Biotechnology Courses

This course is an overview of the life science industry, current and future trends. In depth discussions of the relationship between science and business and the process by which biotech products are designed, developed and brought to market. Course topics will include, biotechnology entrepreneurship, starting, leading and managing biotech companies, and comprehensive thesis on the workings of the biotechnology industry.

This course introduces the basic concepts which underlie the design of experiments. The use of statistical methods to discriminate between real effects (those caused by changes in controlled variables) and experimental error in systems which are inherently noisy are taught. Statistically designed experimental programs which can help test many variables simultaneously are very efficient tools for developing empirical mathematical models which accurately describe physical and chemical processes. These techniques are readily applied to production plant, pilot plant and laboratory systems, and should be a part of every practicing life science professional’s repertoire. At the end of this course, the student will be able to select an appropriate experimental design for the problem at hand, to set up, conduct and analyze the results of statistically designed experiments, and to understand the statistical basis for these techniques.

This course provides a comprehensive coverage of all steps involved with the regulatory approval process for a biotechnology-derived product. Documentation preparation for IND, NDA, BLA. Pre-clinical safety data, clinical studies, facilities inspection and scientific and regulatory principles.

This course teaches the fundamentals of management and managerial leadership and communication. Managers juggle operations, finance, information technology, strategy, and projects, yet much of their success depends less on their own direct input than on their ability to enlist the active involvement of others: direct reports, other managers, other team members, and those above them on the organizational chart. It is imperative, therefore, that managers be adept at influencing those over whom they have no formal authority as well as guiding and directing those who report to them.

This course offers an overview of legal issues affecting biotechnology and other science-based industries and frames basic philosophical and ethical considerations regarding genetic data and manipulation. The course includes a discussion of intellectual property issues.

This seminar-style, capstone course is an in-depth exploration of emerging technologies, innovations, and
new products that are noteworthy to the biotechnology industry. Each student will select an emerging technology
within the biotechnology sector and prepare a research plan designed to bring that technology to commercial
fruition. The students will give oral presentations on the technology that builds the case for the envisioned
product. In addition, each student will prepare an SBIR grant application composed of the technical and
commercialization plans for their invention. Students will also be expected to read the scientific literature in
preparation for each of their classmates’ presentations with the goal of being sufficiently knowledgeable to
participate in a scientific discussion. The objective of the course is to give the student insight into the process of
translating scientific discovery into innovative products.

Prerequisite: BTEC 653

In-depth coverage of developing and implementing good manufacturing practices (GMPs) in the biotech industry. Topics include building and facilities, equipment design, utilities, in-process controls, records, and adequate process validation. 

In-depth coverage of the key issues associated with adequate quality-control systems, assays and stability for novel biotechnology products: quality concepts, product release testing and specifications, in-process testing, product characterization, quality assurance documentation and audits and vendor certification.

Presents an in-depth discussion of the engineering design of a biotech facility under GMP compliance. Topics covered include bulk plant design, process equipment design, utilities, instrumentation, controls and computerization, facility and software validation.

This course is designed to provide students with comprehensive coverage of all aspects for the development and Life Cycle Management (LCM) of Combination Products (CP) and Devices. Subject areas discusses will include: routes of submissions of Devices and Combination Products such as NDA, BLA, MAA, 510(k). Scientific background for the development of Devices and CP. Clinical studies vs. Human Factors studies.

BTEC 659 provides an in-depth study into the concepts of industrial biotechnology. Industrial biotechnology is defined as the exploitation of enzymes, microorganisms, and plants to produce energy, industrial chemicals and consumer goods. It is based on the use of renewable plant-derived carbohydrates, lipids and other compounds to replace petroleum and other fossil fuel feedstocks that are currently the raw material and energy basis of modern industrial societies. This course focuses on the interaction of chemical engineering, biochemistry, and microbiology for the production of commercial products. Key topics include design strategies, concepts of integrating quality systems and process economics used for the production of biomolecules in the biomedical and industrial biotechnology sectors.

An overview and network connection basis concluding with a case study for each team to present on the dynamic and emerging field of Cell and Gene Therapies. Students will learn about all the new modalities, companies, techniques, and future approaches to treating serious diseases worldwide.

Flow Cytometry is a cornerstone technology of modern cellular immunology and immunotherapy, a key tool for both manufacturing QC and Research. In this course, we provide foundational training in flow cytometry theory and practical applications from a multidisciplinary perspective. Theory covered includes instrumentation technology, immunofluorescence, data processing and analysis, and cellular immunology with an emphasis on T-lymphocyte and cell cycle biology. Lab practical modules include hands-on laboratories with training in data analysis software applications, including operation and basic maintenance of the Beckman Cytoflex flow cytometer, and optimization and analysis for T-cell immunophenotyping, and cell-cycle assay protocols.

This course is designed to provide students with comprehensive coverage of all aspects for the development and Life Cycle Management (LCM) of Combination Products (CP) and Devices. Subject areas discusses will include: routes of submissions of Devices and Combination Products such as NDA, BLA, MAA, 510(k). Scientific background for the development of Devices and CP. Clinical studies vs. Human Factors studies.

This course introduces students to clinical trials research as it pertains to the development of a biotechnology product. Students will start by learning about the purpose of clinical trials, the clinical trial phases, pre-clinical trial activities, and key actors in the process. The remaining course will cover the primary elements of each phase, ethical and regulatory issues, and future trends. Students will gain a greater understanding of clinical trials for more productive engagement with such professionals in the biotechnology industry or to start on a path toward a career in clinical trials research.

Students learn the fundamentals of managing projects in a systematic way. These fundamentals can be applied within any industry and work environment and will serve as the foundation for more specialized project management study. Principles and techniques are further reinforced through practical case studies and team projects in which students simulate project management processes and techniques.