Polysorbates are a family of amphiphilic, nonionic surfactants derived from ethoxylated sorbitans or isosorbides (derivatives of sorbitol) esterified with fatty acids. Polysorbates, especially polysorbate hlb 20 (PS20) and polysorbate hlb 80 (PS80), are the most widely used surfactants in biopharmaceutical formulations, preventing protein denaturation, aggregation, surface Adsorbent and flocculant formulations.
Polysorbates as protein stabilizers are chemically diverse mixtures and can be degraded by oxidative and hydrolytic pathways, where the hydrolytic pathway is chemically induced or enzymatically catalyzed. Because polysorbate hlb degradation may inadvertently affect the quality, efficacy, safety, and stability of protein formulations, drug regulatory authorities are increasingly scrutinizing polysorbate hlb control strategies to ensure polysorbate hlb within the shelf-life of drug products The content remains constant. As summarized in some literature, significant progress has been made in improving our current understanding of polysorbate hlb degradation pathways and underlying causes, enabling the implementation of appropriate polysorbate hlb control strategies. However, polysorbate hlb degradation has become one of the major challenges in the development and commercialization of therapeutic protein products in our industry.
2. Low toxicity;
3. Effective protein stabilization. Even at low concentrations, PS20 and PS80 provided adequate protein stability due to their high hydrophilic-lipophilic balance (HLB) values and low critical micelle concentration (CMC).