Our facility and activities:
• operational since 2012
• 4 executed cell therapy programs thus far:
- allogeneic mesenchymal stromal cells (MSCs) for graft-versus-host disease
- graft engineering of stem cell transplants for haploidentical stem cell transplantations
- autologous keratinocytes for burn victims
- leukapheresis (ATMP starting material) service
• cell handling technologies and expertise:
- long-term cell culture procedures in GMP (adherent and suspension cells), for instance mesenchymal stromal cells and T cells
- rapid cell isolations, both open and closed processing
- CliniMACS technology platform
- optimization of cell culture conditions
- xenofree culture conditions and supplements
- cell characterization and functional studies
- procurement of biological starting materials
- stability studies
- transportation conditions
• altogether 220 m2 GMP-grade clean room space, for both open and closed processing
• processing equipment, e.g.:
- 2-chamber grade A isolator for open processing
- CliniMACS Prodigy and CliniMACS Plus cell selection systemsisolators
• comprehensive laboratory analytics especially for living cells
• trained and dedicated GMP personnel
• current manufacturing licenses from the competent authority Fimea: national ATMP manufacturing license (ATMP hospital exemption license), tissue establishment license
Contact persons:
Head of department Johanna Nystedt, Adj.prof, PhD; email: johanna.nystedt(at)bloodservice.fi; https://orcid.org/0000-0002-0351-5478
Production manager Anita Laitinen, PhD; email: anita.laitinen(at)bloodservice.fi
https://orcid.org/0000-0002-8010-9991
