Biotech Core Courses
BTEC 675: Business Principles of the Biotechnology Industry
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.
BTEC 656: Experimental Design
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.
BTEC/ENCH 660: Development and Regulation of Biopharmaceuticals
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.
BTEC 665: Management, Leadership and Communication
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.
BTEC 670: Legal & Ethical Issues in the Science Professions
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.
BTEC 654: Capstone
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
Regulatory Elective Courses
Can be used as electives
BTEC/ENCH 662: Good Manufacturing Practices for Bioprocesses
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.
BTEC/ENCH 664: Quality Control & Quality Assurance for Biotechnology Products
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.
BTEC/ENCH 666: Biotechnology GMP Facility Design, Construction and Validation
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.
Bioprocessing Elective Courses
Can be used as electives
BTEC 653: Principles of Upstream Processing
A chemical engineering course covering basic process engineering, from the milliliter to the kiloliter scale. Topics relevant to the commercial bioprocesses used in the food, pharmaceutical and waste treatment industries will be introduced. Both upstream processes (e.g., fermentation, cell growth, energetics, mass transfer and enzyme kinetics) and downstream processes (chromatographic separations, ultrafiltration, and waste treatment) will be covered.
BTEC 658: Principles of Downstream Processing
In depth study of quality control measures and the analytical tools used to monitor bioprocesses and establish and monitor product specifications. The course aims to provide the student with working knowledge of product finishing techniques, design of stability studies, identification of degradation pathways and the use of statistical analyses.
BTEC 657: Devices and Combination Products
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 668: Introduction to Clinical Trials
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.
BTEC 685: Project Management Fundamentals
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.
BTEC 691: Special Topics in Biotechnology
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