ISPE is presenting a 3 part series that will focus on an introduction to the Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutical development with an emphasis on how they differ from traditional small molecule pharmaceutical development.

In this third part of the series, we will cover 9 major topics:

1. Overview of CG&T Modalities and Platforms
2. Cell and Gene Therapy Market
3. Plasmids
4. mRNA
5. LNPs
6. Viral Vectors
7. Ex-vivo Engineered Cell Therapy
8. CAR-T Platform
9. Cost Controls

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.

The science and technology of biopharmaceutical development and manufacturing is advancing rapidly and the regulatory landscape for these products continues to evolve
If you are eager to learn more…please register for a more in-depth review in our next Learning Activity, Biopharmaceutical : CMC Aspects.

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. https://ispe.org/training.