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Rockville, MarylandMay 10, 2026 /PRNewswire/ — USA — AAVnerGene Inc. today announced the launch of AAVone®2.1, the next-generation evolution of the company’s proprietary AAVone® single-plasmid AAV production system, designed to improve AAV vector production efficiency, full capsid ratio, manufacturing economics, and cost-effectiveness.
AAVone®2.1 achieves a yield of approximately 1×1016 genome copies (GC)/L in cell culture, with a full capsid rate exceeding 70% at harvest. This represents a significant advancement compared to AAVone®1.0 and traditional multi-plasmid AAV production systems, which often generate a high proportion of empty capsids. The platform has been validated across multiple AAV serotypes and confirmed to be compatible with HEK293-based cell lines and existing production process workflows.
These improvements are expected to reduce plasmid requirements, culture volumes, purification burdens, processing steps, processing time, and production costs, while enhancing overall vector quality. By addressing key bottlenecks in AAV production, AAVone®2.1 aims to support the clinical and commercial scale-up of AAV-based gene therapy programs.
Dr. Qizhao Wang, Chief Technology Officer of AAVnerGene, stated: “AAV production remains one of the most significant technical and economic challenges in the gene therapy field. Traditional multi-plasmid systems have been used in the industry for decades, but their limitations in production efficiency, empty capsid ratios, and purification complexity continue to pose obstacles to development and commercialization. AAVone®2.1 directly addresses these challenges through a simplified single-plasmid system, improving vector production efficiency and full capsid rates.”
Dr. Daozhan Yu, CEO of AAVnerGene, stated: “AAV gene therapy continues to face commercialization challenges, with production costs, vector quality, and process scalability being the most critical constraints. AAVone®2.1 has the potential to make AAV production simpler, more scalable, and more cost-effective, helping more AAV gene therapy programs become viable in clinical and commercial settings.”
AAVnerGene’s partners have licensed this technology and are using the platform to advance the development of multiple AAV gene therapy programs. The company aims to provide enabling technologies to help overcome production barriers, reduce development costs, and ultimately allow more gene therapy programs to benefit patients.
About AAVnerGene Inc.
AAVnerGene is a biotechnology company headquartered in Maryland, dedicated to developing solutions that address bottlenecks in AAV gene therapy, covering production, toxicity, characterization, and delivery. Its platforms include AAVone®, the AAV-Q platform for potency and rcAAV detection, and the ATHENA platform for capsid engineering, aimed at improving production efficiency, quality, scalability, efficiency, and safety in AAV gene therapy drug development.
AAV2.1: Titer up to ~1e16 GC/L at harvest, full capsid rate over 70%