Immunology services for the development
of novel medicines

FOCUS Immunology Laboratory Heidelberg (GLP-certified)

Fully equipped tissue culture facility, flow cytometry,
multiformat reader, PCR

Cytokine Release Assays for Safety Assessment of Biologicals

Immunogenicity testing

Functional testing of immune cells for mode-of-action analysis

Immune-monitoring of clinical trials

PK/PD assessment for Biologicals/Biosimilars

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Cytokine Release Assays for Safety Assessment of Biologicals

• Combination of cell culture, stimulation and cytokine detection
• Stimulation of whole blood or defined cellular subpopulations
• Protocols consider post TGN 1412 requirements

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Immunogenicity Testing According to EMA Guidelines

• Assay development, validation and GLP-compliant performance
• Screening assays
• Confirmatory assays
• Assays for neutralizing antibodies
• Various ELISA formats available: Bridging, direct, competitive
• Cellular immunity assessment

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Cell-based Functional Assays

Proliferation

• Metabolic (ATP) assay via luminescence
• CFSE and BrdU assay via fluorescence

Intracellular Cytokine Staining (ICS)

• Multi-parametric analysis for detection of multiple cytokine producing cells

Apoptosis

• Caspase 3/7 induction
• Annexin V assay
• Cell Morphology

Cytotoxicity

• LDH release
• Protease release

NO-production

Histamine release

Innate immunity evaluation via stimulation of
Toll-like receptors (“TLR stimulation assays”)

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Lymphocyte Stimulation Assays
Defined healthy blood donors under EC vote

Immune Cell Preparations

• Whole blood
• Peripheral Blood Mononuclear Cells (PBMC)
• Purified subpopulations

Antigen specific stimulations

• CMV-peptides
• PPD
• Tetanus Toxoid
• Influenza Peptides

Polyclonal stimulations

• Antibody-mediated, e. g. antiCD3/CD28
• Mitogens, e. g. PHA and LPS
• PMA and Ionomycin
• “Superantigens” e. g. SEB

Functional read-out after stimulation

• Proliferation
• Cytokine Release (ELISA, ELISPOT, ICS)
• Induction of apoptosis
• Cytotoxicity

Fully Equipped

• Tissue Culture
• Flow cytometry
• Mulitformat Reader
• PCR

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Mediator/Cytokine Analysis “ready to go”:

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Contact

Dr. Eddy Bruyns Phone: +49 6221 64935-124 Fax: +49 6221 64935-110 eddy.bruyns@focus-cdd.com FOCUS CDD GmbH Im Neuenheimer Feld 515 69120 Heidelberg

Dr. Karl Michaelis Phone: +49 731 9840-240 Fax: +49 7319840-324 karl.michaelis@nuvisan.de Nuvisan GmbH Wegenerstrasse 13 89231 Neu-Ulm

www.focus-immunology.com

Full Service CRO
driven by Experience, Commitment, Technology

www.nuvisan.com

All Services under one roof

LAB Services

• Bioanalytics
• Pharmaceutical Analytics
• Clinical Trial Supplies
• Biopharmaceuticals

Focus Phase I

• Early Stage Clinical Development
• FIM/FIP/BE Studies
• Ethnicity Bridging Studies

Phase II – IV

• Oncology
• EDC Solutions
• Biostatistics
• Regulatory Affairs