Epiontis strives to establish methylation fingerprinting as Gold Standard for quality control in Regenerative Medicine.
Our novel analytical products, based on DNA methylation, are aimed at making Regenerative Medicine safer and better. Methylation analysis is the most appropriate technology for Quality Control (QC) of cells. Such QC is essential for cell therapy appproaches, which are seen as a very promising area of the health care market. Epiontis offers its QC-tool to partners in this industry, i.e., to companies that produce cell therapeutics. Thus, Epiontis safeguards the patients by ensuring that cell therapies are help- rather than harmful.
Epiontis is supported by a network of renowned academic partners and companies with expertise in Regenerative Medicine and DNA methylation. The company is based in Berlin, Germany.
REGENERATIVE MEDICINE employs biological substitutes for the replacement and healing of damaged tissue or failed organs. Currently, such approaches are used e.g., to restore the immune system in cancer patients by providing blood-forming stem cells (from bone marrow) or to treat knee injuries by transplanting cartilage cells grown in the laboratory. Other cells, such as pancreatic cells and neurons, to treat diabetes and Parkinson’s, respectively, are currently being developed and might be available in the future.
However, this new class of medicines, consisting of “living” cells, poses huge challenges to product quality assurance. For this, cell products need to be pure and innocuous. This is especially so, since the prime complication of any engineered cell product is the emergence of unwanted side products, such as inappropriate, in particular malignant, cell types. Since most cells are superficially similar, the main task is to provide specific and sensitive discrimination between target cells and potential contaminations. Such discriminatory power must be provided by a quality control (QC) tool. The introduction of standards for QC tools for cellular therapeutics by the regulatory agencies, such as FDA and EMEA, are currently pending.
Since Epiontis’ DNA methylation fingerprints are specific to cell types, our technology is unsurpassed in assuring their identity, purity and potency. It should therefore soon be adopted as the gold standard of quality control in regenerative medicine.