Years of Experience in Immunomonitoring

Glycotope has many years of experience in assay development and validation to analyze blood/serum samples from patients in the course of clinical trials. Sample handling, storage and analysis are performed under “Good Clinical Laboratory Practice” (GCLP).

We offer ISO 9001 compliant services to ensure controlled quality of Immunomonitoring Services.

Our strength is to assess the pharmacokinetic and pharmacodynamic characteristics of biotherapeutics using sophisticated assays and techniques as well as the analysis for anti-drug-antibodies (ADAs) and their neutralizing activity.

Immunogenicity testing, PK and PD assessment under GCLP
  • Analysis for anti-drug-antibodies (ADAs) using screening/confirmatory/titration assays
  • Analysis of ADA for neutralizing activity
  • PK analysis
  • Biomarker serum levels
  • Cytokine release
  • Cellular immune status (CD marker)
  • Immune cell function (e.g. CDC)
  • Genetic mutations (SNP)
Available technologies
  • ELISA in all formats
  • Electrochemiluminescence (MSD)
  • Mass spectrometry (LC-MS/MS) based PK analysis
  • Flow cytometry
  • Cytotoxicity & cellular immunoassays with >100 cell lines and primary cell preparations
  • FcγR binding assays (αlphaScreen®)
  • DNA melting curve analytics (LightCycler®)
Histology services
  • Tissue processing and embedding
  • Tissue sectioning
  • Immunohistochemical staining
Our core competencies
  • Project consultancy
  • Assay establishment
  • Assay validation
  • Immunomonitoring of clinical trials
  • Sample storage
Dr. Hans Baumeister
t: +49 (0)30 9489 2600
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