Your new horizon in cGMP Gene Therapy manufacturing

Who we are

Viralgen is a CDMO born as a joint venture between Askbio and Columbus Venture Partners, combining decades of technology and drug development experience in multiple platforms to support best-in-class service offerings to the gene therapy market.

Viralgen was created in 2017 in response to the unmet need for manufacturing of gene therapies. Our goal was to help broaden the access to these life-saving therapeutics and contribute to the advancement of health and human welfare around the world. 

We specialize in the production of rAAV viral vectors. Our optimized facility in San Sebastian, Spain maximizes throughput and efficiency of our proprietary Pro10™ suspension manufacturing platform. This enables industry-leading scalability, reproducibility, and speed to market.

Through our superior technology platform, we deliver industry-leading titers and cGMP-certified quality for all AAV serotypes to our client partners, optimize the cost-of-goods and accelerate clinical development and commercialization of life-saving genetic medicines.

Your reliable partner for AAV Manufacturing, Development and Validation.

Our Main Strenghts

Proprietary mammalian suspension cell-based production platform

  • Viralgen Vector Core has licensed the Pro10™ cell line and manufacturing process from Askbio.
  • Pro10™ cell line is derived from HEK293 cells and show high yields across a wide range of serotypes, multiple chimeric, and novel capsids.
  • SV40 sequences are not present in the Pro10™ cell line.
  • Industrial scale serum-free suspension culture system: manufacturing process based on triple transfection of Pro10™ cell line.
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Large-Scale cGMP Capacity

  • 3 independent state-of-the-art cGMP production suites (>1800m2), providing the capability to manufacture 3 different products simultaneously.
  • 50L and 250L production scales to supply preclinical Toxicology/biodistribution studies to streamline development and regulatory review.
  • Viralgen uses 50L, 250L and 500L single-use stirred-tank bioreactors for culture of suspension cells and production of rAAV, in compliance with GMP regulations.
  • In-house QC lab for critical release assays.
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Disruptive R&D Development Partnering with AskBio

  • AAV Capsid Ploïdy.
  • DNA Substrates for AAV Encapsidation.
  • Improvements in AAV Therapeutic Index.
  • Stable Cell Line for AAV Assembly.
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