360biolabs’ Brisbane Laboratory
PRESS RELEASE | SEPTEMBER 2023
360biolabs strengthens clinical trial support in Queensland
Located at the Translational Research Institute, the Brisbane laboratory supports rapid processing of clinical samples from nearby trial sites.
Melbourne, Australia [September 2023]: 360biolabs world class scientific team now has expanded capacity to process time-sensitive samples for PBMC isolation plus flow cytometry, and offer extended biomarker profiling, PK ELISA and central lab services. The new 360biolabs Brisbane lab will support large molecule, advanced modality and vaccine clinical trials under ISO/IEC 17025, GCP and GCLP, allowing acceptance of data from global regulatory bodies.
Located at the prestigious Translational Research Institute Australia (TRI) within the Princess Alexandra Hospital, the laboratory benefits from the bench to bedside philosophy that exists within the precinct and the collaborative mindset between academia, industry and clinicians.
360biolabs new lab in Brisbane puts us in the right place at the right time – receiving requests to process samples for downstream enzymatic or immunological assessments within hours of blood draw.
After an extensive search in 2021, the Translational Research Institute (TRI) in Woolloongabba was selected to house 360biolabs’ Brisbane laboratory. TRI’s vision is ‘Exceptional science, healthier lives’. TRI has two Clinical Trial Units, the Clinical Research Facility co-located at the Princess Alexandra Hospital and TRI@Childrens located in the Centre for Children’s Health Research opposite the Queensland Children’s Hospital. These units provide state-of-the-art specialist facilities to deliver patients-centric, investigator-led or sponsored clinical trials across Phase 1-4 in the pharmaceutical and nutraceutical sectors. The clinical trials team at TRI have extensive experience in clinical trial management and coordination services across multiple phases of clinical research.
TRI’s current clients and partners include leading top 10 pharmaceutical companies, biotechnology and clinical research organisations, hospitals, universities and research institutes. This focus on ‘bench to bedside’ is consistent with 360biolabs’ mission of enabling future medicines.
In April 2022, 360biolabs was contracted by Novavax to conduct sample analysis for the Company’s upcoming Phase 3 clinical trial.
A two-part Phase 3, Randomized, Observer Blinded Study to Evaluate the Safety and Immunogenicity of Omicron Subvariant and Bivalent SARS-CoV-2 rS Vaccines in Adults Previously Vaccinated with Other COVID-19 Vaccines. Novavax is conducting a Phase 3 strain change trial in Australia to determine if its Omicron variant-specific vaccine induces superior antibody responses against the Omicron variant compared to its prototype vaccine in participants who have received either a primary (two doses) or booster (three doses) series of an mRNA vaccine. The trial will also seek to determine the antibody responses to a bivalent COVID-19 vaccine containing both the original vaccine and Omicron strain-specific administered in participants who have received a booster series of an mRNA vaccine.
Novavax is recruiting participants from 18 sites across the eastern seaboard of Australia. Whole blood samples for PBMC isolation and serum samples for immunological testing are shipped to 360biolabs for analysis. Multiple sites located in Queensland ship to 360biolabs’ Brisbane laboratory for PBMC processing, while other sites ship to 360biolabs’ Melbourne laboratory.
“360biolabs has been a responsive partner since our first COVID-19 Phase 1 trial in 2020, consistently delivering excellent quality results. We appreciate their agility and ability to receive samples at two locations in response to our needs for increased PBMC processing capacity in the Phase 3 variant clinical trial.”
– Chijioke Bennett, MD, MPH, MBA Senior Director, Clinical Development, Novavax.
About 360biolabs
360biolabs is Australia’s most comprehensive bioanalytical laboratory, supporting the development of therapeutics, vaccines and diagnostics. With laboratories in Melbourne, Brisbane and Sydney, 360biolabs supports clinical studies across PK, PD, immunogenicity, biomarkers, vaccines, infectious diseases, flow cytometry, molecular biology and central laboratory services. 360biolabs is accredited by Australia’s National Association of Testing Authorities (NATA) for compliance with Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), and ISO/IEC 17025.
About BioAgilytix
BioAgilytix is a global bioanalytical laboratory partner supporting biopharmaceutical and biotechnology companies across every phase, every modality. Through its global laboratory network in Australia, the United States and Europe, BioAgilytix provides integrated scientific and operational support for complex clinical development programs.
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