Agilex Biolabs Pty Ltd

Site

Bio-analytical Laboratory

Accreditation No.

15130

Site No.

15629

Date of Accreditation

01 Nov 2004

Address

28-31 Dalgleish Street
Thebarton, SA 5031
Australia

agilexbiolabs.com

Contact

Ms Holly Stefl P: +61 (08) 83028769

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 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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