Applied Biotechnology (ABT)

Introduction to basic principles and techniques pertaining to biotechnology and its applications to our society. Survey of classical and emerging techniques.

Prerequisites: None.

Offered: Fall, Spring, Summer.

Ethical and safety concerns in development, production, funding, and application of biotechnology. Analysis of socioeconomic impacts. Understanding the importance of data integrity. Overview of risk assessment and management in a regulatory environment designed to ensure safety of workers, study subjects, and patients, and protect intellectual property, data, and the environment.

Prerequisites: None.

Offered: Fall, Spring, Summer.

Application and analysis of professional scientific communication, both written and oral. Focuses on designing documents that convey complex, data-rich technical and scientific content to audiences with diverse information needs using a variety of professional genres, including reports, proposals, presentation, and documentation.

Prerequisites: None.

Offered: Fall, Spring, Summer.

Application of biological and chemical methods to modern biotechnological product development. Overview of analysis techniques used to characterize products and evaluate quality and safety. Exploration of technological pipeline from conception to market, including proof-of-concept assessment, pre-clinical trials, clinical trials and post-production testing.

Prerequisites: ABT 700.

Offered: Fall, Spring, Summer.

Principles of descriptive and inferential statistics with applications in biotechnology including experimental design, quantitative data analysis, and bioinformatic evaluation of complex molecular and biological data sets.

Prerequisites: Admission to the Applied Biotechnology graduate degree program or admission to the Applied Bioinformatics certificate.

Offered: Fall, Spring, Summer.

Focuses on strategies and tools that managers use to maximize employee contribution and create organizational excellence. Basic business and leadership principles. Best practices to overcome biases that inhibit organizations and teams from communicating effectively. Examples will come from diverse biotechnology fields, including pharmaceutics, agriculture, and biotechnology services.

Prerequisites: None.

Offered: Fall, Spring, Summer.

Introduces diverse strategies for computational analysis of macromolecular data using Python including sequence alignment, genome annotation, data retrieval form databases, phylogenetic analysis, and molecular evolution. Experiential learning is emphasized; confidence in practical skills is developed through persistent application of course content to projects focused on current problems in bioinformatic research.

Prerequisites: Admission to the applied bioinformatics certificate.

Offered: Fall, Spring, Summer.

Focuses on the importance of quality control and validation in biotechnology product design, development, and manufacturing. Explores quality systems and documentation, global quality standards, and methods for assessing validation including installation, operational, and performance qualifications. Overviews bio-manufacturing processes, automation, and cGLP/cGMP practices necessary to meet quality standards.

Prerequisites: ABT 700, ABT 705, ABT 710.

Offered: Yearly.

Identifies and examines the key regulatory agencies and practices that govern the highly regulated and diverse biotechnology industry, both domestically and internationally. Highlights current and emerging FDA and ICH regulations and guidance documents to successfully navigate meeting with agencies and to submit required documentation for successful product development.

Prerequisites: ABT 700, ABT 705, ABT 710.

Offered: Yearly.

Examines the global regulatory environments in risk-based assessment of biotechnological developments across diverse sectors, ensuring consumer and environmental protection. Addresses how validation is essential to the incorporation of emerging technologies into viable, accessible, and successful products. Highlights the stakeholders' role in regulatory oversight and policy through relevant industry case studies.

Prerequisites: ABT 735, ABT 740.

Offered: Yearly.

Examines marketing case studies in diverse areas of biotechnology. Addresses marketing fundamentals and strategies, communicating value proposition strategy, ethical and regulatory concerns, startup strategies, pharmaceutical marketing, b2b marketing, salesforce development, branding, and promotion. Culminates with the creation of a marketing plan/analysis.

Prerequisites: None.

Offered: Yearly.

Focuses on the strategic importance of the supply chain to overall performance relevant to a variety of business processes specific to biotechnology. Topics include life cycle analysis, corporate social responsibility, production, transportation, distribution systems, sourcing, and purchasing.

Prerequisites: None.

Offered: Yearly.

Quality and project management issues and roles during different phases from R&D to market. Introduction to installation qualification, operation qualification and process qualification (IQ/OQ/PQ). Project management phases: conceptualizing, planning, executing and closing. Project schedule and time management tools and techniques. Project requirements including quality assurance.

Prerequisites: ABT 720, ABT 725.

Offered: Yearly.

A survey of biotechnology assessments in areas such as regenerative medicine, agricultural biotechnology, and bioremediation. Course links disciplines with the critical evaluative role played by scientific discovery, market valuation, intellectual property, freedom-to-operate (FTO), and licensing strategy by assessing the role each played in the commercialization of a specific technology.

Prerequisites: ABT 700.

Offered: Yearly.

Explores strategies in evaluation and implementing new technologies or products in the context of different bioindustries. Identifies considerations in product valuation, feasibility of production, scalability, and supply chain management. Models the process of business growth and innovation through integration of emerging technologies.

Prerequisites: ABT 700, ABT 715.

Offered: Yearly.

Using a variety of existing and emerging bioinformatics tools and computational methods, emphasizes hands-on experiences analyzing and interpreting large data sets (e.g. genomic, proteomic, microbiomics, target discovery). Students will also evaluate and adapt existing computational approaches for specific use in solving a problem in biotechnology.

Prerequisites: ABT 705, ABT 715.

Offered: Yearly.

Advances the development of competencies promoting efficient analysis of biological data. Emphasizes matching a research problem with the most effective tools for its completion, balancing use of existing software and de novo software development. Advanced aspects of Python and R, algorithmics, machine learning, simulations, and effective communication of results are emphasized.

Prerequisites: ABT 720, ABT 730; admission to the applied bioinformatics certificate.

Offered: Fall, Spring, Summer.

Exploration and application of existing bioinformatic tools. Implementation of pre-coded solutions to data acquisition, wrangling, analysis, wisualization, and structural modeling problems. Students will complete a project that generates a multi-system workflow to solve bioinformatic problems.

Prerequisites: ABT 720, ABT 730; admission to the applied bioinformatics certificate.

Offered: Fall, Spring, Summer.

Prepares the student for applied self-directed capstone experience. Addressing problem identification, research, and project formulation. Culminates in an oral and written proposal with project schedule.

Prerequisites: ABT 700, ABT 705, ABT 710, ABT 715, ABT 720, ABT 725 and at least two courses within a single track.

Offered: Fall, Spring, Summer.

Students will complete a project (report, business plan, program, etc.) in an area of quality assurance and compliance, business and management, and/or research and development. Culminating in a substantive body of work, executive summary, and reflection. Networking and communication in a professional capacity is expected.

Prerequisites: ABT 789.

Offered: Fall, Spring, Summer.