Assessment of changes in freeze-dried protein pharmaceuticals

Smilkov, Katarina and Gjorgieva Ackova, Darinka and Janevik-Ivanovska, Emilija and Stafilov, Trajče and Arsova-Sarafinovska, Zorica and Makreski, Petre and Gjorgoski, Icko (2017) Assessment of changes in freeze-dried protein pharmaceuticals. In: 17th CEEPUS Symposium and Summer School on Bioanalysis, 2-8 July 2017, Ohrid, R. Macedonia.

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Protein pharmaceuticals are becoming an important class of drugs. Due to their complex structure and instability in solution, their development is often challenging (Wang, 2000). Numerous attempts have been made to increase the long-term stability and shelf life, with freeze-drying as one of the most exploited methods.
The design of freeze-dried protein pharmaceuticals includes various methods of assessment of the changes that occur both during and after the process, and various analytical techniques can be exploited. Differential scanning calorimetry can be useful in determination of Tg, Tg`, and crystallization behavior in the frozen state (Meyer, 2009). The degradation is usually monitored using size exclusion chromatography or cation-exchange chromatography, but also electrophoresis can be used in order to detect presence of species with different molecular weight. The changes that occur in the secondary and tertiary structure of various proteins in both pre- and post- freeze drying have been investigated using a number of techniques including FTIR, Raman, NIR, fluorescence, phosphorescence spectroscopic techniques as well as NMR (Gjorgieva Ackova et al., 2015, Park et al., 2013, Kasper et al., 2013).
In this work we give an overview of the most frequently applied analytical techniques, as well as our experience in assessment of the changes in freeze-dried rituximab antibody immunoconjugates.

Item Type: Conference or Workshop Item (Speech)
Subjects: Natural sciences > Biological sciences
Natural sciences > Chemical sciences
Medical and Health Sciences > Health biotechnology
Medical and Health Sciences > Health sciences
Medical and Health Sciences > Other medical sciences
Divisions: Faculty of Medical Science
Depositing User: Katarina Smilkov
Date Deposited: 11 Dec 2017 12:53
Last Modified: 11 Dec 2017 12:53

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