The invention consists of a computational method for modelling biological systems intended for automatic culture processes. The models that follow the proposed method allow to generate the culture protocols to guide the system towards specific objectives.
Stato del brevetto
Numero di priorità
Data di priorità
The global market for regenerative medicine is currently $28.6 billion, and is divided into three main segments: tissue and organs ($14.8 billion), gene therapy ($3.1 billion) and stem cells ($10.7 billion). It is estimated that in 2025 the global size of the regenerative medicine market will reach a peak of $50.5 billion, thanks to a CAGR of 12.04%.
The proposed solution follows a B2B approach, aimed at enhancing the R&D processes of organizations in the regenerative medicine sector with computational approaches. At the moment, more than 980 companies are present globally in this sector, which are potential targets for the proposed solution.
At the moment, the biofabrication of tissues and organs for regenerative medicine has limitations:
Low product quality
The limited understanding of biological complexity makes it difficult to replicate the structural and functional complexities of organs and tissues. Most of the products on the market are based on cells and molecules produced by cells.
The differentiation protocols for stem cells organize the stimuli over time. As a result, they control biofabrication only at the functional, not the spatial level. They are in fact targeted to products based on cells and molecules. Moreover, the protocols derive directly from knowledge about the in vivo development process, and are empirically improved.
Biofabrication is limited to laboratory processes, which for their manual component are not scalable to later stages of industrial production. The procedures are not standardized nor easily shared.
The above factors make the R&D process inefficient, slow and at high risk of failure. This slows down the go-to-market of companies, whose products are biological systems, so it is not possible to patent them. These aspects make them undefensible on the market.
Limiti attuali tecnologie / Soluzioni
Digitization and automation are employed to make the overall R&D process more traceable, reproducible and efficient. The optimization of culture protocols follows Design of Experiment (DoE) paradigms, aiming to make existing protocols more effective, focusing on functional aspects only, and not on the processes that present structural complexities as well, such as the biofabrication of tissues and organs for regenerative medicine. Structural aspects are dealt with in the design of structures for bioprinting, which do not deal with biological and functional aspects though.
Cultūrā is different from competitors for the type of impact it has on the biofabrication process, and for the degree of structural complexity of the products it targets. Mogrify computationally generates groups of factors for cell differentiation, but considering only functional aspects, while our solution also considers structural aspects, and manages the different phases of differentiation.
Ginko Bioworks modifies microorganisms to improve industrial biotechnological processes. It aims to improve the R&D process yet using a different strategy, based on genetic engineering.
Other computational approaches are solutions adjacent and potentially synergistic with ours, for example Synthace, partner of Microsoft Station B, a platform to digitize the entire experimental laboratory process, RoosterBio and Riffyne Orgenesis, which are automation services, relying on digitization and process design.
Tecnologia e nostra soluzione
Cultūrā is a computational method to generate new, improved and suitable biofabrication protocols for complex products such as tissues and organs, starting from existing knowledge on the biological system and the culture process.
The resulting model allows to highlight both the properties emerging from the interaction of the different biological entities that make up the system, and the characteristics of the culture process. Through suitable models, the proposed method allows to automatically generate crop protocols aimed at achieving specific objectives.
The protocols manage both functional and structural aspects, to biofabricate tissues and organs.
The protocols are digitized, therefore traceable, sharable and standardized.
The generated protocols are adapted to the specific process and product, and enable industrial scale-up. They are potentially completely innovative compared to existing ones
The R&D process is innovative, efficient and less risky, facilitating compliance and easy adaptation to regulations and speeding up the go-to-market, making companies in the regenerative medicine market more competitive
Phase I – MVP development
Present – 2021: IP Protection : Two Italian patent applications and one PCT extension (with the support of TTS Polito, DAUIN and SysBioGroup). Technological validationMVP Prototyping, proof-of-concept in silico, in vitro validation. Business Validation: Market analysis, customer validation with original data and pre-acceleration. Go-to-market strategy: Target segment selection, positioning, networking with potential partners and future customers
Phase II – Pre-launch: 2021 – 2023. IP Protection: Strengthening IPR strategy around the final MVP and product design. Product development: Increase of product TRL with joint development activities with partners in the regenerative medicine market and in vitro tests on laboratory and industrial processes. Business development: Network solidification and marketing campaign.
Phase III – Launch: From 2024. Marketing campaign: Expansion of the network to potential customers and execution of the marketing campaign for the target segment. Go-to-market: Market entry and start of sales activities. Adaptation to the market: Flexible organizational structuring in response to market demands.