GMP-Compliant Nucleic Acid Transfer Agent Produced by Polyplus-transfection

Polyplus-transfection (New York, NY), has announced the production of its transfection reagent in vivo-jetPEI, manufactured in full compliance with good manufacturing practices (GMPs). This GMP-compliant in vivo-jetPEI is required for clinical trials involving the delivery of nucleic acids (DNA and siRNA).

The in vivo-jetPEI molecule is able to transfect effectively both in vitro and in vivo, which is not the case with most commercially available transfection reagents.

A Drug Master File (DMF) describing the manufacturing of in vivo-jetPEI has been filed with the US Food and Drug Administration (FDA). The DMF provides confidential detailed information about the manufacturing process of the reagent, simplifying the FDA documentation required for clinical trial applications.

The development of the in vivo-jetPEI GMP-compliant process has required the design of new quality control tests to meet the current requirements in the US and the European Union.

Polyplus-transfection release (PDF)