Quality management and data analysis

This EU incorporates teaching that covers several disciplinary fields and addresses the different methodological approaches used in the industrial bioproduction of a biomedicine. 

Biologics are healthcare products that must meet strictly regulated health control standards for production areas and final product quality control. In order to optimize production times and costs, statistical and mathematical methods are used to model bioprocesses.  

The objectives of this EU are therefore to present:  

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

- Good laboratory practices necessary to ensure sanitary and secure 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 biomedicine 

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

Skills targeted by the EU: 

- Understand the regulatory aspects of developing biopharmaceuticals  

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

- Model and plan experiments to effectively optimize bioproduction stages 

- Mastering methods of statistical analysis of experimental data 

- Use biological databases to characterize a biological product 

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Continuous Integral Control