Precision Medicine

Immunoassays

Contents

Services

Immunoassays

Immunoassays are used for quantifying the concentration of analytes such as protein, hormone, or antibody with high specificity. By combining technologies using absorbance, fluorescent and luminescent detection methods, a high dynamic range can be achieved even for analytes present in low concertation. It is essential to monitor changes in patterns of key analytes in the development phase of new pharmaceutics and the discovery of novel biomarkers.

Furthermore, immunoassays provide additional advantages due to their high throughput, multiplex, and small sample volume requirements. Therefore, clinical samples are protected and enable researchers to perform multiple tests, while reducing the need for repeated sample collection.

Services

Biomarker Analysis

Our biomarker analysis service utilises state-of-the-art technology to perform immunoassays on a variety of sample types including FFPE tissues, urine, liquid biopsies, plasma, serum, nasal swabs & stool samples.  Customers can expect accurate and reliable results that can help inform their research or clinical decision-making. The biomarkers analysed by this service can be useful in a wide range of applications across immune monitoring, including drug discovery, clinical trials, and disease diagnosis and monitoring.

  • Cytokine and Chemokine quantification (including TNF-α, IL-2, IL-6, IL-8 & IFN-γ)

  • Anti-drug antibodies (ADA screening, confirmatory and titration, nAb)

  • Cell cytotoxicity & cell viability (MTT, ROS, ATP-based assay, Delfia cell proliferation assay, Calcein AM, Caspase-3/7 R110, Glutathione Assay)

  • IgG quantitation (High-throughput quantification for clone screening during drug discovery and development, virology and vaccine research)

  • Cell signaling (G protein-coupled receptors, cAMP, NF-kB, Kinases, Phosphatases, Phosphodiesterases)

  • Exosome analysis

  • Circulating tumour cells (CTCs)

Services

ELISA

Enzyme Linked Immunosorbent Assay (ELISA) is a benchmark technology designed for detecting and measuring soluble analytes such as proteins, antibodies, and hormones. The SpectraMax ID5 plate reader (Molecular Devices) ensures high quality measurements using absorbance, fluorescence, and luminescence. Types of ELISA offered: Direct, Indirect, Sandwich, Competitive.

Services

Peptide and Antibody Screening

By deploying competitive ELISAs, our experienced team provides screening services for both peptides and antibodies. Common targets include IL-6, VEGF, NYESO-1, TNF-alpha and c-Myc.

Services

Pharmacokinetics

Pharmacokinetics (PK) provides information regarding the body’s absorption, distribution, metabolism, and excretion of an administered pharmaceutical. By examining the PK of a drug in serum, plasma, urine, and saliva we can determine how it interacts, duration and efficacy.

Services

Pharmacodynamics

Pharmacodynamics (PD) examines the drugs mode of action, i.e., the biochemical, physiological, and molecular effects. Typically, receptor binding studies are used to explore PD. In combination, PK/PD studies enables us to determine the dose- response of a new pharmaceutic. Immunogenicity: anti-drug antibodies (ADAs) and neutralising antibodies (Nab).

Services

Anti-drug Antibodies

Anti-drug antibodies (ADAs) can adversely impact the PK/PD, safety, and efficacy of large therapeutic agents, such as antibodies, peptides, and proteins. This occurs due to the patient’s immune system recognising the therapeutic agent and eliciting an immune response against it. ADAs have also been shown to affect efficiency, clearance, cross-reactivity with endogenous proteins, subsequently causing adverse downstream effects. In regard to neutralising anti-drug antibodies, PeploBio provides both non-cell based and cell based testing.

Services

Additional Cell-based Assay Readouts

Immunogenicity assays and specifically the measurement of ADAs, presents with two main challenges: (1) target interference and (2) target tolerance, generating false positive and false negative results respectively. At PeploBio we understand the need for harmonised ADA validation testing and reporting tools. Therefore, we provide the following testing to support ADA assay validation.

  • Proliferation

  • Cell death

  • Reporter gene

  • Phosphorylation

  • Cytokine expression

Services

Pre-study Validation Cut Point

  • 1. In-study cut points

    Including procedures for mixed populations.

  • 2. System Suitability

    Control criteria for in study plate acceptance.

  • 3. Assay Sensitivity

    Including selection of appropriate low positive control.

  • 4. Specificity

    Including drug and target tolerance.

  • 5. Sample Stability

    Reflecting sample storage and handling conditions.

  • 6. Assay Selectivity

    To matrix components, haemolytic, lipemic and diseases state matrices.

  • 7. Domain Specificity

    For multi-domain therapeutics.

  • 8. Minimum Requirements

    For dilution and extraction- based sample processing for titre reporting.

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