BioAgilytix
Bioanalytical expertise for every phase of drug development.
Listed on cro.directory
Bioanalytical CRO specializing in pharmacokinetics, immunogenicity, biomarkers, and CMC analytics with 30+ years of experience and 1,100+ employees conducting 5M+ tests annually. Headquartered in Durham, United States.
Phases
Services
Modalities
Technical specifications & accreditations
Infrastructure
About this organization
Overview
BioAgilytix is a bioanalytical contract research organization with over 30 years of industry experience. The company employs 1,100+ scientists and develops approximately 800 assays annually, reporting 5 million+ tests annually.
Core Capabilities
BioAgilytix offers a comprehensive suite of bioanalytical services including:
- Pharmacokinetics (PK) — drug exposure and elimination analysis
- Immunogenicity — immune response assessment to biotherapeutics
- Biomarkers — biomarker discovery, development, and validation
- CMC Analytics — chemistry, manufacturing, and controls analytical support
Approach
The organization emphasizes a consultative, scientist-to-scientist partnership model. Senior scientists work collaboratively with sponsor teams to anticipate assay challenges, maintain regulatory compliance, and minimize project risk. The company highlights continuity of scientific oversight and quality focus as key differentiators for accelerating therapeutic advancement to market.
Locations
Research Triangle Park Campus (US Headquarters)
Durham · North Carolina · United States
Morrisville Labs
Morrisville · North Carolina · United States
Boston Laboratory
Boston · Massachusetts · United States
San Diego Laboratory
San Diego · California · United States
Hamburg Laboratory (EU Headquarters)
Hamburg · Hamburg · Germany
Brisbane Laboratory
Brisbane · Queensland · Australia
Melbourne Laboratory (Australian Headquarters)
Melbourne · Victoria · Australia
Partner Labs
Beijing · Beijing · China
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