As presented at Formulation and Delivery 2023 in San Diego!
Biologic drugs are complex and difficult to replicate, however, a biosimilar can be approved if it is shown to be highly similar to the originator. In this study, MMS was used to: 1) show the structural similarity between a commercial mAb and two research-grade biosimilar drugs, 2) compare their structure in different formulations, and 3) test their stability under different stress conditions. None of the three drugs showed structural differences in different buffers, but heat stress had a greater structural effect on the commercial mAb in PBS than in formulation buffer. Future work will replicate the heat stress study with the biosimilars to understand their thermal stability.