AAVnerGene’s proprietary AAV production platforms are designed to streamline plasmid systems, reduce cellular stress, and enhance vector assembly efficiency.

• Higher volumetric yields, including traditionally low-yield serotypes

• Improved full-to-empty capsid ratios, reducing downstream purification burden

• Lower impurity profiles, supporting smoother regulatory review

• Fully compatible with GMP process validation and scale-up

These platforms allow clients to reach clinical supply targets with smaller batch sizes and lower overall costs.

HEK293one Producer Cell Line

The HEK293one cell line is a proprietary HEK293-derived suspension cell line optimized specifically for AAV production.

• High transfection efficiency and robustness

• Consistent growth and productivity at large scale

• Reduced batch-to-batch variability

• Designed for serum-free, scalable cGMP manufacturing

This cell line forms a stable foundation for both early-phase and late-stage clinical production.

High-Efficiency PEIone Transfection Reagent

AAVnerGene has developed high-efficiency PEI based transfection reagents, PEIone and its protocol tailored to its production platforms.

• Reduced plasmid DNA and reagent consumption

• Lower cytotoxicity during production

• Improved reproducibility across scales

• Seamless transfer into validated cGMP workflows

Integrated cGMP Manufacturing Workflow

AAVnerGene provides fully integrated cGMP services, including:

Upstream Processing

• Suspension HEK293-based production

• Optimized cell density, media, and feeding strategies

• Scalable bioreactor systems aligned with clinical supply needs

Downstream Processing

• Chromatography-based purification workflows

• Enhanced recovery of full AAV particles

• Low host-cell protein and residual DNA levels

• Aseptic processing and sterile filtration

Comprehensive Quality Control & Release Testing

All cGMP batches are supported by a robust QC and release testing package, including:

• Vector genome titer (qPCR / ddPCR)

• Capsid titer and full-to-empty ratio

• Purity and identity testing

• Residual host-cell DNA and protein

• Sterility, endotoxin, and mycoplasma

• Optional infectivity and potency assays

Validated analytical methods and complete documentation ensure regulatory readiness.

Regulatory & CMC Support

• IND/CTA-enabling documentation

• Process description and comparability strategies

• Bridging studies between research and cGMP materials

• Technology transfer support to partner CDMOs when needed

Our team works closely with sponsors to de-risk regulatory submissions and accelerate clinical timelines.

A Flexible Partner for Gene Therapy Programs

By combining innovative AAV production technologies with cGMP manufacturing excellence, AAVnerGene enables:

• Faster transition from preclinical to clinic

• Lower cost of goods (COGs)

• Higher product consistency and quality

• Strong protection of client IP for capsids and transgenes

Partner with AAVnerGene

Whether you are preparing for first-in-human studies or scaling toward commercialization, AAVnerGene’s technology-driven cGMP services provide a competitive, reliable, and cost-effective manufacturing solution for your AAV gene therapy program.

Contact us to discuss your clinical manufacturing strategy.