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Innovative tag system providing affordable time-temperature quality control of individual temperature sensitive products

Periodic Reporting for period 1 - T-TAG (Innovative tag system providing affordable time-temperature quality control of individual temperature sensitive products)

Reporting period: 2016-10-01 to 2017-02-28

Temperature-sensitive biopharmaceutical market amounting $225 billion 2014, over $35 billion are lost due to temperature excursions in deficient cold chain logistics. Maintaining cold chain is especially challenging in the last mile because products are scattered and there are many factors that are difficult to predict. In this line is focused the TTAG project developed by our company SCRIBA Nanotechnologie. We propose the first low-cost Time Temperature Indicator (TTI) for cold chain logistics with simple digital readout. Our system uses thermosensitive materials that undergo an irreversible change in their optical contrast when exposed to particular temperature ranges, allowing the monitoring of thermal excursions between -81 to +41ºC with a resolution of up to 30 minutes during 6 months. TTAG is the unique solution in the market that allows, by means of our developed Nanoviewer App, the automatic and digital read out of thermal exposures. Moreover, the En-Tag integrated with our TTAG label allows drug serialization at granular level as a means to avoid anticounterfeiting meeting the latest needs of governmental and regulatory bodies and ensuring the highest patient safety. According to the panel of experts consulted during the Feasibility study (November-February 2017) the unique approach of TTAG in the market will contribute to overcome the major limitations of actual thermochromic solutions: lack of resolution, readout automation and lack of serialization. Thanks to TTAG, Scriba Nanotechnologie will become a European leader in the field of time temperature indicators system for cold chain logistics, reaching at least 4 of the top ten biopharma players across EU that will generate 22,6 M€ in cumulative revenues by 2024 (ROI of 4,2).
We conducted a Feasibility study to guarantee the techno-economic viability of our project. We performed a technical plan, in which we defined the customizable TTAG features, designed the mass manufacturing machine and prepared a detailed work plan for Phase 2, including risks. We carried out a commercial plan and a Freedom to Operate Analysis. In the former we developed a detailed market analysis, verifying that our target market (biopharmaceutical cold-chain logistics market) shows potential for growth (forecasted at €17 billion by 2020). This and the recent Good Distribution Practices by the EC are expected to favour the deployment of TTAG, for which we prepared a detailed exploitation and dissemination strategy. Our updated FTO guaranteed that TTAG ha freedom tooperate. Finally, we prepared a financial plan, in which we reviewed all forecasts, established production costs and pricings: TTAG will enable us to achieve revenues of €10.4 million in Q4 2023.
TTAG will deliver a TTI label that thanks to its automatic readout system and increase resolution will contribute to reduce the economic cost of damaged products and avoid health complications due to the administration of degraded drugs because of thermal excursions. Currently, thermal excursions are determined by the logistic operator who visually decides whether a thermochromic label has changed its colour. TTAG will also contribute to boost the growth of our company, both in economic and headcount terms.