Next Generation Electro Membrane Extraction (EME) for Sample Preparation

Det er forventet et paradigmeskifte fra de store aktørene innen prøveopparbeidelse fordi det er så mange forskjellige løsninger/protokoller som benyttes i dag. Nesten alle metodene bygger på at prøven "filtreres" gjennom flere prosesser og dermed følger fare for tap av prøven, med påfølgende usikkerhet rundt analysesvaret, som faktisk bestemmer liv eller død i ekstremtilfeller. Prosjektet har utviklet en prøveopparbeidelsesteknologi for basiske og sure legemidler i blod som revolusjonerer nåværende prøveopparbeidelse innen kliniske analyser. Teknologien benytter strømledende plastmaterialer i en form (prøvebeholder) som er identisk med nåværende industristandarder, for å senke terskelen for at den tas i bruk. Legemidlene befinner seg etter ekstraksjonen i rent pH justert vann. Dette er skånsomt og kostnadsbesparende for avansert instrumentering som har svært dyre serviceavtaler. Det er publisert flere vitenskapelige artikler som viser at teknologien er jamgod eller bedre enn eksisterende teknologi. Teknologien scorer høyt på internasjonale «grønne» rangeringer, og den gir nær 100 % gjenfinning av legemidler fra blod, samtidig som den ikke er destruktiv for prøven. Prøven kan dermed analyseres på nytt dersom det er nødvendig, og dette er unikt. Teknologien er beskyttet av tre innvilgede patenter og det er utarbeidet patentsøknad for 96 brønnsformatet. Prosjektresultatene har ledet frem til valg av et egnet strømledende materiale, geometri på vialene som det er utviklet to størrelser til 100 uL og 300 uL. Det ferdigstilles et 12 posisjons kommersielt instrument i januar 2024 som lanseres Q2 2024. Instrumentet er satt sammen av komponenter fra norske firmaer samt to firmaer fra europeiske land. En Dr.grad oppnås 8.desember 2023 (disputasdato). Avhandlingen er godtatt.

Scientifically the project has “produced” one PhD, 4 articles in per reviewed journals, and several presentations in media (articles) and at conferences (oral presentations). Commercially GTS, through its daughter company Extraction Technologies Norway AS (ETN), will finalize the instrument in January 2024 through subcontractors. All needed consumables are produced by industrial partners in Norway and other European countries. The first product will be a kit containing the instrument and needed consumables, and it will be presented during Analytica in Munich 9-12.April 2024. Sale will start immediately after this exhibition. ETN has held one soft capital raise in August 2022, and plan for a new one in January 2024. Then there are plans for attracting one or more external investors during Q1-Q2. The mother company GTS established a new daughter company named G&T Septech LLC in Pennsylvania, USA in December 2022. GTS has filed a “petition for a nonimmigrant worker” (I-129) with the USCIS. GTS has sold technology and competence for packing miniaturized HPLC columns to a Xxxx owned subsidiary in Pennsylvania, USA and Roger Trones is already in the process of fulfilling the contract that runs until 31.December 2024. In parallel he is working on a route for funding a US operation that will be responsible for the commercial introduction of the EME instrument (kit) in the US market. NDA is in place with Actuated Medical https://actuatedmedical.com/ for qualifying the instrument for the US market, and initial discussions with Ben Franklin Technology Partners https://cnp.benfranklin.org/ related to funding have started.

Electromigration of ions across an oil membrane is termed Electromembrane Extraction (EME). G&T Septech AS (GTS) is commercializing this Norwegian invention as a sample preparation technology under an exclusive license. The original novel idea is to use electricity to migrate charged drug molecules from the donor solution in a glass vial, through a supported hydrophobic liquid membrane (SLM), to the water solution of the acceptor vial. GTS was industrializing this initial idea, by patenting and prototyping conductive polymer EME vials. The main objective is to deliver reproducible and improved conductive EME vials, instrumentation, and SLMs, for future target molecules. To design those vials, GTS needs to optimize the mass transfer through the membrane by modeling the current flow. In addition, optimal conductive materials and a manufacturing process of EME-instrumentation for single, 96w & 384w EME vials will be selected. For extraction of e.g. peptides, carbohydrates, and nonpolar biomolecules, new types of supported liquid membranes with protocols must be invented. One of the most critical R&D challenges is to model the electric field distribution through the SLM to get the best vial design. The next challenge is to optimize membranes for the next generation of targets by focusing on the desired physical and chemical properties of the SLMs. Sample preparation still remains a significant bottleneck in research, crucial to the success of downstream applications. EME can efficiently extract drug molecules from dirty samples, typically from urine, blood and saliva samples, and it is suited for the high throughput sample preparation market. The potential of this market is worth 7.2 Bn USD by 2021. EME may improve the sample preparation for both HPLC/GC and the new acoustic mist ionization-MS techniques and reduces the maintenance costs of those instruments. It gives a clean extract from complex solutions, being non-destructive for the original sample.