In October 2025, Karolinska Institutet launched a brand-new two-week course giving PhD students a unique insight into how advanced therapy medicinal products (ATMPs), treatments based on cells, genes or tissues, are developed and manufactured.
The course, offered as part of the National ATMP Research School , is worth three credits and combines theory with hands-on training. The next session will run from 12 to 24 October 2026.
A journey through the entire pipeline
The course is designed to provide a comprehensive understanding of the full development pathway for cell and gene therapies, from early-stage research to clinical-grade production. Participants learn how to establish standard operating procedures (SOPs), check product purity and functionality, and explore the differences between pre-GMP and GMP environments. GMP (Good Manufacturing Practice) refers to international standards for producing medicines safely and under strict control, and the course demonstrates how processes can be transferred from research settings to GMP-compliant manufacturing facilities.
Practical training and site visits
Alongside lectures, seminars and workshops, PhD students gain hands-on experience in KI's pre-GMP laboratory. Here, they produce and formulate components such as mRNA (messenger RNA, a template for protein synthesis) and genetically modified cells in closed bioreactor systems. The course also includes visits to GMP facilities, clinics applying cell and gene therapies, and local ATMP companies.
Real-world examples
To illustrate the complexity, the first course drew on real cases from organisations such as Vecura, Nextcell, KITM, Procella, hospital pharmacy radiopharmaceutical units and AFERES (KITM). These examples gave participants a clear picture of how research findings can be transformed into products that reach clinical trials and, ultimately, patients. The programme also featured lectures on gene therapy and CAR T cells, providing a deeper understanding of how these therapies are applied in practice.
"What a journey! Over two intensive weeks we explored the entire ATMP pipeline - from research to GMP production. Hands-on sessions, site visits to organisations like Vecura and SmartCella, and insights from experts made the course both highly educational and truly inspiring," says Sarah Kieler Saietz , PhD student at the Department of Clinical Science, Intervention and Technology, Karolinska Institutet.
Focus on regulation and quality
A significant part of the course is devoted to the regulatory and legal aspects of ATMPs. Participants gain an overview of frameworks such as GLP, GDP, GMP, QC/QA and standards like ATMP/JACIE. This knowledge is essential for understanding how new therapies can be approved and implemented in clinical practice.
Entry requirements and course dates
The course is primarily aimed at PhD students enrolled in the National ATMP Research School, but a limited number of places are also available for other KI doctoral students with an interest in advanced therapy medicinal products.
The National ATMP Research School is a collaboration between Sweden's leading universities, designed to prepare professionals with in-depth knowledge and research experience in the development and clinical application of Advanced Therapy Medicinal Products (ATMPs). The next course will take place from 12 to 24 October 2026.
Investing in the researchers of tomorrow
The course is held at ANA Futura on KI Campus South and combines morning lectures with afternoon laboratory sessions. By offering this type of training, Karolinska Institutet strengthens the expertise of the next generation of researchers and helps position Sweden as a leader in the development of advanced therapies.
