Polyplus gets AFM grant for cGMP development

French drug delivery specialist Polyplus-transfection says it has received an 80,000-euro ($108,293) grant from the the French Muscular Dystrophy Association (AFM) to fund certain aspects of its production operations. Specifically, the award will be used to finance the development of current Good Manufacturing Practice standards for the production of its in vivo-jetPEI gene therapy reagent.

In vivo-jetPEI is a synthetic polyethylenimine molecule that is used for the in vivo delivery of nucleic acids. The firm explained that, in contrast with other gene therapy delivery mechanisms that utilize a viral vector-based system, its product does not trigger an immune response, and is therefore suitable for repeated use.

Polyplus said that the adoption of cGMP will hasten clinical trials of in vivo-jetPEI, establishes new quality control procedures and forms the basis for future stability studies.