Introduction to Cell and Gene Therapy

Cell and Gene Therapy

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.


  • Lab Technicians
  • Manufacturing Operators
  • Scientists
  • Quality Control
  • Quality Assurance
  • R&D

Topics Include

  1. Biology Basics
  2. Genetics
  3. Molecular Biology and Biotechnology
  4. Gene Therapy
  5. Cell Therapy
  6. Discovery, Development, and Launch
  7. FDA Regulations

Learning Objectives

  1. Explain the difference between Cell Therapy and Gene Therapy.
  2. Describe principles of genetics and its importance in understanding therapies.
  3. Compare the types of cell and gene therapy and delivery methods used.
  4. Summarize the gene therapy manufacturing processes.


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Level: Beginner

Lecture HoursLab or Activity HoursTotal

Delivery Options

Delivered in-person in a classroom or lab setting.
Live Instructor Led
Delivered online with a live instructor at a scheduled date and time.
Batch Documents
In this interactive exercise, you will learn the importance of batch documents by reviewing the... more
Deliberate Documentation
Documentation is a critical part of any manufacturing process. Every manufacturing step is... more
Delivering a new pharmaceutical to the market is a very time-consuming and expensive process that... more
Good Laboratory Practices (GLP)
You’re the newest member of the Quality Assurance department at CATT – the Center for the... more
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