PEIpro?-HQ

Pre-clinical and early phase clinical virus production Guaranteed virus production yields equivalent to R&D grade PEIpro?

Viral vector for Gene & Cell Therapy

Pre-clinical and early phase clinical virus production

Guaranteed virus production yields equivalent to R&D grade PEIpro®

Manufactured according to a well-established process

Fully characterized product with extensive Quality Controls

Supplied with appropriate Documentation

Overview

Specifications

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	5°C ± 3°C, 3 years from manufacturing date
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. 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).

Ordering information

Reference Number	Amount of reagent
301-100	100 ml
301-01L	1 L

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