NorthEast BioLab

Bioanalytical CRO services

NorthEast BioLab is a bioanalytical contract research organization offering clinical, preclinical, and discovery-phase bioanalysis for biotech, pharmaceutical, and U.S. government sponsors.

Services

• Pharmacokinetics (PK), PK/PD analysis, ADME and DMPK studies, toxicokinetics, dose formulation analysis, and bioequivalence studies
• Immunogenicity testing (ADA and NAb assays) and multiplex cytokine assays
• Bioanalytical assay development, validation, transfer, and sample analysis, including GLP and clinical method development
• Analytical testing for R&D and formulation needs
• Clinical CRO services, including central lab sample management and GCLP clinical bioanalysis
• Non-GLP preclinical research for biotech and academic investigators

Platforms

The lab reports expertise in mass spectrometry (LC-MS/MS and HRMS), Meso Scale Discovery, ELISA, Luminex multiplex, flow cytometry, qPCR and ddPCR, cell-based and cytotoxicity assays, ELISpot and FluoroSpot, mechanism-of-action studies, and quantitative Western blot.

Compliance and track record

The website states that its GLP/GCLP-compliant facilities have undergone multiple FDA audits and that the lab is approved by the DEA and CT for Schedule I–IV bioanalysis. It reports more than 20 years in bioanalysis, over 700 sponsor studies, over 500 custom assays, and work on more than 200 investigational drugs.