Bench to Bedside Cell Therapy Innovation

Catalog description

This is a team-taught course using multiple faculty content experts. The objective of this course is for each student to understand the concept of stem cell biology from procurement to therapeutic development. This course will provide an overview of the regulatory framework, concepts, lab operations, and biologic techniques to support cell and regenerative medicine product manufacturing. To work in this emerging field, students must understand the scientific and regulatory development of biologic therapies as well as operational issues related to manufacturing in the cleanroom space under quality systems. The goals are to: 1) Develop an understanding of the infrastructure and compliance required to manufacture biologics for clinical use of stem cells. 2) Identify and critically analyze key operational issues related to clinical development and use of biologics from expansion to pre-clinical validation and therapeutic use. 3) Perform hands on activities using current techniques. 4) Discuss ethical and societal issues related to regenerative medicine research and technologies.