360biolabs Pty Ltd

Site

360biolabs

Accreditation No.

15805

Site No.

17036

Date of Accreditation

12 Apr 2010

Address

85 Commercial Road
Melbourne, VIC 3004
Australia

360biolabs.com

Contact

Ms Angela Luttick P: +61 (03) 92822184

Availability

Services conditionally available to external clients

Scope of Recognition

ISO/IEC 17025, ISO 15189 and the GCLP Principles interpreted for research (1)

Healthcare, Pharmaceutical and Media Products

Service Product Determinant Technique Procedure
Conduct of research and analysis to support the development of pharmaceutical drugs, biological agents, vaccines and diagnostics Animal biological samples; Human biological samples - Clinical trials; Human biological samples - Pre-clinical studies Pharmacodynamic (PD) and pharmacokinetic (PK) parameters ELISpot assays; Enzyme linked immunosorbent assay (ELISA); Flow cytometry; Haemagglutination inhibition assays; Immunogenicity testing - ADA; Isolation and cryopreservation of mononuclear cells, plasma and serum; LC-MS-MS; Measurement of infectious titre - TCID50 and plaque assays; Multiplex assays; Neutralisation activity assays; PCR - Quantitative (qPCR); Viral culture; Virus genotyping; Virus molecular typing by polymerase chain reaction (PCR) and sequencing; Virus phenotyping (including measurement of anti-infective activity via cytopathic effect, enzyme and plaque reduction assays); Virus/drug/matrix stability assays Biological samples are securely stored for sample/evidence integrity and chain of custody is maintained.
Data is handled in accordance with principles outlined by the U.S. Food and Drug Administration Guidance for Industry - Computerised Systems Used in Clinical Investigations

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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