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Infectious Diseases 
TNO Triskelion is your independent 
and trusted pre-clinical research 
partner. We provide sponsor-speci-fic 
support for pre-clinical develop-ment 
of your vaccine products 
against infectious diseases. Our 
certified and accredited Bio Safety 
Level 2 and 3 facilities allow us to 
evaluate your vaccines that require 
BSL2 or BSL 3 testing facilities. 
TNO Triskelion facilities supports 
your market authorisation process 
for new vaccines against infection 
and deadly pathogens. 
Our reports have successfully 
supported the market authorisation 
for vaccines of our clients around 
the globe. 
WHAT’S IN IT FOR YOU? 
With over 30 years of vaccine safety and 
efficacy testing, we are confident that we 
will provide you with the research approach 
you need. 
WE OFFER: 
- Biosafety Level 2 & 3 facility 
- Expertise & experience in class 2 
and class 3 challenge studies 
- Tailor-made study designs 
- Flexibility 
- Proven track record 
- Direct contact with our experts 
- Available infectious disease 
efficacy models: 
- Influenza H1, H3 and B 
- Hepatitis B 
- GLP and non-GLP services 
- Regulatory guideline compliance 
BSL 2 & 3 CAPABILITIES: 
- Challenge studies up to class 3 pathogens: 
- Avian influenza (H5N1, H7N7, H7N9) 
- SARS, HIV, Hepatitis B 
- Bacteria (i.e. tuberculosis, polio) 
- Efficacy testing of anti-viral and 
anti-bacterial vaccines 
- Small molecules and biologics 
- Regulatory-compliant virus propagation 
and quantitation (TCID50) services 
- Mouse-adapted influenza strains available 
- Bio-analytical support 
PHARMA
tnotriskelion.com 
Evaluation and 
Authorization 
BIOANALYTICAL SERVICES 
LIGAND BINDING ASSAYS: 
- ELISA 
- Luminex 
- Mesoscale Discovery 
- Serum IgM and IgG isotype titres 
- small molecule serum/plasma analysis 
- Cytokine, chemokine and phospho-protein 
analysis in various matrices 
LC-MS: 
- Serum antibody of small molecule 
analysis 
- Antibody fragments in serum and tissues 
(i.e. nose/lungs) 
YOUR BENEFITS: 
- Fast turnaround times 
- Direct communication with expert 
- Tailor-made study designs 
- Full regulatory & ethical compliance 
- GLP or non-GLP services 
- Consultancy on 3R’s (Refinement, 
Replacement and Reduction) of animal 
testing 
- Knowledgeable staff: 15% PhDs 
- AAALAC accreditation 
- GLP-certified facilities 
- ISO17025-certified analytical labs 
ECHA 
Technical 
Guidance 
Products and 
services 
Triskelion 
New 
PATHOGEN SERVICES 
VIRAL PROPAGATION SERVICES: 
- Propagation on SPF eggs 
- Endotoxin detection 
- Mycoplasma detection 
- Viral genome sequencing 
to successful REACH compliance, which 
is crucial for your licence to operate. 
Being well prepared can make your 
contacts with the authorities more 
confident and meaningful, assisting in 
a smooth and successful inspection. 
TCID50 
Using the MDCK cell line the TCID50 is 
determined for: 
- Viral stocks 
- Tissue viral load 
OUR SOLUTIONS 
an audit may include a review of the 
following aspects: 
• REACH obligations and the expectations 
of inspectors. 
• Substance inventory. 
• Efficiency of current purchasing 
processes (including customs). 
• The process for classification and 
labelling of substances/products. 
• The REACH obligations on the use of 
hazardous substances. 
• The management of (extended) SDSs. 
• The practical implications of REACH in 
the company/plant. 
• Downstream user / supply chain 
communication. 
• Internal documentation / archiving. 
• Internal communication and training of 
personnel regarding rEaCh. 
• Current IT-tools to facilitate the above 
processes. 
IN LIFE EFFICACY MODELS AVAILABLE 
FOR INFLUENZA AND HEPATITS B: 
- Mice 
- Rats 
- Ferrets 
Other pathogens on request 
CHALLENGE STUDY READ-OUTS: 
- Body weight 
- Clinical score 
PATHOLOGY SUPPORT: 
TISSUE (IMMUNO)HISTOPATHOLOGY 
- H&E staining 
- Immunohistochemistry 
- Cytospin analysis of tissue infiltrates 
- FACS analysis of tissue infitrates 
- Broncho-Alveolar Lavage Fluid Analysis 
MOLECULAR BIOLOGY: 
- Whole genome sequencing 
- Real-time qPCR 
WHY TNO TRISkeLION 
• Strong REACH team: regulatory 
scientists highly experienced in 
chemical industry, with EU Competent 
authorities and contract research. 
• Experience with more than 200 REACH 
projects for major chemical industry 
clients: consortium representation, lead 
dossier generation, company dossiers. 
• working in the interest of our clients, 
anticipating the wishes of authorities. 
See our website (www.triskelion.nl) for 
more information on tailor-made support 
to assist your company for REACH, ClP, 
Chemicals Management and Biocides. 
R E A C H AU D I T S 
REACH9/12-11/Ck/0755 
Manufacture 
Ensured 
Succesful 
registration 
Chemical Industry & REACH 
Defensive 
Strategies 
Dossier 
Completion 
Exposure Tools, 
Testing & 
Analysis 
>1000t Annex X 
Substances 
100-1000t Annex 
IX & X Substances 
Partners 
S trate gie s 
REACH And TnO TRiskEliOn: 
suCCEssful REgisTRATiOn ‘wiTHin REACH’ 
The aim of REACH is to describe the safe-use of chemicals 
throughout the product chain. All High Production Volume 
Chemicals and priority substances must be registered by 
2010 or 2013. TNO Triskelion can assist your company in 
achieving this with our proven expertise in the fields of risk 
assessment, registration and testing. With TNO Triskelion, 
your technical dossiers, exposure scenarios and Chemical 
Safety Reports are safe in our hands. 
The added value of TNO Triskelion’s REACH services is 
based on decades of experience with registration and 
safety studies for the Chemicals Industry. TNO Triskelion is 
actively involved in the rgw ongoing work of developing 
technical guidance for REACH and has broad contacts with 
ECHA and the EU Member State Competent Authorities. 
www.TRISkElIon.nl 
TnO TRISkElIOn BV 
TnO Triskelion is a contract research 
organization active in toxicology research, 
analytical chemistry and chemical risk 
analyses. The mission of TnO Triskelion is 
to guarantee the quality and safety of food 
ingredients, chemical substances and 
medicines. TnO Triskelion is a subsidiary 
of TnO, the netherlands Organisation for 
Applied Scientific Research. 
VISITIng ADDRESS 
utrechtseweg 48 
3704 HE Zeist 
the netherlands 
POSTAl ADDRESS 
P.O. Box 844 
3700 AV Zeist 
the netherlands 
for more information, please contact us. 
THE nETHERlAnDS 
P +31 88 866 16 20 
f +31 88 866 69 70 
chemistry@tno.triskelion.nl 
Japan 
P +81 45 478 51 30 
f +81 45 473 79 59 
“ MAjOR REsulTs: 
inCREAsEd 
AwAREnEss And 
HARMOnisATiOn” 
When you look for a trusted independent 
research partner who can offer full support 
in assessing the safety and efficacy of your 
Products, TNO Triskelion offers a complete 
portfolio of high quality and innovative 
services with over 35 years of experience. 
We operate in compliance with the highest 
quality standards, including GLP, ISO17025 
and AAALAC. TNO Triskelion has a track 
record of conducting tailor-made studies 
by integrating expert knowledge and 
flexibility to meet your schedules. 
VISITING ADDRESS 
Utrechtseweg 48 
3704 HE Zeist 
The Netherlands 
POSTAL ADDRESS 
P.O. Box 844 
3700 AV Zeist 
The Netherlands 
For more information, please contact us. 
THE NETHERLANDS 
P +31 88 866 16 20 
F +31 88 866 69 70 
pharma@tno.triskelion.nl 
JAPAN 
P + 81 36 234 41 95 
ariga@tno-pharma.com 
USA 
P +1 416 837 7500 
tmeijers@tnopharma.com 
Infectious Diseases

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Tno productblad infectious diseases_web

  • 1. Infectious Diseases TNO Triskelion is your independent and trusted pre-clinical research partner. We provide sponsor-speci-fic support for pre-clinical develop-ment of your vaccine products against infectious diseases. Our certified and accredited Bio Safety Level 2 and 3 facilities allow us to evaluate your vaccines that require BSL2 or BSL 3 testing facilities. TNO Triskelion facilities supports your market authorisation process for new vaccines against infection and deadly pathogens. Our reports have successfully supported the market authorisation for vaccines of our clients around the globe. WHAT’S IN IT FOR YOU? With over 30 years of vaccine safety and efficacy testing, we are confident that we will provide you with the research approach you need. WE OFFER: - Biosafety Level 2 & 3 facility - Expertise & experience in class 2 and class 3 challenge studies - Tailor-made study designs - Flexibility - Proven track record - Direct contact with our experts - Available infectious disease efficacy models: - Influenza H1, H3 and B - Hepatitis B - GLP and non-GLP services - Regulatory guideline compliance BSL 2 & 3 CAPABILITIES: - Challenge studies up to class 3 pathogens: - Avian influenza (H5N1, H7N7, H7N9) - SARS, HIV, Hepatitis B - Bacteria (i.e. tuberculosis, polio) - Efficacy testing of anti-viral and anti-bacterial vaccines - Small molecules and biologics - Regulatory-compliant virus propagation and quantitation (TCID50) services - Mouse-adapted influenza strains available - Bio-analytical support PHARMA
  • 2. tnotriskelion.com Evaluation and Authorization BIOANALYTICAL SERVICES LIGAND BINDING ASSAYS: - ELISA - Luminex - Mesoscale Discovery - Serum IgM and IgG isotype titres - small molecule serum/plasma analysis - Cytokine, chemokine and phospho-protein analysis in various matrices LC-MS: - Serum antibody of small molecule analysis - Antibody fragments in serum and tissues (i.e. nose/lungs) YOUR BENEFITS: - Fast turnaround times - Direct communication with expert - Tailor-made study designs - Full regulatory & ethical compliance - GLP or non-GLP services - Consultancy on 3R’s (Refinement, Replacement and Reduction) of animal testing - Knowledgeable staff: 15% PhDs - AAALAC accreditation - GLP-certified facilities - ISO17025-certified analytical labs ECHA Technical Guidance Products and services Triskelion New PATHOGEN SERVICES VIRAL PROPAGATION SERVICES: - Propagation on SPF eggs - Endotoxin detection - Mycoplasma detection - Viral genome sequencing to successful REACH compliance, which is crucial for your licence to operate. Being well prepared can make your contacts with the authorities more confident and meaningful, assisting in a smooth and successful inspection. TCID50 Using the MDCK cell line the TCID50 is determined for: - Viral stocks - Tissue viral load OUR SOLUTIONS an audit may include a review of the following aspects: • REACH obligations and the expectations of inspectors. • Substance inventory. • Efficiency of current purchasing processes (including customs). • The process for classification and labelling of substances/products. • The REACH obligations on the use of hazardous substances. • The management of (extended) SDSs. • The practical implications of REACH in the company/plant. • Downstream user / supply chain communication. • Internal documentation / archiving. • Internal communication and training of personnel regarding rEaCh. • Current IT-tools to facilitate the above processes. IN LIFE EFFICACY MODELS AVAILABLE FOR INFLUENZA AND HEPATITS B: - Mice - Rats - Ferrets Other pathogens on request CHALLENGE STUDY READ-OUTS: - Body weight - Clinical score PATHOLOGY SUPPORT: TISSUE (IMMUNO)HISTOPATHOLOGY - H&E staining - Immunohistochemistry - Cytospin analysis of tissue infiltrates - FACS analysis of tissue infitrates - Broncho-Alveolar Lavage Fluid Analysis MOLECULAR BIOLOGY: - Whole genome sequencing - Real-time qPCR WHY TNO TRISkeLION • Strong REACH team: regulatory scientists highly experienced in chemical industry, with EU Competent authorities and contract research. • Experience with more than 200 REACH projects for major chemical industry clients: consortium representation, lead dossier generation, company dossiers. • working in the interest of our clients, anticipating the wishes of authorities. See our website (www.triskelion.nl) for more information on tailor-made support to assist your company for REACH, ClP, Chemicals Management and Biocides. R E A C H AU D I T S REACH9/12-11/Ck/0755 Manufacture Ensured Succesful registration Chemical Industry & REACH Defensive Strategies Dossier Completion Exposure Tools, Testing & Analysis >1000t Annex X Substances 100-1000t Annex IX & X Substances Partners S trate gie s REACH And TnO TRiskEliOn: suCCEssful REgisTRATiOn ‘wiTHin REACH’ The aim of REACH is to describe the safe-use of chemicals throughout the product chain. All High Production Volume Chemicals and priority substances must be registered by 2010 or 2013. TNO Triskelion can assist your company in achieving this with our proven expertise in the fields of risk assessment, registration and testing. With TNO Triskelion, your technical dossiers, exposure scenarios and Chemical Safety Reports are safe in our hands. The added value of TNO Triskelion’s REACH services is based on decades of experience with registration and safety studies for the Chemicals Industry. TNO Triskelion is actively involved in the rgw ongoing work of developing technical guidance for REACH and has broad contacts with ECHA and the EU Member State Competent Authorities. www.TRISkElIon.nl TnO TRISkElIOn BV TnO Triskelion is a contract research organization active in toxicology research, analytical chemistry and chemical risk analyses. The mission of TnO Triskelion is to guarantee the quality and safety of food ingredients, chemical substances and medicines. TnO Triskelion is a subsidiary of TnO, the netherlands Organisation for Applied Scientific Research. VISITIng ADDRESS utrechtseweg 48 3704 HE Zeist the netherlands POSTAl ADDRESS P.O. Box 844 3700 AV Zeist the netherlands for more information, please contact us. THE nETHERlAnDS P +31 88 866 16 20 f +31 88 866 69 70 chemistry@tno.triskelion.nl Japan P +81 45 478 51 30 f +81 45 473 79 59 “ MAjOR REsulTs: inCREAsEd AwAREnEss And HARMOnisATiOn” When you look for a trusted independent research partner who can offer full support in assessing the safety and efficacy of your Products, TNO Triskelion offers a complete portfolio of high quality and innovative services with over 35 years of experience. We operate in compliance with the highest quality standards, including GLP, ISO17025 and AAALAC. TNO Triskelion has a track record of conducting tailor-made studies by integrating expert knowledge and flexibility to meet your schedules. VISITING ADDRESS Utrechtseweg 48 3704 HE Zeist The Netherlands POSTAL ADDRESS P.O. Box 844 3700 AV Zeist The Netherlands For more information, please contact us. THE NETHERLANDS P +31 88 866 16 20 F +31 88 866 69 70 pharma@tno.triskelion.nl JAPAN P + 81 36 234 41 95 ariga@tno-pharma.com USA P +1 416 837 7500 tmeijers@tnopharma.com Infectious Diseases