This training course will provide an introduction to the many types of cell and gene therapy products and a review of current technologies that are unique in the manufacture and testing of these products. Participants will receive hands-on instruction in aseptic processing, procedures commonly used in the production of cell and gene therapy products, and operations of type of equipment and instruments that are employed. Attendees will also learn how to develop a Quality Target Product Profile (QTPP) and identify Critical Quality Attributes (CQAs) for a cell and gene therapy product. Attendees will receive solutions on how to perform key unit operations and how to address the major challenges with performing aseptic operations to manufacture cell and gene therapy products.
Please note that this training course has hands-on lab activities.