Provides skills training in manufacturing of biopharmaceuticals and medical devices. Presents an overview of the manufacturing process and introduces environmental control and process support with a focus on Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP), clean room procedure, monitoring techniques, and required documentation.

Provides skills training in industrial biotechnology with emphasis on manufacturing of pharmaceuticals and medical devices. Introduces validation and quality control. Reviews manufacturing process, including formulation, lyophilization, packaging and filling. Focuses on validation, systems evaluations, testing and reporting.

Provides skills training in industrial biotechnology with emphasis on manufacturing pharmaceuticals. Introduces cell culture and microbial fermentation. Focuses on bacterial techniques, microbial assessment, mammalian cell culture, bioreactor fermentation, and media preparation. Compares small and large industrial scale cell culture.

Provides skills training in industrial biotechnology with emphasis on manufacturing pharmaceuticals. Introduces bioprocessing, recovery, and purification techniques. Focuses on protein separation and purification, chromatography, large-scale recovery, and identification of assays. Reviews skills necessary for a successful job search in the field of biotechnology.

Provides skills training in industrial biotechnology with emphasis on manufacturing pharmaceuticals. Examines manufacturing from the perspective of company operations involved with the drug or medical device development process. Focuses on business practices and governmental regulations.

Examines the role of molecular biology in the manufacturing of commercial pharmaceutical and agricultural products. Introduces basic biotechnology laboratory skills, including documentation, safety, and solution and buffer preparation. Develops student proficiency in aseptic techniques, spectrophotometry, molecular biology techniques, and electrophoresis.

Provides on-the-job learning to develop effective work habits, attitudes, and career awareness in paid or unpaid internships that are related to the discipline. Involves the development and documentation of learning objectives and the completion of an internship paper, presentation, or project. Includes both workplace supervisor and faculty adviser feedback and/or written evaluations.

Builds upon the scientific knowledge underlying chemical engineering principles to design, develop, and optimize key parameters in a biomanufacturing process. Includes the optimization of media composition, fermenter and bioreactor design, the design of downstream processes, instrumentation, engineering systems, and process control systems in process development to maximize the yield and integrity of a protein pharmaceutical.

Teaches the formal approach called “Design of Experiments” (DoE), a system that optimizes a process, makes it more robust, and minimizes variability from external sources through the methodical varying of key parameters and a formalized approach to the analysis, interpretation, and application of the results. Builds upon the statistical concepts required for DoE including hypothesis testing, confidence intervals, statistical models, and analysis of variance (ANOVA), and elucidates the approach to systematically vary the parameters of a biomanufacturing project to improve its operation.

Analyze and evaluate how the design of a biomanufacturing facility uses one-way personnel flow and one-way material flow to maintain appropriate levels of cleanliness and sterility that promote the production of safe and effective products. Analyze the design of the processes, equipment, and instrumentation used in biological production to generate critical utilities, aseptic systems, environmental control and monitoring, upstream production, and downstream (recovery and purification) production within a regulated environment.

Covers the measurement, monitoring, modeling, and control of biomanufacturing processes. Utilizes statistical methodology for measuring, analyzing, and controlling quality during the manufacturing process including control charts and the analysis of process capabilities.

Builds upon previous knowledge of quality assurance and regulatory affairs to study the harmonized quality system approaches of the International Committee on Harmonisation (ICH). Pays special attention to the topics of quality risk management, qualification, and validation. Covers topics in the American Society for Quality’s Body of Knowledge for a Certified Pharmaceutical Good Manufacturing Practice Professional examination.

Examines the emerging field of cell and gene therapy manufacturing for cancer and other therapies. Examines the differences between the new technologies and traditional Biotechnology processes.

Examines how companies manage the complete flow of materials in a supply chain from suppliers to customers. Covers the design, planning, execution, monitoring, and control of raw materials, personnel resources, inventory management, and distribution. Prepares students to take the Certified in Production and Inventory Management (CPIM) certification test administered by the American Production and Inventory Control Society (APICS).

Covers the Six Sigma approach to the maintenance and improvement of biomanufacturing processes. Incorporates the DMAIC phases: design, measure, analyze, improve, and control. Includes the use and implementation of lean manufacturing tools that biomanufacturing companies use to reduce waste. Prepares students to take the certification test administered by the American Society for Quality for qualification with a white belt in Six Sigma.

Examines the investigational methods used by quality assurance departments to analyze process deviations and make the decision about the severity of the deviation. Prepares students to write industry-standard Corrective Action Preventative Action (CAPA) report to conclude what corrective and preventative actions result from the investigation. Explains how a company would perform an internal audit in anticipation of an inspection by the Food and Drug Administration or an external audit for the supplier of a key raw material. Provides students the body of knowledge required for American Society for Quality’s Certified Quality Technician examination.

Introduces the process by which the quality systems of biomanufacturing evolve by examining a selected current trend in the laws and regulations governing pharmaceutical manufacturing. Evaluates the effectiveness of the laws and regulations governing pharmaceutical manufacturing.

Develops practical, hands-on experience with laboratory techniques used in the field of biotechnology. Applies specific techniques that vary depending on the current state of technology. Provides a bridge for entry-level and high school students who are interested in exploring the field of biotechnology.