Biopharmaceuticals: C&GT and ATMP

Biopharmaceuticals: C&GT and ATMP Training Course (T68)

Overview

This new instructor lead course is an advanced level course on Cell and Gene Therapies C&GT and Advanced Therapy Medicinal Products (ATMP). The course provides an overview of the most common and established components that are leveraged in C&GT 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&GT products.

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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

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:

• Existing members of the Biotechnology CoP
• Future members of the new Advanced Therapy Medicinal Products (ATMPs) CoP
• Existing and future members of the ISPE Process/Product Development CoP