Polysorbate 80: Exploring its Impact on IgG Stability
As drug safety regulations intensify, manufacturers must ensure their formulations, like polysorbate 80, are free from visible particles and contain a limited number of subvisible particles larger than 10 µm (per FDA requirements). These particulates aren’t just due to process instability but also the degradation of formulation excipients. Mechanical stress during manufacturing can cause protein…