(595a) The Impact of Polysorbate Quality on Biopharmaceutical Formulations

Polysorbates (PS) are non-ionic surfactants, which are extensively used in mAb based formulations to protect against interfacial stresses, which can lead to protein aggregation and surface adsorption, ^{1,2, 3} The majority of these products today are formulated with either PS20 or PS80 owing to their high surface activity (even at low concentrations) and low critical micellar concentration. These two polysorbates have enjoyed widespread use in a variety of pharmaceutical products and routes of administration and are known for their very low toxicity.²

It is well recognized that despite only being used at very low concentrations, the quality of polysorbates can significantly impact the stability of the final mAb formulation and hence their efficacy products and how quality and stability helps define the stability and efficiency of the final drug product. Polysorbate quality is governed by multiple factors, from the choice of raw materials, the synthesis processes used, through to the handling during formulation and this talk focuses on some of these key steps and the importance of selecting high quality materials and their proper handling.

This talk will provide the audience an appreciation of the complexity of these materials, and the importance of how the synthetic approach and purification processes can impact their performance in the final formulation, as well as some of the current approaches used to address any challenges regarding formulation stability.

References:

1. Jones, M., Mahler, H., Yadav, S., Bindra, D., Corvari, V., Fesinmeyer, R., Gupta, K., Harmon, A., Hinds, K., Koulov, A., Liu, W., Maloney, K., Wang, J., Yeh, P. and Singh, S. (2018). Considerations for the Use of Polysorbates in Biopharmaceuticals. Pharmaceutical Research, 35(8).
2. Martos, A., Koch, W., Jiskoot, W., Wuchner, K., Winter, G., Friess, W. and Hawe, A. (2017). Trends on Analytical Characterization of Polysorbates and Their Degradation Products in Biopharmaceutical Formulations. Journal of Pharmaceutical Sciences, 106(7), pp.1722-1735.
3. Kerwin, B. (2008). Polysorbates 20 and 80 Used in the Formulation of Protein Biotherapeutics: Structure and Degradation Pathways. Journal of Pharmaceutical Sciences, 97(8), pp.2924-2935.