Characterization and Identification of Subvisible Protein and Polysorbate Aggregates in Protein Therapeutics

Polysorbates 20 and 80 are excipients used in >70% of marketed parenteral biological drugs to improve product stability and shelf life. However, unwanted visible and subvisible particles are formed when formulations containing these excipients are stored for long periods of time at low temperatures.

When determining formulations for biologics, developers need high-throughput, sensitive, and utilitarian tools with specific analysis of proteins and polysorbate particles for complex chemistries. Additionally, these analytes exist in extremely low concentrations, so they remain undetectable when using techniques such as optical imaging.

Halo Labs has addressed all these needs and more. With Aura PTx™, polysorbates are quickly identified and distinguished from other particle types. Using Aura’s high throughput and low volume format, months of development time can be saved by knowing the source of particles in your formulation and distinguishing aggregated drug product from degraded excipients.