Polysorbate-80 Determination in BG00002 MAb Using Cobalt Complexation

by David Malliaros, PhD, Drago Clifton, and Paivi Kauppinen
Volume 5, Issue 2 (Summer 2006)

Polysorbate-80, or polysorbitan mono-oleate, a non-ionic surfactant commercially referred to as Tween-80, is commonly employed as an excipient in the biopharmaceutical industry due to its low toxicity as well as its ability to solubilize hydrophobic molecules. Thus, polysorbate-80 is employed as a stabilizer in order to control the formation of protein aggregates and larger particulates in biopharmaceutical drug substance and drug product formulations. Guidelines published by The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the United States Pharmacopeia (USP) classify excipients such as polysorbate-80 as major components in biopharmaceutical formulations and specify that these types of compounds be quantified using a validated analytical method…

Malliaros D, Clifton D, Kauppinen P. Polysorbate-80 Determination in BG00002 MAb Using Cobalt Complexation. BioProcess J, 2006; 5(2): 37-43. https://doi.org/10.12665/J52.Malliaros