Gain Foundational Scientific Knowledge for a Career in Biomanufacturing
Cell therapy, gene therapy and gene editing comprise the next generation of life-enhancing and curative therapies. As new therapies gain approval, the demand for skilled professionals in biopharmaceutical manufacturing, such as cell and gene therapy production, will continue to rise. For those interested in joining this growing workforce, our Cell and Gene Therapy Manufacturing Specialized Study provides fundamental knowledge and skills to advance your career or launch a new career in biomanufacturing—an industry with high income-earning potential and opportunities for upward mobility. Specifically designed to meet the demand for a skilled workforce in this area, our unique program combines a thorough background in scientific principles and practical applications. The program features four online courses plus an intensive in-person bootcamp in cell and gene therapy for hands-on skills training.
Who is This Program For?
- Current biotech employees involved in biomanufacturing
- Recent graduates interested in biotech careers
- Current biotech employees (including C-suite and industry executives) who are not in biomanufacturing but need a general understanding of this subject
- Policymakers or anyone looking for a broad understanding of cell and gene therapy and applications for health
What You’ll Learn
Designed for working professionals, the program curriculum emphasizes biomanufacturing skills and training, particularly in cell and gene therapy production, but has applications in a variety of biomanufacturing-related jobs, as well as related industries in biosciences, agriculture and health care. You’ll learn:
- What cell and gene therapies are and their application to health
- How cell and gene therapies are made and manufactured
- Cell biology and culture techniques relevant to the production of cell therapies in research and industry settings
- Gene therapy concepts, viral vectors, production methods and practical applications
- Stem cell biology concepts, stem cell and CAR-T cell therapies and their production methods and therapeutic applications
- GMP/cGMP and regulatory practices required for cell and gene therapy manufacturing
- Hands-on practice in the production of gene vectors and analytical techniques used to assess quality and meet regulatory standards
What You’ll Get
Our program offers:
- Expert instruction, including faculty from the UC Davis Stem Cell Program and Solano Community College Industrial Biomanufacturing Program, as well as presentations and lab supplies from biotech companies
- Convenient, asynchronous learning with weekly instructor engagement via online office hours
- Exposure to careers in biomanufacturing from industry professionals
- Unique networking opportunities with instructors and fellow students that can help advance your career
Required Courses
The Cell and Gene Therapy Manufacturing Bootcamp is an intensive 5-day, in-person, hands-on training experience in which you will be introduced to the fundamental processes and techniques used in cell and gene therapy manufacturing. In a laboratory setting, you will gain the knowledge and skills required to work in cell and gene therapy by using a human Jurkat T cell model for adoptive cell therapy and an AAV2-GFP model and Baculovirus platform for gene therapy. You will be exposed to the entire end-to-end manufacturing workflow including upstream and downstream processes, gene vector production, cell culture expansion, quality control, cold-chain solutions, and you will gain vital hands-on training with industry standard equipment used in manufacturing for clinical trials and for FDA-approved therapies. You will also learn proper aseptic techniques, GMP cleanroom gowning and execution of standard operating procedures (SOP), as well as cover topics related to analytical techniques that are used to assess quality and meet GMP regulatory standards and requirements.
In this capstone experience, you will gain exposure to careers in biomanufacturing from industry professionals and introduction to other professional opportunities within the cell and gene therapy industry.
Learning Outcomes
- Apply detailed theoretical process knowledge to upstream, cell expansion, and downstream applications
- Comply to GMP and regulatory standards for performing SOP and QC release
- Perform industry standard techniques related to cell and gene therapy manufacturing, with an emphasis on T-cell processes and AAV production
Required Courses
| Required Courses | Units | Fall | Winter | Spring | Summer |
|---|---|---|---|---|---|
| Cell and Gene Therapy Manufacturing Bootcamp |