National Association of Testing Authorities, Australia
Scope of Accreditation
Agilex Biolabs Pty Ltd
Site
Bio-analytical Laboratory
Accreditation No.
15130
Site No.
15629
Date of Accreditation
01 Nov 2004
Contact
Mr Cameron Smith P: +61 (07) 31304745
Availability
Services available to external clients
Scope of Accreditation
Bio-analytical Laboratory
ISO/IEC 17025 (2017)
Healthcare, Pharmaceutical and Media Products
| Service | Product | Determinant | Technique | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Analysis in support of clinical trials and/or pre-clinical studies | Animal biological samples; Human biological samples | Anti-drug antibodies measurement; Immunogenicity parameters | Electrochemiluminescence (ECL) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Biomarker parameters | Flow cytometry - Cell phenotyping, receptor occupancy assay | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pharmacodynamics (PD) parameters; Pharmacokinetic (PK) parameters | Isolation and cryopreservation of mononuclear cells, plasma and serum | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Biomarker parameters; Immunogenicity parameters; Pharmacodynamics (PD) parameters; Pharmacokinetic (PK) parameters; Specialised pharmacodynamic studies | Enzyme linked immunosorbent assay (ELISA) - Immunoassay; LC-MS-MS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Capability Methods validated to FDA and EMA bioanalytical method validation guidances and/or industry consensus white papers. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
The only data displayed is that deemed relevant and necessary for the clear description of the activities and services covered by the scope of accreditation.
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Accreditation No.
15130
Site No.
15629
Print date
10 Sep 2024
END OF SCOPE