Provider profile
BioAgilytix.
Bioanalytical services
BioAgilytix describes PK, immunogenicity and biomarker bioanalysis: assay development, validation and sample analysis using ligand-binding, cell-based, flow cytometry, molecular and mass spectrometry methods, for small molecules, antibodies, oligonucleotides and cell and gene therapies across Phases I–III. It lists laboratories in Durham (headquarters), San Diego, Boston, Hamburg and, through 360biolabs, Australia.
- Website
- bioagilytix.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
Services and capabilities
Development experience
Locations
Locations
- Durham, United States · Headquarters5Research Triangle Park campus with laboratories in Durham and Morrisville, North Carolina
- Brisbane, Australia · Laboratory5Operated by 360biolabs, described as a BioAgilytix company
- Melbourne, Australia · Office5Australian headquarters of 360biolabs, described as a BioAgilytix company
- Sydney, Australia · Laboratory5Operated by 360biolabs, described as a BioAgilytix company
- Hamburg, Germany · Laboratory5Described by the company as its European headquarters
- Boston, United States · Laboratory5
- San Diego, United States · Laboratory5
Quality and regulatory
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.
- CLIA8,12CLIA certification stated for the Boston and Durham laboratories
- GCLP11Stated for flow cytometry bioanalysis
- GCP11,12
- GLP6,11,12GLP certification stated for the European laboratory; other laboratories state operation in accordance with 21 CFR Part 58
- GMP / cGMP11,12Stated for the Durham laboratory and for flow cytometry bioanalysis
Unknowns and questions to ask
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
Evidence and sources
Evidence and sources
- 1Biomarker Testing | BioAgilytix (opens in a new tab)BioAgilytix · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 2Bioanalytical Laboratory Services | BioAgilytix (opens in a new tab)BioAgilytix · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 3Cell Based Assay Development | BioAgilytix (opens in a new tab)BioAgilytix · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 4CMC Analytical Development Services | BioAgilytix (opens in a new tab)BioAgilytix · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 5BioAgilytix | Global Leader for Bioanalytical Services (opens in a new tab)BioAgilytix · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 6ADA Assay Development | BioAgilytix (opens in a new tab)BioAgilytix · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 7PK Assay Services | Pharmacokinetic Assays | BioAgilytix (opens in a new tab)BioAgilytix · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 8Immunogenicity Assay | BioAgilytix (opens in a new tab)BioAgilytix · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 9Molecular Biological Assays | BioAgilytix (opens in a new tab)BioAgilytix · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 10DMPK Assays | BioAgilytix (opens in a new tab)BioAgilytix · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 11Flow Cytometry | BioAgilytix (opens in a new tab)BioAgilytix · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 12Quality Commitment | BioAgilytix (opens in a new tab)BioAgilytix · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 13Clinical Drug Development Process | Global CRO | BioAgilytix (opens in a new tab)BioAgilytix · 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
Contact
Contact the provider directly through its public contact page (opens in a new tab). ArgusBio does not forward inquiries to providers and does not receive referral fees.
ArgusBio sourcing
Need help evaluating this provider or comparing alternatives.
Discuss your sourcing need with ArgusBio. We can help define the scope, identify comparable alternatives and organize proposals so the decision stays yours.
Discuss a sourcing needWe work for the biotech, not the vendor. Vendors do not pay for inclusion or placement.