Accelerated Analysis of Polysorbate 20 and Poloxamer 188 in AAV Samples using Mixed Mode UPLC-ELSD

Promotional banner displaying a scientific poster on mixed mode UPLC-ELSD analysis of polysorbate 20 and poloxamer 188 in AAV samples.

Poster Authors:

Andrew Duckworth, Lee Taylor, Patrick Hoering, Ryan Hylands, John Allen

Pharmaron l Estuary Commerce Park, Speke, Liverpool, L24 8RB, UK

Mixed mode UPLC-ELSD offers a reliable and accelerated approach to analyze non-ionic surfactants like Polysorbate 20 (PS20) and Poloxamer 188 (P188) in adeno-associated virus (AAV) drug substances. This method enables precise, reproducible testing that supports safer gene therapy product development.

Overview of Mixed Mode UPLC-ELSD in AAV Analytics

What Is Mixed Mode UPLC-ELSD?

Mixed mode UPLC-ELSD is a hybrid chromatographic method that combines anion exchange and reversed-phase separation techniques with evaporative light scattering detection. This setup is particularly effective for detecting analytes that lack UV chromophores—like PS20 and P188—within complex biological matrices.

Why Use It for AAV?

In AAV manufacturing, surfactants like PS20 and P188 stabilize proteins and prevent aggregation, but residuals must be carefully measured to ensure clinical safety. This method:

  • Differentiates PS20 and P188 even in complex buffer environments
  • Delivers quantifiable results in under 15 minutes
  • Supports rapid release testing for drug substance (DS) and drug product (DP)

Precision Testing in Gene Therapy Manufacturing

Both PS20 and P188 are integral to viral vector formulations. However, they must be monitored across multiple manufacturing stages:

  • PS20 Titre: Confirmed in both DS and DP to prevent protein aggregation.
  • Residual PS20: Must be cleared post-cell lysis to avoid unwanted interactions.
  • P188 Titre: Essential for protein stabilization and surface adsorption prevention.

Using mixed mode UPLC-ELSD, Pharmaron enables rapid quantitation of these surfactants to meet preclinical safety thresholds, especially within interventional research involving AAV-based therapies.

GMP-Compatible

Pharmaron’s method is validated for both GMP and non-GMP environments, making it scalable from early development to commercial release.

References:

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