Case Studies

Case study 1

Problem: A company was unable to meet biosimilarity, or not enough similarity to the originator drug, for its conjugated antibody drug product. The drug was remaining in the blood longer than desired. The glycosylation profile was impacting the in vivo half-life in humans.

Solution: We discovered, identified, and solved the source of glycan variation by building statistical-process models from combined datasets that included small scale, large scale, analytical, mouse and human PK data.

Case study 2

Problem: Clinical study data did not show efficacy and the data did not conform to typical AUC results.

Solution: We uncovered correlations that showed the medication was working in samples that contained the test article and study drug. We pulled relevant data that demonstrated dose-response through categorizing data already captured in the study. By cleaning data from a busted study we were able to design follow-up studies that were successful.