PHARMACEUTICAL DEVELOPMENT OF FORMULATION BASED ON BIOPHARMACEUTICAL PREPARATIONS FOR GENE THERAPY

PHARMACEUTICAL DEVELOPMENT OF FORMULATION BASED ON BIOPHARMACEUTICAL PREPARATIONS FOR GENE THERAPY

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 developm...

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Veröffentlicht in:Razrabotka i registraciâ lekarstvennyh sredstv (Online) 2019-01 (1), p.74-85
Hauptverfasser: T. V. Budylskaya, D. V. Byrikhina, A. I. Gosudarev, V. D. Gusarova, F. M. Izhaeva, P. V. Mikhailov, D. A. Gusarov
Format: Artikel
Sprache:rus
Schlagworte:
biotechnology
gene therapy
pharmaceutical development
supercoiled plasmid
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Zusammenfassung: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.
ISSN:2305-2066
2658-5049