Deliverables Documents, reports (5) Summary report on hydrogel structure-activity relationships This deliverable will be acheived through: Secondment activities at Hy2Care that will focus on the performance of industry standard tests (biocompatibility, toxicity etc) (Task 5.2) and safety and performance testing in orthotopic animal models (Task 5.3). Secondment activities at UoN that will focus on advanced characterization of the hydrogels to complement the studies performed at Hy2Care and to allow hydrogel optimization. Characterization will include high-resolution microscopy to determine cross-linking density (e.g. AFM/TEM imaging) (Task 5.4), combined with spectroscopy (FT-IR/FT-Raman) and AFM nanoindentation measurements (Task 5.5) to verify chemical and mechanical changes during cross-linking respectively. Later studies will employ surface chemical methods (e.g. TofSIMs, XPS) to define the chemical nature of cell-hydrogel and hydrogel- bone/cartilage interface (Task 5.6) alongside confocal fluorescence microscopy to understand the interaction with and effect on cells. Generation of ISO 1345 Quality Management System This deliverable will be acheived through secondments at Hy2Care which will focus on activities associated with product manufacture. Although product manufacture under cGMP conditions will be outsourced, the secondee(s) will be required to develop an ISO13485 quality management system to underpin this activity. Standardized protocols for the formulation of tunable nanoparticles with defined properties WP 3 aims to explore the potential of new nanoparticle manufacturing methods. This deliverable will be achieved through: Task 3.1 & Task 3.3 - The production, in-vitro characterization (size, morphology, drug loading efficiency) and optimization of nanoparticles loaded with drugs of different solubility and permeability properties (e.g. selected from the 4 classes of the Biopharmaceutical Classification System (BCS) for poorly soluble model drugs). Test formulations for model biopharmaceuticals (e.g. insulin) will also be prepared and characterized. Standardized protocols for the formulation of nanoparticles with defined properties This deliverable will be achieved through: Task 4.1 - the production and in vitro performance testing of a range of nanoparticle delivery systems (containing vitamin A) Task 4.2 - Characterisation of the resulting nanoparticulate formulations by AFM, ToF-SIMS, SEM and other analysis techniques. Standardized SOPs for the optimized isolation of different cell types This deliverable will be acheived by : Task 2.1 - optimization of primary and stem cell isolation protocols from tissues (e.g. adipose derived stem cells, cardiomyocytes, chondrocytes, osteoblasts, hepatocytes, pancreatic islets and fibroblasts) using formulations of specific collagenase class I/II ratios and of protease amount/type (thermolysin, dispase, pronase); Task 2.2 – evaluation of new biomarine enzyme formulations currently under development at Abiel; Task 2.3 – assessment of the reproducibility of results (e.g. cell yield, viability and functionality) and comparison to current standard isolation procedures (e.g. via commercial competitor products). Other (4) FutForm Showcase event The Project Management Board will organise events to foster knowledge transfer and networking. This will include a Showcase event organized towards the end of the project (Month 40) to present and disseminate its research highlights and successes, and support further networking activities. Academic, Industry networking meeting The Project Management Board will organise events to foster knowledge transfer and networking. These will include an academic-industry knowledge sharing workshop (month 18). Consortium agreement signed This deliverable will be achieved as follows: Task 1: The coordinator will ensure all partners are aware of FutForm operational management requirements. Task 3: Compilation, collation and distribution of consortium documentation. The coordinator (assisted by the FutForm project manager) will be responsible for the compilation, collation and distribution of all consortium documentation in relation to operational management and in particular the research secondments. Outreach event The Project Management Board will oversee all aspects of dissemination and outreach to including showcasing the importance of these developments for pharmaceutical research to the general public via events such as the UoN MayFest Community Open Day. Demonstrators, pilots, prototypes (4) Optimized nanoparticle formulations for topical delivery This deliverable will be achieved through: Task 4.1 production and in vitro performance testing of a range of nanoparticle delivery systems (containing vitamin A) Task 4.2 (to UoN) Characterisation of the resulting nanoparticulate formulations by AFM, ToF-SIMS, SEM and other analysis techniques Task 4.3 Franz cell (ex vivo) and skin model (in vivo) testing of the developed formulations (to investigate permeation, potential safety issues etc) Task 4.4 Physicochemical analysis of samples from ex vivo and in vivo permeation studies to determine permeation properties, such as depth and localisation. Proof of concept data to demonstrate the advantages of Abiel technology for drug/toxicity screening applications The deliverable will be acheived by characterization of the formulations and the performance of cells within screening applications as follows: Task 2.4 – characterization of formulations through biophysical assay (e.g. AFM imaging based collagenase degradation studies; assessments of protein aggregation vs activity (e.g. AFM supported by other particle sizing approaches available at UoN); Task 2.5 – the building of 3D printed cell scaffolds yielding organotypic tissues grown from cells isolated using the Abiel technology, and standard procedures.Generated scaffolds will be used to monitor cellular behaviour at pinpoint location on the scaffold surface in response to well-known drugs and toxins (e.g. doxorubicin, troglitazone, quinidine and cobalt chloride). Data to support the attainment of the European CE mark by Hy2Care The data required to achieve this deliverable will be obtained through: Secondment activities at Hy2Care that will focus on the performance of industry standard tests (biocompatibility, toxicity etc) (Task 5.2) and safety and performance testing in orthotopic animal models (Task 5.3). Secondment activities at UoN that will focus on advanced characterization of the hydrogels to complement the studies performed at Hy2Care and to allow hydrogel optimization. Characterization will include high-resolution microscopy to determine cross-linking density (e.g. AFM/TEM imaging) (Task 5.4), combined with spectroscopy (FT-IR/FT-Raman) and AFM nanoindentation measurements (Task 5.5) to verify chemical and mechanical changes during cross-linking respectively. Later studies will employ surface chemical methods (e.g. TofSIMs, XPS) to define the chemical nature of cell-hydrogel and hydrogel- bone/cartilage interface (Task 5.6) alongside confocal fluorescence microscopy to understand the interaction with and effect on cells. An optimized, tunable nanoparticle platform formulation for oral delivery applications This deliverable will be acheived through: Task 3.1 & Task 3.3 - The production, in-vitro characterization (size, morphology, drug loading efficiency) and optimization of nanoparticles loaded with drugs of different solubility and permeability properties (e.g. selected from the 4 classes of the Biopharmaceutical Classification System (BCS) for poorly soluble model drugs). Test formulations for model biopharmaceuticals (e.g. insulin) will also be prepared and characterized. Task 3.2 & Task 3.4 - in-vitro drug release studies and in-house cell models to study intestinal adsorption. Websites, patent fillings, videos etc. (1) FutForm Website up and running The Coordinator will set up a website to support documentation for each secondment undertaken and dissemination of the resultant activities. The coordinator will also ensure the FutForm website provides up to date information regarding secondments (practicalities, outcomes, documentation etc) and training opportunities. Publications Peer reviewed articles (6) Isolation of Adult Rat Cardiomyocytes Using Recombinant Collagenases Author(s): Simona Campora, Paola Sanjuan Alberte, Carmelo Bruno, Giulio Ghersi Published in: CHEMICAL ENGINEERING TRANSACTIONS, 2018, ISSN 2283-9216 Publisher: Online DOI: 10.3303/CET1864005 An injectable platelet lysate-hyaluronic acid hydrogel supports cellular activities and induces chondrogenesis of encapsulated mesenchymal stem cells Author(s): Elaheh Jooybar, Mohammad J. Abdekhodaie, Mansour Alvi, Abbas Mousavi, Marcel Karperien, Pieter J. Dijkstra Published in: Acta Biomaterialia, 2018, ISSN 1742-7061 Publisher: Elsevier BV DOI: 10.1016/j.actbio.2018.10.031 Modelling protein therapeutic co-formulation and co-delivery with PLGA nanoparticles continuously manufactured by microfluidics Author(s): Cláudia Martins, Veeren M. Chauhan, Amjad A. Selo, Mohammad Al-Natour, Jonathan W. Aylott, Bruno Sarmento Published in: Reaction Chemistry & Engineering, Issue 5/2, 2020, Page(s) 308-319, ISSN 2058-9883 Publisher: RSC DOI: 10.1039/c9re00395a Vibrio Proteases for Biomedical Applications: Modulating the Proteolytic Secretome of V. alginolyticus and V. parahaemolyticus for Improved Enzymes Production Author(s): Monica Salamone, Aldo Nicosia, Giulio Ghersi, Marcello Tagliavia Published in: Microorganisms, Issue 7/10, 2019, Page(s) 387, ISSN 2076-2607 Publisher: MDPI DOI: 10.3390/microorganisms7100387 Neural Crest-Derived Chondrocytes Isolation for Tissue Engineering in Regenerative Medicine Author(s): Monica Salamone, Salvatrice Rigogliuso, Aldo Nicosia, Marcello Tagliavia, Simona Campora, Paolo Cinà, Carmelo Bruno, Giulio Ghersi Published in: Cells, Issue 9/4, 2020, Page(s) 962, ISSN 2073-4409 Publisher: MDPI DOI: 10.3390/cells9040962 Multifunctional Bioinstructive 3D Architectures to Modulate Cellular Behavior Author(s): Jayasheelan Vaithilingam, Paola Sanjuan‐Alberte, Simona Campora, Graham A. Rance, Long Jiang, Jordan Thorpe, Laurence Burroughs, Christopher J. Tuck, Chris Denning, Ricky D. Wildman, Richard J. M. Hague, Morgan R. Alexander, Frankie J. Rawson Published in: Advanced Functional Materials, Issue 29/38, 2019, Page(s) 1902016, ISSN 1616-301X Publisher: John Wiley & Sons Ltd. DOI: 10.1002/adfm.201902016 Searching for OpenAIRE data... There was an error trying to search data from OpenAIRE No results available
