π-Alpha 293 AAV High-yield Production Platform

  • PackGene's proprietary π-Alpha 293 AAV High-Yield Platform represents a significant advancement in Adeno-Associated Virus (AAV) production and quality. The platform integrates an optimized PCS3.0 suspension cell line and a uniquely engineered RC plasmid within a triple-plasmid transfection system, achieving a 3 to 8-fold increase in AAV production across diverse serotypes. This foundational enhancement, coupled with rigorous Quality by Design (QbD) optimizations throughout both upstream and downstream processes, culminates in up to a 10-fold overall yield improvement. The platform consistently delivers single-batch yields reaching 1E+17 vg, effectively meeting the demands of clinical and commercial-scale AAV production.

AAV Manufacturing Facility

Key Advantages

  • Enhanced Productivity and Scalability

    Proprietary technologies drive a greater than 10-fold increase in AAV yield within HEK293 serum-free cell suspension systems. 
  • Superior Purity

    Refined process development significantly reduces key impurities, including Host Cell DNA (HCD) and endotoxin. 
  • Improved Safety and Bioactivity

    Innovative technological advancements minimize empty capsid and maximize infection titers.

Performance

  • Enhanced Productivity and Scalability

    The PCS3.0 suspension cell line, combined with a uniquely engineered RC plasmid, enhances AAV production efficiency. This optimized system enables greater scalability for large-scale manufacturing.

    PackGene’s proprietary RC plasmid significantly increases AAV production yield

    Fig 1. PackGene’s proprietary RC plasmid significantly increases AAV production yield

     

    PCS3.0 cell line performance in ssAAV9 AAV production

    Fig 2. PCS3.0 cell line performance in ssAAV9 AAV production

     

    π-Alpha 293 AAV high-yield platform achieves scalable production

    Fig 3. π-Alpha 293 AAV high-yield platform achieves scalable production

  • Superior Purity

  • Improved safety and bioactivity

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