Good Manufacturing Practice (GMP)

For several years already, TICEBA has been committed to compliance with the high standards in accordance with Good Manufacturing Practice.

Any working procedure, manufacturing steps and material is carried out by TICEBA in compliance with the high standards of Good Manufacturing Practice. This is how TICEBA guarantees the best possible quality of your stem cells during preparation and storage.

Among others, our quality assurance contains the following points:

  • Our staff is highly qualified theoretically and practically, is trained regularly, and complies with the required hygiene standards.
  • Our premises and manufacturing equipment have been examined and meet the requirements of Good Practice.
  • We keep a clearly written documentation of all steps in the process for the purpose of traceability.
  • Our production procedures are clearly defined and are strictly followed by our staff.
  • In order to guarantee the quality of the materials used as well as of the final product, strict quality controls are carried out at all times.

News
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