Viralgen Receives EMA cGMP Certification

Spanish contract development and manufacturing organization (CDMO) Viralgen, a joint venture between AskBio and Columbus Venture Partners, has received current Good Manufacturing Practices (cGMP) compliance accreditation and Pharmaceutical Laboratory authorization by the AEMPS (Spanish Agency for Medicines and Health Products) and certification from the European Medicines Agency (EMA). Based in San Sebastián, Spain, Viralgen is a CDMO that specializes in developing, validating and manufacturing adeno-associated virus (AAV) gene therapies.
 
"We have gone from a bare concrete floor to a fully certified, world-class facility in less than two years," said Javier García, chief executive officer, Viralgen. "The quality of our facility, scaled-up manufacturing processes, and this certification underscore our commitment to helping our clients develop safer and more effective therapies for genetic disease. We have an amazing facility and a highly skilled team focused on delivering technology that produces higher yields of rAAV vectors, ultimately contributing to lowering the cost of potentially life-saving therapeutics for patients in need."
 
Viralgen says a key benefit of its technology is the cGMP production of high-quality rAAV in large batches through a unique and robust manufacturing platform. AskBio, which owns 50 percent of Viralgen, has developed a clinical stage gene therapy platform that includes a proprietary cell line manufacturing process known as Pro10. This allows Viralgen to scale cGMP manufacturing of rAAV vectors at levels that exceed what other CMOs can produce and enables flexible, scalable clinical manufacturing faster than current industry standards.

According to Mr. García, Viralgen's current cGMP capacity is comprised of:
 
• Three independent, state-of-the-art cGMP production suites (>1800m2), providing the capability to continuously and simultaneously manufacture three different products;
• 50L scale to supply toxicology/biodistribution studies with full support for research, toxicology and GMP production in parallel;
• 50L, 250L and 500L single-use stirred-tank bioreactors for culture of suspension cells with a total capacity of 1,250 liters of dedicated AAV production; and
• In-house quality control labs for critical release assays.
 
Mr. García also noted that Viralgen plans to expand its current footprint with support for up to 2000L scale for commercial use by the end of 2021. This will enable full life cycle support and maximized flexibility to serve a wide range of AAV capsids for manufacturing potentially curative therapeutics.
 
"Viralgen is a focused and highly capable organization with an unparalleled depth of resources devoted to being the world's best AAV CDMO," said Sheila Mikhail, chief executive officer and co-founder, AskBio. "Viralgen delivers its clients a superior level of quality to ensure safe, reliable AAV vectors for clinical use that are commercially ready for large-scale production. Together, we look forward to solving many of the gene therapy cost and scale issues that face our industry today."

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