Particles In High Concentration Biotherapeutics

Particle formation is a critical concern in the formulation and stability of high-concentration biotherapeutics. Even with commonly used surfactants like PS80, visible and sub-visible particles may still develop, raising red flags for product safety, efficacy, and regulatory compliance. Explore the mechanisms behind particle formation, ranging from protein aggregation to surfactant degradation, and the consequences of PS80 breakdown, including the formation of hydrophobic oil droplets that promote further instability.

Pace Life Sciences provides advanced analytical solutions to tackle these challenges head-on. From specialized quantitation of surfactants via SPE-HPLC CAD to comprehensive characterization techniques like MFI, SEC-MALS, and high-resolution mass spectrometry for host cell protein (HCP) analysis, their methods offer critical insights into formulation behavior and long-term product stability. An integrated approach supports developers from early-phase formulation with the data needed to make informed decisions at every stage.

If your high-concentration biologic is experiencing unexpected aggregation, learn how targeted analysis can help mitigate risks and ensure product integrity.