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Foto: Cytes Biotechnologies.

Cytes Biotechnologies starts a project to predict drug toxicity by 3D bioprinted human liver models

Cytes Biotechnologies, a UB spin-off located in the Barcelona Science Park, and the French company CTIBiotech are starting the Hepnalysis project aiming to produce 3-Dimensional bio-printed human liver models to better predict drug toxicity. This technology will enable better prediction of toxic side effects and save up to 30% on drug development costs.

Liver damage caused by prescription and over-the-counter drugs is an increasingly important medical, scientific and public health problem. Idiosyncratic drug-induced liver injury (also known as drug-induced liver toxicity or DILI) is a major problem in modern hepatology, which is often under-diagnosed. Yet it is the most common cause of acute liver failure (over 50%), is the primary reason for withdrawal of drugs from the market (around 30%) and is a major source of drug-related hospital admissions. Moreover, drug-induced hepatitis is estimated to affect between 1 and 2 million patients per year worldwide. More than 70% of patients waiting for a liver transplant will not find a compatible donor.

Thus, clinicians and pharmaceutical companies are currently looking for models that will allow optimal and early evaluation of the toxicity of drug candidates. However, the high failure rate of drugs in clinical trials is mainly attributed to problems related to their pharmacokinetic profiles, their toxic side effects also known ADME-TOX (absorption, distribution, metabolism and excretion properties and their inherent toxicity). In this concern, the overall amount spent on R&D initiatives in the pharmaceutical/biotech sector has increased from around €118 billion in 2008 to €150 billion in 2018 with 98% of drug candidates not being released on the market.

The added value of the Hepnalysis project

The Hepnalysis project aims to produce predictive human liver bioassays – with a high degree of customization during the preclinical phase, allowing a considerable reduction in development costs and time as well as the number of animals required for preclinical trials.

This technology will make it possible to reduce the number of drugs withdrawn from the market and to support safer drug development, thus saving tens of millions of euros in development costs thanks to the early detection of hepatotoxicity from drug candidates.

By entering this agreement with the support of the French Government, BPIFrance, The Catalonian government and Acció (agència per a la competitivitat de l’empresa), European cooperation is at its most effective with the leading biotechnology companies CTIBiotech and Cytes Biotechnologies combining strengths to advance tomorrows medicine.

“CTIBiotech is excited to combine its expertise in Human tissue 3D-Bioprinting with Cytes know-how in liver bioassay development to nurture the next generation of liver toxicology evaluation for better and safer drug development with a synergistic state-of-the art high throughput production technology platform. This European collaboration will accelerate both companies’ development for the benefit of human health.” explains Professor Colin McGuckin, President and Chief Scientific Officer at CTIBiotech.

“Cytes Biotechnologies is delighted to have the opportunity to develop the Hepnalysis project and create novel highly functional liver cell models to contribute to the research of new drugs. We expect great things from the combination of Cytes Biotechnologies expertise in liver cell isolation and CTI’s knowledge in 3D-bioprinting technology”, explains Dr Natalia Sánchez, R&D Director of Cytes Biotechnologies.

Photo: Cytes Biotechnologies.

Design and production by 3D-Bioprinted human liver models for safer drug development

By combining R&D excellence in cell biology, hepatology, tissue engineering and 3D Bioprinting, the companies CTIBiotech (France) and CYTES (Spain) have developed the Hepnalysis technology building blocks for large-scale production of reliable, robust, reproducible, predictive, personalized human liver models in 3D, in sufficient quantities to accelerate the development of safer drug candidates, by adapting their combined production process.

Particularly, Cytes Biotechnologies has wide expertise in cell derived products and specifically in hepatic cells for ADME−Tox studies, using the latest technology in primary cell isolation, cryopreservation, and culture to provide the best products and services to our customers, therefore is responsible for isolation of liver cells from human livers and the definition of culture media.

As for CTIBiotech is responsible for the 3D printing of liver cells and the definition of the cryopreservation process, due to its expertise in the development in production of predictive models of human tissues and cells for biomedical and pharmaceutical, and great knowledge of 3D bioprinting technology.