A cell donation is just a small step for healthy donors, but it can help find solutions for cancer or autoimmune diseases that have a lasting effect. "Of course, a cell-based drug does not offer a 100% chance of cure, but there is now a very high success rate, which often comes with only weak, or moderate side effects," says CEO Carla Kreissig. "Therefore, our company does not offer a classic business model, but we work with a range of services in the field of cell donation and processing. We work on cells that we take from the affected patients themselves or healthy donors. These do not necessarily have to be stem cells. Our starting material consists of immune system cells, which we genetically modify so that they can have a therapeutic effect on various diseases."

A true full-service provider

The company was founded 22 years ago by Prof. Dr. Gerhard Ehninger, who is still the owner today. At the location in Cologne, 280 employees work on products from cell donations in two areas. While Cellex Medical Services (CMS) focuses on managing a donor database and operating the collection center, Cellex Manufacturing Transports and Logistics (CMT) is the address for product creation plus transport and logistics - both for the company itself and for others.

"The donation of the cells and their further processing must be logistically coordinated. This is a complex task because we transport to the USA or Singapore, for example. Since this is living material, transport expertise is needed," explains Carla Kreissig. "We are a full-service provider and offer not only collection but also product development, logistics, and transport, and we have experience across the entire chain from starting material to the production of cell and gene therapy products and can provide advice accordingly. Cellex offers finished and semi-finished products and is also a service provider for other manufacturers."

Focus on fighting tumors

The extracted cells are processed and genetically modified to target a specific tumor. It is important to distinguish between products made from the patient's own cells, which are for that one patient only, and those made from foreign cell donations that are given to many sick people. "If the cells come from a donor, additional modifications have to be made so that they are accepted by the new immune system," says Carla Kreissing.

New products for many

Medical products go through a three-stage development. The first step is in-vitro development in the laboratory, followed by clinical trials to prove that the product is effective and without serious side effects. The last step is approval following successful clinical trials. "Since this procedure is very expensive, we cooperate with large pharmaceutical companies that own the approval and bear the costs up to that point. We are only the executing element; the products are not ours," explains Carla Kreissig. So far, Cellex can point to around 1,500 donations. "We are the first in Germany to produce allogeneic switchable CAR-T cells," emphasizes Carla Kreissing as a major success factor in the company's history.

"Until now, in Germany, the approved products were for autologous use only. The disadvantage here is that the CAR-T cells are always manufactured for an individual patient from his or her own T lymphocytes, an extremely elaborate process," says Carla Kreissig. "Allogeneic products have a better starting material since they come from healthy donors, and non-preloaded cells generally suit better." Although the manufacturing process is more costly, it allows for the production of up to 40 doses, making the price per unit more economical. Furthermore, allogeneic products can then be made applicable to many patients.

Across the big pond

"Our products can be used for life-threatening illnesses, but also for research purposes. Although the focus is on Germany, as more and more customers urge Cellex to also operate in the USA, the company plans to open its own branch in the USA soon, which will fully take care of customer concerns. "We will not take the database with us, but will create a separate one there," says Carla Kreissig. "There are already regular cooperations with US partners on donations. We look forward to the new challenge."