Rapid Profiling, Fingerprinting, and Speciation of Poloxamer 188 in Biotherapeutic Drug Production Using Comprehensive Liquid Chromatography-Charge Reduction Mass Spectrometry Analysis.

ABSTRACT: Poloxamer 188 (P188) is an alternative surfactant to polysorbates in biologic formulations, stabilizing biotherapeutic drugs in solution. By mitigating the inherent risk of polysorbate 20/80 (PS 20/80) degradation by host cell proteins, P188 ensured product integrity. In cell culture, it is used to minimize bubble formation and reduce shear stress. However, P188's susceptibility to chemical degradation necessitates vigilant monitoring during production, formulation, and storage to ensure biotherapeutic quality and patient safety. The complex composition of P188 poses a significant analytical challenge for its characterization and quantification in the pharmaceutical industry. In this work, we demonstrate two liquid chromatography (LC) methods that can be coupled with either a mass spectrom

SUBMITTER: Yang RS 

PROVIDER: S-EPMC12809350 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature