Lifecycle DoE-The Companion for a Holistic Development Process
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View abstract on PubMed
Summary
This summary is machine-generated.Life-Cycle-Design of Experiments (LDoE) integrates bioprocess data for comprehensive development. This approach enhances model predictions and enables early identification of critical process parameters.
Area Of Science
- Biopharmaceutical Process Development
- Chemical and Biochemical Engineering
- Data Science in Bioprocessing
Background
- Bioprocess development involves numerous independent experimental studies (Design of Experiments - DoE) with diverse objectives.
- Analyzing DoE studies in isolation hinders the integration of data for a holistic process overview.
- Challenges exist in linking individual experimental data sets for comprehensive process understanding.
Purpose Of The Study
- To elucidate the methodology for constructing a Life-Cycle-DoE (LDoE) by integrating data-driven process knowledge.
- To demonstrate how LDoE facilitates the augmentation of existing models with new experiments in a unified design.
- To showcase the application of LDoE for process characterization and early identification of potentially critical process parameters (pCPPs).
Main Methods
- Developing a strategy for Life-Cycle-DoE (LDoE) that integrates data from multiple experimental studies.
- Implementing design augmentations to incorporate new experimental data into an existing model.
- Consolidating all bioprocess development data into a single file and unified model.
Main Results
- The LDoE approach enables the augmentation of existing models with new experiments within a unified design.
- It allows for flexible design adaptations based on subject matter expert requirements, enhancing model predictions.
- The LDoE consolidates all bioprocess development data, enabling process characterization studies using solely development data.
Conclusions
- Life-Cycle-DoE (LDoE) provides a unified framework for integrating experimental data throughout bioprocess development.
- This approach enhances model accuracy and allows for flexible adaptation to expert needs.
- LDoE facilitates early identification of potentially critical process parameters, enabling timely process adaptations and robust characterization.
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