From Research to Cell and Gene Therapy Treatment – Process Development, Quality Assurance, Regulatory Affairs and Logistics

About the course

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, good manufacturing practice (GMP) production and clinical trials.

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

Objectives

The aim of the course is to take the course participant through all steps in process development and production of cell and gene therapy products.

During the course, participants 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 the differences between process development in pre-GMP and GMP environments, as well as the transfer of SOPs from pre-GMP to GMP. They will also learn to understand the differences and similarities between pre-GMP and GMP and the regulatory requirements that exist within ATMP. Participants will also gain an overview of the regulatory and legal aspects of ATMP products.

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

Intended learning outcomes

Upon completion of the course, participants should be able to:

1. Describe the fundamentals of ATMPs, GMP, Quality Control (QC), Quality Assurance (QA), and tissue establishments according to EU regulations.
2. Describe the routines and procedures required for working in a classified cleanroom.
3. Successfully perform aseptic gowning for work in a cleanroom.
4. Perform selected steps in the genetic modification of cells.

Time and place

April 5-16, 2027. Karolinska Institutet Campus South.

Target group

Scientists, clinicians, engineers, and regulatory or quality professionals involved in creating, manufacturing, and translating advanced therapies into clinical use.

Quote from previous participants

“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.”

Sarah Kieler Saietz, PhD student at the Department of Clinical Science, Intervention and Technology, Karolinska Institutet.

Course management, lecturers

Course management

Gustaf Ahlén, Project Manager, Department of Laboratory Medicine

Ewa Ellis, Docent, Department of Clinical Science

Daniela Silva, Research Specialist, Department of Laboratory Medicine

Lara Sweetapple, Postdoctoral Researcher, Department of Laboratory Medicine

Miina Ojansivu,  Research Specialist, Department of Laboratory Medicine

Lecturers

Further information about the lecturers will follow.

Quote from course leader

“Take the opportunity to learn the latest in cell and gene therapy development. During the course you will have a unique opportunity to listen to the leading researchers and clinicians in ATMP. We make several unique study visits to GMP manufacturers and as a course participant you will work in the pre-GMP laboratory with hands on training on advanced equipment for the manufacturing of ATMPs.”

Gustaf Ahlén and Ewa Ellis, course leaders

Course content

 The course will cover basic techniques in the production of ATMPs. To give the course participants 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).

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 and SOPs, ATMPs, JACIE, GLP, GDP, GMP, QC/QA, gene therapy, CAR T cells, and more.

During laboratory sessions, participants will produce and formulate mRNA and genetically modify cells using a closed bioreactor system. The participants will gain practical experience in working in a GMP-like environment.

Course set up

Lectures and site visits in the mornings. Laboratory work in the afternoons. Course participants will be able to manufacture and formulate mRNA and manufacture CAR T cells in a closed and automated system.

Eligibility criteria

Minimum college degree in a relevant field.

Expression of interest

Registration is not open yet, but you can fill in your details below and you will receive information as soon as you can register for the next course round. Submitting an expression of interest is not binding.

Register your expression of interest. 

More information

Questions regarding course content:
Gustaf Ahlén, course leader, Karolinska Institutet, Department of Laboratory Medicine
E-mail: gustaf.ahlen@ki.se

Ewa Ellis, course leader, Karolinska Institutet, Department of Clinical Science, Intervention and Technology
E-mail: ewa.ellis@ki.se

Administrative questions:
Erik Pettersson, project coordinator, Karolinska Institutet Executive and Professional Education
E-mail: erik.pettersson.2@ki.se

Price

The course fee has not yet been determined. This page will be updated as soon as pricing information becomes available.

Contract education

The course is offered as contract education in accordance with Swedish regulations (SFS 2002:760). It can only be commissioned by a legal entity such as an organisation or company. 

If you wish to participate in the course, please make sure to confirm that your employer will cover the cost.

Application

Please note that the course is subject to the condition that we receive a sufficient number of participants.

Registration is binding. For cancellations later than six (6) weeks before the start of the course, 50 percent of the course fee will be charged, and for cancellations later than four (4) weeks before the start of the course, the full course fee will be charged. For complete terms and conditions, see our general terms and conditions.