TATAA Biocenter and pivotal research project will establish Sweden as a major leader in ATMPs

As part of a 320m SEK investment program in biological therapies, one research project will play a pivotal role in making Sweden a major leader in Advanced Therapeutic Medical Products (ATMPs) by 2030.

Huge investments are being made in the development of cell-based therapies, and a new Vinnova funded project called Transfer learning across technologies for Advanced Therapy Medicinal Products (ATMPs), starting in Gothenburg, will spearhead this investment.

ATMPs are therapies based on biological materials, such as genes and cells. They are the latest modality in drug development and will be able to cure diseases in a completely different way compared with previous methods.

The collaborative project focuses on the development of an AI-based Quality Control (QC) method of cells for ATMP manufacturing, adapting it to industrial requirements and needs. It involves five project partners, Takara Bio Europe, TATAA Biocenter, MultiD, RISE and the University of Skövde, who all have strong needs for improving methods of QC testing for ATMP.

The project will develop a method that is more cost-effective, as it will save time and resources.

Limitations of current QC methods
QC methods for quality control of cell material today are inefficient, labour and resource intensive and rely on univariate data analysis. There are also difficulties in detecting poor cell quality early in the process, which can lead to higher costs.

The project will develop a new AI-based QC method that uses gene expression patterns to classify cells. Two different types of data will be used, RNA sequencing data and qPCR data. By utilizing sequencing data for training the model and then fine-tuning the model with qPCR data, this new method will be more accurate, can be carried out early in the process (and repeatedly during development) and will be more cost-effective.

The project group have complementary backgrounds and skills. Takara Bio Europe is an expert in stem cell technologies, GMP and ATMP development. RISE has expertise in single-cell qPCR and validation. TATAA Biocenter has considerable expertise in business development and are pioneers in single-cell technology. MultiD contribute to software development and the University of Skövde provide skills in AI, bioinformatics, and large-scale data analysis.

The 2-year project starts in October 2022 and has long-term plans for commiseration offering an opportunity to develop a service for QC testing of ATMPs.

Commercialisation of the AI QC Method
The method will be implemented in the existing software, GenEx (developed by MultiD and distributed by ThermoFisher) providing access to a worldwide market. Longer term, the method has the prerequisites to become a recommended QC method that can be adapted for various ATMP applications.

Results from the project will also identify new stem cell biomarkers, which can be commercialized in a stem cell assay and be included in TATAAs portfolio of assays.

Vinnova is making major investments in ATMP with the goal that Sweden will become a major leader in ATMP by 2030. This project will be an important piece of the puzzle and will contribute greatly.

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