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Process map

Soon the ’ATMP process map’ will be launched on this page as a beta version!

The process map activity germinated already in 2020 when it was noticed that different Swelife-ATMP projects were using different terminology to describe different stages of ATMP development and implementation. We also noticed that different stakeholder groups would develop resources ”Xx for ATMP” but it was not clear who in the development chain was responsible for those aspects.

The ATMP process map aims to clarify what needs to be addressed in what stage of ATMP development and by which expert stakeholder. We hope that this resource helps developers to put together a team containing the competencies needed to address all aspects of development and that as a community we can ensure that the best information is available to those teams. We do not want the process map to be a text dump, rather a resource that directs stakeholders to useful resources, websites, regulation etc. relevant to their stage of development.

Stakeholders involved in the development since 2021 include Anders Kvanta, Helder Andre, Per Ljungman, Aud Solvberg, Heidi Ekelund, Dag Larsson, Pontus Blomberg, Michael Wagner Christiansen, Miriam Idar, Sharon Longhurst, Ida Duprez, Luisa Lundin, Björn Skölving, Joanna Applequist, Jan Talts, Catharina Brandsten, Ulrica Eistrand, Angelica Loskog, Martina Johannesson, Axel Ståhlbom, Jenny Gustafsson, Juliana Kovacka, Adam Wegelius, Jozsef Vasi, Alexandra Patriksson, Kinga Täckström and Ola Tuvesson. I thank you all for your engagement…..and apologise for the long time it has taken to bring this project to fruition!…better late than never!

DISCLAIMER: We welcome your assistance in making this resource as informative and up to date as possible. While we would like the process map to be as accurate as possible, we must live in the reality that we are trying to generalise processes for many ATMP modalities and are aware of the slightly different views of stakeholders. We do not want to confuse people with too much information. Our objective is to provide a navigation resource where stakeholders have an awareness of stage specific and role specific needs and down the line implications of choices, before they are needing to develop solutions for them.

Please ignore the below….I am using as an example to communicate with the web developer 😉

Product Developer

  • 1. Research adaptation

  • 2. Process qualification

  • 3. GMP manufacture

  • 4. Clinical Trials

  • 5. Market approval and reimbursement

  • 6. Standard of Care