DKMS Stem Cell Bank als Vertragshersteller und -entwickler
Karin Büttner (Dresden / DE), Sina Rößler (Dresden / DE), Carolin Klemm (Dresden / DE), Angela Wobus (Dresden / DE), Anne-Cathleen Rieger (Dresden / DE), Simone Sonnenberg (Dresden / DE), Thomas Schäfer (Dresden / DE), Alexander Schmidt (Dresden / DE; Tübingen / DE), Alexander Platz (Dresden / DE)
Advanced therapy medicinal products (ATMPs) are often developed via academic facilities. For clinical studies, ATMPs have to be processed under conditions of good manufacturing practice (GMP). Furthermore, upscaling is necessary to reach requested quantities. However, research laboratories and clinical facilities often do not have the capacity to fully comply with all GMP requirements. There is therefore a need for CDMOs that offer the required equipment, a quality management, expertise in regulatory affairs, personnel, specific know-how and experience in ATMP processing and testing.
DKMS Stem Cell Bank (DKMS SCB) already evolved from a pure cord blood bank to a stem cell bank by acquiring the manufacturing license and approval for the world's first allogeneic undirected cryopreserved PBSC product. This forms the basis for further development into a CDMO. DKMS SCB is well experienced in manufacturing cellular products for more than 25 years and offers a clean room equipped with isolators to realize aseptic conditions. Moreover, standard processes in cryo-storage, transport, quality management and a set of quality control methods are established and can be expanded for new ATMP. Last but not least, the DKMS SCB has well trained, experienced and responsible persons in terms of the German Medicines Law.
As a first pilot project, a cellular product based on mesenchymal stroma cells isolated from the umbilical cord was chosen. The manufacturing and quality control procedures were developed in university research and transferred to the DKMS SCB. The process is currently being established and validated at the DKMS SCB in accordance with GMP standards for the manufacture and quality control of investigational medicinal products. Finally, we will extend our existing manufacturing license for the new stem cell product.
The DKMS SCB is a CDMO for cell therapeutics including quality control methods. Important factors for a successful process transfer are the definition of requirements by client and CDMO in an early stage as well as a close exchange between all involved people in all project phases. The DKMS SCB offers know-how, state-of-the-art technical equipment and experienced staff to clients with the aim of processing and testing of cellular products.
The authors have no conflict of interest to disclose.