CORDIS bietet Links zu öffentlichen Ergebnissen und Veröffentlichungen von HORIZONT-Projekten.
Links zu Ergebnissen und Veröffentlichungen von RP7-Projekten sowie Links zu einigen Typen spezifischer Ergebnisse wie Datensätzen und Software werden dynamisch von OpenAIRE abgerufen.
Leistungen
Intermediate results of the project will be disseminated by organizing press releases and by realizing leaflets and a web video. All this material will be made available on the project website. Data coming from research activities, which will be decided to not protect by project governing bodies, will be uploaded on OpenAIRE 2020.
Website and project logo (öffnet in neuem Fenster)An assessment of the AMECRYS’s concept and results obtained during the project, including operational, financial and implementation considerations vs conventional downstream processing technology will be conducted. A technology roadmap describing the strategy to support the implementation of continuous crystallization-based purification in biopharmaceutical industry will be prepared.
Techno-economic comparison between conventional batch and innovative DSP (öffnet in neuem Fenster)The comparison will take the form of a software-based comparative life-cycle and cost-of-goods analysis of the traditional chromatographic purification versus the developed crystallisation method for both molecules of interest (assuming full data sets available). As well as the economic and time implications, a full comparison of all the defined quality attributes of material produced from both purification methods will be reported.
Updated Data Management Plan (öffnet in neuem Fenster)The data management plan will be adjusted for data management beyond the project. In principle, the data will be stored in the electronic archives of CNR for at least 5 years after the conclusion of the Project without additional cost. All the research data will be of the highest quality, have long-term validity and will be well documented in order other researchers to be able to get access and understand them after 5 years.
Report on prototype’s operation monitoring & compliance with QS/GMP/CQA regulations (öffnet in neuem Fenster)Following the installation of the continuous nano-template-assisted membrane crystallizer at the CPI’s National Biologics Manufacturing Centre (UK), the crystallizer will be evaluated using the optimal conditions determined in the earlier work packages. This will include both the mAb and the HEL4 fragment, unless one of the molecules has already been ruled out by earlier results. The conditions selected will include biopharmaceutical product purity level, the product concentration, pH/buffer conditions, addition of precipitants or nanotemplates and transmembrane fluxes/input flow rates. During an experimental program, CPI will test the robustness of the new process and the ability to create product of a consistent quality and purity. A report will be prepared that describes how suitable the technology, in its current form, is for GMP operation as part of a biopharmaceutical manufacturing process. Recommendations will be made for further development that would be required for implementation of the technology in an industrial environment and compliance with relevant quality standards and regulations.
Report on structural/morphological/bioactivity properties of mAbs crystals produced by prototype operation crystallizers (öffnet in neuem Fenster)The report will describe properties of crystals produced by the microfluidic system and by the crystallizer prototype, during its development and operation. They will be tested by carrying out X-ray diffraction analyses, mechanical tests, optical spectroscopy, electron and atomic-force microscopy and dynamic light scattering. The results will be used to optimize the prototype design and to assess its operational efficiency.
Report on preparation of nanotemplates for mAb crystallization (öffnet in neuem Fenster)Report on preparation of nanotemplates of pore dimensions (3-20 nm) and characterization to determine pore dimensions and surface area. Nanotemplates will be derivitised to modify surface chemistry and characterized to confirm % of coverage.
Report on selective nucleation and growth kinetics of mAbs from screening tests (öffnet in neuem Fenster)The measured heterogeneous nucleation kinetics using functionalized template surfaces and in microfluidic device will be translated into sound heterogeneous nucleation theories and help to apply the obtained nucleation knowledge on a larger scale. The report will provide specifications for nanotemplate synthesis, membrane optimization, process scale-up, and prototype design.
HEL4 domain fragment & Anti CD20 mAb process specification report (öffnet in neuem Fenster)A process specification report will be prepared detailing the optimised upstream production and conventional downstream purification procedures for anti-CD20 mAb and HEL4 VH domain fragment. This will include details of the analytical methods developed to characterise the material at each of the three purity levels (post-harvest, post-capture column and final product) and the baseline quality attributes generated from these methods to allow for comparison with the crystallization process.
Dissemination and Exploitation Plan (öffnet in neuem Fenster)A dissemination and exploitation plan will be delivered defining key dissemination opportunities within the network and to academia, industry and society outside the network. The plan will describe the dissemination of results to the Project Participants, Scientific Community, Academia, and Related Industry through internal meetings, deliverables publication in Project website, presentations at relevant conferences and symposia, and by publishing results in high-impact factor peer-reviewed journals. All scientific publications will be provided as free on-line open access (green/gold model). To disseminate our project outcomes we will organize an open conference or workshop at the end of the project for which key industrial and academic researchers will be invited. The plan will also define strategies and schedule for the exploitation of project’s foregrounds.
Robust microfabrication protocols to embed hydrophobic fluoropolymers membranes within microfluidic chips (öffnet in neuem Fenster)Report on the development of fabrication protocols to embed the hydrophobic fluoropolymers membranes developed in WP3 within custom-made microfluidic devices obtained by standard PDMS soft lithography. These protocols may use mechanical clamping to seal the membranes between two micro-fabricated PDMS stamps or chemical linking with slight chemical modifications of the PDMS surface (preserving the requirements for mAbs crystallization).
The kinetic Monte Carlo codes with forward-flux sampling (and possibly other rare event techniques) used to simulate crystallization at membranes will be documented and archived on open-source repositories. The deliverable consists of the documented codes and an analysis of the results obtained for conditions corresponding to those of interest to the project.
Simulation code for thermodynamics of course-grained model of mAbs in confined geometry (öffnet in neuem Fenster)This will consist of DFT/MC/Molecular dynamics codes (exact methods to be decided as the work progresses) for determining the phase diagram of a coarse-grained model for mAbs. The deliverable consists of the documented codes and the resulting phase diagrams.
A data management plan will be constructed for the generated data in the project. This will cover data in the form of chemical synthesis protocols, models/simulations/software, design documents including drawings and specifications, construction schedules, regulatory documents, quality control and assurance records. Generated data will be preserved on the intranet platform until the end of the Project.
Fabrication and installation of the continuous flow template-assisted membrane crystallizer prototype: manufacturing the crystallization vessel and membrane modules, selecting and installing impellers/downstream filtration systems/nucleation probes, implementing PID controlers, testing and validation of the final product.
Veröffentlichungen
Autoren:
Pantuso, Elvira; Mastropietro, Teresa F.; Briuglia, Maria L.; Gerard, Charline J. J.; Curcio, Efrem; ter Horst, Joop H.; Nicoletta, Fiore P.; Di Profio, Gianluca
Veröffentlicht in:
Scientific Reports, Ausgabe 10, 2020, Seite(n) 8902, ISSN 2045-2322
Herausgeber:
Nature Publishing Group
DOI:
10.1038/s41598-020-65776-6
Autoren:
Patrick Grosfils, James F. Lutsko
Veröffentlicht in:
Crystals, Ausgabe 11/1, 2021, Seite(n) 4, ISSN 2073-4352
Herausgeber:
Multidisciplinary Digital Publishing Institute (MDPI)
DOI:
10.3390/cryst11010004
Autoren:
Julien Lam, James F. Lutsko
Veröffentlicht in:
Nanoscale, Ausgabe 9/43, 2017, Seite(n) 17099-17108, ISSN 2040-3364
Herausgeber:
Royal Society of Chemistry
DOI:
10.1039/C7NR07218J
Autoren:
Julien Lam, James F. Lutsko
Veröffentlicht in:
Nanoscale, Ausgabe 10/10, 2018, Seite(n) 4921-4926, ISSN 2040-3364
Herausgeber:
Royal Society of Chemistry
DOI:
10.1039/c7nr08705e
Autoren:
Carmen Meringolo, Teresa F. Mastropietro, Teresa Poerio, Enrica Fontananova, Giovanni De Filpo, Efrem Curcio, Gianluca Di Profio
Veröffentlicht in:
ACS Sustainable Chemistry & Engineering, Ausgabe Number 6, Ausgabe 8, 2018, Seite(n) 10069–10077, ISSN 2168-0485
Herausgeber:
American Chemical Society
DOI:
10.1021/acssuschemeng.8b01407
Autoren:
James F. Lutsko, Julien Lam
Veröffentlicht in:
Physical Review E, Ausgabe 98/1, 2018, Seite(n) 012604, ISSN 2470-0045
Herausgeber:
American Physical Society
DOI:
10.1103/PhysRevE.98.012604
Autoren:
Julien Lam, James F. Lutsko
Veröffentlicht in:
The Journal of Chemical Physics, Ausgabe 149/13, 2018, Seite(n) 134703, ISSN 0021-9606
Herausgeber:
American Institute of Physics
DOI:
10.1063/1.5037571
Autoren:
Carmen Meringolo, Teresa Poerio, Enrica Fontananova, Teresa F. Mastropietro, Fiore P. Nicoletta, Giovanni De Filpo, Efrem Curcio, Gianluca Di Profio
Veröffentlicht in:
ACS Applied Polymer Materials, Ausgabe 1/3, 2019, Seite(n) 326-334, ISSN 2637-6105
Herausgeber:
American Chemical Society
DOI:
10.1021/acsapm.8b00105
Autoren:
Huaiyu Yang, Benny Danilo Belviso, Xiaoyu Li, Wenqian Chen, Teresa Fina Mastropietro, Gianluca Di Profio, Rocco Caliandro, Jerry Y. Y. Heng
Veröffentlicht in:
Crystals, Ausgabe 9/5, 2019, Seite(n) 230, ISSN 2073-4352
Herausgeber:
Multidisciplinary Digital Publishing Institute (MDPI)
DOI:
10.3390/cryst9050230
Autoren:
Wenqian Chen, Sung Joon Park, Fanlu Kong, Xiaoyu Li, Huaiyu Yang, Jerry Y. Y. Heng
Veröffentlicht in:
Crystal Growth & Design, Ausgabe 20/2, 2020, Seite(n) 866-873, ISSN 1528-7483
Herausgeber:
American Chemical Society
DOI:
10.1021/acs.cgd.9b01252
Suche nach OpenAIRE-Daten ...
Bei der Suche nach OpenAIRE-Daten ist ein Fehler aufgetreten
Es liegen keine Ergebnisse vor