PEIpro™ has been formulated at 1 mg/mL to fit current standard for transfection with PEI. This concentration eases the transfection protocol optimization. PEIpro protocol is available upon request. Contact the Technical Support.

Positively charged reagent/DNA complexes are needed to achieve high transfection efficiency. The global charge of the complexes is determined by the PEI/DNA ratio (N/P ratio i.e. number of nitrogen residues (N) in the PEI per phosphate (P) of DNA). To obtain positively charged complexes, an N/P ratio of greater than 3 is needed.
The number of nitrogen residues available in the PEI depends on the molecular weight of the polymer, its structure (branched or linear), the deprotection of the protonable residues (deacylation) and the distribution of the fragment length (polydispersity) following hydrolysis.
The linear form of PEIpro™ and the manufacturing process developed by Polyplus-transfection ensure a high, stable and reproducible amount of protonable amines available for transfection while providing a truly deacylated molecule and an extremely lower polymer chain length variation.

The quality of PEIpro™ is continuously assessed during the manufacturing process with the appropriate control testing (Fig. 1). Further, systematic lot management and release testing is performed for each lot produced. To assess activity a standardized transfection assay is performed with a suspension-adapted HEK-293 cell line in animal-component free media to ensure the reliability and reproducibility of the transfection efficiency under conditions that are suitable for biomanufacturing.

Fig. 1. PEIpro™ in-process and lot release quality controls

PEIpro™ is manufactured and formulated using a highly controlled production process (Fig. 1). Moreover, in order to meet or exceed current regulatory guidelines, PEIpro™ is released using advanced quality controls including a specification for a transfection efficiency that enables excellent lot-to-lot consistency (Fig. 2).

Fig. 2. HEK-293 EBNA cells were seeded in synthetic media, incubated at 37°C, 8% CO2 with constant shaking and transfected with PEIpro™ following the standard protocol. Luciferase expression was assayed 48 h after transfection.

PEIpro™ is free of component of animal-origin.
In addition, Polyplus-transfection is ISO 9001 Quality Management System accredited since 2002 and this level of certification assures global customers that the supplier has established reliable and effective processes for product development, manufacturing, sales and customer support.
To ensure reliable production of recombinant proteins during the whole development process, any PEI transfection reagent selected should have the potential to meet cGMP guidelines from FDA, EMA, or ICH when the transfection reagent will be used to produce therapeutic recombinant proteins that are in late stage clinical development (ie, post Phase 1). PEIpro™ is tested to ensure complete sterility, absence of mycoplasma and very low level of bacterial endotoxins following pharmacopeia standards. In addition, on request, Polyplus-transfection can supply fully GMP compliant product delivering the highest quality level reagent and documentation for the production of therapeutic proteins or viral vectors.

Polyplus-transfection SA is the exclusive worldwide licensee of U.S. Patent No. 6,013,240, European Patent No. 0770140, and foreign equivalents, which cover transfection compositions having nucleic acids and a cationic polymer based on polyethylenimine (PEI), and use of this cationic polymer in nucleic acid transfection.
Polyplus sells branded PEI-based transfection reagents under its exclusive license, including the PEIpro™. For PEIpro™ transfection reagent sold by Polyplus and its authorized distributors, Polyplus hereby conveys license rights to the buyer to use the purchased transfection reagents, to the exclusion of human use, to perform stable or transient transfection for research and commercial purposes.
No rights to reverse engineer or resell are conveyed for any purchased transfection reagent. No license rights whatsoever are conveyed for any PEI-based molecules purchased from unauthorized sources for transfection purposes, and Polyplus reserves all rights and remedies relating to such unauthorized purchases.