The importance of immunological assay methods for validating the efficacy of pharmacokinetics and pharmacodynamics of drugs has recently increased due to the rapid growth and development of bio-therapeutics, including antibody and protein therapeutics.

In response, ABION CRO aims to offer research infrastructure optimized for the quantitative and qualitative analysis of ELISA-based protein therapeutics and high-quality analytical services for investigators involved in new drug development and biotechnology-related research through a variety of scientific tools and well-established SOPs.

We conduct method validation in compliance with ICH Q2 guidelines to guarantee reliable and accurate data.

Immunoassay - .

[Reference]

- ICH guideline Q2 category: Analytical validation (Finalized Guidelines: October 1994/November 1996)

ELISA (enzyme-linked immunosorbent assay) is a widely used assay designed for the accurate detection and quantitative measurement of antigen or antibody at very lowconcentrations. This assay is a highly convenient biochemical technique and serves as a sensitive analytical tool for the toxicological, immunological, pharmacokinetics, and pharmacodynamics analyses of biologics as part of new drug development.

ABION CRO offers a vast range of ELISA assays, including direct and indirect ELISA, sandwich ELISA, and multiplex. Multiplex, in particular, is a highly effective beadbased analysis tool that allows simultaneous detection of up to 100 analytes in a single sample and requires less samples, reagents, and time than conventional single-plex assays.

We also provide customized assay designs for many applications to suit your analyte combinations or the intended targets in order to accomplish your specific research goals. We guarantee superior services and ensure effective test results through our integrated and automated technology platforms, which are coupled with our extensive expertise.

ELISA Analysis

Pharmacokinetics (Protein Drug pharmacokinetics)

  • Quantitative analysis
  • Titer analysis

Pharmacodynamics

  • Single target analysis: Cytokine, Chemokine, Hormone analysis

Immunotoxicity analysis

  • Anti-drug antibody quantitative/titer analysis
  • Cytokines and chemokine analysis

Antibody specificity analysis

  • Competitive ELISA

Device: GENESIS RSP

Customized ELISA

Non-clinical and Clinical scale kit development

Commercial kit development (IVD class)

Development steps

  • Step. 1: Antibody selection (Commercial/Development)
  • Step. 2: Kit optimization
  • Step. 3: Kit validation
  • Step. 4: Kit production (Optional)

Kit validation: IHC Q2 guideline

Multiplex

Pharmacodynamics

Immunotoxicity: Cytokine analysis

Device: Bio-plex®200 systems (Bio-Rad)

ELISpot assay

Immunotoxicity: Immune cell activity analysis 

We have a vast range of services ranging from lab scale experiments to high-quality antigen-antibody responserelated services, such as surface plasmon resonance (SPR), designed to meet your research needs. In particular, SPR is used for screening monoclonal and polyclonal antibodies during the antibody-based drug development process and also for measuring the affinity of the selected antibodies.

Western blotting

Flow cytometry

  • Immunotoxicity: Immune cell population analysis

Device: FACS Calibur Flow Cytometer (BD)

Surface Plasmon Resonance (SPR)

  • Protein/Drug Interaction
  • Determination of antibody affinity

Device: SPR7500DC (Richert) 

ABION CRO has capabilities to provide a wide range of customized research services that range from drug development to analytical services for non-clinical and clinical trials. We provide solutions for your research challenges and offer consulting and analytical services for drug development including antibody and drug screening to efficacy analysis.

Research level support

  • Experiment design
  • Antibody development (for analysis)

Non-clinical analysis service

  • Animal experiments
  • Analysis design consulting

Clinical analysis service

  • Clinical Trial Phase I, II, III level analysis 

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