This self-study course is designed to be taken at your convenience, and on your own schedule. You have 90 days to finish the course from the time of purchase.
ASME’s Cell Manufacturing for Engineers online course is the only learning product designed specifically for engineering professionals that provides education on cell culture techniques, manufacturing and production processes, and regulatory and other business requirements. The course introduces cell therapy through the lens of a series of engineering problems or challenges which exist throughout the process.
Engineers will be able to develop solutions that improve scalability, automate processes, and maintain quality assurance with reduced labor costs of the reproduction of fragile living cells.
Topics covered in this course include:
- Fundamentals of cell therapy
- Production and manufacturing technologies
- Processes and scaling
- Quality control and quality assurance instructions
- Regulatory issues
- Cell preservation
You Will Learn To:
- Assess the current ethical considerations and past controversies associated with cell engineering
- Describe how the cell manufacturing industry needs mechanical engineers at different levels of the cell therapy process, and identify their roles
- Describe the process and purposes for collecting cord blood cells
- Construct a diagram of cell therapy supply chain
- Assess how automation applies to cell characterization, and the challenges associated with the storage and movement of cells
- Explain how cells are genetically modified, as well as cell manufacturing facility/process requirements such as repository, documentation and facility training
- List and describe the steps of downstream processing, and commonly used methods in upstream cell culture
- Recall cell separation and purification processes and techniques
- Assess the role of automation within the cell characterization process for determining purity, identity, and potency of a cell product
- Describe the history of regulation and FDA-approved therapies
Click HERE to review the course outline
Who Should Attend
Engineers and bioengineers looking to update themselves with the cutting-edge technology that is impacting their field; mid-career engineers who want to evaluate cell manufacturing for a potential career change; engineers who want to understand how their skills and experience either stack up against, or integrate with, skills required for success in cell manufacturing; early career engineers; engineers with some prior exposure to health science who want to make a practical difference in people’s lives; entrepreneurial engineers with some health science training who want to work for a biomedical startup; engineers who want to add to their skillset; engineering technicians or technologists who want to investigate how their talents and capabilities can fit in this growing field; QA, QC, cGMP, and regulatory affairs personnel, as well as scientists, biologists and medical personnel who are interested in engineering and its contribution to the cell therapy process.