Is the PF included in CTC
We manufacture drugs that are individually tailored to the patients and their serious illnesses, especially those affecting the blood-forming system. CTC preparations contain functional cells from peripheral blood or bone marrow as active components.
After these have been obtained from the patients themselves, from their relatives or from third parties in extraction facilities at home and abroad, we can remove unwanted cellular or liquid components "in the test tube", enrich or activate desired cell types, and, if necessary, then afterwards Freeze either processed or largely native product in portions and store it deep-frozen for years until it is used by our clinical partners.
To avoid contamination of our preparations with, for example, bacteria or viruses, the patients and donors are extensively examined beforehand and relevant processing steps are carried out in CTC's own clean rooms. Constant extensive monitoring of this manufacturing environment and the personnel involved, the initial preparations and materials, the intermediate and by-products occurring during processing and, last but not least, the drug (and finally the methods used for monitoring themselves) ensure its optimal quality in accordance with GMP. So that their safety and effectiveness are no coincidence.
Order apheresis and preparations as well as the delivery of cryopreserved products with 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, drugs 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.
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