AAV Edge System

The AAV Edge System, developed by Asimov, is a modular suite of technologies designed to support the design and manufacture of adeno-associated virus (AAV) gene therapies. It is intended for gene therapy developers and manufacturing organizations seeking tools for payload design, cell line development, and scalable AAV production in a single platform.

The system offers three production approaches — stable, semi-stable, and transient — alongside a set of payload design tools that address tissue-specific expression, transgene toxicity during production, and in vivo potency. Users can either develop cell lines in-house using Asimov's software and materials, or engage Asimov to develop custom cell lines on their behalf.

Production System Options

• Stable AAV Production: Fully stable HEK293 producer cell lines with custom capsid and transgene. No transfection required — production is initiated by adding an inducer. Achieves up to 6E15 vg/L before purification. Custom stable AAV producer cell lines are delivered in 20 weeks.
• Semi-Stable AAV Production: Semi-stable HEK293 cell lines requiring only one plasmid transfection with no inducer. Includes optimized production protocols. (Listed as coming soon.)
• Transient AAV Production: Robust HEK293 cell lines using a transient plasmid system with optimized production protocols.

Stable AAV Production: Key Attributes

• Lower cost of goods: High-titer, scalable manufacturing is designed to reduce cost per dose.
• Reduced supply chain risk: Eliminates GMP plasmids required for transient transfection, simplifying production and reducing supply chain complexity.
• Increased manufacturing control: Clonal stable lines provide greater consistency within and across batches.
• Fast timelines: Custom stable AAV producer cell lines can be delivered in 20 weeks.

Payload Design Tools

• Tissue-specific promoters: Tools to enable precise, tissue-specific gene expression.
• GOI silencing during production: Mechanisms to reduce transgene toxicity during the manufacturing process.
• Sequence optimization: Computational and genetic tools to improve manufacturability and enhance in vivo potency.

Cell Line Development Workflows

1. In-house development (tools provided): Asimov ships the software, cells, and genes needed for the user to design and develop a cell line internally. Users design DNA constructs using Asimov's software, transfect cells, generate stable cell lines, and use the software for data analysis.
2. Fully outsourced development: Asimov designs a custom cell line using its platform, conducts cell line development and process development at its own site, shares progress and data through its software, and ships clonal cell banks with process transfer to the client's site.

Asimov is headquartered in Boston, MA. The AAV Edge System is positioned for organizations working across gene therapy development and manufacturing, with engagement available through direct contact with the Asimov team.