Mathematical Modeling of Cell-based Potency Data for mAb Biotherapeutics

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The four-parameter logistic (4PL) and five-parameter logistic (5PL) models are widely used models for the evaluation of potency data. Choosing the relevant curve fit model is critical for the accurate interpretation of the experimental data. In this paper, cell-based potency in the functional comparability of biosimilars has been taken as a case study. Mathematical modelling has been performed on the potency data by using 4PL and 5PL logistic functions without using the PLA software. It has been demonstrated that using the 4PL or 5PL in the traditional bioassay software can bias the outcome concerning precision, accuracy, and passing the parallelism test. Whereas, the proposed modelling approach for curve fitting offers a more accurate prediction of potency data.

About the authors

Rozaleen Dash serves as the coordinator of Functional Characterization Division and Shyamapada Mandal was a research associate at the DBT Centre of Excellence for Biopharmaceutical Technology at the Indian Institute of Technology under the guidance of Professor Anurag S. Rathore, Department of Chemical Engineering, Indian Institute of Technology, Delhi, India.