Services
We manufacture medicines that are custom-designed for the patients and their serious medical conditions, especially those of the hematopoietic system. Preparations of the CTC contain functional cells of the peripheral blood or bone marrow as active ingredients.
Once apheresis product or bone marrow has been obtained in procurement facilities in Germany or abroad by the patients themselves, by their relatives, or by third party donors, we can remove unwanted cellular or liquid ingredients and enrich or activate desired cell types. If necessary, we can also portion, freeze and cryopreserve the mostly native or genetically modified product for years before their final distribution and application by our clinical partners.
In order to avoid cross-contamination with bacteria or viruses, for example, the patient and donor are extensively examined before the procedure. We also strictly follow the relevant processing steps in our own clean rooms at the CTC. Permanent and extensive monitoring of production environment and personnel involved, of the starting preparations and - materials, of the intermediate and secondary products obtained during the processing, and not least of the final cellular therapeutics (and ultimately of the methods themselves applied for monitoring) ensure its optimal GMP compliant quality. Thus, their safety and efficacy is not a coincidence.
Forms
Order apheresis and preparations as well as the delivery of cryopreserved products using the current version of our controlled forms.
Standard preparations / immune selection / depletion
Since 2011, the following approvals according to §21a AMG from the competent higher federal authority, the Paul Ehrlich Institute (PEI), have been available for placing on the market.
Extended work-up
In addition to our drug strengths already approved by the Paul Ehrlich Institute, sophisticated new procedures for preparative immune selection and depletion are in different stages of establishment and validation.
Other services
On the basis of our many years of experience in the areas of good manufacturing practice, pharmaceuticals for novel therapies, aseptic production and cellular analysis, we are at your side with training, advice and expert opinions, but also practically with process establishment and validation in your projects - including clean room capacity.