Quantitative Analysis of Poloxamer 188 in Biotherapeutic Process Streams Using Liquid...

Area of Science:

• Biopharmaceutical Manufacturing
• Analytical Chemistry
• Process Development

Background:

• Poloxamer 188 (P188), a nonionic surfactant, is vital for protecting biotherapeutic proteins during manufacturing.
• Effective monitoring of P188 clearance is essential for downstream bioprocessing quality control.

Purpose of the Study:

• To develop and validate a robust analytical method for quantifying Poloxamer 188 (P188) process clearance.
• To enable accurate monitoring of P188 removal during biotherapeutic downstream purification steps.

Main Methods:

• Development and validation of a liquid chromatography-triple-quadrupole mass spectrometry (LC-MS/MS) method.
• Utilized a Phenomenex Luna phenyl-hexyl column for chromatographic separation.
• Quantification performed using selected reaction monitoring (SRM) mode.

Main Results:

• The LC-MS/MS method demonstrated linearity over a range of 250-10,000 ng/mL.
• Method validation showed precision and accuracy within 15% of theoretical values.
• The method proved effective for monitoring P188 clearance during tangential flow filtration.

Conclusions:

• A validated LC-MS/MS method provides reliable process clearance monitoring for Poloxamer 188.
• This analytical approach supports quality control in biotherapeutic downstream processing.
• The method is suitable for assessing P188 removal and supporting mixing studies.