Dr. Sina Rößler (Dresden/ DE), Dr. Anja Sauer (Dresden/ DE), Dr. Deborah Buk (Tübingen/ DE), Dr. Karin Büttner (Dresden/ DE), Dr. Carolin Klemm (Dresden/ DE), Dr. Angela Wobus (Dresden/ DE), Anne-Cathleen Rieger (Dresden/ DE), Anne-Katrin Dietze (Dresden/ DE), PD Dr. Kristina Hölig (Dresden/ DE), Dr. Dr. Alexander H. Schmidt (Dresden/ DE; Tübingen/ DE), Dr. Alexander Platz (Dresden/ DE)
Background
Cord blood transplants are a promising opportunity for patients with hematological diseases. However, application rates are declining, complicating the economic sustainability of public cord blood banks. The DKMS Stem Cell Bank has established high standard processes in terms of processing, cryopreservation, quality control, transport and quality management. These represent excellent conditions for the development, processing and storage of further cell products.
Methods
For the further development of a cord blood bank into a stem cell bank, existing processes, facilities and resources were used to expand activities. An existing quality management system and official approvals were built on. The technical requirements of the cord blood bank were adopted and expanded for the stem cell bank. The manufacturing process had to be implemented and validated, the quality control methods had to be adapted to the new cell product and re-validated. Further adjustments were made, e.g. with regard to the integration of apheresis centers, the expansion of the IT infrastructure, the addition of official approvals and the implementation of the PBSC listing via the DKMS Registry.
Results
In the new GMP clean room unit of the DKMS Stem Cell Bank, allogeneic undirected cryopreserved PBSC products are produced with 5% DMSO and a volume of 2x100 ml. The quality of each batch is verified using validated quality control methods. The documentation is carried out using GMP-compliant software. The high quality of the stem cell products was verified both before freezing and after thawing and after 18 months of storage as part of approval-relevant validations. In 2022, the manufacturing license of the DKMS Stem Cell Bank was extended to include allogeneic undirected cryopreserved PBSC preparations. In 2023, approval was granted for "Allogeneic cryoPBSC, DKMS-1", the world's first allogeneic undirected cryopreserved PBSC product.
Conclusion
The DKMS Stem Cell Bank has evolved from a pure cord blood bank to a stem cell bank. With "Allogeneic cryoPBSC, DKMS-1" the world's first allogeneic undirected cryopreserved PBSC product was approved. The advantages of this ready-to-use drug are a significant reduction of the time-to-transplant, the improved possibility of transplantation coordination and the previously known product specifications of the selected preparation.
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