Biomarkers play an integral role in new drug development by providing valuable information to facilitate the decision-making process for new therapies. Biomarker-based stratification can be used to enrich clinical populations, reducing cost and trial duration. Drawing from years of experience as pioneers in the field of clinical biomarker science, Inotiv provides guidance to help you better understand what your data means for your program and how it can be applied to advance your therapeutic along its development pipeline.

Our scientists are experts in finding the optimum analytical strategy for biomarker detection analysis and data interpretation. Our method development and validation strategies are shaped by industry guidelines to provide data that is preclinically and clinically relevant and of the highest quality and value.

Support Across the Drug Development Continuum

Our team supports your program from preclinical discovery and translational research and biomarker development through clinical bioanalysis.

Inotiv has extensive experience designing preclinical and clinical biomarker strategies to support our clients’ broader clinical development objectives. Working collaboratively with you, we focus on carefully selecting biomarkers to deliver results that support your decision making and produce a significant return on investment.

Our specialized biomarker services include:

  • Advice on the optimal selection of biomarkers in the context of your drug candidate, target disease, and project budget
  • Development, optimization, and validation of biomarker assays across a wide range of matrices and technology platforms
  • Biomarker analysis of preclinical and clinical samples for exploratory or clinical trial settings
  • Explanation/interpretation of results and advice on key outcomes and decisions to be made about candidate therapies

Our biomarker strategies encompass the full biological spectrum, including DNA, RNA, protein, cell, and tissue analysis, matched with proven and trusted technology platforms:

DNA

  • Targeted PGx
  • Microarray
  • Sequencing
  • Electrophoresis

RNA

  • NanoString (clinical)
  • RT-qPCR
  • PCR expression array

Protein

  • ELISA, cytometric bead array (CBA), and Meso Scale Discovery (MSD)
  • ELISpot
  • Protein arrays
  • Nephelometry (clinical)
  • Fluorescence- and luminescence-based assays

Cell

  • Flow cytometry
  • Sorting
  • Cell culture assays
  • Circulating tumor cells (CTC) (clinical)
  • Fluorescence microscopy
  • Microbiology (clinical)

Tissue

  • NanoString (clinical)
  • Organotypic culture (clinical)

Inotiv’s flow cytometry expertise will provide the data needed to get your therapeutic to market faster and provide patients with the treatment they deserve. We specialize in customized flow cytometry panels in early-phase preclinical and clinical trial research and are equipped to process samples from a wide range of matrices, from fresh to cryopreserved.

We analyze samples using a variety of sophisticated approaches, including multimer, phospho-flow cytometry, and receptor occupancy (RO) assays. We utilize dedicated peripheral blood mononuclear cell (PBMC) processing units that are linked to biosafety level 2 (BSL2) cell culture laboratories.

Analytical assay capabilities

We are fully capable of managing samples throughout the complete analytical cycle, with dedicated project, logistics, and sample management policies.

Immunoprofiling and phenotyping assays

  • Lymphocytes (TN, TH, TFH, Treg, TEFF, TEM, TCM, NK & B cells)
  • Dendritic cells (DCs)
  • Monocytes
  • Macrophages
  • Myeloid-derived suppressor cells (MDSCs)
  • Multimers
  • Intracellular staining
  • Treg polarization assessment

Target engagement/PK/PD assays

  • Receptor occupancy assays
  • Phospho-flow assays
  • Polyamine uptake assessment
  • SARS-CoV-2 immune response assessment (clinical)
  • Flow cytometry-based PK assessment

Function assays

  • Cytokine expression
  • Cytotoxic markers
  • Activation markers
  • Proliferation assays
  • Basophil degranulation
  • Rare cell detection and quantification
  • Antibody-dependent cellular cytotoxicity (ADCC)
  • Complement-dependent cytotoxicity (CDC)
  • Small particle detection and analysis
  • ELISpot assays

Robust and proven platforms

Our technology platforms are robust, reliable, and reputable in the clinical field and provide comprehensive and detailed data readouts for your application.

Flow and Cell

  • Multicolor flow cytometry
  • ELISpot
  • Cell culture assays
  • Microbiology (clinical)
  • Histopathology
  • Immunohistochemistry/IHC
  • Fluorescent in situ hybridization/FI