A computational method for predicting the aggregation propensity of IgG1 and IgG4(P) mAbs in common storage buffers.

ABSTRACT: The propensity for some monoclonal antibodies (mAbs) to aggregate at physiological and manufacturing pH values can prevent their use as therapeutic molecules or delay time to market. Consequently, developability assessments are essential to select optimum candidates, or inform on mitigation strategies to avoid potential late-stage failures. These studies are typically performed in a range of buffer solutions because factors such as pH can dramatically alter the aggregation propensity of the test mAbs (up to 100-fold in extreme cases). A computational method capable of robustly predicting the aggregation propensity at the pH values of common storage buffers would have substantial value. Here, we describe a mAb aggregation prediction tool (MAPT) that builds on our previously published isotyp

SUBMITTER: Heads JT 

PROVIDER: S-EPMC9704409 | biostudies-literature | 2022 Jan-Dec

REPOSITORIES: biostudies-literature