Cell and Gene Therapy Course Bundle: 4 Online Courses

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 Program 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 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 four courses in the bundle are:

Course 1: Introduction to Cell and Gene Therapy

This course serves as an introductory course for the program 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.

Academic Units

Section Number

244CGT200

Instruction Method

Online class

Section Notes

The courses are self-paced and will be available on the Canvas site beginning 03/31/25. You should expect to complete the course in as few as two months, and you will have 10 weeks to work on the course presentations and assignments. You will have access to course instructors through 06/06/25. Online class is available beginning 03/31/25, enrollment deadline is 05/03/24. All courses must be completed no later than 6/7.

By enrolling in the bundle, you will be automatically enrolled in the following 4 courses:

244CGT201 - Introduction to Cell and Gene Therapies
244CGT202 - Cell Biology and Culture Techniques
244CGT203 - Overview and Production of Gene Therapies
244CGT204 - Stem Cell and Gene Therapies: GMP Manufacturing and Associated Regulations

Refunds for this course must be requested within two weeks after the start date. The refund processing fee is $100. Refund Deadline: April 14, 2025. Refunds and/or enrollment transfers will not be approved after this date.

Enrollment Deadline:

Enrollment Policies

Refunds for this course must be requested within two weeks after the start date. The refund processing fee is $100. View complete enrollment policy information including details on withdrawals and transfers.

Refund Deadline: 04/14/25. Refunds and/or enrollment transfers will not be approved after this date. 05/03/24 enrollment deadline.

Technical Requirements

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

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Fees

$2,000

Instructors

Kyle Fink

Kyle Fink, Ph.D., is an assistant professor of neurology and works in the Stem Cell Program, Gene Therapy Center, MIND Institute and the Institute for Regenerative Cures at UC Davis. His research team focuses on developing novel cell and gene therapies for genetically-linked neurological disorders. Much of the work in the Fink lab centers around the development of genetic modifiers and delivery using gene therapy. Dr. Fink works closely with patient-run organizations and biotech to help shape the future direction of treatments for these devastating disorders.

Brian Fury

Brian Fury is the GMP facility Manufacturing Director. He is responsible for manufacturing
scheduling, allowing for proper utilization of segregated manufacturing spaces within the GMP
facility, safely and efficiently manufacturing clinical products. He oversees generation/execution
of SOPs and Batch Records, implements and develops novel large scale gene therapy
manufacturing procedures.

Jason Lambert

Jason Lambert, Ph.D., is a postdoctoral researcher at the UC Davis Center for Neuroscience as well as a lecturer at California State University, Sacramento. In his research, he uses cell culture techniques as part of an experimental strategy to learn how gene expression is regulated during neurodevelopment. He teaches cell and molecular biology, including courses on the practical application of cell biological techniques.

David Segal

David Segal, Ph.D., is a professor of biochemistry and molecular medicine at UC Davis and works in the Genome Center. His research interests include molecular therapy for neurologic genetic diseases and addressing the challenges for gene editing in the clinic. He is a member of the NIH Somatic Cell Genome Editing Consortium and is editor-in-Chief of Frontiers in Genome Editing.