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AutoMTP

Automated Mass Tissue Production

Projektbeschreibung

Es ist allgemein bekannt, dass neun von zehn Arzneimittelkandidaten die klinischen Studien während des sehr teuren und zeitaufwändigen Entwicklungsprozesses nicht erfolgreich durchlaufen. Dies wird durch kritische Probleme während vorangegangener präklinischer Studien verursacht, bei denen die Ergebnisse der Wirksamkeits- und Toxikologieanalysen nicht die tatsächliche In-vivo-Situation in einem menschlichen Körper widerspiegeln.
Der Stand der Technik zur Erprobung neuer Behandlungen und Substanzen im Zuge von präklinischen Analysen basiert hauptsächlich auf ethisch bedenklichen Tierversuchen und physiologisch fragwürdigen in vitro 2D-Zellmodellen. Obwohl 3D-Gewebemodelle weit verbreitet sind, führen ihre Komplexität und Inkonsistenz im Aufbau zu großen Herausforderungen in Bezug auf Reproduzierbarkeit und Standardisierung. Zudem stehen die Kosten für solche Modelle in einem unangemessenen Verhältnis zum Nutzen für den Kunden (Pharma/CRO).
Unter Berücksichtigung der oben genannten Aspekte wurde das größte Problem während der Arzneimittelentwicklung als die sogenannte „Evolutionslücke“ von Tieren in den Menschen identifiziert.

Das vorliegende F&E-Projekt befasst sich mit diesem kritischen Schritt und zielt auf die Beseitigung der „Evolutionslücke“ durch die Einführung standardisierter in vitro 3D-Gewebe für respiratorische Anwendungen ab. Aufgrund der innovativen Technologie der „Vertikalen Zellkultivierung“ in Kombination mit einer „Zelloberflächen-Charakterisierung“ (beide entwickelt und im Besitz der Konsortialführers LifeTaq) sind wir das erste Unternehmen weltweit, das Robotersysteme für die automatisierte Kultivierung von scaffold-basierten 3D Geweben anbieten kann .

Das Konsortium strebt eine enge Zusammenarbeit von Nutzers (G.ST, OFI), Anbietern (LifeTaq) und Software-Entwicklern (BS) für die Entwicklung maßgeschneiderter Gewebeskultivierung für die In-vitro-Modellierung von menschlichem, respiratorischem Gewebe und die Implementierung des Kultivierungsprozesses in ein automatisiertes Robotersystem für reproduzierbare Kultivierungsbedingungen an.

Abstract

It is a well known fact that nine out of ten drug candidates do not pass clinical trials during the very expensive and time-consuming drug development process. This is caused by critical issues during antecedent preclinical trials where efficacy and toxicology analyses results are not reflecting the actual in vivo situation in a human body.
The state-of-the-art for testing new treatments and substances in the preclinical stage is mainly based on ethically questionable animal trials and physiological disputable in vitro 2D cell models. Although 3D tissue models are widespread, their complexity and inconsistency in the assembly lead to major challenges in terms of reproducibility and standardization. Additionally, the costs for such models are unreasonable in comparison to their benefit for the customer (pharma/CRO).
Taking the above mentioned issues in consideration, the biggest problem during drug development was identified as the so-called 'evolutionary gap' from animals into humans.

The proposed R&D project addresses this critical step and aims for an elimination of the 'evolutionary gap' by introduction of standardized in vitro 3D tissues for respiratory applications. Due to the innovative technology of 'Vertical Cell Cultivation' combined with a 'Cell Surface Characterization Analysis' (both developed and owned by LifeTaq), we are the first company worldwide able to offer robotic systems for the automated cultivation of scaffold-based 3D tissues.

The consortium aims for a close collaboration of users (G.ST, OFI), providers (LifeTaq) and software developers (BS) for the development of customized tissue cultivation for the in vitro modelling of human respiratory tissues and the implementation of the cultivation process into an automated robotic system for reproducible cultivation conditions.

Endberichtkurzfassung

Due to the AutoMTP project a innovative approach to mass produce in vitro models for preclinical drug development was evaluated by early adoperts and stakeholders of the industry. With the support of the FFG, all partners were able to finance new jobs and increase visibility of their valubale work to reduce animal testing in line with the ongoing transformation of drug testing according to the global regulatory changes (3Rs, FDA Modernization Act 2.0 & 3.0, Bill S-5 etc.).

In detail, the consortium leader LifeTaq was able build a team of eleven highly skilled automation experts, lab technicians and programmers combined with a solid management to enable the validation of the AutoMTP unit, an automated system for the high throughput production of human in vitro models with a focus on respiratory tract as a first proof of market application. The machine was built by the end of project year 1 in August 2024 followed by the production of in vitro models for the pre-validation of the project partner OFI and the testing of viral infection by G.ST Antivirals. This was supported by BioSistemika with its contribution of software to plan, monitor and analyze the in vitro model generation inside the AutoMTP unit. The result is a market-ready concept for the mass production of transwell-based cell cultures for the pharma and CRO industry. In addition, new customer segments were identified in tobacco industry as well as partnering opportunities with biotech companies already working in the field of respiratory in vitro models. As a result of this collaboration and joint effort, several business cases could be generated and will be executed beyond the project end with users from the big pharma, CRO and biotech industry as well as the acdemic field especially in Austria but also over the entire DACH-region.

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