Reagent :FectoVIR-AAV GMP.

Molecule delivered :Plasmid DNA and co-delivery of several plasmid DNA.

Applications :GMP compliant Recombinant AAV virus production.

Virus types :Adeno-Associated Viruses (AAV).

Cell types :Mammalian producer cell lines (HEK-293, HEK-293 derivatives) grown in suspension cultures.

Number of transfections :100 mL of FectoVIR-AAV transfection reagent is sufficient to transfect on average 50 L of cell culture.

Storage :
Store FectoVIR-AAV GMP at 5 °C ± 3°C.
Expiry date is indicated in the certificate of analysis (available in "My account") and on the product.

Provided with :
Protocol.
Certificate of Compliance.
Certificate of Analysis.
Certificate of Origin.
Non-Hazardous Product Statement.

Summary:
AAV Gene therapy manufacturers must meet regulatory requirements across their manufacturing process to ensure patient safety. This includes all starting materials, excipients and ancillary materials used to create the therapeutic AAV particle, because they can have an effect on the final product.

Transfection reagents are ancillary materials, which are used during the manufacturing but are not intended to be present in the final drug product.

AAV manufacturers expect their raw material suppliers to comply with regulatory agencies by upholding to the highest quality standards and aligning with CMC guidelines.

At Polyplus, we do not compromise on quality or performance. FectoVIR-AAV GMP is a premium transfection reagent that ensures:

Patient safety. FectoVIR-AAV GMP manufacturing strictly follows the ICH Q7 & Part II GMP guidelines. It is manufactured in compliance with the most stringent guidelines for the use of raw material (Eudralex Vol 4 Part II, Annex 1).
Robust & reliable aseptic manufacturing. FectoVIR-AAV GMP is produced following a robust and aseptic manufacturing process to guarantee quality of each batch and ensure batch to batch consistency.
Manufacturing cost-effectiveness. FectoVIR-AAV GMP is the scaled duplicate of FectoVIR-AAV to guarantee similar AAV production yield during process development for large scale GMP manufacturing and commercialization.
Accelerated time to market. FectoVIR-AAV GMP is intended to increase transfection performance and industrial scalability to expand the number of doses per production batch to treat more patients.