GMP production of CG01 begins as planned after the recent release of the GMP plasmids that make up the starting material for the production of CG01 by CombiGene’s plasmid producer Cobra Biologics.
The CG01 material is now produced on a large scale for use in the first clinical study with CG01. The produced material will be analyzed from all relevant aspects and data from the analyses will form a central part of the upcoming Clinical Trial Application (CTA). The material will then be used in CG01's first clinical study, which is scheduled for the second half of 2022.
“The fact that
“We are excited to continue to build our relationship with
About CG01
Unlike many gene therapies, which are developed for the treatment of rare diseases, CG01 caters to a large population of patients. Epilepsy is a major global problem. Every year, approximately 47,000 drug-resistant patients with focal epilepsy are estimated to be added in the US, EU4,
Horizon 2020
CombiGene’s lead project CG01 has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 823282.
About
CombiGene’s vision is to offer patients affected by severe life-changing diseases opportunities for a better life through innovative gene therapies. CombiGene’s business concept is to develop effective gene therapies for serious diseases that today lack adequate treatment methods. Research assets are taken in from a network of external researchers and developed further up to clinical concept verification. Drug candidates for common diseases will be co-developed and commercialized through strategic partnerships, while
About Viralgen
viralgenvc.com
Viralgen is a CDMO born as a joint venture between
Viralgen was created in 2017 to respond to the unmet need for manufacturing of gene therapies, with the goal to help broaden access to these life-saving therapeutics and to contribute to the advancement of health and human welfare around the world. We specialize in the production of rAAV viral vectors, and have built an optimized facility in San Sebastian,
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.
Viralgen new commercial facility will be in production by the end of 2021 in San Sebastian (
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