Abstract

Pre-Clinical Test Requirements For EVs Drugs

Marcin Jurga, R&D Manager, The Cell Factory (Esperite)

Extracellular vesicles (EVs) are promising drug candidates and drug delivery tools in treatment of multiple diseases. Currently, one of the most popular source of EVs are mesenchymal stromal cells (MSCs) with a broad spectrum of anti-inflammatory and immunosuppressive activity. Translation of the EVs drug candidates into clinic requires well-established production system and effective quality control procedures. The presentation will give an overview of the clinical-grade production process of the EVs drugs and will describe the quality control and activity assays developed and validated for clinical translation of the EVs drugs.