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|
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:
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).
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.
Tandem Labs will perform biomarker assays in support of:
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:
Tandem Labs offers quantitative immunoassays for the measurement of macromolecules (therapeutic biological products) in biological matrices.