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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.

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

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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