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Bioprocess Data Analysis
Coordinator
Isabel Rocha
Objectives
The aims this Curricular Unit are to:
• Provide the student with sufficient knowledge to understand how processes are monitored and controlled in the biopharmaceutical industry, including instrumentation and theoretical methods;
• Provide students with an understanding of spectroscopy and the fundamental aspects of signal processing and multivariate statistical analysis. In particular, how to analyze spectral data and build robust calibration models using appropriate signal processing tools;
• Convey understanding of the purpose and scope of Process Analytical Technology (PAT) and Quality by Design (QbD) initiatives in the biopharmaceutical Industry;
• Demonstrate how systems biology tools can be used to improve bioprocess yields, in particular the applications of “omics” technologies, its contextualization in cellular models and the design of metabolic engineering strategies.
Syllabus
The first part will cover concepts and applications of process measurement and control, detailing the target variables, instrumentation and theoretical methods involved. In particular, tools for large-scale process data collection and mining will be addressed. The second part will focus on rational bioprocess optimization. Emphasis will be given to systems biology tools used to improve bioprocess yields, including cellular data generation and contextualization in mathematical models.
Bioprocess characterization and control
•Sensors for physicochemical parameters, medium and cell properties
•Control of physicochemical parameters and medium components
•Large-scale data collection and mining
Spectroscopic methods (Fluorescence, NIR, MIR, Raman)
Multivariate Statistical Analysis (PCA, PLS, ANN)
•PAT and QbD initiatives
Rational process optimization
•The Systems Biotechnology Paradigm
•Generation of cellular data: the “omics”
•Modeling growth and productive phenotypes
•Metabolic Engineering
Evaluation
The evaluation procedure will take place at the end of the CU and consists of a short essay on a given topic, chosen by the student from a list of topics timely provided.
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