National marketing authorization in Germany for novel cell therapy
Our daughter company RHEACELL has been granted national marketing authorization (§4b of the German Medicinal Products Act) in Germany for its cell therapy product AMESANAR®, produced by TICEBA, for the use in patients with chronic wounds.
TICEBA: pioneer and expert of a stem cell drug for diseases with high and unmet medical need
Pioneering the production of ABCB5-positive (ABCB5+) mesenchymal stem cells. With more than 15 years of expertise in the field of advanced stem cell research and regenerative medicine - paving the way to the patient.
GMP production
Highest quality stem cells using our in-house developed process and quality control to generate ABCB5+ mesenchymal stem cells ("H.F.M Stem Cells") and produce an ATMP (Advanced Therapy Medicinal Product) in accordance with the AMG (German Medicinal Products Act).
Translational Medicine: from In-house Potency Assay to clinical efficacy
Science based Mode-of-action translated into GMP-validated Potency Assays and release criteria to predict clinical efficacy.
Off the shelf & ready to use: serving market needs
High throughput stem cell production with worldwide patented technology and proprietary know-how serving global market needs - anytime and anywhere.
Clinical development pipeline and established technology platform focusing on rare diseases and beyond
Using our established and patented technology platform to feed the next generation technologies (CRISPR/Cas, iPS Technology and 3D Bioprinting) to develop next generation of Cell Therapeutics.
Worldwide exclusive ABCB5 patents
TICEBA is an exclusive licensee of the full ABCB5 patent portfolio from Boston Children's Hospital, a teaching affiliate of Harvard Medical School, Boston, Massachusetts. Several of these were invented together and are co-owned by TICEBA.
TICEBA history
First patent on ABCB5
First description of ABCB5+ cells and founding of TICEBA
Start of TICEBA's business activities
Authorization for tissue procurement and processing
Founding of RHEACELL
Manufacturing License (AMG)
First clinical trial using ABCB5+ cells
Technology platform IP expanded (H.F.M Stem Cells)
Filed for national marketing authorization in Germany
Pediatric Investigation Plan (PIP) approved by PDCO (EMA) for RHEACELL
National marketing authorization (§4b) in Germany for AMESANAR® granted
Production
State-of-the art clean room facility according to current international standards.
Quality Control
Stringent quality controls are carried out to guarantee product safety and quality according to international GMP standards. Every product batch complies with a set of standardized and in-house developed and validated release criteria.
Quality Assurance
Implementing the regulatory and authority requirements and maintaining the Quality Assurance System to ensure GMP-compliant processes.