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 stored skin cells 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.
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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.

Clinical Trial

Together with our subsidiary RHEACELL we are recruiting patients with the indication chronic venous ulcer (CVU) for the clinical trial in phase 1/2a. 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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