Study of aggregation, denaturation and reduction of interferon alpha-2 products by size-exclusion high-performance liquid chromatography with fluorescence detection and biological assays

Journal of Chromatography. a
Abebaw DiressMichel Girard

Abstract

Interferon alpha-2 (IFN alpha-2) products have been widely used as antivirals for the treatment of serious diseases such as hepatitis B and C. However, reports of adverse reactions following treatment have prompted investigations into the cause of these undesirable events. In this study size-exclusion HPLC (SE-HPLC) methods coupled with intrinsic fluorescence detection were developed for evaluating the stability and degradation profiles of IFN alpha-2 drug substances and drug products. The method allowed baseline resolution of the active ingredient from the excipients present in the finished products that included large amounts of albumin. Limits of detection (S/N>or=3) for IFN alpha-2a and IFN alpha-2b were 32 ng/mL and 28 ng/mL, respectively and good repeatability of chromatographic profiles (%RSD<2.1) was obtained. High molecular weight (HMW) aggregates with apparent molecular weight of approximately 650 kDa as well as dimers, denatured and reduced variants were successfully identified and separated from native IFN alpha-2 proteins. This chromatographic method, which quantitatively measures physical and chemical changes taking place in solution formulations, was found to be capable of monitoring IFN alpha-2a and IFN alpha-2b...Continue Reading

References

Nov 29, 1996·Journal of Immunological Methods·U CanosiG Galli
Feb 27, 1999·Journal of Interferon & Cytokine Research : the Official Journal of the International Society for Interferon and Cytokine Research·J HiscottR Lin
May 29, 1999·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·H YanoM Kojiro
May 18, 2005·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Dion M A M LuykxPeter M J M Jongen
Aug 12, 2008·Biologicals : Journal of the International Association of Biological Standardization·Marta M C G SilvaC Jane Robinson

❮ Previous
Next ❯

Citations

Apr 23, 2013·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Andréa R Chaves, Maria Eugênia C Queiroz
May 13, 2014·Journal of Pharmaceutical and Biomedical Analysis·Szabolcs FeketeDavy Guillarme
Jun 18, 2011·Biologicals : Journal of the International Association of Biological Standardization·Diogo Paim LealSérgio Luiz Dalmora
Nov 7, 2015·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Elnaz Tamizi, Abolghasem Jouyban
Sep 1, 2015·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Jiangtao DongXiaoqing Miao
Mar 16, 2011·Journal of Biomedicine & Biotechnology·Louise LarocqueXuguang Li
Nov 16, 2016·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Faranak Salmannejad, Nastaran Nafissi-Varcheh
Aug 5, 2017·Journal of Biomedical Materials Research. Part a·Maja Kaisersberger VincekVanja Kokol
Feb 5, 2013·Journal of Liquid Chromatography & Related Technologies·Paula HongEdouard S P Bouvier
Feb 27, 2020·International Journal of Molecular Sciences·Hsuan-Ju LinHong-Ting Victor Lin

❮ Previous
Next ❯

Related Concepts

Related Feeds

Antivirals

Antivirals are medications that are used specifically for treating viral infections. Discover the latest research on antivirals here.

Antivirals (ASM)

Antivirals are medications that are used specifically for treating viral infections. Discover the latest research on antivirals here.