TICEBA

Stem Cell Experts

making the difference with ABCB5

About Us

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

2000

First patent on ABCB5

2003

First description of ABCB5+ cells and founding of TICEBA

2005

Start of TICEBA's business activities

2009

Authorization for tissue procurement and processing

2012

Founding of RHEACELL

2014

Manufacturing License (AMG)

2016

First clinical trial using ABCB5+ cells

2019

Technology platform IP expanded (H.F.M Stem Cells)

2020

Filed for national marketing authorization in Germany

2021

Pediatric Investigation Plan (PIP) approved by PDCO (EMA) for RHEACELL

2021

National marketing authorization (§4b) in Germany for AMESANAR® granted

Production

Production

State-of-the art clean room facility according to current international standards.

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Quality Control

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.

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Quality Assurance

Quality Assurance

Implementing the regulatory and authority requirements and maintaining the Quality Assurance System to ensure GMP-compliant processes.

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