Analytic

TICEBA has created its own in-house analytical department. Necessary quality tests and the preparation of the stem cells can be executed simultaneously. The methods of the analytical 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 analytical 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
Coronavirus and Mesenchymal Stem Cells

Therapy for Pneumonia Patients infected by 2019 Novel Coronavirus

Treatment With Mesenchymal Stem Cells for Severe Corona Virus Disease 2019(COVID-19)

Mesenchymal Stem Cell Treatment for Pneumonia Patients Infected With 2019 Novel Coronavirus

Article about our study with limbal stem cells

On the website of the Harvard Stem Cell Institute you will find the following news release about the ongoing clinical trial conducted by our daughter company RHEACELL in patients suffering from limbal stem cell deficiency: Restoring vision: A stem cell therapy for cornea regeneration reaches the clinical-trial stage.

Clinical Trial - EB

The international phase I/IIa clinical trial has been approved by the U.S. Food and Drug Administration (FDA) and several European competent national regulatory authorities. The medicinal drug product tested in this trial has recently been granted Orphan Drug designation from the FDA and the European Medicines Agency (EMA) for the treatment of EB.

Clinical Trial - LSCD

The international phase I/IIa clinical trial has been approved by the U.S. Food and Drug Administration (FDA) and the German regulatory authority (Paul Ehrlich Institute). The medicinal drug product tested in this trial has recently been granted Orphan Drug designation from the FDA and the European Medicines Agency (EMA) and Fast Track designation from the FDA for the treatment of LSCD.

Safety

In a comprehensive preclinical study program, safety and local tolerability of ABCB5+ MSCs following subcutaneous, intramuscular and intravenous application has been demonstrated (Tappenbeck et al., 2019).

Newsletter