacity in each of up to 2,000 L per batch, he continued. This will increase Viralgen’s current viral vector capacity 15-fold, the firm claims to help feed the demand for gene therapy production.

“There is a strong drive from our current customers at Viralgen to find options to manufacture vector for the commercial stage. We are seeing a great growth in the market from 2023 onward and there is not enough capacity right now to fulfill all requests.”

It is not just at Viralgen, as across the industry demand for gene therapy capabilities is outpacing supply as the sector blossoms.

“In the USA, the offer of GMP gene therapy manufacturing is limited [as well],” said García. The same happens with commercial grade manufacturing.”

He added that Viralgen serves the global market but believes “there are tremendous advantages to have manufacturing capacity in Europe for European biotech companies.”

Viral vectors are in short supply due in part to the complexity and high price of production, and there are very few CDMOs globally that have the manufacturing capabilities.

With 24 gene therapies alone in Phase III development, “CDMOs with viral vector capacity will have a huge advantage as the clinical pipeline for these advanced therapies gets approved,” Fiona Barry, Associate Editor at GlobalData’s PharmSource recently told this publication.