GMP Fundamentals Bundle Series - Limited Offer

On Demand Biopharmaceutical Three-Part Bundle Series

$775 Savings by Purchasing All Three Courses


ISPE is presenting a three-part series that will focus on an introduction to Large Molecules and the Chemistry, Manufacturing, and Controls (CMC) aspects of biopharmaceutical development with an emphasis on how they differ from traditional small molecule pharmaceutical development. The bundle also 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. This offering provides all three modules of the series.

  • Part 1 - Biopharmaceuticals: Introduction to Large Molecules
  • Part 2 - Biopharmaceuticals: CMC Aspects
  • Part 3 - Biopharmaceuticals: C&GT and ATMP

This course is intended to provide a general roadmap for the development of a protein-based biopharmaceutical product.

The primary focus is a comparison of small and large molecules and on a pathway for the process development, manufacturing, and analysis of products produced in mammalian cell culture that are intended for clinical and commercial use.

Sneak Peek of What to Expect

Watch this short clip from Neal Gordon as he introduces the Biopharmaceuticals: C&GT and ATMP module of this three-part series.

What You Will Learn

  • Cell and Gene Therapy (C&GT) market and the diversity of C&GT modalities and platforms
  • Key components of C&GT 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

  • Interactive Exercises
  • Learning Assessments

Additional Course Details

Communities of Practice (COP)

This training course will be of particular interest to:

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For an enhanced learning experience, ISPE also offers these learning activities as live courses and gives you an opportunity to learn with a live instructor, ask questions, and participate in exercises. View upcoming courses