Special immune selection / depletion
- from leukapheresis - TCR-α / β-depletions;
- from bone marrow - CD34 enrichment, CD3 / CD19 or TCR-α / ß depletions;
- from lymphapheresis - CD25 depletion or purification of donor lymphocytes and purification of antigen-specific IFN-ɣ secreting T cells (such as against CMV *);
- On request and after applying to the local supervisory authority, the sGAA, further preparations are also possible, the processing time of the authority must be taken into account.
* to be requested from the Institute of Transfusion Medicine.
GMP-compliant production of non-routinely manufactured drugs for advanced therapy medicinal products (ATMPs) in accordance with Section 4b AMG (after required validation and approval by the PEI)
GMP-compliant production of cell or tissue preparations as test products for e.g. clinical trials (after the required validation and extension of the manufacturing permit).