Working Paper Review Version 1 This version is not peer-reviewed

About Model Validation in Bioprocessing

Version 1 : Received: 28 April 2021 / Approved: 10 May 2021 / Online: 10 May 2021 (09:57:09 CEST)

How to cite: Rajamanickam, V.; Babel, H.; Montano-Herrera, L.; Ehsani, A.; Stiefel, F.; Haider, S.; Presser, B.; Knapp, B. About Model Validation in Bioprocessing. Preprints 2021, 2021050155 Rajamanickam, V.; Babel, H.; Montano-Herrera, L.; Ehsani, A.; Stiefel, F.; Haider, S.; Presser, B.; Knapp, B. About Model Validation in Bioprocessing. Preprints 2021, 2021050155

Abstract

In bioprocess engineering the Qualtiy by Design (QbD) initiative encourages the use of models to define design spaces. However, clear guides on how models for QbD are validated are still missing. In this review we provide a comprehensive overview about validation methods, mathematical approaches and metrics currently applied in bioprocess modeling. The methods cover analytics for data used for modeling, model training and selection, measures for predictiveness and model uncertainties. We point out general issues in model validation and calibration for different types of models and put this into context of existing health authority recommendations. This review provides the start-point for developing a guidance for model validation approaches. There is no one-fits-all approach but this review shall help to identify the best fitting validation method or combination of methods for the specific task and type of bioprocess models that is developed.

Subject Areas

bioprocess models; model validation; model calibration; Quality by Design; mechanistical and statistical models; hybrid models; chemometric models; Biopharmaceutical engineering; regulatory guidance

Comments (1)

Comment 1
Received: 10 May 2021
Commenter: Hans H. Diebner
The commenter has declared there is no conflict of interests.
Comment: "Verification and validation of numerical models of natural systems is impossible."

Found in: Naomi Oreskes, Kristin Shrader-Frechette, Kenneth Belitz: Verification, Validation, and Confirmation of Numerical Models in the Earth Sciences. Science 263, 4 FEBRUARY 1994

A reviewer recently pointed me to the above quoted work while asking for revising my manuscript containing a ODE-based response model accordingly.

I'm curious to see how everything proceeds, since this is an important epistemological issue.

Best,
Hans
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