Case Study For Developability Assessment Of Three Therapeutic Antibodies

By Tao Bi, Yesenia Aguilar, Paul Phelan, Laura McDevitt, Henry Yong, David Gae, Anjali Patel, Wen-Rong Jiang, Tao He, Zhiping Yao

Developability assessment is gaining in popularity in the field of antibody discovery and development. It evaluates the drug like properties of lead candidates for the potential of being successfully developed into a stable, manufacturable, safe, and efficacious drug product. It is important to carry out this assessment as early as possible in the pre-clinical stage of development to eliminate candidates that do not present a favorable developability profile. This will minimize the risks of costly late stage failures and avoid potential issues that may occur during the clinical application of a biotherapeutic.

At JOINN Biologics, a panel of small scale, fast, and predictive tests are used to evaluate therapeutic antibodies’ developability. The developability evaluation comprises in silico analysis as well as a series of in vitro assays for the drug candidates, so to provide information about the integrity, purity, aggregation, thermostability, charge heterogeneity, glycosylation, poly reactivity, potency, stability over low pH and accelerated storage conditions, and potential PKPD profile. Here we report case studies for three monoclonal antibody drug candidates utilizing those predictive tests. The developability assessments utilizing both in silico analysis and in vitro assays for those three antibodies were performed, and the results are rather interesting.