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immunoassays SIGNED

Development of new immunoassays for the diagnosis and prediction of drug-related complement pathology

Total Cost €

0

EC-Contrib. €

0

Partnership

0

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 immunoassays project word cloud

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

activation    mac    regulatory    fda    iges    cell    ige    hsrs    amplifying    massive    sometimes    anaphylatoxins    liposome    responds    cleavages    fusion    safety    release    proposes    arise    formulations    mediated    therapeutic    ema    attack    innate    pseudoallergy    hypersensitivity    cleave    events    abs    cytokines    class    industry    causing    immunoassays    stimulated    evaluation    adaptable    antibodies    severe    regarding    pharmaceuticals    elisa    blood    nor    inflammatory    irs    animal    patients    immune    biologics    molecules    proteases    globulin    guidance    date    foreign    life    complement    cascade    published    adverse    membrane    latter    validated    caused    carpa    liposomes    allergy    nonclinical    uuml    dr    medical    reactions    proteins    allergies    ouml    hemocompatibility    small    manner    acute    biomarker    intravenous    nanotechnology    infusion    initiate    threatening    requested    models    biomarkers    killing    quantitative   

Project "immunoassays" data sheet

The following table provides information about the project.

Coordinator
TECODEVELOPMENT GMBH 

Organization address
address: MARIE-CURIE-STR. 1
city: RHEINBACH
postcode: 53359
website: n.a.

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 Germany [DE]
 Total cost 174˙806 €
 EC max contribution 174˙806 € (100%)
 Programme 1. H2020-EU.1.3.2. (Nurturing excellence by means of cross-border and cross-sector mobility)
 Code Call H2020-MSCA-IF-2019
 Funding Scheme MSCA-IF-EF-SE
 Starting year 2020
 Duration (year-month-day) from 2020-04-01   to  2022-03-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    TECODEVELOPMENT GMBH DE (RHEINBACH) coordinator 174˙806.00

Map

 Project objective

Infusion reactions (IRs) are complex, immune-mediated side effects, also known as hypersensitivity reactions (HSRs), that can occur upon intravenous infusion of pharmaceuticals, leading to severe and sometimes life-threatening conditions in patients. Those reactions may arise from a real allergy which is immune globulin class E (IgE) mediated or a “pseudoallergy”. The latter involves no IgEs and may arise because of activation of the complement (C) system called C activation-related pseudoallergy (CARPA). The complement (C-) system is part of the immune system called the innate immune system that is not adaptable and responds to foreign challenges in a non-specific manner. When stimulated proteases of the complement system cleave other C proteins and initiate an amplifying cascade of further cleavages. The end-result of this activation cascade is a massive acute inflammatory response caused by the release of cytokines, anaphylatoxins and the cell-killing membrane attack complex (MAC). Products triggering severe adverse events can include both traditional small molecules but also biologics such as therapeutic antibodies (Abs), fusion proteins, etc. and novel formulations using liposomes or nanotechnology. Regulatory guidance on the assessment of C-mediated infusion hypersensitivity has been published recently for the case of generic liposome production. Hemocompatibility (blood safety) testing for medical devices is requested by EMA and FDA since many years. However, regarding the potential of new pharmaceuticals causing allergies and/or CARPA remains a significant challenge for the industry during nonclinical development as no established safety biomarker nor meaningful, validated animal models are available up to date. During the project “IMMUNOASSAYS” Dr Fülöp proposes the development and quantitative evaluation of three promising specific safety biomarkers via ELISA technology.

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The information about "IMMUNOASSAYS" are provided by the European Opendata Portal: CORDIS opendata.

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