Assessment Of Quality Of Biological Products
This course will consist of theory, practical and tutorial sessions about quality parameters desired in a typical biological preparation and the methods by which such parameters can be precisely, accurately and reproducibly assessed. Quality assurance aspects of these products will also be covered.
There is a growing surge in the use of biologicals such as vaccines, antibodies, hormones and blood products as therapeutic agents. This course develops the student’s ability to assess quality of immunological products, biologicals, and crude drug preparations meant for either human or veterinary use.
EXPECTED LEARNING OUTCOMES
At the end of the course, the students should be able to:
1. Describe the quality parameters required of biological preparations.
2. Describe the techniques used in the assessment of quality parameters in biological products.
3. Describe the methods of assessing the quality of biological products.
4. Explain the factors and ways in which these factors affect the quality of biological products
5. Explain the labeling, transport and storage of biological products