Cell and Gene Therapy Manufacturing Specialization – 4 Online Courses plus in-person Bootcamp

Online

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. 

Academic Units
0
Section Number
214CGT206
Instruction Method
Online class

Section Notes

Courses 1-4 are self-paced and will be available on the Canvas site beginning June 6. You should expect to spend 10-12 hours per week on course presentations and assignments and will have access to course instructors through July 31. You can enroll after the June 6 start date, up until July 15. All courses must be completed no later than July 31.

By enrolling in the Specialization, you will be automatically enrolled in the following 5 courses:

  • 214CGT201 - Introduction to Cell and Gene Therapies
  • 214CGT202 - Cell Biology and Culture Techniques
  • 214CGT203 - Overview and Production of Gene Therapies
  • 214CGT204 - Stem Cell and Gene Therapies: GMP Manufacturing and Associated Regulations
  • 221CGT205 - Cell and Gene Therapy Manufacturing Bootcamp

The Cell and Gene Therapy Manufacturing Bootcamp will take place on the Solano Community College campus, 2001 N. Village Parkway, Vacaville, CA, which is about a 20-minute drive from Davis, CA.  Participants will be responsible for their own lodging and transportation.  Lunch and snacks will be provided.

 

Enrollment Policies

Refunds for this course must be requested within two weeks after the start date. The refund processing fee is $30. View complete enrollment policy information including details on withdrawals and transfers.

Technical Requirements

Please review the technical requirements for participating in an online class: https://cpe.ucdavis.edu/areas-study/online-programs/technical-requirements