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.:
- 102000006
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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
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ApplicationrAAV (Adeno-Associated Virus) manufacturing using HEK-293 derivative cells
Biological Information
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Number of transfections1 L of FectoVIR®-AAV transfection reagent is sufficient to transfect on average 500 L of cell culture (using standard conditions)
Compliance Information
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GMP ComplianceYes
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OriginAnimal-Component Free
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Product Documentation
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Protocol
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Certificate of Analysis
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Certificate of origin
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Non-hazardous product statement
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Certificate of compliance
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Drug master file
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Protocols for identity and activity testing
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Regulatory support package including toxicity statement
- Quality agreement
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Protocol
General Specifications
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Amount of ReagentFectoVIR®-AAV GMP 100 mL Bottle
Storage Conditions
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Storage Conditions5 °C ± 3 °C
