Agilex Biolabs, Australia’s largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, and B2S Life Sciences, a biotherapeutic enablement company advancing improved analytical methods and outcomes for developers of biotherapeutic drugs and diagnostics, shared key ways to navigate the immunogenicity and biomarker requirements for clinical trials via webinar.
“Hot Topics in Immunoassay Bioanalysis – Key points in navigating the immunogenicity and biomarker requirements for clinical trials” was presented by Endpoints Webinars on April 6. Hosted by Endpoints Editor Arsalan Arif, the webinar featured Dr Kurt J. Sales, Agilex Biolabs’ Director of Immunoassay, Ronald R. Bowsher PhD, Partner and Chief Scientific Officer at B2S Life Sciences, and Amy Rosen, Associate Director of Statistics at B2S.
The panel shared insights from many years working in immunoassay bioanalysis for clinical trials. Ronald R. Bowsher said B2S has been working with Agilex Biolabs for more than four years, “Our relationship has evolved very well, and we understand each other’s needs. And despite the geographic differences, I think we’ve had a very productive collaboration serving Agilex Biolabs’ customers,” he said.
Dr Kurt J. Sales said, “Our world-class laboratories feature state-of-the-art equipment including Gyrolab Xplore, MSD Quickplex 120, Luminex Magpix, BD FACSymphony A3 flow cytometer and soon to be released, digital droplet quantitative real-time RT-PCR, while our scientists have experience in solving the most complex immunogenicity and drug tolerance issues, often encountered in immuno-oncology studies in both an early phase and later phase setting.”
Agilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale, Gyrolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser), and has leading certifications including OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.
Australian clinical trials have remained open for business. Agilex Biolabs, a designated essential service so clients can be assured of study continuity, can assist international clients with a rebate of up to 43.5% on clinical trial bioanalytical services spend as part of the Australian Government clinical trial attraction program. The company has recently expanded its labs by more than 30% to accommodate biotech demand from APAC and the USA. Watch the new lab video walkthrough here: https://youtu.be/WNdPGkdr9FA.
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.
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