Clinical Bioanalysis

Sponsors have access to a full-service bioanalysis organization with deep expertise supporting clinical pharmacokinetic (PK), immunogenicity, and biomarker assessments across small molecules, biotherapeutics, and novel modalities. 

Our team supports clinical development from first-in-human through Phase III across a broad range of therapeutic areas.

We leverage advanced LC-MS/MS, ligand-binding, molecular, and cell-based platforms to rapidly develop and validate methods supporting: 

• PK/ PD analysis
• Immunogenicity (Tier 1-3 & neutralizing antibody, nAb)
• Biomarker development and analysis
• Drug–drug interaction studies
• Biosimilars
• Gene therapy and vaccine endpoints

GLP nonproprietary bioanalytical methods are validated in accordance with current regulatory guidelines. 

Bioanalytical Testing Platforms: 

• Liquid Chromatography, Tandem Mass Spectrometry (LC‑MS/MS) AB SCIEX™ Platform (4000, 5000, 5500, 6500, 7500)

• Ligand Binding and Molecular Platforms ELISA, HELISA, Meso Scale Discovery (MSD) (single and multiplex) Luminex®, DNA/RNA Isolation, qPCR, Flow Cytometry, Cytokine Panels ELISpot, Protein Expression Analysis,
• Additional Analytical Tools UV‑Vis, Fluorescence, Electrochemical, and Charged Aerosol Detection, Watson LIMS™, Phoenix WinNonlin™, Noncompartmental PK Analysis, Projects Database System for lifecycle management.

Our LC-MS division provides fully compliant regulated clinical bioanalytical services supported by scientists averaging over 15 years of experience. 

The team supports PK/ PD sample analysis, drug–drug interaction studies, concomitant drug analysis, and bioequivalence programs. With dedicated metrology support and rigorous instrument maintenance, we deliver precise, reproducible results that meet regulatory expectations. 

For biotherapeutic programs, our team brings experience supporting pharmacokinetic and immunogenicity assessments, biomarker development, and gene and cell therapy programs from early clinical through late-stage development across multiple biological matrices supported by scientists with up to 50 years of experience.

Using advanced molecular and cell-based platforms, we develop and validate methods supporting PK /PD, immunogenicity, immunophenotyping, biosimilars, gene therapy, and vaccine endpoints. From monoclonal antibodies and fusion proteins to ADCs and novel modalities, we provide the specialized analytical capabilities your clinical program requires.

Inotiv designs and executes biomarker strategies that support broader clinical development goals including target engagement, pharmacodynamic response, and patient stratification.

Our experts collaborate with you to identify biomarkers aligned with your drug candidate and target disease, develop and validate assays across multiple matrices and platforms, and analyze clinical samples for exploratory or regulated settings.

Capabilities span DNA, RNA, protein, cell, and tissue analysis.

Clinical immunogenicity assessments require a multi-tiered approach including screening, confirmatory, titer, and neutralizing assays.

For gene and cell therapies, our team navigates the complexities of multicomponent modalities and immune responses, assessing pre-existing and drug-induced humoral ADA and cell-mediated immune responses.

For vaccines, where strong anti-drug antibody responses are expected, we apply tailored analytical strategies aligned with your program’s requirements.

Our flow cytometry experts design customized panels for clinical trial research and process samples from fresh or cryopreserved matrices.

The team applies advanced approaches including multimer analysis, phospho-flow cytometry, and receptor occupancy (RO) assays. Dedicated PBMC processing units are linked to BSL2 cell culture laboratories to support complex clinical workflows.

Inotiv’s proteomics platform uses high-resolution proteomic targeted mass spectrometry to deliver precise, sensitive, and specific measurements. Multiplexed analyses enable simultaneous quantification of dozens of proteins per sample.

The platform provides direct, quantitative assessment of drug target systems in cells, tissues, and tissue models, including FFPE—integrating protein-level pharmacology and pathology to inform dose selection, target engagement, and clinical decision making from discovery through clinical development.