AAVnerGene announces AAVone®2.1, a next-generation single-plasmid AAV production platform that achieves ~1e16 GC/L and >70% full capsids at harvest


/PRNewswire/ — USA — AAVnerGene Inc. today announced the launch of AAVone®2.1, the next generation 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 hat ~1×1016 genome copies (GC)/L cell culture and greater than 70% full capsids at harvest, representing a significant advance over AAVone®1.0 and conventional multi-plasmid AAV production systems, which often produce a high proportion of empty capsids. The platform has demonstrated performance across multiple AAV serotypes and compatibility with HEK293-based cell lines and existing manufacturing workflows.

These improvements can reduce plasmid requirements, culture volume, purification effort, processing steps, processing time, and manufacturing costs while improving overall vector quality. AAVone®2.1 is designed to support the clinical and commercial scalability of AAV-based gene therapy programs by addressing key limitations in AAV production.

“AAV production remains one of the most important technical and economic challenges in gene therapy,” said Qizhao Wang, Ph.D., Chief Technology Officer von AAVnerGene. “Conventional multi-plasmid systems have enabled the field for decades, but limitations in productivity, empty capsid burden, and purification complexity continue to present barriers to development and commercialization. AAVone®2.1 was designed to address these challenges through a simplified single-plasmid system that improves vector productivity and full capsid content.”

“AAV gene therapy continues to face commercialization challenges, with manufacturing costs, vector quality and process scalability among the most critical factors,” said Daozhan Yu, PhD, Chief Executive Officer von AAVnerGene. “AAVone®2.1 has the potential to make AAV manufacturing simpler, more scalable and more cost-effective, thereby making more AAV gene therapy programs clinically and commercially viable.”

AAVnerGene’s partners have licensed the technology and are developing multiple AAV gene therapy programs based on this platform. The company’s goal is to provide 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 biotech company developing solutions to address bottlenecks in AAV gene therapy, including manufacturing, toxicity, qualification and delivery. Its platforms include AAVone®AAV-Q (a potency and rcAAV assay platform) and ATHENA (a capsid engineering platform), which are intended to improve the productivity, quality, scalability, efficiency and safety of developing AAV gene therapeutics.

Inquiries from media and companies:
[emailprotected]
www.aavnergene.com

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