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Viralgen Receives cGMP Certification from European Medicines Agency

Plans to expand current footprint with support for up to 2000L scale for commercial use by the end of 2021

By: Cassandra Gervolino

Viralgen 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). 
 
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.
 
“We have gone from a bare concrete floor to a fully certified, world-class facility in less than two years,” said Javier García, Viralgen’s CEO. “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 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, CEO and co-founder of 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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