ZKT gGmbH Awarded AMG Manufacturing Licence for Platelet Lysate
News Aug 06, 2015
The Centre for Clinical Transfusion Medicine in Tübingen, ZKT gGmbH, has been granted the manufacturing licence for human platelet lysate in accordance with the German Drug Law (AMG) by the Tübingen regional government office.
Thanks to the development activities of pharmacist Dr. Marc Waidmann, a particularly safe and effective culture media additive is now available for the cultivation of stem cells that meets the regulatory requirements for use on humans.
Stem cells represent one of the rays of optimism in modern medicine, and stem cell therapies are being developed worldwide and are already undergoing tests in numerous clinical trials. The REGiNA project, a users' centre for regenerative medicine that forms part of the STERN BioRegion, is also devoted to this sector. As a result, the demand for human mesenchymal stem cells (MSC) continues to grow.
To produce quantities on a therapeutic scale, laboratories and research facilities have so far mainly used foetal bovine serum as a culture media additive. Although this is available in large quantities, it has the disadvantage even apart from ethical considerations that animal pathogens such as BSE can potentially infect the stem cell culture. For this reason, platelet lysate, which is generated from human blood donations, is now the gold standard for cultivating MSC.
It contains growth factors and cytokines proteins that regulate the growth and differentiation of cells which stimulate the proliferation of the stem cells. ZKT has now been awarded the manufacturing licence for the production of human platelet lysate in accordance with the German Drug Law by the Tübingen regional government office.
The platelet lysate obtained under GMP cleanroom conditions is now supplied as "raw material of human origin" for pharmaceutical manufacturing such as for use in clinical trials or for manufacturing licensed medicinal products for cell therapy.
"We can manufacture the same amount of platelet lysate with only 25 percent of the donors previously required for conventional processes. Our product does not require the addition of heparin, as is otherwise the case, and thanks to its 0.1 micrometre final filtration, it is also free of mycoplasma (a kind of bacteria that is not reliably removed by regular sterile filtering)," the pharmacist explains.
Customers are also very satisfied with the quality of the product. "The platelet lysate from Tübingen is perfectly suited for use as an additive to cell culture media for the production of cells in combination with human serum or plasma, or as an alternative to bovine serum for cultivating human stem cells for use in human beings," says Professor Wilhelm Aicher from the University Department of Urology Tübingen. Waidmann and his team are now preparing to meet the growing demand for their "turbo-drive for stem cell cultivation".
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