PHARMACEUTICAL DEVELOPMENT OF FORMULATION BASED ON BIOPHARMACEUTICAL PREPARATIONS FOR GENE THERAPY

Abstract

Biopharmaceuticals intended for gene therapy are mostly presented by supercoiled plasmid DNA obtained with bacteria cell lines. The properties of their formulations, including stability under different storage conditions, are barely studied. This article describes the typical pharmaceutical development of freeze-dried gene therapeutics. By means of process analytical technological methods the preparations formulated were controlled during storage. Furthermore, the composition of the formulations was optimized for prolonged storage.

Keywords

• gene therapy
• pharmaceutical development
• supercoiled plasmid
• biotechnology