Curriculum

Full-Time Course Schedule

Part-Time Course Schedule

Course Descriptions

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 scientist as ethical agents. (1)

Biopharmaceutical Microbiology

This course will introduce the principles of microbiology as applied to biomanufacturing aspects of 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 benchtop 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. (3)

Microbial Fermentation

This lecture/laboratory course builds upon the scientific knowledge underlying the principles (e.g. fluid dynamics, mass and heat transfer, and the energy balance of bioprocess systems) of upstream fermentation technology to design, develop, and optimize key parameters in a biomanufacturing process. Topics include the optimization of media composition, fermenter and bioreactor design, the strain and host selection, instrumentation, scale-up and process analytical tools to maximize the yield and integrity of a fermentation process.  We begin by covering introductory headings such as lab-scale and shake-flask fermentation techniques. Then we dive into fundamental engineering aspects of microbial bioprocessing from thermodynamics, fluid mechanics and transport phenomena perspectives in basic engineering fermentation processes. We continue by complementing these with covering fermentation regimes, process optimization and scale-up strategies and finally finish with several industrial case studies and product development considerations. (3)

Mammalian Cell Culture

The course introduces the students to the principles of mammalian cell culture. Students will learn through active learning activities, including lab-based experiments, case studies, presentations, lectures, and group debates. The course will focus on upstream mammalian cell culture. Through a combination of lectures and laboratory experiments, students will gain real-world experience in culturing and subculturing techniques for mammalian cells from frozen cell banks through scaling up to bioreactors. A suspension-adapted CHO cell line will be used as the model cell line. In parallel, students will also learn cell culturing techniques of adherent mammalian cells. In addition, students will gain hands-on training in constructing and working with bench-scale bioreactors. Upon completion of this course, students will learn the principles and applications of mammalian cells and the utilization of mammalian cells for the biomanufacturing of safe and effective biologics. (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. (3)

Regulatory Science

The course introduces the students to principles of regulatory science, specifically, how drugs and biologics are regulated. Students will learn through active learning activities, including case studies, presentations, lectures, and group debates. The course will focus on (1) origins of regulations, (2) overview of FDA and FDA-regulated products, (3) regulation of drugs and biologics, (4) overview of drugs and biologics approval and commercialization process, and (5) where in the drug/biologics development and commercialization cycle GxP apply. In addition, students will learn the importance of regulatory strategies and FDA-expedited programs. Upon completion of the course, students will demonstrate the ability to understand how small-molecule drugs and biologics are approved and 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)

Industrial Pharmaceuticals and Biopharmaceuticals Entrepreneurship

This course will provide an overview of the pharmaceutical/biopharmaceutical industry covering the following topic areas: research, development, clinical pharmacology, medical affairs, regulatory marketing, sales, distribution, ethics and compliance, and brand safety.  Headquarters and field-based perspectives will be shared.  The course will provide the student with an overview of the various types of careers available within the pharmaceutical/biopharmaceutical industry in each of the listed topic areas.  This course will be taught by a team of industry experts and will be coordinated by ACPHS faculty. (3)

Biopharmaceutical Capstone

The Capstone Course will serve as a culminating part of the MS degree program. 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 and analyze a complex industrial/scientific topic using critical thinking skills, evaluating possible outcomes and clearly presenting sound scientific conclusions. Students will be required to orally present and successfully defend their final capstone report for committee review. (3)