Biontech Se

Tron—translationale Onkologie An Der Universitátsmedizin Der Johannes Gutenberg—universitÄt Mainz Gemeinnützige Gmbh

Tron-translationale Onkologie an Der Universitatsmedizin Der Johannes Gutenberg-universitat Mainz

Technische Universitat Darmstadt

Biontech Rna Pharmaceuticals Gmbh

Tron—translationale Onkologie An Der Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Ggmbh

Sebastian Hörner

Heinrich Haas

Thomas Michael Hiller

Ugur Sahin

Sebastian Kreiter

Mustafa Diken

Kerstin Walzer

Annette Vogel

Isaac Hernan Esparza Borquez

Thorsten Klamp

Harald Kolmar

Anne Schlegel

Sascha Knauer

Stephanie Erbar

Ferdia Bates

Jorge Moreno Herrero

Daniel Zucker

Olga Avrutina

Christina Uth

Jorge Herrero Moreno

Phillip Heller

The present disclosure relates to methods for preparing RNA lipoplex particles for delivery of RNA to target tissues after parenteral administration, in particular after intravenous administration, and compositions comprising such RNA lipoplex particles. The present disclosure also relates to methods which allow preparing RNA lipoplex particles in an industrial GMP-compliant manner. Furthermore, the present disclosure relates to methods and compositions for storing RNA lipoplex particles without substantial loss of the product quality and, in particular, without substantial loss of RNA activity.

Preparation and storage of liposomal RNA formulations suitable for therapy

The present invention relates to compositions comprising polyplex formulations for delivery of RNA to a target organ or a target cell after parenteral administration, in particular after intramuscular administration. More precisely, the present invention relates to formulations for administration of RNA such as self-replicating RNA, in particular by intramuscular injection. In more detail, the formulations comprise polyplex particles from single stranded RNA and a polyalkyleneimine.

Formulation for administration of RNA

The present invention relates to compositions comprising polyplex formulations for delivery of RNA to a target organ or a target cell after parenteral administration, in particular after intramuscular administration. More precisely, the present invention relates to formulations for administration of RNA such as self-replicating RNA, in particular by intramuscular injection. In more detail, the formulations comprise polyplex particles from single stranded RNA and a polyalkyleneimine. The RNA may encode a protein of interest, such as a pharmaceutically active protein. Furthermore, the present invention relates to pharmaceutical products, comprising said RNA polyplex formulations for parenteral application to humans or to animals. The present invention relates as well to manufacturing of such pharmaceutical products, comprising, optionally, steps of sterile filtration, freezing and dehydration.

Growing community of inventors

Mainz, Germany

Sebastian Hörner