This new instructor lead course is an advanced level course on Cell and Gene Therapies C> and Advanced Therapy Medicinal Products (ATMP). The course provides an overview of the most common and established components that are leveraged in C> products (e.g. plasmids, mRNA, lipid nanoparticles, viral vectors), covering terminology, manufacturing processes and subsequent analytical characterization of the manufactured components and therapeutic products. The adeno-associated virus (AAV) and chimeric antigen receptor (CAR) T-cell platforms are presented as the two most common and established therapeutic technologies for Gene Therapy and Cell Therapy, respectively. The purpose of this course it to provide a fundamental understanding of the CMC considerations for C> products.
What You Will Learn
Cell and Gene Therapy (CGT) market and the diversity of CGT modalities and platforms
Key components of CGT products
Plasmid production and characterization
mRNA production and characterization
Lipid nanoparticle encapsulation
CRISPR gene editing basics
Viral vector production and characterization
Ex-vivo engineered cell therapy
CAR-T cell therapy manufacturing and characterization
Challenges associated with autologous cell therapy
Factors and opportunities to control cost of goods
Resources and Activities
Pre-Course Work Materials
Interactive Exercises
Learning Assessments
Course Modules
Overview of CG&T Modalities and Platforms
Cell and Gene Therapy Market
Definitions, Manufacturing and Analytical Characterization of CG&T Products
Plasmids
mRNA
Lipid Nano Particles
Viral Vectors
Cell Therapy
Cost Controls
CEUs are provided once you achieve an 80% passing grade and complete the evaluation.
The course is self-paced. On average, the time required for completion ranges from 1 to 3 hours.
Who Should Attend
Individuals who want to improve their working knowledge of biopharmaceutical development
Service organizations, suppliers, and vendors who serve pharmaceutical industry Clients focused on biopharmaceutical manufacturing
Academic institutions engaged in biopharmaceutical development/manufacturing
Vendors and suppliers of equipment/systems focused on the global biopharmaceutical launch process
Industry professionals focused on manufacturing risk assessment/mitigation
Quality assurance and quality control specialists
Validation specialists
Additional Course Details
Communities of Practice (COP)
This training course will be of particular interest to: