Trace Metal Induced Polysorbate Degradation Challenges and Risk Mitigation Strategies

Sponsored By 

Chalk Talk Presenter(s)

• SV

  Sudhakar Voruganti, n/a

  Director, Business Development
  Pfanstiehl Inc
  Waukegan, Illinois

Description: PS80 is a non-ionic surfactant routinely used in biotherapeutic formulations. PS80 prevents protein aggregates and protects proteins from denaturation from various stresses. However, there are challenges associated with PS80 as it is prone to degradation via oxidative or hydrolytic pathways. There are several root causes for PS80 degradation via oxidative pathway including transition metal contamination such as Fe and Cu. In this presentation we will discuss about mitigating risks with PS80 degradation using high purity, low endotoxin, low metal excipients.