Ethics in Research

This course includes a discussion format based on ethical issues involved in the research process. Students will have focused reading on ethical theory and its application to issues involved in research. This involves close readings, case studies, and in-class discussions. Topics covered will include, but are not limited to, ethical theories as applied to research ethics, ethical issues before research committees, ethical issues involving human and animal subjects, reporting of research, conflict of interest, and the creation of scientists as ethical agents. (1)

Biopharmaceutical Microbiology

This course will introduce the principles of microbiology as applied to biomanufacturing aspects of the biopharmaceutical industry. It will cover a wide range of topics, including the nature of microorganisms, contamination sources and control, sterilization and disinfection, and sterility testing methodologies. Mainly, students will see in depth how microorganisms are selected, modified or engineered and then seed trains are conducted for biomanufacturing from frozen vials to bench-top scale alongside microbial metabolism, strain selection and genetic engineering principles. Antimicrobial agents, their modes of action and mechanisms of drug resistance will also be discussed. The students will also acquire knowledge of various microbiological assays. Good Manufacturing Practices (GMP), Quality Control (QC) and Quality assurance (QA) in the biomanufacturing processes of biopharmaceuticals based on current regulatory requirements will also be introduced. This course includes a required in-person lab component. (3)

Microbial Fermentation

This course introduces students to the fundamental principles and techniques of microbial fermentation relevant to biotechnology and biomanufacturing. Through a combination of lectures and lab sessions, students will learn about diverse microbial cells and their industrial applications, recombinant DNA technology, engineering microbial strains, and cell banking. Emphasis will be placed on risk mitigation through aseptic techniques. Practical experience also includes hands-on training in fermentor design and operating principles. This course emphasizes the application of scientific communication and technical writing principles. Students will research and present their findings on current trends in microbial fermentation technology. Peer reviews will be incorporated to enhance critical evaluation and communication skills. Upon completion of this course, students will learn the principles and industrial applications of microbial cells. (3)

Mammalian Cell Culture

This course introduces students to the fundamental principles and techniques of mammalian cell culture relevant to biotechnology and biomanufacturing. Through a combination of lectures and lab sessions, students will learn mammalian cell culture basics, including media formulation, passaging, cell banking, mammalian cell line development, and scale-up strategies from cell banks to bioreactors. Emphasis will be placed on risk mitigation through aseptic techniques. Practical experience also includes hands-on training on automated cell counters, microscopy, and bioreactors. This course emphasizes the application of scientific communication and technical writing principles. Students will research and present their findings on current trends in mammalian cell culture. Peer reviews will be incorporated to enhance critical evaluation and communication skills. Upon completion of this course, students will learn the principles and industrial applications of mammalian cells. (3)

Downstream Processing of Biopharmaceutical Products

The course introduces the students to the principles of purification and analysis of biopharmaceutical products. Students will learn through active learning activities, including lab-based experiments, case studies, presentations, lectures and group debates. The course will focus on downstream processing of biopharmaceuticals. Through a combination of lectures and laboratory experiments, students will gain real-world experience downstream processing, including cell disruption, separation, purification, and formulation technologies (homogenization, centrifugation, filtration, chromatography, TFF) used in the purification of biologics will be discussed with hands-on lab training. Upon completion of the course, students will demonstrate the ability to understand how biopharmaceuticals are purified and certified safe and effective. This course includes a required in-person lab component. (3)

Regulatory Science

This course provides a comprehensive overview of regulatory science, focusing on the principles and practices governing regulated products. The course will delve into the historical context of regulatory agencies, particularly the FDA, and explore the evolution of regulatory frameworks. Students will gain insights into the diverse range of regulated products, including drugs, medical devices, biologics, combination products, food, cosmetics, tobacco products, veterinary drugs, and dietary supplements. Through a combination of lectures, discussions, and case studies, students will develop critical thinking and problem-solving skills. A significant component of the course is a term project, where students will research a real-world regulated product, analyze its regulatory pathway, and present their findings to the class. Peer reviews will be incorporated to enhance critical evaluation and communication skills. Upon completion of the course, students will demonstrate the ability to understand how products are regulated. (3)

Technical Writing for the Biopharmaceutical Industry

The course is an advanced study in technical writing with a focus on writing for the biopharmaceutical industry. The course will provide information on various forms of writing documents in the industry including memos, proposals, formal and informal reports, Standard Operating Procedures (SOPs), batch documents, facility and environmental monitoring reports, validation reports and protocols. Regulatory requirements, along with examples of documents reviewed by regulatory bodies, will also be discussed. Emphasis is on understanding the differences between scientific and technical writing, including techniques for organizing, evaluating, and presenting information. Instruction will include writing as a process, from researching a problem to organizing and drafting a document to testing, revising, and editing that document. (2).

Statistical Inference and Modeling

This course provides students with a basic knowledge of biostatistics. It includes methods of experimental design and data analysis used to make inference. Topics covered include confidence intervals, hypothesis testing, multivariable regression, generalized linear models, survival models and analysis of variance. The course will also include a component which introduces the students to statistical programming. (3)

Clinical Biochemistry

Clinical Biochemistry is foundational to medical science and will help students develop an understanding of biological molecules and their relationship to common disorders. Using applications and clinical correlations, the course will reinforce the role of enzymes as building blocks of life and in catalyzing and regulating biochemical reactions within the body. The integration of various metabolic pathways, cellular metabolism, and biosynthesis with emphasis on the key concepts of structure and function of macromolecules involved in physiological processes will serve as the basis for an understanding of drug action and drug development. Biomolecular techniques related to clinical analysis will also be explored. This course will combine lecture discussion and assignments designed to enhance student learning. Upon the completion of this course, students will learn the applications and clinical implications of human biochemistry, the cellular basis for several common genetic diseases and metabolic disorders, and essential techniques related to clinical biochemistry. (3)

Advanced Cell Biology

This lecture-based course provides an in-depth analysis of the general concepts of cell biology with a particular focus on eukaryotic cells within the animal kingdom. Topics presented will include key events in the cytosol and cytoplasmic organelles (including protein production, protein modifications, vesicle trafficking and energy production), structural components of cells (including membranes, the cytoskeleton, and extracellular matrix), cell signaling, programmed cell death modules, and functions of specialized cell types (including coverage of the immune system). This course is focused on lecture-based, graphical presentation but also includes components of self-directed learning and critical thinking including group discussions and student presentations. (3)

Advanced Molecular Biology

This lecture-based course provides an in-depth analysis of the general concepts of molecular biology in prokaryotic and eukaryotic cells that occur in nature as well as those applied to the laboratory. The course consists of 3 parts. The first part of the course will focus on aspects of molecular biology that occur in nature. Topics presented will include detailed mechanisms of DNA organization, DNA replication, transcription, gene regulation, genetic recombination, translation, protein folding and degradation, and biochemistry of lipids and membrane formation. The second part of the course will focus on concepts of molecular biology that have been exploited for use in laboratory research. 

Topics will include cell growth and tissue culture, analysis and manipulation of DNA (DNA isolation, hybridization, PCR, sequencing, creation of knockouts/mutants, RNAi, qPCR, & RNA seq), the functions and importance of antibodies in research, recombinant protein expression and purification, and protein analysis/detection methods. The third part of the course will focus on scientific communication. In this part of the course students will give a journal-club style oral presentation on a topic in molecular biology. (3)

Biopharmaceutical Capstone

The Biopharmaceutical Capstone will serve as a culminating part of the MS in Biotechnology. This capstone course is designed to provide students with the opportunity to apply their knowledge and skills to advanced topics in biotechnology, including cell line development, high throughput platforms, process development, scaling-up technologies, biomanufacturing, bioprocessing and regulatory landscapes in biotech/biopharma. It will require the production of a peer-reviewed, journal article quality, written document. The document (25–40 pages) will either be (1) a major literature review on an existing scientific topic that is relevant to the student’s field of study, or (2) based on a no-credit experiential learning experience such as a co-op, internship, or lab research. Upon completion of the course, the student will demonstrate the ability to understand, synthesize, evaluate possible outcomes, and analyze a complex industrial/scientific topic using critical thinking skills, and clearly present sound scientific conclusions. Students will be required to orally present and successfully defend their final capstone report for committee review.  (3)