Description
Cell and Gene Therapy is a technique that modifies a person's genes to treat or cure disease. This course will focus on an introduction to the applications of Cell and Gene Therapy. The topics covered will include cell biology, virology, microbiology, and immunology as a basic background and then will move into the principles of genetics. Concepts of molecular biology and biotechnology will be discussed to understand the techniques used in gene therapy. The final part of the course will focus on the difference between cell and gene therapy, types and delivery options, manufacturing processes, FDA regulations, ethical concerns, current Good Manufacturing Practices, and Good Documentation Practices.
Audience
- Lab Technicians
- Manufacturing Operators
- Scientists
- Quality Control
- Quality Assurance
- R&D
Topics
- Biology Basics
- Genetics
- Molecular Biology and Biotechnology
- Gene Therapy
- Cell Therapy
- Discovery, Development, and Launch
- FDA Regulations
Objectives
- Explain the difference between Cell Therapy and Gene Therapy.
- Describe principles of genetics and its importance in understanding therapies.
- Compare the types of cell and gene therapy and delivery methods used.
- Summarize the gene therapy manufacturing processes.