Viralgen Earns cGMP Certification at New Spanish Plant

Viralgen Vector Core, an independently operated subsidiary of Asklepios BioPharmaceutical, Inc. and a company that falls under Bayer umbrella, has received certified good manufacturing practices (cGMP) certification for the manufacture of human medicinal products, investigational medicinal products, and sterile or biological active substances at its new San Sebastian, Spain facility.

This certification was given after a successful inspection by the Spanish Agency for Medicines and Medical Devices (AEMPS), which is a part of the European Medicines Agency (EMA) network. The company now operates two facilities in the Spanish city, 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. The company expects to open additional manufacturing, science and technology (MSAT) and analytical development space at the same facility at the end of Q1 this year.

"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," says 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."

Read more about Viralgen’s cGMP certification here.