Sartorius, 102000006, 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

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.

Specifications
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 100 mL Bottle

Storage Conditions:
Storage Conditions: 5 °C ± 3 °C