Cell and gene therapy is revolutionizing healthcare and holds the promise of life changing treatments for a wide range of diseases. A well-trained workforce with cell and gene therapy manufacturing skills is critical to the success of this exciting new field.
In the Cell and Gene Therapy Manufacturing Specialization you will gain the scientific knowledge and practical skills needed to perform effectively in roles related to the manufacturing of cell and gene therapy products. The program will provide foundational scientific knowledge of cell and gene therapies and an understanding of the production of these therapies in research and industry settings. The curriculum consists of four online courses and a capstone in-person laboratory experience where you will gain in-demand hands-on training in a five-day intensive bootcamp. The program is primarily focused on preparing learners to enter or advance in careers in biomanufacturing but would also benefit research and clinical trials support staff working with cell and gene therapies.
The five courses in the program are:
Course 1: Introduction to Cell and Gene Therapy
This course serves as an introductory course for the specialization in cell and gene therapy manufacturing. It provides an overview of cell and gene therapies, how they are developed, applications for health and perspectives from industry professionals.
Course 2: Cell Biology and Culture Techniques
This course covers the topics of cell biology and how cell biological methods can be applied to answer biological and medical questions. You will explore various techniques for culturing, maintaining and manipulating cells in the lab and how these techniques may be used to gather data to test scientific hypotheses. You will gain an understanding of how cells work at the molecular level and how cultured mammalian cells can be used as a model organism to study cell biological processes. You will learn how cells are used as therapies and will be introduced to a variety of techniques that are used in manufacturing of cell therapies.
Course 3: Overview and Production of Gene Therapies
Introduction to gene therapy concepts, production methods and industry applications with an emphasis on AAV as a platform for manufacturing. Topics will include history and future directions of gene therapy, design considerations, methods for production, quality control and validation, regulatory considerations and current challenges in the field.
Course 4: Stem Cell and Gene Therapies: GMP Manufacturing and Associated Regulations
Introduction to human stem cell biology with specific emphasis on adult, embryonic and induced pluripotent stem cells. Topics will include how stem cells are isolated or generated, how they are cultured and how they are used for regenerative therapies. An introduction to CAR-T cells and their application will be provided. In addition, you will learn about Good Manufacturing Practice (GMP), how to manufacture human stem cells and the regulatory requirements for approval and manufacturing of cell and gene therapies.
Course 5: Cell and Gene Therapy Manufacturing Bootcamp
An intensive 5-day (30 hour) in-person, hands-on training experience in which you will be introduced to techniques used in cell and gene therapy manufacturing. You will practice the production of gene vectors and the analytical techniques that are used to assess quality and meet regulatory standards. You will also gain exposure to careers in biomanufacturing from industry professionals. This bootcamp component is the capstone experience following the four online courses for the specialization.