Viralgen is a fully integrated Contract Development and Manufacturing Organization (CDMO) founded in 2017 as an independently operated subsidiary of Asklepios Biopharmaceutical, Inc. (AskBio), part of the Bayer AG group. Viralgen was created to support development through large-scale commercial production of Certified Good Manufacturing Practices (cGMP) AAV (adeno-associated virus) for cell and gene therapies. Through the AskBio licensed proprietary Pro10™ suspension manufacturing platform, Viralgen delivers industry-leading titers for all AAV serotypes, optimizing speed to market and cost-of-goods to accelerate clinical development and commercialization.

The company’s state-of-the-art facilities based in San Sebastian, Spain include a commercial facility consisting of three modules, each having three cGMP suites with capacities of >2,000 L, one of which has received the cGMP certification by the Spanish Agency for Medicines and Medical Devices (AEMPS) as part of the EMA for the manufacture of human medicinal products, investigational medicinal products and sterile or biological active substances. The recently inaugurated MSAT laboratory provides advanced services for transitioning programs from clinical to commercial manufacturing. Leveraging the proven expertise in AAVs, Viralgen has recently launched several development services offerings focused on construct optimization, process optimization and right-sized scaling for customers needing additional support, in addition to the established research, process development, formulation and filling activities.