FectoVIR®-AAV GMP

Tech Support Documents
FectoVIR®-AAV GMP
 

FectoVIR®-AAV is a novel generation of synthetic transfection reagent specifically developed for industrial scale production of recombinant AAV (rAAV) in both suspension and adherent HEK-293 derivative cell systems

Amount of Reagent
Item No.: 
102000009
Availability: 

*Custom/bulk order quotes are provided within 72 hours of request.

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FectoVIR®-AAV transfection reagent guarantees higher rAAV titers, improves scalability for large scale production and de-risks manufacturing process with its availability at pharma GMP grade. FectoVIR®-AAV-GMP is manufactured under a validated and aseptic process in compliance with ICH Q7, GMP part II guidelines, the quality grade of reference for active pharmaceutical ingredients (API).

Key Benefits:

  • Process Economics: High AAV productivity expands the number of doses per batch to reduce manufacturing costs.
  • Industrial Scalability: Designed for large scale with low complexation volume, long complex stability, and high reproducibility.
  • GMP Grade Availability: Validated Manufacturing process following ICH Q7 guidelines, provided with full regulatory documentation.
  • Risks Mitigation: Both residual test and toxicity statement enable to mitigate risks and ensure patient safety.

Applications

  • Application
    rAAV (Adeno-Associated Virus) manufacturing using HEK-293 derivative cells 

Biological Information

  • Number of transfections
    1 L of FectoVIR®-AAV transfection reagent is sufficient to transfect on average 500 L of cell culture (using standard conditions) 

Compliance Information

  • GMP Compliance
    Yes
  • Origin
    Animal-Component Free
  • Product Documentation
    • Protocol 
    • Certificate of Analysis 
    • Certificate of origin 
    • Non-hazardous product statement
    • Certificate of compliance
    • Drug master file
    • Protocols for identity and activity testing
    • Regulatory support package including toxicity statement
    • Quality agreement 

General Specifications

  • Amount of Reagent
    FectoVIR®-AAV GMP 1 L Bag

Storage Conditions

  • Storage Conditions
    5 °C ± 3 °C
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