Assay Technology
Overall Course Objectives
The course will teach the application and evaluation of assays used in the chain from discovery to clinical use of (bio)pharmaceuticals with emphasis on how and why different assays are used at specific steps in the pipeline. Basic assay principles, concepts and statistics for validation and development of assays and for evaluation of results will be discussed, and various types of equipment and technologies used for assay measurements will be presented. The laboratory exercises will demonstrate the use, practical execution, and analysis of examples of assays.
See course description in Danish
Learning Objectives
- describe the basic immunoassay principles and methods (incl ELISA), quantitative as well as qualitative
- explain how to perform quantitative immunoassays (ELISA) and explain the different formats available
- describe the principles and uses of the polymerase chain reaction (PCR) in different formats, including quantitative PCR (qPCR)
- describe the basic principles of flow cytometry and assays based on this method
- explain how quantitative assays are validated
- explain and discuss the principles of signal generation and signal detection in assays
- perform immunoassays and qPCR- and flow cytometry-based assays practically in the laboratory
- analyse and present data from experimental assays (immunoassay, qPCR, and flow cytometry)
- explain the basic principles in analysis of assay data and the statistical parameters that are used in the analysis
- apply the knowledge obtained in the course to select or suggest improvements to assays for specific analyses, for instance different steps in the pharma process
Course Content
This course will provide the basic concepts for evaluating and validating assay performance, and how different types of assays can be used to analyze different types of samples. In addition, the principles and applications of different types of assays will be demonstrated, including immuno-based assays, cellular assays (flow cytometry), and quantitative molecular biology-based assays (PCR type assays). Signal generation methods including fluorescence and chemiluminescence will also be explained. Finally, the principles behind the selection and application of different assays in the process from discovery to the clinical use of pharmaceuticals will be discussed.
Teaching Method
The course consists of a combination of practical laboratory exercises, lectures, and group work.
Faculty
Remarks
Pharmaceutical Design and Engineering students have priority as this course is mandatory (specialization) for these students.
The participants have to bring their own lab coat and safety glasses!
Limited number of seats
Maximum: 75.
Please be aware that this course has a limited number of seats available. If there are too many applicants, a pool will be created for the remainder of the qualified applicants, and they will be selected at random. You will be informed 8 days before the start of the course, whether you have been allocated a spot.