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. Lecture presentations will cover the workflow and major components in gene and cell therapies production, while the laboratory sessions will mainly teach the knowledge and skills required to manufacture autologous CAR-T cell therapies. You will be exposed to the entire end-to-end manufacturing workflow including upstream and downstream processes, cell culture expansion, quality control, and cold-chain solutions, and will gain vital hands-on training with industry standard equipment used in manufacturing for clinical trials and for FDA-approved therapies. This bootcamp will also teach proper aseptic techniques, GMP cleanroom gowning, and execution of standard operating procedures (SOP), as well as analytical techniques that are used to assess quality and meet GMP regulatory standards and requirements. In addition, learners will gain exposure to careers in biomanufacturing from industry professionals and introduction to other professional opportunities within the cell and gene therapy industry.
This bootcamp component is the capstone experience following the four online courses for the Cell and Gene Therapy Manufacturing professional concentration program.
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
Skills You Will Gain
- CAR-T manufacturing technologies, methods, and workflow
- Cell culture expansion
- Proper aseptic techniques and GMP cleanroom gowning
- Execution of standard operating procedures
- Quality control methods and analysis
Major topics covered for gene therapies (lecture only):
- End-to-end workflow for Gene Therapy production
- Cell culture using aseptic technique; including cell counts, viability, QC release, cell selection
- Cell purification with centrifugation, filtration, and affinity chromatography
- DNA transduction using an AAV model system/platform
- QA/QC processes using analytical techniques such as flow cytometry, SDS-page
- GMP processes and regulatory requirements – gowning, required documentation, batch records, deviations
Major topics covered for cell therapies (lecture and lab):
- Introduction to adoptive cell therapy products, including the principles and challenges underlying cell therapy treatment
- Quality control methods at each stage of production
- Overview of cGMP as it relates to production of cell therapy
- Upstream processing: cell isolation, activation, and transduction
- Cell expansion and perfusion applications
- Downstream processing: harvesting platforms, final formulation, cryopreservation, and cold-chain logistics
- Characterization and analysis of cell therapy products: FACS panel, cell counting and viability, metabolic analysis
- Digital automation: electronic SOP, manufacturing execution systems (MES)