Course Offerings

This introductory course for cell and gene therapy is designed to give participants the basic knowledge and strategies that can be used to create products from molecular biotechnology techniques. It also aims to provide a background into genetics, cell culture techniques and gene sequencing so participants understand how these concepts play into industrial processes to make useful therapeutic products. Ethical and regulatory considerations are also presented.

Course Objectives

Learn the basics of microbiology, virology and immunology

Be exposed to various molecular biology techniques, including DNA/RNA extraction, PCR techniques, genotyping, sequencing, gel electrophoresis and more

Learn how molecular cell and gene therapy techniques can be used in applications for commercial product manufacturing

Learn the basics of the process from inception in research and development through product realization in manufacturing

Outline of Instruction

Cell Biology
a. Eukaryotic vs. Prokaryotic
b. Structures and Functions

Microbiology

Virology
a. Characteristics
b. Types

4. Immunology
a. Immunotherapy

Genetics
a. DNA vs. RNA
b. Mitosis vs. Meiosis
c. Central Dogma and Its Steps
i. Video (From DNA to Protein)
d. Genes/Genotype/Phenotype
i. Human Genome Sequencing Video
ii. Variations (Sequencing.com Interactive Genome Map)
iii. Genetic Disorders

Concepts of Molecular Biology and Biotechnology
a. DNA Extraction/RNA Extraction
b. PCR
c. Genotyping vs. Sequencing
d. Gel Electrophoresis
e. Gene Expression
i. Regulation
f. Gene Editing
i. CRISPR/Cas9
g. Recombinant DNA
h. Plasmid Construction
i. Insulin Production Example
i. Cell Culture
i. Transfection
ii. Transformation
iii. Transduction
iv. Applications
j. Aseptic Technique

Cell vs. Gene Therapy
a. "Gattaca" video
b. Applications and Products
c. Types
i. Somatic
ii. Germline
iii. In Vivo
iv. Ex Vivo
d. Techniques
i. Augmentation
ii. Inhibition
iii. Suicidal
e. Delivery
i. Viral
ii. Non-Viral
f. Case Studies

Development of Drug Process
a. Discovery, Development and Launch Process
b. Comparison to Regular Biomanufacturing

FDA regulation
a. Analytical Techniques
b. Product Safety Requirements
c. Cell Characterization

Ethical Concerns

cGMP

Good Documentation Practices

Contact Hours

4

CEUs

No

Industry Standard, State or National Certification

Certification

None

Website

None

Certification Learning Outcomes/Requirements

CE or CU Articulation

No

Prerequisites

N/A

Learning Supplies Needed

Lab supplies and the text are provided by the program.

Clinical Site/Special Facilities

N/A

Requirements for Successful Completion

100% attendance

Accreditation/Special Approval Requirements

N/A

Intended Audience

Industry personnel, biology faculty at community colleges, persons interested in a career in biotechnology or biopharmaceuticals

Specific Industry or Business Support Needs

Bioprocess Technician, Gene Therapy Operation Specialist, Manufacturing Process Technician

Wake County Need for Industry Positions

N/A

Industry or Job Titles Related to Training Outcomes for Employment

Bioprocess technician

Gene therapy operation specialist

Manufacturing process technician

Related Courses

CTP-JI01

SEF-79634

CTP-FE01

Course Contact Information

[email protected]