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Provider profile

Agilex Biolabs.

Bioanalytical services

Agilex Biolabs describes regulated bioanalysis for nonclinical and clinical studies: method development, validation and sample analysis, PK/TK and biomarker assays on LC-MS/MS and ligand-binding platforms, immunogenicity, flow cytometry, cell-based and PCR assays, for small molecules, peptides, oligonucleotides, antibodies and vaccines. It lists laboratories in Thebarton (headquarters), Adelaide, Brisbane and Sydney.

Website
agilexbiolabs.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

  • Biomarker assays5
  • Cell-based assays4
  • Flow cytometry5
  • Immunogenicity (ADA/NAb)3,4
  • Method development1,2
  • Method validation8
  • Molecular assays (qPCR/ddPCR)5,6
  • PK/TK bioanalysis6
  • Regulated study-sample analysis2,3

Platforms and methods

  • LC-MS/MS5
  • Ligand-binding assays6

Sample types

  • Cerebrospinal fluid5
  • Plasma and serum5
  • Tissue5
  • Urine2,5
  • Whole blood4

Development experience

Development experience

Development stage

  • Phase 13
  • Preclinical6

Modality

  • Antibody-drug conjugates6
  • Gene therapies8
  • Monoclonal antibodies6
  • Oligonucleotides6
  • Peptides6
  • Recombinant proteins6
  • Small molecules2,6,7
  • Vaccines4

Locations

Locations

  • Thebarton, Australia · Headquarters10Listed by the company as Agilex Adelaide (headquarters)
  • Adelaide, Australia · Laboratory10Gray Street site: PBMC isolation and flow cytometry
  • Herston, Australia · Laboratory10Listed by the company as Agilex Biolabs Brisbane; flow cytometry and PBMC isolation
  • St Leonards, Australia · Laboratory10Listed by the company as Agilex Biolabs Sydney; PBMC isolation and flow cytometry
  • Thebarton, Australia · Laboratory10Headquarters laboratory (LC/MS, immunoassay and immunobiology divisions), listed by the company as Agilex Adelaide

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.

  • GCLP7Stated for the Brisbane flow cytometry laboratory; the accrediting body is not named on reviewed pages
  • GCP2,8
  • GLP2,8
  • ISO/IEC 270019

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

How to select a bioanalytical laboratory

Evidence and sources

Evidence and sources

  1. 1Oligonucleotide Bioanalysis Challenges and Regulatory Solutions (opens in a new tab)Agilex Biolabs · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  2. 2Regulated Bioanalysis For The Pharmacokinetic Profiling of Cannabinoids and Psychedelics | ​Agilex Biolabs Regulated Bioanalysis for Cannabinoids and Psychedelics | Agilex (opens in a new tab)Agilex Biolabs · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  3. 3Agilex Biolabs page: agilexbiolabs.com (opens in a new tab)Agilex Biolabs · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  4. 4Pharmacodynamics (PD) | ​Agilex Biolabs (opens in a new tab)Agilex Biolabs · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  5. 5Biomarker Analysis Services | ​Agilex Biolabs (opens in a new tab)Agilex Biolabs · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  6. 6Pharmacokinetics (PK) | ​Agilex Biolabs (opens in a new tab)Agilex Biolabs · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  7. 7Agilex Biolabs Opens New Flow Cytometry Lab in Brisbane (opens in a new tab)Agilex Biolabs · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  8. 8Agilex Biolabs page: agilexbiolabs.com/about-us (opens in a new tab)Agilex Biolabs · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  9. 9The Benefits of ISO 27001 for Agilex Biolabs | ​Agilex Biolabs (opens in a new tab)Agilex Biolabs · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  10. 10Agilex Locations | ​Agilex Biolabs (opens in a new tab)Agilex Biolabs · 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.

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