Characterization of the Hydrolytic Activity of Polysorbate Degrading Host Cell Proteins

• Polysorbate degradation as a topic will be introduced
• The identification and purification of polysorbate degrading hydrolases
• Screening of these enzymes for their degradation activity
• Characterization of enzyme kinetics and specificity on a subset of hydrolases

 Polysorbate degradation is an industry-wide issue for biopharmaceutical drug product development. This degradation can be catalysed by the low-level presence of hydrolytic host cell proteins which co-purify with the target molecule in bioprocessing. The degradation of this key excipient can cause a variety of issues, including loss of surfactant activity and the formation of subvisible or visible products in liquid formulations. In this work, we aimed to purify and characterize several CHO cell host cell proteins with respect to their ability to degrade polysorbate.
 

Anthony Tomlinson, Technical Development Principal Scientist