Overview BIOPHARMACEUTICALS & BIOMARKERS

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

Cytokine Release Assays for Safety Assessment of Biologicals

• Protocols consider post TGN 1412 requirements

• Combination of cell culture, stimulation and cytokine detection

• Stimulation of whole blood or defined cellular subpopulations

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 multiplecytokine producing cells

Apoptosis

• Caspase 3/7 induction

• Annexin V assay

• Cell Morphology

Cytotoxicity

• LDH release

• Protease release

NO-production

Histamine release

TLR stimulation assays: Innate immunity evaluation via stimulation of Toll-like receptors

 

METHODS/TECHNIQUES

Lymphocyte Stimulation Assays

Defined healthy blood donors under EC vote

Immune Cell Preparations

• Whole blood

• Peripheral Blood MononuclearCells (PBMC)

• Purified subpopulations

Antigen specific stimulations

• Cytomegalovirus (CMV)-peptides

• PPD („purified protein derivative“ of Mycobacterium 
  tuberculosis, “tuberculin”)

• Tetanus Toxoid

• Influenza Peptides

Polyclonal stimulations

• Antibody-mediated, e.g. antiCD3/CD28

• Mitogens, e.g Phytohemagglutinin (PHA) and Lipopolysaccharide (LPS)

• Phorbol Myristate Acetate (PMA) and Ionomycin

• “Superantigens” e.g. Staphylococcal Enterotoxin B (SEB)

Functional read-out after stimulation

• Proliferation

• Cytokine Release (ELISA, ELISPOT, Intracellular Cytokine Staining [ICS])

• Induction of apoptosis

• Cytotoxicity

Fully Equipped

• Tissue Culture

• Flow cytometry

• Mulitformat Reader

 

Mediator/Cytokine Analysis “ready to go”:

• IL-1ß

• IL-2

• IL-4

• IL-5

• IL-6

• IL-8

• IL-10

• IL-12p70

• IL-13

• IL-17

• IL-18

• IL-23

• TNF-α

• IFN-α

• IFN-γ

• TGF-ß1

• IP-10

• sTNFRI

• sTNFRII

• sIL-2R

• IGF-1

• FGF-19

• ß-Defensin-2

• LTB4

• PGE2

• M30 Apoptosome

• M65 Apoptosome

• Adrenaline

• Noradrenaline

• Dopamine

• Cortisol

• DHEA-S

• Serotonin

• Histamine

 

QUALITY STANDARDS IMMUNOASSAYS

• GLP certified since 1994 (German regulatory authorities)

• GCP – Good Clinical Practice

• Detailed internal audit program 

• License for handling narcotics

• ANVISA (Brazil) Inspected and Approved

• FDA (frequent BIMO inspections)

• Bayrisches Landesamt für Gesundheit und Lebensmittelsicherheit 
  (GLP, Local Agency)

• ZAB, Regierung von Oberbayern (GCP, local Agency)

• QM Service for Clients / Customers

• 100% internal QC check

• EMA reflection paper

Contact

Business Development
Please send us an Email!

 

 

Dr. Eddy Bruyns
Scientific Director

Dr. Uwe Kärcher
Director
Biopharmaceutics

Dr. Dwight D. Stiff
Vice President 
Business Development

Dr. Florian Schwaak
Director 
Business Development