Reagent ：PEIpro-GMP

Concentration ：1 mg/mL.

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

Applications ：Large scale virus production for clinical trials and commercialization.

Virus types ：Mainly adenovirus, Adeno-Associated Viruses (AAV), Lentiviral Vector (LV), influenza virus, retrovirus, Virus-Like Particles (VLP).

Cell types ：Mammalian producer cell lines (HEK-293, HEK-293 derivatives, BHK, VERO cell lines, virus-specific packaging cell lines) grown in adherent or suspension cultures.

Number of transfections ：1 L of PEIpro-GMP is sufficient to transfect on average 500 L of cell culture.

Storage ：
Store PEIpro-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 ：
Certificate of Analysis.
Certificate of Compliance.
Certificate of Origin.
Non-Hazardous Product Statement.

Regulatory documentation available upon request ：
DMF (Drug Master File) on file (FDA).
CMC section (Chemistry, Manufacturing and Control).
Protocol for identity testing.
Quality agreement.

Summary：
Qualified raw material for therapeutic viral vector production: PEIpro-GMP is manufactured in compliance with EU “Guidelines of good manufacturing practice for medicinal products for human and veterinary use” (ICH Q7 and EudraLex Vol 4, Part II and Annex I).

Flexibility and cost-efficient for viral vector platforms: PEIpro-GMP is the highest quality grade PEI and only transfection reagent available on the market supplied in single-use bags and in polypropylene (PP) or PETG bottles for manufacturing of therapeutic viral vectors.

Reliability in viral vector infectious titer: Smooth transition from initial process development to large scale manufacturing of therapeutic viral vectors. Transfection protocols established with PEIpro and PEIpro-HQ are guaranteed to be directly transferable when moving on to PEIpro-GMP to produce therapeutic viral vectors for late phase clinical trials and commercialization.