SURFACTANT QUANTITATION IN HIGH CONCENTRATION BIOTHERAPEUTICS
Surfactants are an important component in biological formulations,
reducing aggregation resulting from shear stress, thermal stress,
interfacial stress and inherent molecule hydrophobicity. Because
of the critical role surfactants play in product stability, a detection
method that is accurate, sensitive, and able to measure degradation
is highly desirable. Method specificity with respect to surfactant type
is also beneficial.
Using HPLC separation, coupled with evaporative light scattering or
charged aerosol detection (ELSD and CAD), Pace® Life Sciences has
developed a robust platform for quantitative and qualitative analysis
of the most commonly used surfactants (polysorbate 80 and 20,
and poloxamer 188), with no interference from other formulation
excipients or high concentration biotherapeutics.
Benjamin Buer, Ph.D., Director of Pharmaceutical Development
Amy Chamberlain, Scientist