The unique immune

monitoring service

center for your drug

development

www.cimna.org

CIMNA Objectives

Why perform immuno monitoring analyses in early clinical developments ?

Regulatory environmentNew 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 valueto strengthen your pipeline

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

CIMNA PARTNERS

TcLand-Expression Global Management

Bio-informatic & biostatistics

T cell repertoire units

Biomarkers & companion diagnostic

Atlanstat Regulatory affairs Clinical operations Data Management Statistics

Immunology LaboratoryNantes university Hospital

Elispot Flow-cytometry Multiplex assays Elisa

Transcriptomic PlatformBiogen Ouest

Transcriptomic unit Genomic Biostatistics

CIMNA organisation

1300sqm of Laboratories, +60 employees, 1 location (Nantes, France)

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

Sample management

PBMC preparation (Ficoll, up to 50ml)

PBMC freezing / thawing

Cell counting

Cell storage in liquid nitrogen

Serum storage at -80°C

Working according SOP

Well experienced technicians / Hospital Lab

GBEA

CYT

OM

ICU

NIT

ELISPOT

antigen-specific cytokine-secreting T cells

antigen-specific CTL

antigen-specific antibody producing B cells

Applications:

Vaccine development

Autoimmunity

Infectious disease

Cancer

Transplantation…

GBEA

CYT

OM

ICU

NIT

Flow Cytometry

immune cells (T, B, NK, DC, Mono.)

T cell subsets (naive, effector, central memory, effectormemory)

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

BD Canto II

BD FACS Aria Cell sorter

BD LSR II

GBEA

CYT

OM

ICU

NIT

Luminex, ELISA

Multiplex bead array assays Multiple cytokine/chemokine quantification (immune

response, inflammation, cytokine storm, etc..).

Multiple auto-antibody titration

ELISA

Cytokine/chemokine dosage

Immunoglobulin dosage

Auto-antibody detection and titration

Development of custom assays

GBEA

CYT

OM

ICU

NIT

Repertoire Analysis

TcLandScape Analysis of T cell receptor populations

Transcriptomic approach

Qualitative analysis of the TCR Vb Gene usage and CDR3 Length distribution

combined with qPCR on TCR mRNA transcripts

REP

ERTO

IRE

UN

IT

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

REP

ERTO

IRE

UN

IT

qPCR unit

Customized service using our real-time PCR platform (ABI 7900HT)

ISO 17025 compliant

Easy and rapid transfer of your protocol to ISO 17025

ISO 17025

REP

ERTO

IRE

UN

IT

Pangenomic Microarrays services

Agilent Multiplex Gene Expression MicroarraysHuman 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

ISO 9001

TRA

NSC

RIT

OM

IC U

NIT

Other Microarrays

miRNA expression microarrays866 human miRNA + 89 viral miRNA, 15 000 probes / 60-mers

SNP genotyping

BioInformatics & biostatistics (21CFR part11)

ISO 9001

TRA

NSC

RIT

OM

IC U

NIT

Clinical operations, Medical Writing

Identification of medical leaders/experts

Selection of investigators sites

Regulations management

Study Site follow-up

Project global management

clinical study protocols & reports writing

GCP

CLI

NIC

AL

OP

ERAT

ION

UN

IT

Data Management, Biostatistics

Data base set up, imports, exports, lock, transfers

Medical data coding

Final quality control, data entry audits, blind data review

Statistical analysis programming

Full validation and quality control of results

Clinical Study Reports (ICH)

GCP

CLI

NIC

AL

OP

ERAT

ION

UN

IT

The unique immune

monitoring service

center

www.cimna.org