Quality Management

The handling of human cells requires extreme diligence and the compliance with the highest safety standards. Due to our successful quality management, we are able to meet these requirements.

TICEBA - Quality Management


Medicinal Products Act

First and foremost, our product Back-up is subject to the Medicinal Products Act. 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. TICEBA also possesses the license within the meaning of §20b (1 and 2), §20c, and §72b of the AMG for the authorization for the extraction of tissue, the treatment or processing, preservation, testing, storage, import of tissue or tissue preparations.

All described activities are carried out by TICEBA in accordance with the authoritative European and German instructions in compliance with Good Manufacturing Practice (GMP).

Under these strict conditions, your cells from the skin and the stem cells contained therein can be used in the case of need as raw material for the manufacturing of an autologous (from the patient himself) or allogeneic (from a donor) medicine.


Good Manufacturing Practice

Due to the high significance of "Good Manufacturing Practice" at TICEBA, this issue of quality management is contemplated separately.


Quality Assurance System

Tissue institutions are obligated by law and other requirements to set up a quality assurance system (QA-system). It is supposed to contribute to the proper proceeding of any procedures in connection with the manufacturing of the products. The required quality is thereby to be assured. In addition, a QA-system contributes to reaching a higher level of security with regard to complex proceedings; to enable employees to act on their own responsibility within the framework of clear specifications and to increase the trust of patients and employees in the institution.


TICEBA's Quality Assurance System Consists of the Following Components:

  • Master documents contain a basic description of the quality concept and a description of premises and processes.
  • Standard operating procedures (SOPs) and operating instructions (AAW) exist for any quality-related process. SOPs describe superordinate processes, while AAWs regulate single processes and process steps in detail.
  • Implementation documents are protocols that are consulted by the employees on a daily basis in their professional day-to-day work.
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