Reagent :PEIpro-HQ.

Concentration :1 mg/mL.

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

Applications :Large scale virus production for pre-clinical and early phase clinical trial.

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-HQ is sufficient to transfect on average 500 L of cell culture.

Storage :
Store PEIpro-HQ 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 Origin.
Non-Hazardous Product Statement.

Regulatory documentation available upon request :
Batch Production Documentation.
Quality agreement.

Summary:PEIpro-HQ is a Highly Qualified version of PEIpro DNA transfection reagent manufactured in an ISO 9001 environment. Large-scale transfection protocols established with PEIpro during process development are guaranteed to be seamlessly applicable with PEIpro-HQ for manufacturing of viral vectors for pre-clinical and early phase clinical trial. To move on to therapeutic viral vector production for late phase clinical trials and in fine commercialization, PEIpro-HQ should be replaced by PEIpro-GMP, 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).