Biotech Core Courses
BTEC 675: Business Principals 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 655: Emerging Topics in Biotechnology
This seminar-style course is an in-depth exploration of emerging technologies, innovations, and new products that are noteworthy to the biotechnology industry. The course focuses on examining and critiquing what new scientific discoveries will likely impact the industry and in what ways. Literature research expands and deepens the student’s understanding of key fields within the life science area and allows the student to gain more in-depth knowledge on subjects that are relevant to their careers. Oral presentation and written papers help to refine the student’s communications skills.
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 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. The first half of the course focuses on examining and critiquing what new scientific discoveries will likely impact the industry and in what ways. In the second half of the course, students, working in teams, will give written and oral presentations on case studies that attempt to predict products derived from the new innovations and discoveries. 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 Pathway Courses
Can be used as electives
BTEC/ENCH 660: Regulatory Issues in Biotechnology
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/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 Pathway
Can be used as electives
BTEC 653: Princials 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.
Prerequisite: BTEC 652 or permission of instructor
BTEC 658: Principals 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 659: Fundamentals of Bioprocess Development
Bioseparation is the process of fractionating and purifying biological materials: DNA, proteins, living cells, antibiotics, biofuels, food ingredients, and biochemical among others. This course covers separation methods used in the biotechnology industry, principles governing these methods, approaches to improving bioseparation performance, and the special challenges of scale-up. Key topics include techniques such as centrifugation, filtration, extraction, membrane methods, liquid-liquid separations, chromatography and electrophoresis.
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.
Other Electives
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 680: Financial Management
This course will cover the fundamentals of setting up, reading, and analyzing financial statements and reports in a business setting. Course topics will include: project budgeting, profit planning, return on investment, and basic corporate finance. Students will analyze case studies from the specific industries.
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 682: Drug Discovery to Markets
BTEC 681 is a comprehensive study of the scientific and commercial practices used to deliver healthcare products to the market. Commercial development timelines are long and expensive, manufacturing is complex, and products are subjected to regulatory scrutiny to protect safety of users. The new IT revolution has empowered biotechnology and has reduced the time and cost of the product development process, providing biotechnology products with market advantages and ability to meet public needs and market demands faster and less costly than other suppliers can. This course aims to introduce students to the biotechnology industry in healthcare, in the area of medical devices. Topics covered will focus on assessment of market needs, and product discovery and development to meet those needs. Students will learn the whole process from generating an idea, elaborating a concept, and producing a prototype to a medical device product. Topics will also include manufacturing, market research, regulatory issues, and financing. Each student will deliver an oral presentation and submit a written project in the format of an SBIR Phase-1 grant application. Gaining new knowledge, skills and abilities will help students to advance in their current positions, or to transition to a new career that involves biotechnology and the pharmaceutical industry, hospitals and/or universities, public health and/or governmental agencies.
BTEC 681 is a required course of the M.P.S. Healthcare Certificate and is the first course taken in that certificate program.
BTEC 699: Professional Bioscience Experience
The Professional Bioscience Experience course is an internship or independent study with an organization that is engaged in activities relevant to the life science industry. The course is intended to give the student the opportunity to gain valuable experience in a biotechnology-related area and is taken in conjunction with participation in the Professional Experience Program offered by the MPS in Biotechnology Program. The opportunity engages the student in a professional capacity where the student is mentored by a working professional in the industry. The level of effort is expected to be required between 15 and 30 hours per week depending on the sponsoring organization.
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