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An ex vivo potency assay to assess active drug levels of a GLP-1 agonistic peptide during preclinical safety studies. | LitMetric

An ex vivo potency assay to assess active drug levels of a GLP-1 agonistic peptide during preclinical safety studies.

Bioanalysis

Roche Pharmaceutical Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center Penzberg, Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany.

Published: December 2015

AI Article Synopsis

Article Abstract

Background: During development of biologics, safety and efficacy assessments are often hampered by immune responses to the treatment. To assess active exposure of a drug peptide in a toxicology study, we developed an ex vivo potency assay which complemented the total drug quantification assay.

Methodology: Compound activity was assessed in samples of treated monkeys by cell-based cAMP measurements. For each animal, activity was compared with its predose sample to which the compound has been added at the postdose concentration as determined by a total LC-MS/MS assay.

Conclusion: We were able to show that despite a high total test compound level, activity was reduced tremendously in antidrug-antibody-positive monkeys. Therefore, the applied ex vivo potency assay supplements drug quantification methods to determine active exposures.

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Source
http://dx.doi.org/10.4155/bio.15.189DOI Listing

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