Quality Management and Data Analysis

This course unit incorporates instruction that spans several disciplinary fields and addresses the various methodological approaches used in the industrial bioproduction of a biopharmaceutical. 

Biopharmaceuticals are health products that must meet strictly regulated health control standards for production facilities and final product quality control. To optimize production time and costs, statistical and mathematical methods are used to model bioprocesses.  

The objectives of this learning unit are therefore to present:  

- The development cycle of a biopharmaceutical and the good manufacturing practices required by regulations  

- Good laboratory practices necessary to ensure sanitary and safe control of production areas, as well as to ensure the traceability and integrity of experimental data 

- Quality control of biopharmaceuticals  

- Biostatistical methods and statistical analysis tools (software) for data from experiments 

- Bioinformatics (databases, OMICS, big data processing, etc.) for the characterization of a biopharmaceutical 

- Modeling bioprocesses using the design of experiments method to optimize the production of biopharmaceuticals 

Competencies targeted by the EU: 

- Understand the regulatory aspects of biopharmaceutical development  

- Conduct an experiment in accordance with safety rules and good manufacturing practices 

- Design and plan experiments to effectively optimize the stages of bioproduction 

- Master methods for the statistical analysis of experimental data 

- Use biological databases to characterize a biological product 

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Continuous Integral Control