Adelaide, AUS, July 22, 2020 – (ACN Newswire) – Agilex
Biolabs, Australia’s largest specialist bioanalytical laboratory for clinical
trials, and Endpoints News launched a new webinar “How Easy is it to Move
Your Trials to Australia” at BIO Taiwan 2020.
Watch here: https://tinyurl.com/y2ktufhv.
Register here: https://tinyurl.com/y2ktufhv.
The webinar details step-by-step guidance for moving new or
delayed trials to Australia, and Agilex Biolabs’ clients discuss how they made
the decision and the benefits, and any challenges.
Agilex Biolabs, the only FDA-inspected lab of its type in
the region, is located in Adelaide, South Australia in a science and biotech
specialist hub.
Australia’s relatively moderate COVID-19 impact due to rapid
localised lockdowns for case clusters, combined with the world’s most
attractive 43.5% rebate on clinical trials costs, makes it the ideal
destination for re-booting clinical trials, according to Agilex Biolabs.
Agilex Biolabs and all the early phase units have been open throughout
the global COVID-19 pandemic.
CEO Jason Valentine said the key to success was engaging
with Agilex Biolabs early.
“By contacting Agilex Biolabs first, for any new trial
or trial transition process from another region, we can facilitate the scoping
exercise for sponsors by assessing compatible service providers to ensure a
good streamlined fit.
Our 20 years of experience working with all the service
providers means we understand the nuances of the Australian trial landscape and
can recommend the right partners to accelerate start up and save on costs.
Getting the right fit for size and experience is vital for success.
This includes everything from CROs, Phase 1 units, sites,
Ethics Committees, Government authorities, setting up an Australian affiliate
and legal support. Considerations also include later phase plans and
continuity.
Australia is well known as an early phase trials destination
and at Agilex Biolabs we have a powerful network of early phase units, sites
and other providers with whom we work regularly.
In addition, our R&D team need at least 1-2 months to
properly develop the assays, and conduct feasibility studies if required.”
Biotechs are particularly attracted by Agilex Biolabs’
FDA-inspected status, and the 43.5% rebate on clinical trial spend that applies
in Australia.
Agilex Biolabs’ world-class bioanalytical facilities have
OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance
monitoring authority) and ISO 17025 Accreditation for global recognition.
The company has just expanded its labs by more than 30% to
accommodate biotech demand from APAC and the USA. Watch the New Labs
Walkthrough Video Here https://www.agilexbiolabs.com/new-labs-video
Agilex Biolabs specialises in bioanalysis of small molecules
and biologics for PK, immunogenicity, biomarkers and immunological
pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale,
Gurolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell
analyser).
Agilex also offers pharmacodynamics services that include
immunobiology services using the latest state-of-the-art technology to support
immunology, cell biology and mode of action assays, including:
– Immunophenotyping
– Receptor occupancy
– Cytokine release assays (whole blood or PBMC stimulation
assays) and cytokine/biomarker profiling
– PBMC assays and cellular mechanism of action assays (eg:
ADCC)
The biolabs has more than 90 staff including 65 dedicated
laboratory staff, and annually support more than 80 clinical trials. This year
they will analyse more than 60,000 samples for pharma/biotechs from US, Europe
and APAC.
Please Book a Briefing with us before you start your next
clinical trial. https://calendly.com/agilexbiolabs/15min
Australia: +61 8 8302 8777 | China: +86 21 8036 9483 | South
Korea: +82 80 812 1255 | USA: +1 800 247 1909
About Agilex Biolabs https://www.agilexbiolabs.com/
Agilex Biolabs, Australia’s leading bioanalytical
laboratory, has more than 20 years’ experience in performing regulated
bioanalysis, including quality method development, method validation and sample
analysis services. We have successfully supported hundreds of preclinical and
clinical trials around the world where customers choose Australia for the
streamlined regulatory process and access to the world’s most attractive
R&D rebate of more than 40% on clinical trial work conducted in Australia.
We offer services for both small molecules and biologics for
PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms
of LC-MS/MS and Immunoassay.
Agilex Biolabs operates a fully quality-assured laboratory
ensuring that, within the principles of GLP, assays are validated to the latest
FDA/EMA guidance and study samples are assayed and reported to the sponsor’s
desired format using WATSON LIMS. Laboratory certifications include OECD GLP
and ISO/IEC17025.
Our highly experienced team consists of over 65 dedicated
laboratory staff with over 15 years average industry experience across senior
scientists. Expertise includes development of robust compliant PK and PD assays
de novo or by method transfer.
Our laboratory is fitted with 7 SCIEX tandem mass
spectrometers, 6 API 4000 and 1 QTRAP 5500 as our standard platform for
LC-MS/MS analysis. For immunoassay, we employ the state-of-the-art systems of
Meso Scale Discovery (MSD) and Gyrolab xPlore.
Agilex Biolabs owns a suite of validated biosimilar assays
that have already supported biosimilar studies executed in the region. These
assays include Avastin/Bevacizumab, Lucentis/Ranibizumab, Actemra/Tocilizumab,
Xolair/Omalizumab, Herceptin/Trastuzumab and Solaris/Eculizumab. We would like
to discuss how we can support companies with biosimilar pipelines looking to
conduct trials in the region. Our validated biosimilar assays require less
setup saving time and money.
Agilex Biolabs also have a suite of biomarker assays that
have been developed to support studies in the areas of endocrinology (estrone,
estradiol, progesterone, testosterone and others).
Recently, Agilex Biolabs has added a comprehensive
cannabinoid assay to its suite of validated assays to support clinical trials.
The fully validated assay includes the five cannabinoids THC, CBD, CBN and the
two THC-metabolites OHTHC and COOHTHC.
Our LC-MS/MS experience includes NCEs, sugars, nucleotides,
enantiomers, steroids, prodrugs, peptides, immunosuppressants, nanoparticles,
neurotransmitters, oligonucleotides and polymeric mixtures.
Our biologics experience entails PK analysis using
colorimetric, fluorescence or chemiluminescence detection for recombinant or
fusion proteins, monoclonal antibodies, ADCs, immunogenicity testing, biomarker
analysis and PBMC blood stimulation assays.
Media Contact:
Media@AgilexBiolabs.com
Kate Newton