CIMNA, the unique center for Immune monitoring. CRO / Central Lab / Services in Cytometry, ELISpot, Luminex, Miccroarrays, biostatistics, clinical management, medical writing...

1. The unique immune
monitoring service
center for your drug
development
www.cimna.org

2. CIMNA Objectives
Why perform immuno monitoring analyses in early clinical
developments ?
 Regulatory environment
New requirements of EMEA and FDA for a better understanding of:
• drug mechanisms of action
• scientific context
• initial drug dose evaluation
 Industrial environment
• Obtain necessary information for GO/NO GO decisions
• Strategic discovery of Biomarkers
Immune response analysis is a real added value
to strengthen your pipeline

3. A unique integrated Immunomonitoring center
CIMNA is a niche service provider specialized in immunology
CIMNA associates industrial & academic partner to ensure a
high-quality one-stop shop:
 EXPERTISE
 State of the Art Technologies
 QUALITY Services
 Project Management

4. CIMNA PARTNERS
TcLand-Expression Atlanstat
 Global Management  Regulatory affairs
 Bio-informatic & biostatistics  Clinical operations
 Data Management
 T cell repertoire units
 Statistics
 Biomarkers & companion diagnostic
Immunology Laboratory Transcriptomic Platform
Nantes university Hospital Biogen Ouest
 Elispot  Transcriptomic unit
 Flow-cytometry
 Multiplex assays  Genomic
 Elisa  Biostatistics

5. CIMNA organisation
1300sqm of Laboratories, +60 employees, 1 location (Nantes, France)

6. Scientific Committee
A high-level scientific committee ensuring best adequacy and
interpretation of information for the specific needs of our
partners
 Chairman: Prof. Régis JOSIEN
 TECHNOLOGY EXPERTS
• Cytomics: Dr. Marie RIMBERT
• Transcriptomics : Dr. Rémi HOULGATTE
• Repertoire: Dr. Marina GUILLET
• Statistics: Dr. Nadine GODFROID
 EXPERTS BY THERAPEUTIC AREA
• Transplantation: Prof. Jean-Paul SOULILLOU
• Autoimmunity/inflammation: Prof. Mohamed HAMIDOU
• Oncology & Immunotherapy: Prof. Marc BONNEVILLE
• Neuroimmunology: Dr. David LAPLAUD
• Allergy: Prof. Antoine MAGNAN

7. Sample management
GBEA
 PBMC preparation (Ficoll, up to 50ml)
 PBMC freezing / thawing
 Cell counting
 Cell storage in liquid nitrogen
 Serum storage at -80°C
CYTOMIC UNIT
Working according SOP
Well experienced technicians / Hospital Lab

8. ELISPOT
GBEA
 antigen-specific cytokine-secreting T cells
 antigen-specific CTL
 antigen-specific antibody producing B cells
Applications:
 Vaccine development
 Autoimmunity
CYTOMIC UNIT
 Infectious disease
 Cancer
 Transplantation…

9. Flow Cytometry
GBEA
 immune cells (T, B, NK, DC, Mono.)
 T cell subsets (naive, effector, central memory, effector
memory)
 Counting of antigen-specific T cells with tetramers
 Intracellular cytokine staining to assess T cell function
4 cytometers / up to 12 colors:
 BD Canto I
CYTOMIC UNIT
 BD Canto II
 BD FACS Aria Cell sorter
 BD LSR II

10. Luminex, ELISA
GBEA
Multiplex bead array assays
 Multiple cytokine/chemokine quantification (immune
response, inflammation, cytokine storm, etc..).
 Multiple auto-antibody titration
ELISA
 Cytokine/chemokine dosage
 Immunoglobulin dosage
CYTOMIC UNIT
 Auto-antibody detection and titration
Development of custom assays

11. Repertoire Analysis
TcLandScape
 Analysis of T cell receptor populations
 Transcriptomic approach
REPERTOIRE UNIT
Qualitative analysis of the TCR Vb Gene usage and CDR3 Length distribution
combined with qPCR on TCR mRNA transcripts

12. TcLandScape Indications
 Immune response characterization
 Targeting immune populations for functional analyses
 Effects of drug candidates on T cell mobilization
 Epitope spreading
 Clonality testing
 animal models
REPERTOIRE UNIT

13. ISO qPCR unit
17025
 Customized service using our real-time PCR platform (ABI
7900HT)
 ISO 17025 compliant
 Easy and rapid transfer of your protocol to ISO 17025
REPERTOIRE UNIT

14. ISO
Pangenomic Microarrays services
9001
 Agilent Multiplex Gene Expression Microarrays
Human or Mouse, 41 000 Transcripts, 44 000 probes / 60-mers
 Affymetrix Genechip Human Genome U133 Plus 2.0
Human, 47 000 Transcripts, 54 000 probes / 25-mers
TRANSCRITOMIC UNIT

15. ISO
Other Microarrays
9001
 miRNA expression microarrays
866 human miRNA + 89 viral miRNA, 15 000 probes / 60-mers
 SNP genotyping
 BioInformatics & biostatistics (21CFR part11)
TRANSCRITOMIC UNIT

16. Clinical operations, Medical Writing
GCP
 Identification of medical leaders/experts
 Selection of investigators sites
 Regulations management
 Study Site follow-up
CLINICAL OPERATION UNIT
 Project global management
 clinical study protocols & reports writing

17. Data Management, Biostatistics
GCP
 Data base set up, imports, exports, lock, transfers
 Medical data coding
 Final quality control, data entry audits, blind data review
 Statistical analysis programming
CLINICAL OPERATION UNIT
 Full validation and quality control of results
 Clinical Study Reports (ICH)

18. The unique immune
monitoring service
center
www.cimna.org