Immunoanalytical Testing (Ligand-Binding Assays)

Immunoanalytical Testing (Ligand-Binding Assays)

Tandem Labs performs a wide variety of immunoanalytical chemistry assays on specimens obtained from research animals during preclinical studies and from human subjects enrolled in clinical studies.

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Among others, Tandem Labs offers:

Consultation for critical reagent preparation Method transfer
Method development Method optimization
Method feasibility Method validation

The technologies included are:

Chemiluminescent immunoassay (CIA) ‒ direct measure (glow) and pulse measure (flash) Enzyme linked immunosorbent assay (ELISA) ‒ indirect, sandwich, and competitive binding
Electrochemiluminescence (ECL) using MSD and BioVeris™ Multiplexed assays using Bio-Plex and MSD
Enzyme immunoassay (EIA) Cell-based bioassays

Tandem Labs has two locations dedicated to biotechnology services in the United States: West Trenton, New Jersey and San Diego, California. Our core biotechnology service offerings include:

  • Biotherapeutic macromolecule PK
  • Immunogenicity assays
  • Cell-based assays (bioassays)
  • Biomarker assays, esoteric and proprietary single and multiplexed assays
  • Quantitative immunoassays: EIA, CIA, FIA, IRMA
  • Ligand-binding assays

Method Development and Validation Experience

Tandem Labs has extensive experience in method development and validation, including the specialized areas of anti-drug antibody (ADA) assays, cell-based assays, PK, TK, and biomarkers. Tandem Labs follows regulatory guidance documents in its standard practices. We work closely with the Sponsor to develop a Validation Plan to drive the project. Our bioassay experience includes neutralization and PK assays. The modes of action for this analysis include reporter gene assays, cell proliferation, apoptosis, viral assays, and cyclic AMP assays. We have tested samples in cell-based assays for pre-clinical and Phase I, II, and III studies. Tandem Labs also converts and validates existing potency assays to neutralization assays.Biomarker assay development and validation at Tandem Labs follow the Fit-for-Purpose concept described by Lee et al (2006). Biomarker assay capabilities include ELISA (single analyte), Meso Scale Discovery (single and multiple analytes), and BioPlex (multiple analytes).

Cell-Based Assays (Bioassays)

Tandem Labs performs various cell-based assays to measure the biological activity of drugs in ex vivo samples, as well as the evaluation of antibody neutralization in ex vivo samples.

Specialized Biomarker Assays

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Tandem Labs will perform biomarker assays in support of:

  • Phase I and IIa: Proof of concept; determine if mechanism works in healthy subjects and/or mild disease patients; PK/PD concentration and responses
  • Phase IIb: Efficacy and safety markers with dose responses in patients
  • Phase III: Confirm outcome with safety markers; determine polymorphism impact on PK/PD responses; variability in gender, age, renal, and hepatic impaired
  • Phase IV: Post-approval surveillance, safety in all populations in various environments, diet, multiple diseases, and medications
  • PK/PD models for simulation and prediction.

Immunogenicity Assays

Tandem Labs offers a complete suite of antibody testing, including:

Antibody screening Total immunoglobulin testing
Antibody titration Humoral response testing: cytokine and growth factor immunoassays
Antibody isotyping Neutralizing antibody assay

Typical testing sequence entails:

  • Screening assay: Detect all antibodies capable of binding to a therapeutic drug
  • Characterization of antibodies prior to bioassay
  • Bioassay determines the ability of the antibody to neutralize the effect of the drug.

Biotherapeutic Macromolecule PK

Tandem Labs offers quantitative immunoassays for the measurement of macromolecules (therapeutic biological products) in biological matrices.