Periodic Reporting for period 2 - SaPher (Disruptive Nano Photonics-based bio sensing platform for simultaneous analysis of multiple allergens in food industry)
Période du rapport: 2022-01-01 au 2023-12-31
Detecting and quantifying allergens in food is essential to protect the food-allergic population, but this can only be accessible if standardised control plans and affordable testing equipment is available. It is therefore our objective to, on the one hand elaborate best practice guidelines as a reference procedure enabling the food producing companies to identify where and how many tests will be required to ensure proper labelling; and on the other hand, the industrialization of our innovative rapid and low-cost SaPher biosensing technology. To reach the food allergen testing market, we need to raise SaPher´s technology up to TRL9. So, we aimed the development of the full set of cartridges to cover the 11 food allergens, industrialize and demonstrate both technology and guidelines with different target end-users.
Partners involved in Sapher have performed their tasks in accordance with the Grant Agreement until (approximately) April 2023. Since them the performance of Lumensia was diminishing due to their financial situation, which was derived from the acquisition procedure of their mother company (DAS Photonics) by a big company. In the view of the coordinator, the project was being nicely executed until an unexpected situation “strangled” Lumensia financially. Since this kind of project (FTTI) was aimed at helping LUME to bring their platform to the market, it made no sense to continuing the project unless Lumensia was replaced by the company acquiring DAS Photonics, which could not be achieved. Therefore, we proceeded to the project termination.
WP1. The main activities during this period were the supervision of periodic online meetings and the termination of the project due to Lumensia financial situation.
WP2. the “Practical Guidance on the Application of Food Allergen Quantitative Risk Assessment” was published, ending task T2.3.
WP3. UPV-NTC acquired mass-production fabrication equipment improving results: a wafer can be manufactured within 2 days with a yield of 95% (previous conditions: 1 week and 70%). A first batch of 2000 assemblies were fabricated in M24, and a second batch of 2000 assemblies manufactured by mould injection. At M24, 2000 PICs (from UPV-NTC) and 2000 microfluidics cartridges (from ChipShop) were delivered to Lumensia facilities and assembled. 1000 units were used with possible customers (Spanish food companies), while the other 1000 units were internally used for method development. UPV-NTC fabricated 2000 more PICs.
WP4. Lumensia prepared biosensors against Gluten, Milk proteins, Egg proteins by means of INGE provided antibodies and biosensors against Soya proteins, Peanut proteins and Celery proteins employing commercial antibodies. INGE has also developed monoclonal antibodies for mustard and almond. LUME developed tools and methodologies to implement the functionalization process for industrial batches.
WP5. Tasks T5.1 T5.2 T5.3 and T5.4 were finished. Lumensia was working on the selection of feasible matrices to include in the certification process as well as in the adaptation of the internal procedures to the new AOAC requirements. Remarkably, Lumensia achieved the CE mark external certification.
WP6. Task T6.1 was finished by DTU, defining the needed specifics of the Sapher capabilities, dates for demos fixed and protocols for its demonstration. Tasks T6.2 T6.3 T6.4 and T6.5 have not been implemented due to the situation with Lumensia.
WP7. Communication and promotion materials, including newsletters, website and intranet, were created. In task T7.2 an online demonstration of the technology was done to Eurofins Food Testing UK. LUME updated the data management plan at M24.
WP8. Lumensia defined the commercial interest per consortium members, registered the Sapher trademark and logo, and visited several food companies to gather assessment needs. As part of de Business Plan elaboration task, the in-deep study of the investment needs to be raised in the upscaling of the SAPHER production was done. Lumensia contacted and visited stakeholders in the food.
WP9. During the period reported, INGE used experimental animals for the production of fish, almond and mustard antibodies. All of them hold correspondent authorizations and seals of approvement, always considering the principle of 3R.
WP1. The main activities during this period were the supervision of periodic online meetings and the termination of the project due to Lumensia financial situation.
WP2. the “Practical Guidance on the Application of Food Allergen Quantitative Risk Assessment” was published, ending task T2.3.
WP3. UPV-NTC acquired mass-production fabrication equipment improving results: a wafer can be manufactured within 2 days with a yield of 95% (previous conditions: 1 week and 70%). A first batch of 2000 assemblies were fabricated in M24, and a second batch of 2000 assemblies manufactured by mould injection. At M24, 2000 PICs (from UPV-NTC) and 2000 microfluidics cartridges (from ChipShop) were delivered to Lumensia facilities and assembled. 1000 units were used with possible customers (Spanish food companies), while the other 1000 units were internally used for method development. UPV-NTC fabricated 2000 more PICs.
WP4. Lumensia prepared biosensors against Gluten, Milk proteins, Egg proteins by means of INGE provided antibodies and biosensors against Soya proteins, Peanut proteins and Celery proteins employing commercial antibodies. INGE has also developed monoclonal antibodies for mustard and almond. LUME developed tools and methodologies to implement the functionalization process for industrial batches.
WP5. Tasks T5.1 T5.2 T5.3 and T5.4 were finished. Lumensia was working on the selection of feasible matrices to include in the certification process as well as in the adaptation of the internal procedures to the new AOAC requirements. Remarkably, Lumensia achieved the CE mark external certification.
WP6. Task T6.1 was finished by DTU, defining the needed specifics of the Sapher capabilities, dates for demos fixed and protocols for its demonstration. Tasks T6.2 T6.3 T6.4 and T6.5 have not been implemented due to the situation with Lumensia.
WP7. Communication and promotion materials, including newsletters, website and intranet, were created. In task T7.2 an online demonstration of the technology was done to Eurofins Food Testing UK. LUME updated the data management plan at M24.
WP8. Lumensia defined the commercial interest per consortium members, registered the Sapher trademark and logo, and visited several food companies to gather assessment needs. As part of de Business Plan elaboration task, the in-deep study of the investment needs to be raised in the upscaling of the SAPHER production was done. Lumensia contacted and visited stakeholders in the food.
WP9. During the period reported, INGE used experimental animals for the production of fish, almond and mustard antibodies. All of them hold correspondent authorizations and seals of approvement, always considering the principle of 3R.
SaPher biosensing test platform will go beyond existing analytical techniques being the first certified technology enabling to simultaneously and automatically assess multiple food allergens with the highest sensitivity (μg/kg – ppb). SaPher will be introduced as a label-free detection technique, which contributes to be much cheaper and faster than existing alternatives. SaPher will provide testing results within 30 minutes, without the need of highly skilled personnel and at a market price of only 35€ per cartridge, being nearly 4 times cheaper than ELISA. Our key differentiation is that we will deploy a cheap, fast, easy to use and accurate allergen analysis device that will enable to comply with the novel best practice guidelines, reshaping the way in which food producers tackle nowadays allergen management.
Summary of Exploitable Results:
The main exploitable result is a whole biosensing platform. The results achieved in the project allow us to state that:
• The Sapher platform, including tunable lasers and photodetectors, operates as expected, and it is available at Lumensia offices.
• The silicon nitride PICs can be fabricated at low cost and high yield in the NTC-UPV clean room.
• The PICs can be functionalized with the right antibodies towards highly-sensitivy allergen detection.
Sapher’s technology works and Lumensia may exploit it if their financial problems are solved. Other companies could also make use of the Sapher platform. This reinforces the idea that the termination of the project in an unsuccessful way has not been caused by any technological or scientific issue. The technology is working but the Lumensia financial situation caused by external events has prevented us to complete the validation process.
Impact:
Sapher platform is technically operative and could ultimately reach the industrialization level as originally planned. The bankruptcy of Lumensia has prevented the realization of the final phase (validation) but this does not mean that technology is not worthless: all the members of the consortium share the idea that the Sapher platform could play a role in the field of allergen testing. Moreover, as Lumensia situation is not definitive (the company could be saved after acquisition of DAS Photonics by the Oesia group is completed), it may eventually happened that these activities could be retaken after some budget injection and recovery of the former Lumensia engineers (most of them are in DAS Photonics) meaning that the Sapher platform could make a real impact in the foreseen application.
Summary of Exploitable Results:
The main exploitable result is a whole biosensing platform. The results achieved in the project allow us to state that:
• The Sapher platform, including tunable lasers and photodetectors, operates as expected, and it is available at Lumensia offices.
• The silicon nitride PICs can be fabricated at low cost and high yield in the NTC-UPV clean room.
• The PICs can be functionalized with the right antibodies towards highly-sensitivy allergen detection.
Sapher’s technology works and Lumensia may exploit it if their financial problems are solved. Other companies could also make use of the Sapher platform. This reinforces the idea that the termination of the project in an unsuccessful way has not been caused by any technological or scientific issue. The technology is working but the Lumensia financial situation caused by external events has prevented us to complete the validation process.
Impact:
Sapher platform is technically operative and could ultimately reach the industrialization level as originally planned. The bankruptcy of Lumensia has prevented the realization of the final phase (validation) but this does not mean that technology is not worthless: all the members of the consortium share the idea that the Sapher platform could play a role in the field of allergen testing. Moreover, as Lumensia situation is not definitive (the company could be saved after acquisition of DAS Photonics by the Oesia group is completed), it may eventually happened that these activities could be retaken after some budget injection and recovery of the former Lumensia engineers (most of them are in DAS Photonics) meaning that the Sapher platform could make a real impact in the foreseen application.