– AAVnerGene Announces AAVone®2.1, a Next Generation Single Plasmid AAV Production Platform Achieving ~1e16 GC/L and >70% Complete Capsids at Harvest
/PRNewswire/ –United States — 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.
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AAV2.1, achieving ~1e16GC/L and >70% Full Capsids at Harvest
AAVone®2.1 has achieved approximately 1 x 10¹⁶ genome copies (CG)/L of cell culture and more than 70% complete capsids at harvest, representing a significant advance over AAVone®1.0 and conventional multiplasmid AAV production systems, which often generate high proportions of empty capsids. The platform has demonstrated its performance with multiple AAV serotypes and its compatibility with HEK293 cell lines and existing manufacturing workflows.
These improvements can reduce plasmid requirements, culture volume, purification burden, processing steps, processing time, and manufacturing cost, while improving overall vector quality. By addressing major limitations in AAV production, AAVone®2.1 is designed to support clinical and commercial scalability of AAV-based gene therapy programs.
“AAV manufacturing remains one of the most important technical and economic challenges in gene therapy,” he said. Qizhao Wang, Ph.D., director of Technology at AAVnerGene. “Conventional multi-plasmid systems have driven the field for decades, but limitations in productivity, loading of empty capsids, and complexity of purification continue to create barriers to development and commercialization. “AAVone®2.1 was developed to address these challenges through a simplified single-plasmid system that improves vector productivity and the proportion of complete capsids.”
“AAV gene therapy continues to face challenges in commercialization, with manufacturing cost, vector quality, and process scalability being some of the most critical limitations,” he stated. Daozhan Yu, Ph.D., CEO of AAVnerGene. “AAVone®2.1 has the potential to simplify, scale and make AAV manufacturing cheaper, helping to make more AAV gene therapy programs clinically and commercially viable.”
AAVnerGene partners have licensed the technology and are developing multiple AAV gene therapy programs using the platform. The company’s goal is to provide enabling technologies that help overcome manufacturing barriers, reduce development costs and expand 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 gene therapy, including manufacturing, toxicity, qualification and administration. Its platforms include AAVone®, AAV-Q (a potency and rcAAV assay platform) and ATHENA (a capsid engineering platform), designed to improve productivity, quality, scalability, efficiency and safety in AAV gene therapy drug development.
Media and business inquiries:
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www.aavnergene.com
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