Introduces students to the fundamentals of developing, optimizing, and manufacturing large-molecule biologic pharmaceuticals with an emphasis on therapeutic proteins, therapeutic antibodies, and antibody modifications. Course will cover the regulatory and ethical landscape of biopharmaceuticals, along with the biopharmaceutical industry in general.
Additional Requirements for Graduate Students: Graduate students will be required to add an additional chapter to their portfolio on a topic of their choosing related to biopharmaceutical engineering. Topics will be approved by the instructor. Graduate students will also be required to lead one full 50-minute class where they will present the topic of their choosing to the class. Graduate students should work with the instructor to practice leading their class and to incorporate active learning components into their presentation.
Athena Title
Biopharmaceutical Engineering
Undergraduate Prerequisite
CHEM 2211 and (ENGR 3160 or ENGR 3160E)
Graduate Prerequisite
Permission of department
Undergraduate Corequisite
BCMB 3100 or BCMB 3100E or BCMB 3100H
Semester Course Offered
Offered fall
Grading System
A - F (Traditional)
Student Learning Outcomes
Students will be able to describe the regulatory and manufacturing pathways of pharmaceutical and biopharmaceutical products, including comparing and contrasting the two.
Students will be able to describe key types of biopharmaceutical products and classify existing biopharmaceutical therapeutics on the market into their respective categories.
Students will be able to explain key features of innate and adaptive immunity and link these features to biopharmaceutical (antibody) therapeutics or potential therapeutic targets.
Students will be able to describe and illustrate antibody structure, function, modifications, and compare/contrast different methods of antibody development.
Students will be able to describe and evaluate the different methods of biopharmaceutical (protein) production.
Students will be able to create a work portfolio demonstrating knowledge of bio/pharmaceutical topics, including proposing and completing a semester-long individual project related to a self-selected topic in biopharmaceutical engineering.
Topical Outline
Regulatory pathways for pharmaceutical and biopharmaceutical industries in the United States
Steps in manufacturing pharmaceutical and biopharmaceutical products
Ethical considerations in the bio/pharmaceutical industry
Types of biopharmaceutical products
The innate and adaptive immune system
Antibody function and structure
Antibodies with modified structures
Technology used in antibody development
Recombinant DNA technology
Protein production systems
DNA mutagenesis methods
Scaling-up biopharmaceutical production and manufacturing
