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
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)