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EuroBioTox: European programme for the establishment of validated procedures for the detection and identification of biological toxins - The ...
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                                           EuroBioTox:
                                           European programme for the establishment of
                                           validated procedures for the detection and
                                           identification of biological toxins

                                           Dr. Brigitte Dorner, Dir. and Prof.
                                           Biological Toxins (ZBS3), Robert Koch Institute, Berlin, DE

CERIS Meeting, 9th Nov 2022
Brussels
EuroBioTox: European programme for the establishment of validated procedures for the detection and identification of biological toxins - The ...
Biological toxinsdurch
                                                      Titelmasterformat    as biothreat  agents
                                                                                Klicken bearbeiten

Accociated Press News, 14 June 2018

 https://www.apnews.com/0c9f61222765459890bcf0dd7cffb482/Prosecutor:-
 Man-makes-deadly-toxin-for-an-attack-in-Germany

       9th Nov 2022 / Brigitte Dorner / CERIS Meeting
EuroBioTox: European programme for the establishment of validated procedures for the detection and identification of biological toxins - The ...
Biological toxinsdurch
                                                            Titelmasterformat    as biothreat  agents
                                                                                      Klicken bearbeiten

Accociated Press News, 14 June 2018

                                                    26.03.2020

 https://www.apnews.com/0c9f61222765459890bcf0dd7cffb482/Prosecutor:-
 Man-makes-deadly-toxin-for-an-attack-in-Germany

            Main suspect sentenced to 10 years in
            prison; his wife to 8 years in prison
        https://www.ksta.de/koeln/terroranschlag-geplant-gericht-faellt-
        urteil-im-rizin-bomber-prozess-36472666

       9th Nov 2022 / Brigitte Dorner / CERIS Meeting
EuroBioTox: European programme for the establishment of validated procedures for the detection and identification of biological toxins - The ...
Biological toxinsdurch
                                                            Titelmasterformat    as biothreat  agents
                                                                                      Klicken bearbeiten

Accociated Press News, 14 June 2018
                                                                                          Indonesia, 2019

                                                    26.03.2020

 https://www.apnews.com/0c9f61222765459890bcf0dd7cffb482/Prosecutor:-
 Man-makes-deadly-toxin-for-an-attack-in-Germany

            Main suspect sentenced to 10 years in
            prison; his wife to 8 years in prison
        https://www.ksta.de/koeln/terroranschlag-geplant-gericht-faellt-
        urteil-im-rizin-bomber-prozess-36472666

       9th Nov 2022 / Brigitte Dorner / CERIS Meeting
EuroBioTox: European programme for the establishment of validated procedures for the detection and identification of biological toxins - The ...
Biological toxinsdurch
                                                            Titelmasterformat    as biothreat  agents
                                                                                      Klicken bearbeiten

Accociated Press News, 14 June 2018
                                                                                                                  Indonesia, 2019

                                                    26.03.2020

                                                                                                                                      Morocco, 2016: Clandestine lab of
                                                                                                                                      a suspected terrorist cell exposed

 https://www.apnews.com/0c9f61222765459890bcf0dd7cffb482/Prosecutor:-
 Man-makes-deadly-toxin-for-an-attack-in-Germany

            Main suspect sentenced to 10 years in
            prison; his wife to 8 years in prison
        https://www.ksta.de/koeln/terroranschlag-geplant-gericht-faellt-
        urteil-im-rizin-bomber-prozess-36472666
                                                                           http://www.ibtimes.com/arrested-isis-militants-morocco-planned-biological-attacks-report-2329753
                                                                           Press release as of 19.02.2016, BCIJ, Marocco
       9th Nov 2022 / Brigitte Dorner / CERIS Meeting
EuroBioTox: European programme for the establishment of validated procedures for the detection and identification of biological toxins - The ...
Biological toxinsdurch
                                                            Titelmasterformat    as biothreat  agents
                                                                                      Klicken bearbeiten

                                                                                                                                                                              04.04.2002

Accociated Press News, 14 June 2018
                                                                                                                  Indonesia, 2019

                                                    26.03.2020

                                                                                                                                      Morocco, 2016: Clandestine lab of
                                                                                                                                      a suspected terrorist cell exposed

 https://www.apnews.com/0c9f61222765459890bcf0dd7cffb482/Prosecutor:-
 Man-makes-deadly-toxin-for-an-attack-in-Germany

            Main suspect sentenced to 10 years in
            prison; his wife to 8 years in prison
        https://www.ksta.de/koeln/terroranschlag-geplant-gericht-faellt-
        urteil-im-rizin-bomber-prozess-36472666
                                                                           http://www.ibtimes.com/arrested-isis-militants-morocco-planned-biological-attacks-report-2329753
                                                                           Press release as of 19.02.2016, BCIJ, Marocco
       9th Nov 2022 / Brigitte Dorner / CERIS Meeting
EuroBioTox: European programme for the establishment of validated procedures for the detection and identification of biological toxins - The ...
Biological toxinsdurch
                                                            Titelmasterformat    as biothreat  agents
                                                                                      Klicken bearbeiten

                                                                                                                                                                                         04.04.2002

Accociated Press News, 14 June 2018
                                                                                                                             Indonesia, 2019

                                                                           What do we learn from these incidents?
                                                    26.03.2020
                                Toxins can be and have been prepared by laypersons and can be intentionally released in
                                                              a criminal act to harm people.
                                                                                                Morocco, 2016: Clandestine lab of
                                                                                                a suspected terrorist cell exposed
                                        It is not clear how well we are prepared for a potential biotoxin incident.

 https://www.apnews.com/0c9f61222765459890bcf0dd7cffb482/Prosecutor:-
 Man-makes-deadly-toxin-for-an-attack-in-Germany

            Main suspect sentenced to 10 years in
            prison; his wife to 8 years in prison
        https://www.ksta.de/koeln/terroranschlag-geplant-gericht-faellt-
        urteil-im-rizin-bomber-prozess-36472666
                                                                                      http://www.ibtimes.com/arrested-isis-militants-morocco-planned-biological-attacks-report-2329753
                                                                                      Press release as of 19.02.2016, BCIJ, Marocco
       9th Nov 2022 / Brigitte Dorner / CERIS Meeting
EuroBioTox: European programme for the establishment of validated procedures for the detection and identification of biological toxins - The ...
State Actorsdurch
                                     Titelmasterformat   – facts or fiction:
                                                               Klicken bearbeiten
                               Suspected attacks or politically motivated accusations?

                                                       Aug 20, 2022

Russia's defence ministry accused Ukraine on Saturday of
poisoning some of its servicemen in the Russian-controlled part
of Ukraine's southeastern region of Zaporizhzhia in late July.
An adviser to Ukraine's interior ministry said in response that
the alleged poisoning could have been caused by Russian forces        https://www.farsnews.ir/en/news/14010529000818/Rssia-Says-Prf-f-
eating expired canned meat.                                           Ukraine%27s-%27Chemical-Terrrism%27-Be-Sen-OPCW-Sn
The Russian defence ministry said a number of Russian
servicemen had been taken to a military hospital with signs of
serious poisoning on July 31. Tests showed a toxic substance,
botulinum toxin type B, in their bodies, it said.
https://www.reuters.com/world/europe/russia-accuses-
ukraine-poisoning-some-its-soldiers-2022-08-20/

  9th Nov 2022 / Brigitte Dorner / CERIS Meeting
EuroBioTox: European programme for the establishment of validated procedures for the detection and identification of biological toxins - The ...
State Actorsdurch
                                     Titelmasterformat   – facts or fiction:
                                                               Klicken bearbeiten
                               Suspected attacks or politically motivated accusations?

                                                       Aug 20, 2022

Russia's defence ministry accused Ukraine on Saturday of
poisoning some of its servicemen in the Russian-controlled part
of Ukraine's southeastern region of Zaporizhzhia in late July.
An adviser to Ukraine's interior ministry said in response that
the alleged poisoning could have been caused by Russian forces        https://www.farsnews.ir/en/news/14010529000818/Rssia-Says-Prf-f-
eating expired canned meat.                                           Ukraine%27s-%27Chemical-Terrrism%27-Be-Sen-OPCW-Sn
The Russian defence ministry said a number of Russian
servicemen had been taken to a military hospital with signs of
serious poisoning on July 31. Tests showed a toxic substance,                     True or not true? Hybrid warfare!
botulinum toxin type B, in their bodies, it said.
                                                                          If requested in an international investigation,
https://www.reuters.com/world/europe/russia-accuses-
ukraine-poisoning-some-its-soldiers-2022-08-20/                                 who would perform BoNT analysis?
  9th Nov 2022 / Brigitte Dorner / CERIS Meeting
EuroBioTox: European programme for the establishment of validated procedures for the detection and identification of biological toxins - The ...
Biological toxins are regulated
                                       Titelmasterformat  durch under
                                                                Klickenthe BCW and CWC
                                                                        bearbeiten

Adopted from Graham S Pearson and Robert Mathews

   9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Detection of biological
                                           Titelmasterformat durchtoxins:
                                                                   KlickenAbearbeiten
                                                                            challenge

           Ricin / Abrin:                                                                                   Botulinum toxins:
           RNA-N-glycosidases                                                                               Neurotoxins
           >> accidental intoxications                                                                      >> botulism
          LD50: 3 µg/kg (inhalation)                                                                        LD50: 1 ng/kg (inhalation)

           Saxitoxin:                                                                                       Staphylococcal enterotoxins:
           Na+ channel blocker                                                                              Superantigens
           >> food intoxications                                                                            >> food intoxications
          LD50: 6 µg/kg (oral)                                                                              LD50: 27 ng/kg (inhalation)

                                                 Dorner BG et al., (2016) Trends in Analytical Chemistry 85, 89

9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Detection of biological
                                               Titelmasterformat durchtoxins:
                                                                       KlickenAbearbeiten
                                                                                challenge

   Toxins are active in the absence of the producing organism and its genetic information; detection of DNA not
    sufficient, protein/toxin detection necessary
               Ricin / Abrin:                                                                                   Botulinum toxins:
               RNA-N-glycosidases                                                                               Neurotoxins
               >> accidental intoxications                                                                      >> botulism
              LD50: 3 µg/kg (inhalation)                                                                        LD50: 1 ng/kg (inhalation)

               Saxitoxin:                                                                                       Staphylococcal enterotoxins:
               Na+ channel blocker                                                                              Superantigens
               >> food intoxications                                                                            >> food intoxications
              LD50: 6 µg/kg (oral)                                                                              LD50: 27 ng/kg (inhalation)

                                                     Dorner BG et al., (2016) Trends in Analytical Chemistry 85, 89

    9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Detection of biological
                                               Titelmasterformat durchtoxins:
                                                                       KlickenAbearbeiten
                                                                                challenge

   Toxins are active in the absence of the producing organism and its genetic information; detection of DNA not
    sufficient, protein/toxin detection necessary
               Ricin / Abrin:                                                                                   Botulinum toxins:
               RNA-N-glycosidases                                                                               Neurotoxins
               >> accidental intoxications                                                                      >> botulism
              LD50: 3 µg/kg (inhalation)                                                                        LD50: 1 ng/kg (inhalation)

               Saxitoxin:                                                                                       Staphylococcal enterotoxins:
               Na+ channel blocker                                                                              Superantigens
               >> food intoxications                                                                            >> food intoxications
              LD50: 6 µg/kg (oral)                                                                              LD50: 27 ng/kg (inhalation)

                                                     Dorner BG et al., (2016) Trends in Analytical Chemistry 85, 89

   Very high toxicity poses per se a challenge for detection technology; LOD: few pg/mL

    9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Detection of biological
                                               Titelmasterformat durchtoxins:
                                                                       KlickenAbearbeiten
                                                                                challenge

   Toxins are active in the absence of the producing organism and its genetic information; detection of DNA not
    sufficient, protein/toxin detection necessary
               Ricin / Abrin:                                                                                   Botulinum toxins:
               RNA-N-glycosidases                                                                               Neurotoxins
               >> accidental intoxications                                                                      >> botulism
              LD50: 3 µg/kg (inhalation)                                                                        LD50: 1 ng/kg (inhalation)

               Saxitoxin:                                                                                       Staphylococcal enterotoxins:
               Na+ channel blocker                                                                              Superantigens
               >> food intoxications                                                                            >> food intoxications
              LD50: 6 µg/kg (oral)                                                                              LD50: 27 ng/kg (inhalation)

                                                     Dorner BG et al., (2016) Trends in Analytical Chemistry 85, 89

   Very high toxicity poses per se a challenge for detection technology; LOD: few pg/mL

   Toxins are rapidly metabolized in the human body limiting the time window for detection in clinical samples

    9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Detection of biological
                                               Titelmasterformat durchtoxins:
                                                                       KlickenAbearbeiten
                                                                                challenge

   Toxins are active in the absence of the producing organism and its genetic information; detection of DNA not
    sufficient, protein/toxin detection necessary
               Ricin / Abrin:                                                                                   Botulinum toxins:
               RNA-N-glycosidases                                                                               Neurotoxins
               >> accidental intoxications                                                                      >> botulism
              LD50: 3 µg/kg (inhalation)                                                                        LD50: 1 ng/kg (inhalation)

               Saxitoxin:                                                                                       Staphylococcal enterotoxins:
               Na+ channel blocker                                                                              Superantigens
               >> food intoxications                                                                            >> food intoxications
              LD50: 6 µg/kg (oral)                                                                              LD50: 27 ng/kg (inhalation)

                                                     Dorner BG et al., (2016) Trends in Analytical Chemistry 85, 89

   Very high toxicity poses per se a challenge for detection technology; LOD: few pg/mL

   Toxins are rapidly metabolized in the human body limiting the time window for detection in clinical samples

   Toxins are produced in different variants which might differ in characteristics; challenge to detect and – if necessary
    – to differentiate toxin variants
    9th Nov 2022 / Brigitte Dorner / CERIS Meeting
From EQuATox
                                             Titelmasterformat    to Klicken
                                                               durch EuroBioTox
                                                                             bearbeiten

35 institutions from 20 countries
2012 – 2014
EU contribution: 1,338,634 EUR

 Main result and impact:
  Snapshot on biological toxin detection
   capabilities (status quo)
  Identification of gaps and technical limitations

  9th Nov 2022 / Brigitte Dorner / CERIS Meeting
From EQuATox
                                             Titelmasterformat    to Klicken
                                                               durch EuroBioTox
                                                                             bearbeiten

35 institutions from 20 countries                                      63 institutions from 23 countries
2012 – 2014                                                            06/2017 – 05/2023
EU contribution: 1,338,634 EUR                                         EU contribution: 7,998,747 EUR
                                                                       Total cost:       9,526,721 EUR

 Main result and impact:                                                Main objectives:
  Snapshot on biological toxin detection                                Increase detection capabilities
   capabilities (status quo)                                              to an advanced technical level
  Identification of gaps and technical limitations                      Pan-European network of competence

  9th Nov 2022 / Brigitte Dorner / CERIS Meeting
From EQuATox
                                              Titelmasterformat    to Klicken
                                                                durch EuroBioTox
                                                                              bearbeiten

35 institutions from 20 countries                                       63 institutions from 23 countries
2012 – 2014                                                             06/2017 – 05/2023
EU contribution: 1,338,634 EUR                                          EU contribution: 7,998,747 EUR
                                                                        Total cost:       9,526,721 EUR

 Main result and impact:                                                 Main objectives:
  Snapshot on biological toxin detection                                 Increase detection capabilities
   capabilities (status quo)                                               to an advanced technical level
  Identification of gaps and technical limitations                       Pan-European network of competence

             Establishment of a comprehensive mechanism to increase quality assurance in the field
              (certified reference materials, repository of tools, training courses, proficiency tests)
GOALS

             Evaluation and refinement of measurement procedures
             Evaluate potential replacement methods for animal experiments (BoNT)
             Coordination of laboratories, industrial partners and end-users working on biological toxins in the EU to
              spread know-how from experts to practitioners
   9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Project
                                           Titelmasterformat    partners
                                                             durch Klicken bearbeiten

                                                                       13 core partners (beneficiaries)
                                                                       50 network partners

                                                                       63 expert institutions from 23 countries

                                                                       10 work packages

                                                                       www.EuroBioTox.eu

9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Essential pieces
                                           Titelmasterformat durchofKlicken
                                                                     the puzzle
                                                                            bearbeiten

                                                 Certified               Repository
                                                 reference                of tools &
                                                 materials                 reagents

                                                             WP1   WP2

                                                             WP3   WP5

                                                 Proficiency               Training
                                                 tests                     courses

9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Development  & productiondurch
                                 Titelmasterformat  of certified
                                                         Klicken reference
                                                                 bearbeitenmaterials
                                                   (WP1)

     Candidate CRMs                                    Candidate CRMs
     purified from natural sources                     produced by recombinant techniques

                              10,500 vials (ricin)      10,070 vials (BoNT/A)

                              240 vials (abrin)         1,500 vials (BoNT/B)

                                                        1,500 vials (SEB)

9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Development  & productiondurch
                                 Titelmasterformat  of certified
                                                         Klicken reference
                                                                 bearbeitenmaterials
                                                   (WP1)

     Candidate CRMs                                          Candidate CRMs
     purified from natural sources                           produced by recombinant techniques

                              10,500 vials (ricin)           10,070 vials (BoNT/A)

                              240 vials (abrin)              1,500 vials (BoNT/B)

     CRMs = „Anchor points for precise analytics“            1,500 vials (SEB)
     Decision makers rely on correct and reliable
     laboratory data in order to make appropriate and
     timely decisions (e.g. amount, purity and activity of
     biotoxins)
9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Development  & productiondurch
                                 Titelmasterformat  of certified
                                                         Klicken reference
                                                                 bearbeitenmaterials
                                                   (WP1)

 Purity / Identity                               Concentration
 SDS-PAGE,                                       Amino acid analysis/Photometry
 Capillary Gel Electrophoresis,                  • AAA: Hydrolysis conditions,
 LC-MS/MS and MALDI-TOF MS,                        number of amino acids
                                                                                                  Homogeneity / stability
 ELISA, Western blot                             • Value assignment
 • Main component                                                                                 High-throughput method
 • Identification of impurities                                                                   with sufficient precision
                                                 Biological activity                              • Short term stability (weeks):
 • Quantification of impurities
                                                 In vivo / ex vivo methods                          dispatch conditions
 • Molecular weight
                                                 In vitro method                                  • Long term stability (years):
 • Comparison with other toxin
                                                 • Activity of all toxin chains:                    storage conditions
   preparations
                                                    Receptor binding
 • Correct folding
                                                    Enzymatic activity
 • Identification of post-trans-lational
                                                 • Binding of target molecule
   modifications
                                                 • Value assignment

Zeleny R, Rummel A, Jansson D, Dorner BG (2019). ACS Symposium Series #1339.   https://edoc.rki.de/handle/176904/6290

9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Development  & productiondurch
                                 Titelmasterformat  of certified
                                                         Klicken reference
                                                                 bearbeitenmaterials
                                                   (WP1)

 Purity / Identity                               Concentration
 SDS-PAGE,                                       Amino acid analysis/Photometry
 Capillary Gel Electrophoresis,                  • AAA: Hydrolysis conditions,
 LC-MS/MS and MALDI-TOF MS,                        number of amino acids
                                                                                                  Homogeneity / stability
 ELISA, Western blot                             • Value assignment
 • Main component                                                                                 High-throughput method
 • Identification of impurities                                                                   with sufficient precision
                                                 Biological activity                              • Short term stability (weeks):
 • Quantification of impurities
                                                 In vivo / ex vivo methods                          dispatch conditions
 • Molecular weight
                                                 In vitro method                                  • Long term stability (years):
 • Comparison with other toxin
                                                 • Activity of all toxin chains:                    storage conditions
   preparations
                                                    Receptor binding
 • Correct folding
                                                    Enzymatic activity
 • Identification of post-trans-lational
                                                 • Binding of target molecule
   modifications
                                                 • Value assignment

    First CRM (SEB) was released in Jan 2022;
    CRMs for ricin, abrin, BoNT/A and BoNT/B are expected to be released in 2023

Zeleny R, Rummel A, Jansson D, Dorner BG (2019). ACS Symposium Series #1339.   https://edoc.rki.de/handle/176904/6290

9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Repository of tools
                                           Titelmasterformat    andKlicken
                                                             durch  reagents  (WP2)
                                                                           bearbeiten

WP2                                                 Highly specific, proprietary monoclonal antibodies
                                                    Panel of bacterial supernatants and recombinant toxins representing toxin
                                                     subtypes
                                                    Peptide standards for MS (AQUA peptides), multiplex lateral flow assays
                                                    Real sample materials
                                                       More than 190 shipments of materials executed within the network

9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Repository of tools
                                           Titelmasterformat    andKlicken
                                                             durch  reagents  (WP2)
                                                                           bearbeiten
                                                    Training courses (WP5)

WP2                                                 Highly specific, proprietary monoclonal antibodies
                                                    Panel of bacterial supernatants and recombinant toxins representing toxin
                                                     subtypes
                                                    Peptide standards for MS (AQUA peptides), multiplex lateral flow assays
                                                    Real sample materials
                                                       More than 190 shipments of materials executed within the network

WP5
                                                    19 different training courses tailored to the different toxins and methods
                                                    Immunological, spectrometric, functional, chromatographic methods
                                                    Basic or advanced training levels
                                                    On-site courses and remote training courses
                                                       33 laboratories trained

9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Establishment
                                               Titelmasterformat          of a bearbeiten
                                                                 durch Klicken
                                              European proficiency testing scheme (WP3)

                                                       Generation & characterisation of
                                                       toxin reference material
                                                       combining the expertise from
                                                       EU labs

                                                       Setting up PT schemes
                                                       including real sample materials
                                                       (test for sample preparation
                                                       strategies)

Method 1                                               Evaluation of results:
Method 2
Method 3                                               - Comparison of methods used
Method 4
Method 5                                                (qual./quant./funct. analysis)
Method 6
Method 7
                                                       - Performance of laboratories
Method 8
                                                       - Identification of gaps and best practices
     9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Establishment
                                               Titelmasterformat          of a bearbeiten
                                                                 durch Klicken
                                              European proficiency testing scheme (WP3)

                                                       Generation & characterisation of
                                                       toxin reference material                      Ricin       Abrin
                                                       combining the expertise from
                                                       EU labs

                                                                                                     BoNTs        SEs
                                                       Setting up PT schemes
                                                       including real sample materials
                                                       (test for sample preparation                              On-site-
                                                                                                      STX
                                                       strategies)                                              detection

                                                                                                       11 PTs    
Method 1                                               Evaluation of results:
Method 2
Method 3                                               - Comparison of methods used
Method 4
Method 5                                                (qual./quant./funct. analysis)
Method 6
Method 7
                                                       - Performance of laboratories
Method 8
                                                       - Identification of gaps and best practices
     9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Establishment
                                               Titelmasterformat          of a bearbeiten
                                                                 durch Klicken
                                              European proficiency testing scheme (WP3)

                                                       Generation & characterisation of
                                                       toxin reference material                           Ricin       Abrin
                                                       combining the expertise from
                                                       EU labs

                                                                                                         BoNTs         SEs
                                                       Setting up PT schemes
                                                       including real sample materials
                                                       (test for sample preparation                                   On-site-
                                                                                                           STX
                                                       strategies)                                                   detection

                                                                                                            11 PTs    
Method 1                                               Evaluation of results:
Method 2
Method 3                                               - Comparison of methods used                  Highly relevant insights into
Method 4
                                                        (qual./quant./funct. analysis)               actual detection capabilities
Method 5
Method 6
                                                       - Performance of laboratories                 and the potential for further
Method 7
Method 8
                                                       - Identification of gaps and best practices   technical improvement

     9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Establishment
                                               Titelmasterformat          of a bearbeiten
                                                                 durch Klicken
                                              European proficiency testing scheme (WP3)

                                                       Generation & characterisation of
                                                       toxin reference material                  Ricin       Abrin
                                                       combining the expertise from
                                                       EU labs

                                                                                                BoNTs         SEs
                                                       Setting up PT schemes
                                                       including real sample materials
                                                       (test for sample preparation                          On-site-
                                                                                                  STX
                                                       strategies)                                          detection

                                                                                                   11 PTs    
Method 1                                     Evaluation of results:
Method 2
Method 3
                                    Current status
                                             - Comparison of methods used                   Highly relevant insights into
Method 4
                                              (qual./quant./funct. analysis)                actual detection capabilities
Clearly, more time and effort has to be invested to further increase biotoxin detection
Method 5
                                                                                            and the potential for further
Method 6
                                             - Performance of laboratories
Method 7
             capabilities in EU Member States beyond the current status                     technical improvement
Method 8
                                             - Identification of gaps and best practices
     9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Additional EuroBioTox
                                           Titelmasterformat           highlights
                                                             durch Klicken bearbeiten

               WP4 – Quality management and SOPs

                                                 -Surveys
                                                 -QM documents
                                                 -Method SOPs
                                                 -Validation SOP

9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Additional EuroBioTox
                                           Titelmasterformat           highlights
                                                             durch Klicken bearbeiten

               WP4 – Quality management and SOPs                   WP6 – In-situ detection and forensics

                                                 -Surveys                              -Guidelines, work-
                                                 -QM documents                          shop and movie for
                                                 -Method SOPs                           first responders
                                                 -Validation SOP                       -Forensic database

9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Additional EuroBioTox
                                           Titelmasterformat           highlights
                                                             durch Klicken bearbeiten

               WP4 – Quality management and SOPs                    WP6 – In-situ detection and forensics

                                                 -Surveys                               -Guidelines, work-
                                                 -QM documents                           shop and movie for
                                                 -Method SOPs                            first responders
                                                 -Validation SOP                        -Forensic database

               WP7 – Animal replacement methods

                                       -Evaluation of 5 potential
                                        replacement methods
9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Additional EuroBioTox
                                           Titelmasterformat           highlights
                                                             durch Klicken bearbeiten

               WP4 – Quality management and SOPs                    WP6 – In-situ detection and forensics

                                                 -Surveys                               -Guidelines, work-
                                                 -QM documents                           shop and movie for
                                                 -Method SOPs                            first responders
                                                 -Validation SOP                        -Forensic database

               WP7 – Animal replacement methods                     WP8 – Dissemination & communication
                                                                                   -Project website
                                                                                     (>35,000 visitors)
                                                                                   -3 scientific papers
                                                                                    > 50 oral presentations
                                                                                   -6 posters
                                                                                   -2 movies
                                       -Evaluation of 5 potential                  -1 brochure
                                        replacement methods                        -e-learning materials
9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Impact and
                                           Titelmasterformat    benefits
                                                             durch Klickenfor
                                                                            bearbeiten
                                                    EuroBioTox participants

                                             Confidence building, development of mutual trust

                                                   Strengthening laboratory capabilities

                                                  Harmonization of technical approaches

9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Impact and
                                           Titelmasterformat    benefits
                                                             durch Klickenfor
                                                                            bearbeiten
                                                    EuroBioTox participants

                                             Confidence building, development of mutual trust

                                                   Strengthening laboratory capabilities

                                                  Harmonization of technical approaches

                                                   Enable and/or maintain accreditation

                                                        Enable 3R activities (BoNT)

9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Impact and
                                           Titelmasterformat    benefits
                                                             durch Klickenfor
                                                                            bearbeiten
                                                    EuroBioTox participants

                                             Confidence building, development of mutual trust

                                                   Strengthening laboratory capabilities

                                                  Harmonization of technical approaches

                                                   Enable and/or maintain accreditation

                                                        Enable 3R activities (BoNT)

                                        Liaison with relevant international organisations (OPCW)

9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Impact and
                                           Titelmasterformat    benefits
                                                             durch Klickenfor
                                                                            bearbeiten
                                                    EuroBioTox participants

                                             Confidence building, development of mutual trust

                                                     Strengthening laboratory capabilities

                                                    Harmonization of technical approaches

                                                     Enable and/or maintain accreditation

                                                          Enable 3R activities (BoNT)

                                        Liaison with relevant international organisations (OPCW)

                                                     Spreading of excellence to end users

                                                 Improved preparedness and response planning

9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Future of EuroBioTox
                                               Titelmasterformat        beyond
                                                                 durch Klicken   2023
                                                                               bearbeiten

   EuroBioTox contributes to minimize potential health and security threats in EU and increases resilience of civil
    society by sound capacity building (only until end of the project)

    9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Future of EuroBioTox
                                               Titelmasterformat        beyond
                                                                 durch Klicken   2023
                                                                               bearbeiten

   EuroBioTox contributes to minimize potential health and security threats in EU and increases resilience of civil
    society by sound capacity building (only until end of the project)
   A long term perspective is needed how to further develop the network based on the status quo reached under
    EuroBioTox

    9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Future of EuroBioTox
                                               Titelmasterformat        beyond
                                                                 durch Klicken   2023
                                                                               bearbeiten

   EuroBioTox contributes to minimize potential health and security threats in EU and increases resilience of civil
    society by sound capacity building (only until end of the project)
   A long term perspective is needed how to further develop the network based on the status quo reached under
    EuroBioTox

   Need for an “EU reference laboratory for security-relevant biotoxins”                        Food safety networks
    supporting tasks relevant in the security sector, complementary to existing
    networks

                                                                                            Communicable diseases networks

    9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Future of EuroBioTox
                                               Titelmasterformat        beyond
                                                                 durch Klicken   2023
                                                                               bearbeiten

   EuroBioTox contributes to minimize potential health and security threats in EU and increases resilience of civil
    society by sound capacity building (only until end of the project)
   A long term perspective is needed how to further develop the network based on the status quo reached under
    EuroBioTox

   Need for an “EU reference laboratory for security-relevant biotoxins”                        Food safety networks
    supporting tasks relevant in the security sector, complementary to existing
    networks

   If resources are not allocated for future actions, gaps will remain or even
    increase!
   Central need: Repository function, training, regular proficiency testing
                                                                                            Communicable diseases networks
   Stabilization of interaction between expert labs, sustainability of technical
    improvement
   Very specialized expertise needed not available in many EU countries on all
    relevant biotoxins >> burden sharing necessary; support of Eastern European
    countries necessary
   Coordinated action is needed in a cross-border event related to biotoxins
    9th Nov 2022 / Brigitte Dorner / CERIS Meeting
Thank you for
                                           Titelmasterformat   yourKlicken
                                                             durch   attention!
                                                                           bearbeiten

       RKI, DE:                        S. Worbs, B. Kampa, M. Skiba, D. Stern,                       FUNDING
                                       M.B. Dorner, J. Millert, A. Kowalczyk,
                                       E. Schlereth, H. Ranisch, B.G. Dorner (coordination)
       EC-JRC, BE:                     K. Busschots, R. Zeleny
                                                                                              Grant Agreement No: 740189
       Sciensano, BE:                  J. Masquelier, T. van Nieuwenhuysen,
                                                                                               EUROPEAN COMMISSION
                                       J. van Loco
                                                                                                Co-funding by Swiss SERI
       UH Verifin, FI:                 A. Puustinen, M. Kjellberg, P. Vanninen
       Inst. Pasteur, FR:              C. Rasetti-Escargueil, M. Popoff, E. Lemichez
       CEA, FR:                        A.-S. Mierzala, H. Volland, F. Becher,
                                       S. Simon
       ANSES, FR:                      B. Boran, Y. Nia, J.-A. Hennekinne                      www.EuroBioTox.eu
       Toxogen, DE:                    J. Weisemann, A. Rummel                                 Contact: DornerB@rki.de
       FOI, SE:                        T. Bergström, J. Naslund, D. Jansson
       Spiez Lab, CH:                  M. Avondet, C. Müller, M. Wittwer
       ChemStat, CH:                   W. Luginbühl                                              THANKS TO ALL
       ZHAW, CH:                       R. Josuran, C. Zaborosch, S. Gerber                     NETWORK PARTNERS
       Queen’s Univ., UK:              L. Burns, K. Campbell                                   FOR THEIR SUPPORT

9th Nov 2022 / Brigitte Dorner / CERIS Meeting
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