Leukopaks and cell products for research
Cellex is developing CAR-Ts, which are manufactured in their own lab facilities. Therefore, they are continuously in need of blood products to run R&D and clinical trials. Due to the small number of providers in Europe for these purposes, Cellex started to develop its own database of donors who are willing to support these requests. This database is made available for pharmaceutical companies and research institutions to receive customised cell products. Meanwhile, almost one thousand volunteers are registered and are willing to donate. Cellex is proud to look back on a 20-years history of blood product collections and has a large expertise in apheresis procedures. This ensures that customers receive high-quality products according to their specific needs.
Our product line
In the Cellex collection sites in Cologne and Dresden, Germany, we have already performed over 40,350 cell collections. As the development of new therapies in most cases requires individual cell material, Cell Community gives the opportunity to order different, trial-specific materials such as MNC-products with different volumes, bone marrow (100 ml) and whole blood. Material for research & development as well as GMP-compliant clinical-grade products can principally be ordered. In addition, the possibility is always given to adapt products in consultation with the responsible experts according to the client’s needs.
All products, provided from our wide donor pool, can be selected to fit certain donor criteria and can be recalled for longitudinal trials. Donor information is available on high-resolution HLA typing, CMV status, gender, age, ethnicity and further donor selection criteria. Once the perfect cell donor is identified, he can be reserved for the purpose/request.
Cellex has been one of the first facilities in Germany to receive an ethical vote from the authorities to perform MNC-collections for research & development. Today we are in regular exchange with the ethic committee and the local authorities to guarantee a regular support of all customers in their scientific work or within their clinical trials.
Besides the fact that Cellex has 20 years of experience in stem cell and bone marrow harvest and is subsequently the most experienced facility worldwide, Cellex has built more than 15,000 square feet of dedicated clean rooms and in addition space for cryostorage. This provides the opportunity to perform cell selection, isolation, genetic modification, cryopreservation and cryo-storage also on-site. Cellex medical and scientific expertise allows providing tailored support during preclinical research and all phases of clinical trials.
Since the beginning, we collected and delivered products in a timely manner to researchers and biomanufacturing organisations all over the world – fresh or cryopreserved with the support of Cellex’ own experienced transport and logistics team. Cellex is able to ensure consistent product production, providing biopharma companies and academic institutions with pharmaceutical-grade cells for research, clinical trials and commercial needs.
This article was originally published in Summer Edition European Biotechnology Magazine 2021.