/PRNewswire/ — USA — AAVnerGene Inc. today announced the launch of AAVone®2.1, the next generation evolution of its proprietary AAVone single-plasmid AAV production system®designed to improve AAV vector productivity, full capsid yield, manufacturing efficiency and cost-effectiveness.
70% Full Capsids at Harvest” data-getimg=”https://mma.prnewswire.com/media/2975162/AAVnerGene_achieving_Full_Capsids_at_Harvest.jpg?w=500″ id=”imageid_2″ itemprop=”contentUrl” loading=”lazy” rel=”newsImage” title=”AAV2.1, achieving ~1e16GC/L and >70% Full Capsids at Harvest”>
AAV2.1, achieving ~1e16GC/L and >70% Full Capsids at Harvest
AAVone®2.1 reached around 1×1016genomic copies (CG)/L of cell culture and more than 70% full capsids upon harvest, which represents an important advance compared to AAVone®1.0 and conventional multiplasmid AAV production systems, which often generate high proportions of empty capsids. The platform has demonstrated efficacy across multiple AAV serotypes and compatibility with existing HEK293-based cell lines and manufacturing processes.
These improvements can reduce plasmid requirements, culture volume, purification burden, processing steps, processing time, and manufacturing costs, while improving overall vector quality. By tackling the main constraints of AAV production, AAVone®2.1 is designed to support the clinical and commercial scalability of AAV-based gene therapy programs.
“AAV manufacturing remains one of the most significant technical and economic challenges in gene therapy,” said Qizhao Wang, Ph.D., CTO of AAVnerGene. “Conventional multi-plasmid systems have enabled industry development for decades, but productivity limitations, the burden of empty capsids, and the complexity of purification continue to create barriers to development and commercialization. AAVone®2.1 was developed to address these challenges with a simplified single-plasmid system that improves vector productivity and the proportion of full capsids.”
“AAV-based gene therapy continues to face commercialization challenges, with manufacturing cost, vector quality and process scalability among the most critical constraints,” said Daozhan Yu, Ph.D., CEO of AAVnerGene. «AAVone®2.1 has the potential to make AAV manufacturing simpler, more scalable and more economical, helping more AAV-based gene therapy programs become clinically and commercially viable.”
AAVnerGene partners have licensed the technology and are developing multiple AAV-based gene therapy programs using the platform. The company’s goal is to provide enabling technologies that help overcome manufacturing barriers, reduce development costs, and increase the number of gene therapy programs that can reach patients.
About AAVnerGene Inc.
AAVnerGene is a Maryland-based biotechnology company developing solutions to address bottlenecks in AAV-based gene therapy, including manufacturing, toxicity, qualification and execution. Its platforms include AAVone®AAV-Q (a platform for analyzing biological activity and replication-competent AAVs) and ATHENA (a capsid engineering platform), designed to improve productivity, quality, scalability, efficiency and safety in the development of AAV-based gene therapy drugs.
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