close
close
close
In recent decades, the focus in cell and gene therapy has increasingly shifted to personalized medicine. However, these individual therapies, which are often based on the patient's cell material, are complex and costly to produce. In addition, the entire process is extremely complex. Therefore, such treatments focus primarily on rare diseases as well as on the therapy of children with oncological and immunological diseases. This development shows the potential, but also the challenges, of personalized medicine in the field of cell and gene therapy.
Life-threatening diseases require a quick and decisive start of therapy. Conventional therapies often reach their limits and weaken patients, which is why they are now supplemented by individual drugs. These new treatment methods offer patients for whom previous therapies did not work a new chance for a cure.
One particularly promising approach is to genetically adapt the patient's immune cells outside the body so that they can recognize and fight the cancer cells. This method has proven to be particularly successful for diseases of the blood and lymphatic system, as the immune cells of the blood reach the cancer cells particularly well.
Newer therapeutic methods aim to fight solid tumors in the patient's body. In this process, immune cells that are already active in the tumor are multiplied outside the body and then reused to support treatment. This innovative approach could significantly expand the treatment options for many cancer patients.
The first therapies in the field of cell and gene therapy were often developed and produced manually in academic medical institutions. The industry reacted to this by developing the first devices that prepare valuable patient material, isolate, modify, multiply and finally fill special patient cells.
Recent developments aim to further automate this process. However, not every material, container or device used is suitable for automation. Future developments must take these aspects into account in order to produce personalized medicine more broadly applicable, faster to produce and more cost-efficient.
In addition, new drugs are being developed that use cell material from healthy donors to produce immune cells targeted at specific cancers. These advances make it possible to offer effective therapy to not just one, but many patients. This is where the automation of production offers great advantages.
Optima Pharma is right on the cusp of bridging the gap between academic product development and commercial manufacturing of cell and gene therapeutics. With its expertise in special machine construction and its strength in the field of automation, the company offers tailor-made machine solutions.
Systems are being developed that carry out the entire process – from the blood reserve from leukapheresis to the filled personalized transfusion solution – fully automatically. A process control system controls, monitors and documents the production, whereby the pharmaceutical regulations can be precisely mapped and adapted if necessary. These facilities enable the production of different immune cells using different manufacturing protocols and offer the possibility of multi-patient production.
When it comes to live saving products, every drop is precious. Our Fill Cell for gene therapy and allogeneic products offers a fill technology specifically for these high value products.
Future developments aim to create modular plants that make it possible to separate manufacturing processes. This would allow preparation and filling steps to be separated from the actual manufacturing process, giving pharmacists the flexibility to adapt the line to their own manufacturing strategies.
