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Innovative solution for maintenance and storage of Biospecimens at Room Temperature

Periodic Reporting for period 1 - Biotem (Innovative solution for maintenance and storage of Biospecimens at Room Temperature)

Reporting period: 2019-05-01 to 2019-10-31

Biospecimen storage has evolved greatly in terms of complexity and demand in the last years. The number of samples stored by research laboratories, biobanks and biorepository facilities grow dramatically driven by emerging fields such as genomics and proteomics.

Use of ultra-low temperatures freezers (-80ºC) for DNA, RNA and plasma storage, and liquid nitrogen tanks (-180ºC) for storing viable cells require continuous energy or liquid nitrogen supply to keep these samples stored, resulting in a significant environmental and monetary cost source on a long term nowadays. To this, we shall add the costs of equipment maintenance, replacement, and working backup systems to minimize potential losses. Moreover, freezers release enormous amounts of heat which need to be compensated with air conditioning continuously working in the freezer rooms, adding to the overall energetic cost of sample storage. In addition, freezers are very inefficient in terms of space; the thick walls and the mechanical parts, which account for a significant part of the volume occupied by these devices, and the need for leaving free space between units result in a low effective space used to sample store, resulting in the need for very large storage rooms, not always available and costly to build.

300K is a high-tech start-up devoted to developing efficient solutions for storage of biospecimens, based on a patented solution using lyophilization. 300K arose with the aim of commercializing the technology developed within the Spanish DNA National Bank (DNANB), which comes from the uncovered necessities and shortcomings stated above. Users which are currently using low and ultra-low technologies for biospecimens conservation are demanding sustainable and economic alternative solutions and 300K fills this gap.

The overall objective of the Biotem project (SME Instrument Phase I) is to obtain relevant information regarding user requirements, market acceptance, marketing strategy, identification of supply chain partners for implementation and scale-up, and design study.

The information collected during the Biotem project has been analysed and incorporated in an updated business plan. The conclusion of the action has been that the project shall continue once the feasibility and commercial success have been confirmed. In fact, some relevant figures such as Internal Return Investment and personnel recruited have grown when compared with our initial business plan.
During the Biotem project, 300K has performed the several tasks with the objective of update our business idea. Following we provide a summary of the activities carried out.

Task 1- Validation of market feasibility, focused on colleting valuable feedback from stakeholders. The goal was to validate our initial hypotheses regarding our business idea. We have met with 37 potential customers from 14 countries in different fields which have confirmed that our innovative approach can revolutionize the current way of storing biological samples. We have identified among those potential customers, some willing to become early adopters of the technology as soon as we can deliver it.

Task 2- Validation of technical feasibility, we have analysed potential impact and technical viability of further modifications on current prototypes, mainly based on feedback of tasks 1 and 3. Every potential marketable product has been assessed and technical feasibility ensured, building blocks of our complete solution.

Task 3- Analysis of IP and legal/regulatory, the work on this task has been focused on continuous management of potential IP and study of applicable regulations in order to commercialize our solution. We have identified protectable IP related to designs, and study of relevant regulations to commercialize our solution in European Union, and main markets. Identification of other recommended certifications such as ISOs and sustainability label has been also performed.

Task 4- Partner search, was focused on identifying, contacting and selecting key partners for the implementation of the next phases of the project. We have searched and contacted partners in order to build a sustainable supply chain for the development and manufacturing of our products.

Task 5- Validation of economic feasibility, most of the information collected in the previous tasks have been used to update the financial data and the business plan of the project. A seven-year business plan includes two years for products development and five years. Key indicators such as Internal Rate of Return, profit and sales have significantly increased after recalculation, confirming our initial hypothesis of business feasibility and viability.

As a summary conclusion, direct contact with potential customers have confirmed a clear interest in our technology for long term storage of biological samples. Valuable feedback obtained from them allowed us to better understand their necessities and changes to be adopted. Those changes have technically assessed, and feasibility confirmed. In addition, we have found new IP elements of our proposed solution, which will be protected, in order to differentiate from potential competitors, building a very strong IP position. We have confirmed and quantified availability of key providers in order to cover the whole supply chain for product development. Finally, all those elements have been included in an updated business plan which confirmed the economic feasibility of our business idea.
As previously commented the current state-of-the-art the is the use of freezers, ultra-low temperatures freezers and liquid nitrogen tanks, subject to the type of biological sample to be stored. Long-term maintenance of frozen samples results in critical environmental impact. Our complete solution based on lyophilization will have an important impact reducing energy consumption and decreasing fossil fuels consumption. In addition, our room temperature storage solution will contribute to reducing biological sample loss and degradation risk associated to freeze based technologies.

The efforts carried out during the project, allowed us to update our business plan, with recalculation of key socio-economic figures including a forecast of turnover compound annual growth rate, over 60 % in a five years period after product development and ready for commercialization, and an employment compound annual growth rate estimation, over 10% for the same period of time.

Our contacts with potential customers, also permitted to confirm and design a plan to validate of our technology among early adopters across Europe. This pre-commercial validation will boost the visibility and advantages of our technology through the scientific community.
Flyer presented at Spanish Biobank Congress, Valencia, October 2019