This course serves as an introduction to the category of medicines known as Advanced Therapy Medicinal Products, often commonly referred to as Cell and Gene Therapies. Over two days, trainees will learn about what these therapies are, how they work, current manufacturing techniques, and possible future trends. They will learn about viral vectors, nucleases, and the wider field of gene therapy as well as cellular immunotherapies and stem cells. In addition, they will learn how companies ensure the quality of these products.
They will also get an opportunity to use the specific cell culture and downstream purification equipment that is commonly used to manufacture these products. This equipment includes adherent and suspension cell culture systems such as controlled rate thawers, cell factories, rocker bioreactors, fixed bed bioreactors, and single-use stirred tank reactors. It also includes harvest and downstream equipment such as centrifuges, depth filtration systems, single-use chromatography system, single-use ultrafiltration systems, and controlled-rate freezers.
Course delivery method: Fully onsite in NIBRT
Introduction to ATMPs/CGT
Who should attend
Anyone who has a basic knowledge of the biopharmaceutical industry and would like to learn more bout this expanding field of therapeutics.
Key topics covered
- What are ATMPs?
- Viral Vectors and Nucleases for Gene Therapy/Editing
- Autologous and Allogeneic Cell Therapies
- QC and regulatory challenges
- Stem Cell Culture (Cell factories)
- Immune Cell Culture (Rocker bioreactors)
- Cell Culture for Gene Therapy (Fixed bed bioreactors and single-use stirred tank bioreactors)
- Downstream Purification (Single-use ultra-filtration and ion exchange chromatography)
- Formulation and Cryopreservation
Upon completion of this course the trainee will be able to:
- Define the terms ATMP and CGT
- Discuss the similarities and differences between classes of ATMPs
- Describe how viral vectors and nucleases can be used as therapies
- Differentiate between autologous and allogeneic cell therapies
- Identify the equipment commonly used in the manufacture of ATMPs
- Describe the importance of certain process conditions in the manufacture of these products
Trainees will receive a certificate of completion for attending all parts of the course and for passing a short post-course assessment.