3 credits
Fall 2025 Lecture Upper Division
Pharmaceutical biotechnology is the array of scientific and engineering principles used to develop, manufacture, and regulate biologic drugs. Biologic drugs - also known as "biologics", "biopharmaceuticals", or "large molecule drugs" - are medicinal agents derived from living systems, in contrast to more conventional "small molecule drugs" produced by organic chemical synthesis. Since the approval of the first recombinant human insulin in 1982, biologics have grown from niche products to occupy a prominent place in the pharmaceutical armamentarium. Today, biologics provide innovative treatments for a host of previously intractable diseases, including cancers, autoimmune disorders, and diabetes. The global biologics market was more than $300 billion in 2019, accounting for 20-25% of all pharmaceutical sales. This course introduces students to pharmaceutical biotechnology. The five didactic sections of the course present: (i) the biotech drug market, (ii) cellular and molecular biology foundations, (iii) formulation and stability of biotech drug products, (iv) analytical methods for quality assurance, and (v) manufacturing methods. In the sixth and final section of the course, students will present case studies on currently approved biotech drugs, integrating and applying what they've learned. The course is intended for beginning graduate students in the Departments of Industrial and Physical Pharmacy, Chemical Engineering, and Biomedical Engineering. The course may also be suitable for well-qualified upper-division undergraduates. Permission of department required.
Learning Outcomes1Understand and be able to describe the current state of the biopharmaceutical industry, including major drug classes, top-selling biotech drugs, innovative biotech drugs under development, and leading pharma biotech companies.
2Understand and be able to describe the fundamental cellular and molecular biology principles and interrelationships that undergird pharmaceutical biotechnology, including (e.g.) the roles of cells as protein factories, drug targets, and vehicles for gene delivery; the roles of viral vectors as drug delivery and cell transfection agents; the roles of proteins as drugs, drug targets, and products of mRNA vaccines.
3Understand and be able to describe the mechanisms of chemical and physical degradation of peptide/protein and nucleotide therapeutics. Be able to suggest formulation strategies to control various types of degradation.
4Understand and be able to describe various chromatographic and electrophoretic methods used to analyze biologics. Be familiar with other types of chemical and biophysical methods used for these drugs.
5Understand and be able to describe the manufacturing methods used for different classes of biologics, with a more detailed understanding of the methods used for recombinant proteins.
6Develop a detailed knowledge of one current biotech drug product, including methods of manufacturing, analytical methods for quality control and assurance, formulation approaches and any instabilities, indications, and current market.
Restrictions
made by Purdue students.