From Research to ATMP Treatment, Process, Development, Quality Assurance, Regulatory Affairs and Logistics

During the course students will gain insight into establishing standard operating procedures (SOPs) for the production of cell and gene therapy products, and how to validate product purity and function. They will learn to understand differences between process development within pre-GMP and GMP and transfer of SOP from pre-GMP to GMP. They will also learn to understand differences/similarities between pre-GMP and GMP and the regulatory requirements that exist within ATMP. The students will also obtain an overview of both regulatory regulations and legal aspects of ATMP products.

Upon successful completion of the course, students will have acquired basic knowledge of how to set up production of a cell or gene therapy product according to good manufacturing practice (GMP).

Course Content:

The course will cover basic techniques in the production of ATMP. To give the students a good knowledge of the complexity of all steps we will use real world examples of the development of various ATMP products such as; Vecura, Nextcell, KITM, Procella, Hospital pharmacy, (radiopharmacy) preparation, AFERES (KITM)

The fundamental differences between research, process development and clinical production will be the focus of the course. Lectures by experienced researchers will showcase the development of a product from research, process development, GMP production and clinical trials. Lectures will cover topics such as: pre-GMP and GMP, Process development/SOP, ATMP/JACIE, GLP, GDP, GMP, QC/QA, Gene therapy, CAR T-cells and more.

In laboratory sessions the students will produce and formulate mRNA, genetically modified cells in the closed bioreactor system. The students will gain practical experience in working in a GMP-like environment.

Course Design:

The course is 2 weeks long on site at ANA Futura at KI Campus South. Lectures, seminars, workshops and study visits are held Monday to Friday in the morning. Laboratory work will be carried out in the afternoons in our state-of-the-art pre-GMP laboratory. The students will visit several ATMP production facilities including Karolinska GMP facilities, clinics using cell and gene therapy and local ATMP SMEs.

Course Details

Course Dates:         

(Preliminary) Week 41 and 42, 6-17 October 2025

Course Format:

On site at ANA Futura at Karolinska Institutet Campus South.

Course Lecturers:

Gustaf Ahlén, Department of Laboratory Medicine, Karolinska Institutet, Division of Clinical Microbiology: gustaf [dot] ahlen [at] ki [dot] se

Host University:

Karolinska Institutet

Eligibility Requirements

To be eligible to join this course, applicants must be registered as a PhD student or hold a PhD in a relevant subject area.

Priority is given to postgraduate students admitted to the National ATMP Research School and a limited number of extra places are available.

Registration deadline: Information coming soon