Provider profile

Inotiv.

Bioanalytical services

Inotiv describes preclinical and clinical bioanalytical services: method development, validation and sample analysis, PK/TK, immunogenicity, biomarker, flow cytometry and qPCR assays on LC-MS/MS and ligand-binding platforms, for small molecules, peptides, oligonucleotides, antibodies, ADCs, vaccines and cell and gene therapies, from first-in-human through Phase III.

Website: inotiv.com (opens in a new tab)
Sources reviewed: November 3, 2026 · Source pages re-checked within 4 months
First published: November 3, 2026

This profile summarizes what public sources state about the provider, mostly its own website. It is not an audit, qualification or endorsement by ArgusBio. Confirm capabilities directly with the provider before contracting.

Services and capabilities

Biomarker assays1,5
Flow cytometry1,4
Immunogenicity (ADA/NAb)1,2,4
Method development1,2,3
Method validation1
Molecular assays (qPCR/ddPCR)4,5
PK/TK bioanalysis2,4
Regulated study-sample analysis4

Platforms and methods

LC-MS/MS4
Ligand-binding assays4

Sample types

Tissue4Stated for the proteomics platform

Development experience

Development stage

Phase 14
Phase 34
Preclinical2

Modality

Antibody-drug conjugates4
Cell therapies2,4
Gene therapies1,5
Monoclonal antibodies2,4
Oligonucleotides1
Peptides1
Recombinant proteins4
Small molecules4
Vaccines2,4

Locations

Not established from reviewed sources.

Quality and regulatory

The provider’s own materials state that it works to, or holds, the following. ArgusBio has not inspected or audited these claims.

21 CFR Part 111Listed for bioanalytical information systems
GCLP2
GLP4

Unknowns and questions to ask

Public sources rarely establish what matters most for a specific project. Confirm directly:

Whether a validated method already exists for your molecule or a close analogue, and who owns it
Validation scope against ICH M10 for your assay type, and expected timeline
Current instrument and analyst capacity, and turnaround per sample batch
Sample receipt, storage conditions, chain of custody and international shipping experience
Most recent regulatory inspection or audit outcomes relevant to your studies
Data-integrity controls and the format of data delivered to your PK or biometrics vendor

Not established from reviewed sources: service geography.

How to select a bioanalytical laboratory

Evidence and sources

1Bioanalysis: Small Molecule (GLP) (opens in a new tab)Inotiv · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
2Bioanalysis: Large Molecule (GLP) (opens in a new tab)Inotiv · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
3Biomarker Solutions for Biotherapeutics (opens in a new tab)Inotiv · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
4Clinical Bioanalysis (opens in a new tab)Inotiv · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
5Supporting Your Drug Discovery and Nonregulated Bioanalysis (opens in a new tab)Inotiv · Provider website · retrieved November 3, 2026 · last checked November 3, 2026

“Last checked” means we confirmed the page was still available and still contained the cited statement. It does not mean ArgusBio verified the provider or its capabilities.

Something out of date or wrong? Request a correction. Corrections are reviewed against public sources before publication.

Contact

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