Analytic

TICEBA has created its own in-house analytic department. Necessary quality tests and the preparation of the stem cells can be executed simultaneously. The methods of the analytic department were established in accordance with GMP guidelines and the requirements of the European Regulation on Medicines (European Pharmacopoeia).

TICEBA - Company - Analytic - Picture 01TICEBA - Company - Analytic - Picture 02

 

Due to the implementation of our in-house analytic department we are in the position to conduct all relevant quality tests on our own. This enables us to realize an unobstructed and continuous preparation process of the stem cells with simultaneous monitoring of the quality and immediate response to possibly changing quality standards.

One of our devices is the flow cytometer (BD Accuri™), which is able to identify the valuable ABCB5+ stem cells. The following parameters can be determined:

  • Quality of the isolated cells (e.g. amount of ABCB5+ cells)
  • Number of cells, vitality and viability
  • Cell cycle analysis and exclusion of chromosomal aberrations

The qRT-PCR (quantitative real-time polymerase chain reaction) allows us to detect the expression of stem cells at gene level. Testing for mycoplasma contamination will be conducted according to European Pharmacopoeia.

The Endosafe®-PTS™ enables us to check for possible endotoxin contamination of the cell culture medium within few minutes.

By means of ELISA (Enzyme Linked Immunosorbent Assay) we are able to detect proteins (e.g. antibodies), viruses, hormones, toxins and pesticides in a sample.

The Fluorescence microscope (Floid®) illustrates the morphology of cells in different light spectrums. Thus, we can carry out the differentiability of ABCB5+ cells.

Furthermore, TICEBA is able to perform the following tests:

  • RNA isolation
  • DNA isolation
  • cDNA synthesis
  • Agarose gel electrophoresis
News
Clinical Trials

We are now also recruiting patients for further clinical studies in phase I/IIa with allogeneic ABCB5-positive (ABCB5+) mesenchymal stem cells for the following indications: chronic venous ulcer (CVU), diabetic foot ulcer (DFU) and peripheral arterial occlusive disease (PAOD). For more information click HERE.

License

Besides the authorization to manufacture a human medicinal product in accordance with § 13 (1) of the German Medicinal Products Act (AMG) for autologous mesenchymal stem cells, TICEBA is also authorized to manufacture a medicinal product for allogeneic mesenchymal as well as allogeneic limbal ABCB5 + stem cells following a recent extension. For more information click HERE.

The Story of Stem Cells

Review our category "The Story of Stem Cells" with the newest topic "Stem cells in wound healing" HERE.

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