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Biopharmaceuticals: C&GT and ATMP

Biopharmaceuticals: C&GT and ATMP Training Course

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.

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:

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