Introduction to Drug Development and Careers in Biomanufacturing
Introduction to discovery and development of biopharmaceuticals, industrial enzymes, food ingredients and biologics. Discussion of majors that prepare students for positions in the biotechnology industry. Lectures from staff and from professionals in the biotechnology industry focus on drug development, biopharmaceutical process development, design of biomanufacturing facilities, overview of methods used for manufacturing biopharmaceuticals, drug and enzyme purification, formulation, as well as careers in FDA compliance documentation related to manufacturing products using microbial biotechnology.
At the end of this course, students should be able to:
- Describe the steps in discovery of a drug, vaccine, antibody (or fragment), enzyme or food ingredient leading to development of a process for manufacturing these products for human use using microbial biotechnology and genetic engineering methods.
- List and define terms used to describe the steps, methods, and regulatory compliance in bioprocesses using microorganisms optimized by genetic engineering.
- Explain general methods used in biomanufacturing and how these methods are regulated by the U.S. Food and Drug Administration (FDA) to insure that food ingredients, vaccines, antibodies and biopharmaceuticals manufactured using biotechnology are pure, active and do not contain harmful contaminating biomolecules.
- Describe the life science, engineering and regulatory compliance careers and disciplines involved in each step in the process of manufacturing of a biopharmaceutical, vaccine, enzyme or food ingredient.
- Explain the significance and evaluate the impact of currently available and emerging biotechnology processes which produce products for human health, human food and nutrition, generation of renewable sources of energy or bionanomaterials, and how microbial biotechnology and genetic engineering are used to produce thee products.
C or better in BIO 183 or permission of instructor (with some biology coursework).