Tandem Labs
Biotechnology services
Tandem Labs develops, validates, and performs immunoanalytical-based methods in support of clinical, pre-clinical, and discovery studies in a stringent GLP environment. The Biotechnology Services division has extensive experience in method development and validation, including the specialized areas of antidrug antibody (ADA) assays, cell-based assays, and biomarkers. Tandem Labs has two locations dedicated to biotechnology services in the United States: West Trenton, New Jersey and San Diego, California. Total square footage for Tandem Labs is 74,000. Our core biotechnology service offerings include:
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).
Major Instrumentation
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