Functional design of experiment for potency assay optimization and in-silico simulation.

J Pharm Biomed Anal

Analytical Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co KG, Birkendorfer Straße 65, 88397 Biberach an der Riß, Germany. Electronic address:

Published: September 2023

AI Article Synopsis

  • Robust potency assays are crucial for biotherapeutic analytics and Design of Experiment (DoE) approaches help analyze how different assay parameters affect these assays.
  • Current methods evaluate specific assay features in isolation, making it hard to understand their combined effects.
  • The proposed functional DoE approach models the relationships between assay features, optimizing assay design through a multivariate desirability, which enhances the understanding and reliability of biotherapeutic analytics.

Article Abstract

For biotherapeutic analytics, robust and reliable potency assays are required. Design of experiment (DoE) approaches are used to investigate the impact of multiple assay parameters. Currently, specific assay features (e.g., half effective concentration) are modelled independently from each other. A joint interpretation of several assay features is thus difficult. In our functional DoE approach, we use the functional relationship of the assay features to describe the sigmoidal dose-response curve. With the composed functional form, the direct impact of assay parameters on the dose-response curve shape was modelled. Moreover, a multivariate desirability was defined and used for assay optimization. We believe that functional modelling contributes to understanding the joint influence of assay parameters and helps to design robust biotherapeutic analytics.

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Source
http://dx.doi.org/10.1016/j.jpba.2023.115584DOI Listing

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