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AMECRYS SIGNED

Revolutionising Downstream Processing of Monoclonal Antibodies by Continuous Template-Assisted Membrane Crystallization

Total Cost €

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EC-Contrib. €

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Partnership

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 AMECRYS project word cloud

Explore the words cloud of the AMECRYS project. It provides you a very rough idea of what is the project "AMECRYS" about.

separation    efficiencies    resin    biopharmaceuticals    usually    molecular    monoclonal    mabs    time    reuse    solutions    microfluidic    template    fluoropolymer    nanotemplate    replacement    revolutionize    largely    preserved    macroporous    of    assisted    ca    purification    media    single    paradigm    heterogeneous    antibodies    batch    gt    cancer    capacity    network    selective    amecrys    throughput    eur    combination    manufacturing    nanotemplates    formulation    screening    manufacture    recognition    flow    downstream    innovative    mab    buffer    platform    solid    chromatography    dsp    3d    designed    proteins    total    qs    broth    prototype    fold    compliance    chip    instance    commercial    footprint    decrease    25000    gmp    pharma    multilevel    operations    60    nucleation    continuous    disadvantages    binding    capex    storage    membranes    purity    visionary    anti    crystallization    intense    unprecedented    66    chromatographically    crystallizer    recognitions    biological    membrane    fermentation    synthesis    protein   

Project "AMECRYS" data sheet

The following table provides information about the project.

Coordinator
CONSIGLIO NAZIONALE DELLE RICERCHE 

Organization address
address: PIAZZALE ALDO MORO 7
city: ROMA
postcode: 185
website: www.cnr.it

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Italy [IT]
 Project website http://www.amecrys-project.eu/
 Total cost 3˙533˙813 €
 EC max contribution 3˙533˙813 € (100%)
 Programme 1. H2020-EU.1.2.1. (FET Open)
 Code Call H2020-FETOPEN-2014-2015-RIA
 Funding Scheme RIA
 Starting year 2016
 Duration (year-month-day) from 2016-10-01   to  2020-09-30

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    CONSIGLIO NAZIONALE DELLE RICERCHE IT (ROMA) coordinator 608˙073.00
2    CENTRE FOR PROCESS INNOVATION LIMITED LBG UK (REDCAR CLEVELAND) participant 705˙015.00
3    UNIVERSITA DELLA CALABRIA IT (ARCAVACATA DI RENDE) participant 375˙000.00
4    IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE UK (LONDON) participant 368˙125.00
5    UNIVERSITY OF STRATHCLYDE UK (GLASGOW) participant 335˙500.00
6    UNIVERSITE LIBRE DE BRUXELLES BE (BRUXELLES) participant 299˙375.00
7    GVS S.P.A. IT (ZOLA PREDOSA (BO)) participant 291˙250.00
8    FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED UK (BILLINGHAM) participant 277˙359.00
9    CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRS FR (PARIS) participant 274˙115.00

Map

 Project objective

Separation and purification of biopharmaceuticals is today one of the most time and cost intense Downstream Processing (DSP) operations in the manufacture of commercial products. Separation and purification of proteins is usually achieved chromatographically, with all of its disadvantages including high buffer requirements, large footprint, reuse and storage of resin studies as well as costs. Traditional DSP based on batch chromatography contribute ca. 66% of the total production cost of anti-cancer monoclonal antibodies (mAbs). Largely contributing to this is the cost of chromatography media; for instance, the cost of 1 L of protein A resin with binding capacity of 20-70 g mAb is about 25000 Eur. By a visionary and ambitious combination of the emerging Continuous Manufacturing Paradigm with innovative Membrane Crystallization Technology and the selective nanotemplate-recognitions directly from the fermentation broth, the AMECRYS Network aims to develop a new Continuous Template-Assisted Membrane Crystallizer in order to revolutionize the DSP platform for mAbs production, thus achieving unprecedented purification and manufacturing efficiencies. Major research challenges will include: i) the synthesis of 3D-nanotemplates with specific molecular recognition ability towards mAbs from complex solutions; ii) the development of tailored macroporous fluoropolymer membranes for advanced control of selective heterogeneous nucleation; iii) the design of multilevel microfluidic devices for high-throughput mAb crystallization screening in a wide range of conditions under continuous flow (“pharma-on-a-chip” concept); iv) technology scale-up to a L-scale continuous prototype designed with recognition of QS/GMP compliance for biopharmaceuticals. The replacement of chromatography with a single membrane-crystallization unit will lead to >60% CapEx and O&M costs decrease, 30-fold footprint reduction and high-purity solid formulation of mAbs with preserved biological activity.

 Deliverables

List of deliverables.
Communication events Websites, patent fillings, videos etc. 2019-11-19 09:11:15
HEL4 domain fragment & Anti CD20 mAb process specification report Documents, reports 2019-11-19 09:11:15
Open-source MC-FFS computational simulation packages Other 2019-11-19 09:11:15
Robust microfabrication protocols to embed hydrophobic fluoropolymers membranes within microfluidic chips Documents, reports 2019-11-19 09:11:14
Simulation code for thermodynamics of course-grained model of mAbs in confined geometry Other 2019-11-19 09:11:14
Website and project logo Websites, patent fillings, videos etc. 2019-11-19 09:11:14
Dissemination and Exploitation Plan Documents, reports 2019-11-19 09:11:14
Report on preparation of nanotemplates for mAb crystallization Documents, reports 2019-11-19 09:11:14
Data Management Plan Open Research Data Pilot 2019-11-19 09:11:14

Take a look to the deliverables list in detail:  detailed list of AMECRYS deliverables.

 Publications

year authors and title journal last update
List of publications.
2019 Huaiyu Yang, Benny Danilo Belviso, Xiaoyu Li, Wenqian Chen, Teresa Fina Mastropietro, Gianluca Di Profio, Rocco Caliandro, Jerry Y. Y. Heng
Optimization of Vapor Diffusion Conditions for Anti-CD20 Crystallization and Scale-Up to Meso Batch
published pages: 230, ISSN: 2073-4352, DOI: 10.3390/cryst9050230
Crystals 9/5 2019-11-19
2018 Carmen Meringolo, Teresa F. Mastropietro, Teresa Poerio, Enrica Fontananova, Giovanni De Filpo, Efrem Curcio, Gianluca Di Profio
Tailoring PVDF Membranes Surface Topography and Hydrophobicity by a Sustainable Two-Steps Phase Separation Process
published pages: 10069–10077, ISSN: 2168-0485, DOI: 10.1021/acssuschemeng.8b01407
ACS Sustainable Chemistry & Engineering Number 6, Issue 8 2019-11-19
2018 Julien Lam, James F. Lutsko
Lattice induced crystallization of nanodroplets: the role of finite-size effects and substrate properties in controlling polymorphism
published pages: 4921-4926, ISSN: 2040-3364, DOI: 10.1039/c7nr08705e
Nanoscale 10/10 2019-11-19
2018 James F. Lutsko, Julien Lam
Classical density functional theory, unconstrained crystallization, and polymorphic behavior
published pages: 12604, ISSN: 2470-0045, DOI: 10.1103/PhysRevE.98.012604
Physical Review E 98/1 2019-11-19
2018 Julien Lam, James F. Lutsko
Solvent-mediated interactions between nanostructures: From water to Lennard-Jones liquid
published pages: 134703, ISSN: 0021-9606, DOI: 10.1063/1.5037571
The Journal of Chemical Physics 149/13 2019-11-19
2017 Julien Lam, James F. Lutsko
Solute particle near a nanopore: influence of size and surface properties on the solvent-mediated forces
published pages: 17099-17108, ISSN: 2040-3364, DOI: 10.1039/C7NR07218J
Nanoscale 9/43 2019-11-19

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