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The industrialization and market entry of a novel bioengineered hydrogel grid to standardize stem cell cultures for precision medicine.

Periodic Reporting for period 1 - Gri3D (The industrialization and market entry of a novel bioengineered hydrogel grid to standardize stem cell cultures for precision medicine.)

Reporting period: 2018-03-01 to 2018-08-31

SUN bioscience is commercializing Gri3D, the first 3D culture platform designed and dedicated to stem cell organoids. Organoids are the new hot topic in science. They are stem cell derived tissues, that mimic functions of organs. They can be multiplied without changing the DNA of the cells and are therefore a true representation of the entire genetic and functional machinery of patients and their diseases. Organoids serve as ideal testbeds for pharmaceutical drug discovery and clinical diagnostics. Organoids could serve as the missing link between genetic predictions and the patient to make personalized medicine a more affordable and more widespread reality. However the use of organoids is limited by lack of standardized technologies to fabricate them. Gri3D was developed to overcome these limitations. More than 500 Gri3D prototypes have been recurrently tested by different stem cell researchers at universities and companies in the Europe and North America over the last 18 months. First sales have been completed on the Gri3D prototype. In order to fulfill demand and quality standards, a process was developed to move Gri3D from manual to automated production as there was no industrial off-the-shelf manufacturing solution available for hydrogel micromolding. The main objective of this feasibility study was to address the technical, commercial and financial strategies needed to compile a solid business plan for SUN bioscience’s future developments.
The first objective of this feasibility study was to set up the production line for Gri3D, this included the custom modification of a liquid handling robot to accommodate for the hydrogel structuring process that is unique to Gri3D. In combination with custom designed multiwell base plates, the production process for Gri3D is reduced from ten hours of manual work down to thirty minutes. This twenty-fold increase in production throughput is the stepping stone to achieve the target of 10’000 units Gri3D produced annually.
The second objective of this feasibility study was the production of 1’000 Gri3D units. Limited by the availability of sufficient custom multiwell base plates from our external manufacturers, we could only reach the production of ca. 100 Gri3D units.
These 100 units were tested and used for drug screening campaigns internally and externally. Ten new clients were acquired during the course of this feasibility study, including pharmaceutical industry groups who currently evaluate the technology for large-scale screening campaigns requiring 1’000 units annually.
Gri3D was presented at various industry-related conferences and fairs including Biointerfaces International 2018 in Zurich, EMSO 2018 in Cambridge, UK and the 2018 Basel Life MipTec Exhibition. The outcome of these conferences was a network of potential new clients, especially non-academic clients, who will be our focus for the coming 12 months to make SUN bioscience a sustainable business.
The project will continue. The strategic vision remains very close to that described in the initial proposal. The aim of SUN bioscience is to drive adoption of organoids by providing technologies to standardize organoids across industries and to make them user-friendly. Gri3D has received tremendous attention over the past months and the feedback has been throughout positive. The first goal for SUN bioscience is to commercialize this technology and to transform it into a profitable business unit before focusing on providing standardized organoid assays for clinical diagnostics and pharmaceutical drug discovery screenings. Gri3D is currently used for the validation of a new diagnostic test for Cystic Fibrosis in which patient-derived organoids are grown on Gri3D to allow for automated culture and analysis of the organoids under different approved Cystic Fibrosis treatments to group patients into responder and non-responder groups. Treatment efficacy is a tremendous problem for Cystic Fibrosis, as new life-saving CF medications only work for some of the patients and because of that there are major issues regarding availability and reimbursement. And where no efficient treatments can be found, the same organoid screening test can be used for the development of new medications. The long-term goal of SUN bioscience is therefore to develop this Cystic Fibrosis and other disease-specific organoid tests on Gri3D.
Gri3D for standardized organoid screenings