Čes. slov. farm. 2014, 63(5):199-205 | DOI: 10.36290/csf.2014.038

Lyophilisation of protein-based drugs

Andrej Murányi^1,*, Mária Vitková²

¹ hameln rds a.s., Modra, SR

² Univerzita Komenského v Bratislave, Farmaceutická fakulta, Katedra galenickej farmácie, SR

Lyophilisation is a well-established method for drying of various substances with a wide range of applications in the pharmaceutical area. During the last decade its relevance increases with a number of therapeutically used proteins. A sensitive protein drug may undergo several changes, like unfolding and loss of activity due to various stresses during the lyophilisation process. Understanding of these processes (freezing, primary drying, secondary drying) is fundamental for manufacturing of a drug product with desired properties, namely its safety and efficacy. In order to reduce costs and increase the quality, new technologies are being rapidly developed and established in industrial lyophilisation (e.g. process analytical technologies, control nucleation techniques).

Keywords: lyophilisation; freeze-drying; proteins; process analytical technologies

Grants and funding:

Táto práca vznikla s podporou projektu "Priemyselný výskum nových liečiv na báze rekombinantných proteínov", kód ITMS: 26240220034; "Podporujeme výskumné aktivity na Slovensku/Projekt je spolufinancovaný zo zdrojov EÚ."

Received: July 25, 2014; Accepted: September 2, 2014; Published: May 1, 2014  Show citation