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. 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

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

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.

eCL Expertise

The recent acquisition of BioVeris™ by Roche as well as Roche’s announcement that it will only suppport the BioVeris™ product line through the end of 2008 has left many scrambling to decide how they should proceed with their existing, long-term BioVeris™ projects. Tandem Labs provides your solution; we believe that assay conversion from BioVeris™ to MSD® is the most efficient and effective choice. The BioVeris™ to MSD® conversion is easy, fast, inexpensive, and results in similar or improved assay performance. In addition, Tandem Labs has extensive experience developing ligand
binding assays based on both MSD® and BioVeris™ platforms. Download Information Sheet