Glycotope Biotechnology’s expertise reaches from ELISAs to FACSs to cell-based bioassays, from antibodies to hormones to blood factors. Whether you start from scratch or already have a partially developed method – we design, and develop your assay for release testing.

Bioactivity and Cellular Assays

Bioactivity of final products is one of the key features in the specification of biopharmaceutical drug substances and clinical samples.

With our broad experience in GCLP assay development, we at Glycotope Biotechnology have a proven track record when it comes to establishing qualified and validated methods for product quality control. For decades, we have successfully used our ability, proficiency and expertness in immunology and routine assays.

Choosing the right partner for bioactivity and cell based assays is decisive for your project. Successful development of such assays requires profound expertise – and that only comes with experience. Cell based assays are among the most challenging to perform. Consistent assay performance requires a controlled setting, highly skilled analysts with in-depth understanding of cell physiology and a well-developed and characterized method.

Glycotope Biotechnology is your dedicated expert partner for all aspects of bioassay development, validation, method transfer and long-term assay maintenance. With our broad experience, we stand for quality completion of your testing program.

We specialize in:

  • Specific binding assays
  • FcgRIIIa binding assays
  • Antibody-dependent cell-mediated cytotoxicity (ADCC)
  • Cell proliferation assays, cell based potency assays for rhGH, G-CSF and GM-CSF

  • Custom-made NK cell cytotoxicity assays
  • Custom-made lymphocyte proliferation assays
  • Evaluation of customer-provided samples

Cell-Based Assays for Drug Substance Release Testing

Cell-based assays are powerful in vitro test systems – they are very versatile and measure almost any induced physiological product response in a living system and consequently provide vital information on the product. Cell-based assays are mandatory when drug candidates are finally released for human use in clinical trials.

We at Glycotope Biotechnology develop custom-made assays for your specific lead-substances, looking at

  • Proliferation
  • Migration & invasion
  • Apoptosis
In Vitro Diagnostics

Glycotope Biotechnology offers several clinical diagnostics and research reagents based on flow cytometry procedures for the fast and precise measurement of various cell functions focused on functional characterisation of the cellular immune reponse and characterisation of haematological relevant auto-immune disease.

Our Core Competencies:

We offer a range of flow cytometry-based assays for the analysis of the functional activity of

  • Neutrophilic granulocytes
  • Monocytes

  • Basophilic granulocytes
  • Natural killer cells

MIGRATEST

Clinical diagnostic for the quantitative determination of the chemotactic function of neutrophilic granulocytes

Simple and sensitive method for the flow cytometric quantification of the chemotactic function of neutrophilic granulocytes.

24 analyses for 12 patients. Test kit contains multiwell plates and precoated cell culture inserts for chemotaxis studies, the chemotactic peptide N-formyl-Met-Leu-Phe (fMLP), an antibody reagent, counting beads and necessary reagents. Evaluation by flow cytometry.

PHAGOTEST

Clinical diagnostic for the quantitative analysis of leukocyte phagocytosis in human whole blood.

Whole blood assay:

  • No isolation procedures and optimal culture medium
  • Suppressible fluorescence (quenching)
  • Physiological target
  • Standardized fluorescence intensity
  • Compatible for simultaneous immunofluorescence

  • Good opsonizability
  • pH dependent FITC fluorescence
  • No electrostatic charging or absorption artifacts like latex
  • Favourable size range of bacteria
  • Exclusion of aggregation artifacts by DNA staining

PHAGOBURST

Clinical diagnostic for the quantitative analysis of leukocyte oxidative burst in human whole blood.

  • Functional test ex vivo
  • Evaluation of single cells to detect heterogenous populations
  • Whole blood assay: No isolation procedures and optimal culture medium
  • Physiological stimulans for phagocytes: Bacteria and fMLP
  • Dose response: Low and high stimulant

  • No electrostatic artifacts in polystyrol tubes compared to latex beads
  • Standardized test procedure
  • Exclusion of aggregation artifacts by DNA staining
  • Compatible with whole blood of mice and rats
  • Fast assay: Whole assay time is 1.5 hours

100 analyses. Clinical Diagnostic for the Quantitative Analysis of Leukocyte Oxidative Burst in Human Whole Blood. Evaluation by flow cytometry.

NKTEST

Clinical diagnostic for the quantification of the cytotoxic activity of human natural killer cells.

  • Simple and sensitive method for the routine clinical assessment of NK lytic activity
  • Easy discrimination between effector and target cells
  • Avoidance of radioisotope usage and reduction of overall assay time
  • No cell culture equipment necessary

  • Complete kit containing cryopreserved K562 target cells, complete medium and staining reagents
  • Standardized test procedure
  • 20 analyses.

Kit contains cryopreserved K562 target cells and all required reagents.  Evaluation by flow cytometry.

BASOTEST

Clinical diagnostic for the determination of the allergen-induced basophil degranulation.

  • Simple: Whole blood assay for clinical routine analysis. Does not require isolation procedures
  • Fast and Sensitive: Data within 2 hours. Stimulation buffer amplifies the signal.

  • Diagnostic: Standardized test procedure for – detecting immediate-type hypersensitivity – testing of natural allergens – checking the success of immunotherapy (e.g. hyposensitisation)
  • Complete: Kit contains important allergens plus positive and negative controls. No disturbance by potential histamine in allergen extracts.

100 analyses. Kit contains antibodies, allergens and all required reagents. Evaluation by flow cytometry.

THROMBOCYTEST immune

Clinical diagnostic for the quantification of platelets-associated immunoglobulin

  • Simple method for the flow cytometric determination of platelet associated immunoglobulin for the differential diagnosis of
  • Idiopathic Thrombocytopenic Purpura (ITP).
  • High reliability through polyclonal anti-sera against human IgA, IgG, IgM.

  • Improved sensitivty through use of RPE conjugates for detection of autoimmune-globulines.
  • Standardized test procedure.

Antibodies and reagents for 25 tests. Test kit contains CD42a FITC conjugate, polyclonal anti-human Immunoglobulins, RPE conjugate; polyclonal anti-human IgA, IgG, IgM, RPE conjugates; polyclonal anti-human rabbit, RPE conjugate,negative control; goat serum and 10 x washing buffer. Evaluation by flow cytometry.

Immunomonitoring

The development of biotherapeutics, especially vaccines and immunotherapeutics, requires the sophisticated assessment of immune responses in human clinical trials. Immune cell-mediated modes of action became more and more important for biotherapeutics and involve the activity of specialized cells including macrophages, dendritic cells, natural killer cells (NK), antigen-specific cytotoxic T lymphocytes, helper T lymphocytes and the release of various cytokines in response to an antigen stimulation. Finally, genetic mutations can affect the efficacy of drugs. Glycotope Biotechnology provides its customers full project consultancy, including assay creation and validation, sample measurement and immune monitoring in clinical trials.

Based on a variety of technology platforms and measurements, Glycotope Biotechnology provides comprehensive services for immunogenicity testing, pharmacokinetic (PK) and pharmacodynamics (PD) assessment measures.

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