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Biopharmaceuticals: C&GT and ATMP Training Course

Part 3 - Late Phase Biopharmaceutical Development

Overview

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:
  • 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



*** Each course purchase is intended for individual use only and cannot be shared or transferred. If you need to make multiple purchases of this course for your colleagues, please contact Member Services at +1-813-960-2105 or by email, [email protected].
1,195.00