Streptamer®-purified cells for therapy
Streptamer® - your gateway to clinical trials
The therapeutic potential of minimally manipulated cells opens up new avenues for the development of individualized therapies. For this purpose a mild isolation procedure of defined cell populations is necessary under conditions approvable by regulatory authorities. The Streptamer® technology is an attractive new option to purify cells for therapeutic applications, since it enables the complete dissociation of staining and isolation reagents from a target cell population. The removal of reagents enables the new Streptamer® isolation procedure to provide cells with uncompromised biological function, and potentially adverse effects of the markers in clinical applications can also be excluded. Therefore, the Streptamer® technology offers optimal solutions for innovative cell therapy. The complete dissociation of Streptamer® reagents is also a major advantage with regard to medical regulation of the reagents and the cells they are used to isolate. The regulatory authorities in both Germany and Great Britain have accepted clinical trials with Streptamer®-selected cells in which the Streptamer® reagents were not produced under GMP conditions. Furthermore, Streptamer®-purified cell therapeutics have been classified by the European Medicines Agency (EMEA) as non-“advanced therapy medicinal products” (non-ATMP); this classification results in considerably fewer requirements for clinical testing.
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