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GMP - Stem cell isolation according to  to "Good Manufacturing Practice" and "Codes of Good Practice" (GFP) for material procurement

The manufacturing of stem cell products from human sources for therapeutic application in the cardiovascular field requires permission from the authorities (according to §13 German Medicines Act, AMG) and needs to be conducted  according to GMP). For the procurement of the human „raw material“ for production of medicinal products the AMG (§20b) and the Transplantation Act (TPG, section 3b) define the quality criteria according to the state of the art of science and technology formulated in the „Guidelines of the German Society of Surgery for “Codes of Good Practice”(Gute Fachliche Praxis) for the procurement of human tissues and cells for the manufacturing of medicinal products“. the procurement requires permission (AMG, §20b). The RTC has been granted this permission.
At the RTC all stem cell products – both for clinical studies and for patient care- are manufactured according to the Pharmaceuticals and Active Agent Manufacturing Ordinance (German: Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV)). At present, we still charge our partner  Seracell stem cell technology GmbH (Rostock) with the manufacturing of any investigational medicinal products and products for therapy applications.

 In future, we will manufacture our products on our own in those cases which are beneficial for the procedure. For this we have already established a prototype facility for our „Point of Care“ (PoC)-manufacturing of stem cell products (on-site patient care) in the operation area of the Clinic for Heart Surgery.

In advance, we have evaluated several systems which are available on the market for GMP-compliant in-house manufacturing of stem cells from bone marrow or blood. We are the world-wide first clinical trial site for routine tests of a “closed system” for GMP-manufacturing of bone marrow-derived sub-populations for clinical use. This system (CliniMACS-Prodigy-System)  produced by the company Miltenyi Biotec GmbH (Teterow) is actually validated and standardized in our manufacturing site supported by the company. The next step  is the application for manufacturing authorization for PoC-manufacturing of CD133+ stem cells at the competent federal state authority. Later, we also plan to isolate other cell populations for clinical applications.
We will apply for manufacturing authorization for both: to manufacture investigational medicinal products (IMP) for clinical trials and to manufacture products for application according to to §4b AMG.

EU-GMP Directive
Pharmaceuticals ans Active Agent Manufacturing Ordinance (AMWHV)
Transplantation Act (TPG)
German Medicines Act (AMG)

 


 

 

 

Legal The RTC is supported by the BMBF and the State Mecklenburg-Western Pomerania using EU Structural Funds.