Quality management and data analysis

This course covers a number of disciplinary fields and addresses the different methodological approaches used in the industrial biomanufacturing of biomedicines. 

Biopharmaceuticals are healthcare products which have to comply with strictly regulated sanitary control standards for production areas and quality control of the final product. To optimize production times and costs, statistical and mathematical methods are used to model bioprocesses.  

The objectives of this UE are to present :  

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

- The good laboratory practices required to guarantee sanitary and safe control of production areas and to ensure the traceability and integrity of experimental data. 

- Quality control for biomedicines  

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

- Bioinformatics (databases, OMICS, big data processing, etc.) for characterizing biomedicines 

- Bioprocess modeling using experimental design to optimize biomedicine production 

Skills targeted by the EU : 

- Understanding the regulatory aspects of biomedicine development  

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

- Model and plan experiments to efficiently optimize biomanufacturing steps 

- Master methods of statistical analysis of experimental data 

- Use biological databases to characterize a biological product 

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Integral Continuous Control