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: stem cell pioneer and expert - navigating hitherto unchartered waters
Drawing on over 15 years' experience in advanced stem cell research and regenerative medicine to pioneer the production of ABCB5-positive (ABCB5+) mesenchymal stem cells and innovative treatment pathways.
GMP production
Using cutting-edge, in-house process technology and quality control systems to generate state-of-the-art ABCB5+ mesenchymal stem cells ("H.F.M Stem Cells") and ATMP (Advanced Therapy Medicinal Products) in line with AMG (German Medicinal Products Act) requirements.
Translational medicine: from in-house potency assay to clinical efficacy
Science-based mechanisms-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 through-put stem cell production based on globally patented technology and expertise - catering for world-wide market needs - anytime, anyplace, anywhere.
Clinical development pipeline and established technology platform focusing on rare diseases and more
Our tried and tested patented technology platform nurturing next-generation technologies (CRISPR/Cas, iPS Technology and 3D Bioprinting), heralding the arrival of next-generation cell therapies.
ABCB5 patents – a world-wide exclusive
TICEBA - 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 at the same time and are jointly owned by TICEBA.
TICEBA history
First ABCB5 patent
First description of ABCB5+ cells and creation of TICEBA
TICEBA launches business activities
Approval granted for tissue procurement and processing
Creation of RHEACELL
Manufacturing license granted (AMG – German Medicinal Products Act)
First clinical trial using ABCB5+ cells
Technology platform patent granted ("H.F.M Stem Cells")
National marketing authorization applied for in Germany
Pediatric Investigation Plan (PIP) approved by PDCO (EMA) for RHEACELL
National marketing authorization in Germany granted for AMESANAR®
Production
State-of-the art clean room facility meeting current international standards.
Quality Control
A stringent quality control procedure is the hallmark of guaranteed product safety and quality in line with international GMP standards. Every product batch meets standardized, validated in-house release criteria.
Quality Assurance
Satisfying regulatory and legislative requirements and fine-tuning the Quality Assurance program to guarantee GMP-compliant processes.