GMP-grade SAINT-Solid Lipid

GMP-grade transfection reagents
For the development of innovative new therapies based on the use of gene expression vectors, siRNA or miRNAs, there is an urgent need for safe, non-viral, GMP-grade transfection reagents. Therefore, Synvolux has put much effort in optimizing the synthesis, production processes and manufacturing conditions to develop a cost-effective transfection reagent that is readily amenable to high-volume, GMP-grade production for clinical use. One of the unique properties of SAINT lipids that distinguishes it from other lipids, is its heat tolerance (see the picture below).

Currently, heat-sterilized, GMP-grade SAINT lipids are being used in a clinical trial at the Radboud University Medical Center (Nijmegen, the Netherlands) for dendritic cell vaccinations to boost graft-versus-tumor immunity. Preceding work describing the benefits of SAINT lipids for this and other clinical studies is described by Roeven et al.

The specifications of GMP-grade SAINT lipids:
Purity > 96%
Endotoxin < 5 EU/ml
RNAse activity < 0.1 mU/ml

Bioburden
Cetrimide < 5 CFU/ml
R2A < 5 CFU/ml
Sabouraud < 5 CFU/ml
Caso < 5 CFU/ml
Endo < 5 CFU/ml

* GMP-grade means: Production of the transfection reagent (SAINT-RED) under pharmaceutical conditions. To be approved by EMEA or FDA after inclusion of the active pharmaceutical ingredient (siRNA) delivered by the customer.

Please contact us at for specific academic pricing.

Background

SAINT™ delivery technology is based on a set of proprietary, entirely synthetic, cationic lipid structures which have demonstrated to be safe and non-toxic both in vitro and in vivo. Due to its cationic headgroup and amphiphilic nature, SAINT lipids readily bind to most biomolecules (DNA, RNA, and protein) and to cellular membranes, facilitating efficient uptake and release of these biomolecules inside cells. SAINT lipids have demonstrated to reach similar or much higher transfection efficiencies (depending on the cell type) than competing, well-known products for a fraction of the price.