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!



Exhibitions

CURIOUS 2018
Future Insight Conference
16.07. - 18.07.2018
Darmstadt / Germany


CPhI Korea
Mix the world of Pharma products, People & solutions
28.08. - 30.08.2018
Seoul / South Korea


BioFit
7th edition
Fostering Innovation & Transfer
04.12. - 05.12.2018
Lille / France