Bioprocess Analytical Technologies

Aim

The course will give an introduction to the bioanalytical techniques and sensors used in biomanufacturing industry and during process development as well as how they are used for product quality control, analysis of metabolites, nutrients, bioproducts and product variants, and for monitoring of process parameters, optimization and control of bioprocesses. The course will also give the students a good understanding on how bioanalytical techniques and sensors can be used for measuring different relevant quality parameters and quality attributes and how this information ca be used for implementation of Quality-by-Design in production of biotechnological products and to facilitate more sustainable production. After the course, the students should be able to:

• Account for common bioanalytical methods, technologies, and sensors that are used in the bioprocess industry and the chemical, biochemical, and/or physical principles upon which they are based.
• Describe which bioanalytical technologies that are relevant to apply to address relevant questions that may arise during biotechnological production and process development.
• Account for the concept Quality-By-Design (QbD) and how process analytical technologies (PAT) enable QbD in the bioprocess industry.
• Analyze, reflect upon and present experimental data from common bioanalytical techniques for analysis of samples from biotechnical processes.

Content

The course covers various bioanalytical techniques and sensors that are used in biological production and during process development. Their chemical and physical principles are discussed, as well as how they are used to address different analytical questions related to quality control of products, raw materials, analysis of metabolites, nutrients, bioproducts, product variants and biomolecular interactions. Possibilities to use process analytical technologies (PAT) and real-time bioanalytical data for monitoring process parameters, process optimization and control are discussed as we all as possibilities to use PAT to improve sustainability of biological processes. In addition, the course covers the role of PAT for determining and monitoring different quality parameters and attributes and how this information can be used for implementation of Quality-by-Design concepts in bioproduction. Bioanalytical techniques that are discussed include mass spectroscopy, chromatography, biosensors, various chemical and physical sensors, immunological methods, and spectroscopy. The course also touches upon methods for data collection and data treatment, multidimensional data representation and data structures, and multivariate data analysis.