Viralgen, an independently operated subsidiary of Asklepios BioPharmaceutical, (AskBio), and a member of the Bayer worldwide group of companies, has received Certified Good Manufacturing Practices (cGMP) certification for the manufacture of human medicinal products, investigational medicinal products and sterile or biological active substances. This certification was granted following a successful inspection by the Spanish Agency for Medicines and Medical Devices (AEMPS), a part of the European Medicines Agency (EMA) network. The company now operates two facilities in San Sebastian, Spain, with seven state-of-the-art single-use suites that have up to 2,000 liters of manufacturing capacity.

The contract development and manufacturing organization (CDMO) is now licensed for the commercial manufacturing of recombinant adeno-associated virus (rAAV) gene therapies up to 2,000 liters and has completed seven successful runs at this maximum scale. This first phase of the expansion of the new facility, which has added 300,000 square feet of clinical and commercial rAAV manufacturing, is now complete. The new facility currently has three independent state-of-the-art quality control labs and commercial manufacturing suites with 500- and 2,000-liter single-use bioreactors. Viralgen anticipates opening additional manufacturing, science and technology (MSAT) and analytical development space at the same facility at the end of Q1 2023.

“Being a fully integrated CDMO, we offer a continuum of products and services, including process, analytical development, stability studies and fill and finish for all types of rAAV serotypes,” said Jimmy Vanhove, CEO of Viralgen. “This can significantly shorten the time to market, help with predictable cost of goods and reduce the waiting time experienced by patients who have run out of options and hope for breakthrough treatments.”

With this approval, Viralgen expands its ability to partner with customers in the rAAV space that are initiating Phase III studies and seeking approvals to commercialize their products. This builds on the company’s achievement of its 2022 pivotal milestone, which was the manufacturing over 135 batches of clinical and preclinical material, and its enabling more than 24 INDs since its inception in 2019.

Javier García, co-founder and chairman of the board of Viralgen, said, “With this certification, we have three times the rAAV production capacity we had previously. This solidifies our position as a global leader in the CDMO rAAV field. We are now able to manufacture at the industry’s largest scale and supply Phase III and commercial products for our global customers.”