Applied Biotechnology (ABT)

Courses

ABT 700   PRINCIPLES OF BIOTECHNOLOGY   3 Units

Introduction to basic principles and techniques pertaining to biotechnology and its applications to our society. Survey of classical and emerging techniques.
PREREQ: ADMISSION TO MASTER'S OF SCIENCE IN APPLIED BIOTECHNOLOGY PROGRAM

ABT 705   ETHICS, SAFETY, AND REGULATORY ENVIRONMENT IN BIOTECHNOLOGY   3 Units

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.
PREREQ: ADMISSION TO MASTER'S OF SCIENCE IN APPLIED BIOTECHNOLOGY PROGRAM

ABT 710   PROFESSIONAL AND TECHNICAL COMMUNICATION IN BIOTECHNOLOGY   3 Units

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, presentations, and documentation.
PREREQ: ADMISSION TO MASTER'S OF SCIENCE IN APPLIED BIOTECHNOLOGY PROGRAM

ABT 715   TECHNIQUES IN BIOTECHNOLOGY   3 Units

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.
PREREQ: ABT 700

ABT 720   EXPERIMENTAL DESIGN AND ANALYSIS IN BIOTECHNOLOGY   3 Units

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.
PREREQ: ADMISSION TO MASTER'S OF SCIENCE IN APPLIED BIOTECHNOLOGY PROGRAM

ABT 725   LEADERSHIP IN ORGANIZATIONS   3 Units

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.
PREREQ: ADMISSION TO MASTER'S OF SCIENCE IN APPLIED BIOTECHNOLOGY PROGRAM

ABT 735   QUALITY CONTROL AND VALIDATION   3 Units

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 biomanufacturing processes, automation, and cGLP/cGMP practices necessary to meet quality standards.
PREREQ: ABT 700, 705, AND 710

ABT 740   REGULATORY PRACTICES AND COMPLIANCE   3 Units

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 the agencies and to submit required documentation for successful product development.
PREREQ: ABT 700, 705, AND 710

ABT 745   INDUSTRIAL APPLICATIONS IN REGULATORY AFFAIRS   3 Units

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.
PREREQ: ABT 735 AND 740

ABT 750   BIOTECHNOLOGY MARKETING AND ENTREPRENEURSHIP   3 Units

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.

ABT 755   GLOBAL OPERATIONS AND SUPPLY CHAIN MANAGEMENT   3 Units

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

ABT 760   QUALITY AND PROJECT MANAGEMENT   3 Units

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.
PREREQ: ABT 720 AND 725

ABT 765   ASSESSING INNOVATION IN BIOTECHNOLOGY   3 Units

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.
PREREQ: ABT 700

ABT 770   PRODUCT DEVELOPMENT   3 Units

Explores strategies in evaluating 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.
PREREQ: ABT 705 AND 715

ABT 775   TOOLS FOR DATA ANALYSIS   3 Units

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, interactome, target discovery). Students will also evaluate and adapt existing computational approaches for specific use in solving a problem in biotechnology.
PREREQ: ABT 700 AND 715

ABT 789   PRE-CAPSTONE   1 Units

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.
PREREQ: COMPLETION OF COURSES WITHIN THE CORE AND AT LEAST ONE TRACK COREQ: FINAL COURSE IN TRACK

ABT 790   CAPSTONE   3 Units

Student 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.
PREREQ: ABT 789