(408j) Investigating the Influence of Polysorbate 20/80 and Polaxomer P188 on Bovine Serum Albumin and Lysozyme Aggregation, Rheology & Interfacial Properties

The current challenges faced in the formulation of high concentration protein based therapeutics include protein stability, protein aggregation, and high viscosity. Although there has been significant progress in developing mechanistic understanding for the protein systems themselves, the impact of the other formulation components has been very limited. Excipients like surfactants such as Polysorbate, or Polaxomers which are commonly utilized in biotherapeutic formulations may potentially impact many of these aspects. However, a detailed and systematic study of the effect of these excipients on protein aggregation and corresponding effects on bulk rheology evolution has not been carried out. Additionally the impact on interfacial and surface properties has been limited in the range of formulation conditions and impacts on interfacial rheology has not been investigated in detail. In this study, we utilize a range of advanced characterization techniques such as optical and microfluidic rheometry, interfacial rheometry, raman spectroscopy, DLS and tensiometry to develop new insights into the impact of polysorbate 20, polysorbate 80 and polaxomer P188 surfactants on the aggregation behaviour, rheology and interfacial and surface properties of Bovine Serum Albumin (BSA) and Lysozyme