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Precisely Patterned Nanofibers for High Performance Bioseparations

Periodic Reporting for period 3 - PURE (Precisely Patterned Nanofibers for High Performance Bioseparations)

Periodo di rendicontazione: 2023-04-01 al 2025-03-31

Bioseparation is a critical step in biopharmaceutical manufacturing. It employs polymeric adsorbents decorated with affinity ligands to increase the selective capture of target biological products. The EU-funded PURE project developed precisely functionalised adsorbents. The project has brought together an interdisciplinary team of leading scientists from academia and industry with expertise in biology, chemistry, computational modelling, materials science, bioprocess engineering and applied social sciences.
Biopharmaceutical drugs save lives and drastically improve well-being. The number of new bio-drugs approved or in pipeline is rising but only 1/4 of patients have access to them. Bioseparation is a critical step in biopharmaceuticals manufacture. Bioseparation processes have low productivity and are responsible for the environmental footprint and high cost of manufacturing. Only a radical change in purification technologies can reduce the environmental footprint of biopharma industry, and increase productivity, making biopharmaceuticals quickly accessible to all.
Scientific and engineering principles were combined to produce the new adsorbents, putting Europe in the forefront of sustainable and patient-oriented biopharma.
The new scientific knowledge and technological paradigm established in PURE have a wide window of opportunities. PURE revolutionizes the way advanced functional materials are thought today and enables new technological breakthroughs.
The project has been successfully implemented and achieved the expected deliverables and milestones. In more detail, the team focused on the bioproduction of reactive amino acids and on the design and production of affinity ligands. The ligands were immobilized on purification matrices and tested for binding and recovering pure and crude samples with target biotherapeutics. In these supports the ligands achieved 64-89% recovery of IgG from pure samples and 59-83% of IgG from crude samples. These results were benchmarked with commercially available chromatographic resins, showing that the in-house resins have comparable selectivity. Also, the first steps towards the production and characterization of novel adsorbents were made. The immobilization of affinity ligands in the new adsorbents was optimized. The functionalized adsorbents were tested both in gravitational and in automated systems (AKTA systems). In both systems, after optimization of binding and elution conditions, the novel adsorbents can capture and elute antibodies. As next steps include improvement of the binding capacity of the novel adsorbents.
The project has been presented through diverse platforms, e.g. radio, websites and youtube, and beneficiaries participated in conferences and scientific events to disseminate the project (https://pure-fetopen.eu/communication/(si apre in una nuova finestra)).

PURE has 22 scientific outputs (7 published articles published and 4 to be published soon and 6 thesis/dissertations published, 5 to be published soon) and 2 provisional patent applications. The PURE team has participated in 54 international scientific conferences (1 best communication award), 3 industry-oriented conferences, 4 workshops and 7 events other than conferences or workshops. PURE members also participated in many outreach activities, namely in public schools, Pint of Science, EXPO FCT and European Researchers’ Night (2020, 2022, 2023 & 2024).
The main communication channel of the PURE project is the webpage (https://pure-fetopen.eu/(si apre in una nuova finestra)) where all the information related with the project can be found as well as the PURE leaflet, the PURE newsletters, the 1st episode of #PURE_project In A Nutshell series and a sneak peek of our project.
PURE project developed precisely functionalised adsorbents for the purification of biopharmaceuticals, as antibodies. The new adsorbents can be applied in the purification of other relevant biological products by tuning the ligands coupled. The technologies used to produce PURE´s adsorbents are environmentally friendly and can be adapted to products in distinct markets. Overall, the socio-economic benefit from the project comes from turning the production of biopharmaceuticals more environmentally friendly and easily accessible, by using adsorbents that are prepared in a sustainable manner.
Resume of the PURE technology
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