01Triple Plasmid Transfection
02Flowchart cGMP Production
Pro10™ Cell line
Proprietary Pro10™ is an animal-derived component-free suspension-adapted cell line, derived from HEK293 cells. Pro10™ is a unique high yield universal system that can produce all serotypes and chimeric forms of rAAV.
Plasmid-based transfection of a master cell bank. 50 to 500L single-use stirred-tank bioreactors.
VIRALGEN has the capability of continuously processing 50L to 500L batches with depth filtration, affinity and Ion exchange chromatography & tangential flow filtration.
Fill & Finish
Inhouse aseptic fill & finish process.
Manufacturing includes drug product and in-process testing services to ensure the identity, quality and purity of the product.
VIRALGEN has been accredited as a Pharmaceutical Laboratory in July 2019 by the AEMPS (Spanish Agency for Medicines and Health Products) and has received the cGMP (Good Manufacturing Practices) certification for the manufacture of recombinant Adeno associated Viral Vectors from the AEMPS which forms part of the European Medicines Agency.