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

ACS Omega
November 24, 2025

Poloxamer 188 (P188) is an alternative surfactant to polysorbates in biologic formulations, stabilizing biotherapeutic drugs in solution. By mitigating the risk of polysorbate 20/80 degradation by host cell proteins, P188 ensures product integrity. However, its susceptibility to chemical degradation necessitates vigilant monitoring during production, formulation, and storage to ensure biotherapeutic quality and patient safety. 

Using Genedata Expressionist^®, the team automated end‑to‑end MS processing, including direct Waters file import, recalibration, de‑noising, and peak/isotope clustering, for lot quality ranking, impurity tracking, and stability assessment. Coupled with a CAD quantitation method, the streamlined workflow increases throughput and confidence in P188 control strategies across development and manufacturing.