Partner with the right bioanalytics firm at start-up to de-risk drug development
One of the most important drug development start-up decisions is finding a centrally located bioanalytical laboratory that can support clinical research across all the study locations, and through pre-clinical then potentially for all Phases.
Quality control and consistency of sample management and analysis from early Phase onwards can make a real difference to quality of data and final outcomes.
Selecting a lab that can work across time zones and collaborate closely with the CRO and sponsor with regular reporting and 24×7 availability can save valuable time and ensure full compliance with sites across Asia, Australia, USA, EU and Eastern Europe.
Having the right bioanalytics partner that can deliver consistency is a key to successful clinical research, even if the CRO and site locations change throughout the clinical phases.
The only FDA Inspected Lab
Australia-based Agilex Biolabs, the only FDA-inspected lab in the Asia region, is a globally focussed facility that specialises in early Phase studies and supports sponsors through the full drug development process.
Agilex Biolabs has seen rapid growth of more than 40% over the past 2 years as sponsors and CROs recognise the calibre of Australian scientists, and Agilex Biolabs’ track-record of 300 early phase clinical trials.
Agilex Biolabs has just celebrated its first year as a separate company, having evolved from parent company CPR Pharma Services.
CEO Jason Valentine said in our 20 years of performing regulated bioanalysis of small and large molecules, we have accelerated hundreds of preclinical and clinical trials around the world.
The company, positioned in the same time-zone as most of Asia and working overnight while the USA sleeps, is able to deliver real advantages in speed and support.
More than 60 percent of the Agilex Biolabs client base is from the U.S, while 30% is from the Asia region.
Valentine said many clients come to Australia for their early phase trials because of the quality of research and the Government R&D rebate of up to 43.5%.
“With over ten years of experience, our scientists are capable of developing and validating the most complex assays for preclinical and clinical programs.”
“Then clients stay with us through the later clinical Phases because we can support their studies globally.”
“Agilex Biolabs is the leading bioanalytics lab in the region so we are a natural choice.”
“Our 65 person experienced scientific team is rapidly scaled for speed across multiple time-zones.”
Immunology expansion at Agilex Biolabs
Immunology is a broad area of science that intersects multiple therapeutic areas of emerging importance in Asia. Building on its strong immunoassay team, Agilex is expanding its suite of services to include immunological assessments to investigate the potential impact of the drug on the immune system. Services will include immunophenotyping and receptor occupancy assays by flow cytometry, biomarker assessments with Luminex and Mesoscale and cell-based assays for mode of action, immunogenicity and cytokine release, to assist clients better understand the mechanisms behind their drugs and fully evaluate the effects of test compounds.
Agilex Biolabs taps the best of Australia and around the world having recently progressed visa approvals for analysts and specialists from as far as the UK.
The Agilex Biolabs Internship encourages PhD students to learn about the company and share the latest knowledge – which also means the company is first in line to recruit the best once they graduate.
The company’s boasts the latest technology including the Sciex 4000 LC-MS/MS, Sciex QTRAP 5500 LC-MS/MS, SpectraMax Plate Reader, Mesoscale Discovery System (MSD) and Gyrolab xPlore that deliver the most accurate data for clinical trials.
Platforms – LC-MS/MS Bioanalysis
Agilex Biolabs conducts high performance, regulated bioanalysis by liquid chromatography tandem mass spectrometry (LC-MS/MS) analysis of small molecules, peptides and proteins.
Our dedicated LC-MS/MS team of experts averages over 15 years of experience each. Our areas of expertise include: new chemical entities (NCEs), sugars, nucleotides, enantiomers, steroids, prodrugs, peptides, immunosuppressants, nanoparticles, neurotransmitters, oligonucleotides and polymeric mixtures. Learn more.
Agilex Biolabs are recognised industry leaders in high performance, regulated immunoassay bioanalysis of large molecules. Our scientists have over 10 years experience in developing and validating robust compliant PK, PD and Immunogenicity assays to support preclinical and clinical programs. Learn more.
Agilex Biolabs identifies the best assay methodology to meet the clinical and regulatory needs for each project, for each client.
When you partner with us, we can support your drug development with either our existing Biomarker menu or develop and validate a suitable assay for your particular requirements.
Agilex Biolabs has an ever-growing menu of biomarker assays, including more than 300 validated assays.