Tag: Agilex Biolabs

Agilex Biolabs Shares How to Select the Right Bioanalytical Tools for Immuno-oncology and Vaccines Studies – OCT Webinar

Agilex Biolabs, the Australian regulated bioanalytical and toxicology laboratory facilities for clinical trials is presenting a new webinar entitled “Getting it right! Considerations for Immuno-oncology and Vaccine Studies and the Bioanalytical Tools used” in partnership with Outsourcing Clinical Trials (OCT).

Agilex Biolabs’ Director, Immunoassay, Kurt J. Sales (B.Sc; B.Sc (MED) Hons; M.Sc, Ph.D, PGCM) said:

“Choosing the right bioanalytical platform for your immunology or vaccines clinical trial is critical to data collection. But navigating the intricate bioanalytical process and selection of assay platforms can be difficult. This webinar covers these platforms in detail and the selection process.”

Agilex Biolabs is the largest regulated bioanalytical laboratory in Australia with over 24 years’ experience in early phase clinical trials with a track record of enabling the movement of new drug entities to market.

Agilex Biolabs specialises in pharmacokinetics, pharmacodynamics, and biomarker evaluation, which is key to understanding the drug absorption, distribution, metabolism, and excretion as well as target engagement and efficacy of the drug during clinical development.

“This webinar will demystify the bioanalytical requirements for clinical studies and will discuss the most common bioanalytical platforms used during clinical trials to measure vaccine responses and levels of inflammatory mediators in biological fluids,” said Dr. Sales.

Key Learning Objectives
– Learn how to determine the right bioanalytical platform for your immunology or vaccines clinical trial
– Understand what do these bioanalytical platforms look like in use
– Understand the process of selecting the right bioanalytical platform
– Demystify the bioanalytical requirements for clinical studies

The webinar will also cover Australian research, and regulatory and clinical infrastructure, which provides a favorable environment for rapid vaccine development. It will also include discussion of a case study for rapid vaccine development based on non-clinical research conducted with a novel COVID-19 protein subunit vaccine.

Register Here https://bit.ly/3aPlWsx
Date: 4 November
Time: 2PM London/3PM CET
Speaker: Dr Kurt Sales: Director, Immunoassay, Agilex Biolabs

Agilex Biolabs’ world-class laboratories feature state-of-the-art equipment including Gyrolab Xplore, MSD Quickplex 120, Luminex Magpix, BD FACSymphony A3 flow cytometer and digital droplet quantitative real-time RT-PCR.

The company offers services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms of LC-MS/MS and Immunoassay.

Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity.

Agilex Biolabs has more than 140 staff which includes 85 dedicated laboratory staff, and supports client pharma and biotech companies from US, Europe and APAC.

Book a confidential briefing with our scientists before you start your next clinical trial. https://calendly.com/agilexbiolabs/30min

About Agilex Biolabs https://www.agilexbiolabs.com/

Agilex Biolabs, the Australian specialist bioanalytical and toxicology laboratory facilities for clinical trials, has more than 24 years’ experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. It has successfully supported hundreds of preclinical and clinical trials from 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 up to 43.5% on clinical trial work conducted in Australia.

Agilex Biolabs also offers toxicology services through its company TetraQ.

Agilex Biolabs has the leading certifications including OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.

The company has recently expanded its main labs by more than 30% to accommodate biotech demand from APAC and the USA. In addition it has launched a new Immunobiology lab – watch the video here. https://www.agilexbiolabs.com/launch-of-immunobiology-laboratory/

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).

Agilex 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

Agilex Biolabs Media Contact:
Kate Newton
Media@AgilexBiolabs.com

Agilex Biolabs Announced as Citeline Award Finalist for COVID-19 Vaccine Toxicology Preclinical Research

Agilex Biolabs, Australia’s most experienced and technologically advanced bioanalytical laboratory and the only biolab in the region with a dedicated toxicology unit, has been selected as a finalist for the Most Successful Early Phase Research (Preclinical & Phase I) category in the Citeline Awards 2021.

The Citeline Awards were created to recognize accomplishments across the biopharmaceutical industry, providing an opportunity for the industry to honor its highest achievers. Achievements across the spectrum of key R&D activities are celebrated, from successes in early and late-stage research, to advances in technological tools, to innovations in trial design and execution.

Agilex Biolabs offers advanced bioanalytical services for biotech companies and delivers toxicology services to support pre-clinical and early phase research within their TetraQ, division.

Dr. Peter Tapley, Director Toxicology at TetraQ, said the research submitted for the Citeline Award focussed on preclinical assessment of the safety and tolerability of a SARS-CoV-2 Sclamp protein subunit COVID-19 vaccine in rats.

“The preclinical toxicity studies conducted by TetraQ were required to enable the rapid approval and safe progression of the novel SARS-CoV-2 Sclamp subunit vaccine into clinical testing in healthy volunteers,” he said.

“This research highlights the pathways that biotech companies can take for rapid vaccine development, and how the Australian research, regulatory and clinical infrastructure provides a supportive environment.”

The TetraQ safety studies conducted in support of the vaccine development were referenced in Watterson et al ‘Preclinical development of a molecular clamp-stabilised subunit vaccine for severe acute respiratory syndrome coronavirus 2’ Clin Transl Immunology. 2021 Apr 5;10(4): e1269. doi: 10.1002/cti2.1269. eCollection 2021. The important contributions of TetraQ to the program were acknowledged by the inclusion of Drs. Brockman, Tran and Tapley as co-authors.

A description of the clinical study facilitated by the preclinical toxicity study program was reported in Chappell et al ‘Safety and immunogenicity of an MF59-adjuvanted spike glycoprotein-clamp vaccine for SARS-CoV-2: a randomised, double-blind, placebo-controlled, phase 1 trial’ Lancet Infect Infect Dis. 2021 Apr 19; S1473-3099(21)00200-0. doi: 10.1016/S1473-3099(21)00200-0. This publication also included reference to vaccine serum antibody titre analyses conducted by Agilex Biolabs to support the clinical program. This contribution was acknowledged by the inclusion of Drs Tran and Tapley as co-authors. Although the development of this version of the SARS-CoV-2 Sclamp vaccine was ultimately discontinued the clinical study demonstrated the potential of the Sclamp vaccine technology.

The COVID-19 pandemic has seen the rapid development of a series of novel vaccines targeting SARS-CoV-2 in Australia, facilitated by the availability of high-quality contract research organizations such as Agilex Biolabs, and a favorable regulatory environment.

Agilex Biolabs’ TetraQ division offers a range of toxicology services to support early to late stage development programs. These services include exploratory toxicology and pharmacokinetics studies and GLP toxicology services. Studies requiring non-rodent species including dogs and non-human primates are conducted via our partner labs. Studies are also supported by Agilex Biolabs’ world class bioanalytical and immunoassay services.

Agilex Biolabs offers 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’ world-class immunoassay and immunobiology 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.

Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity.

Agilex Biolabs has more than 140 staff which includes 85 dedicated laboratory staff, and supports client pharma and biotech companies from US, Europe and APAC.

The 2021 Citeline Awards will take place October 14, 2021 in Boston, MA, USA.

Book a confidential briefing with our scientists before you start your next clinical trial. https://calendly.com/agilexbiolabs/30min

About Agilex Biolabs https://www.agilexbiolabs.com/
Agilex Biolabs, the Australian specialist bioanalytical and toxicology laboratory facilities for clinical trials, has more than 24 years’ experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. It has successfully supported hundreds of preclinical and clinical trials from around the world where eligible customers choose Australia for the streamlined regulatory process, quality data and access to the world’s most attractive R&D rebate of up to 43.5% on both nonclinical and clinical trial work conducted in Australia.

Agilex Biolabs also offers toxicology services through TetraQ an Agilex Biolabs company, an established GLP toxicology facility in Australia.

Agilex Biolabs has the leading certifications including OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.

The company has recently expanded its main labs by more than 30% to accommodate biotech demand from APAC and the USA. In addition Agilex Biolabs has launched a new Immunobiology lab – watch the video here. https://www.agilexbiolabs.com/launch-of-immunobiology-laboratory/

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).

Agilex 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

Agilex Biolabs Media Contact:
Kate Newton
Media@AgilexBiolabs.com

Agilex Biolabs Partners with Endpoints News for the First Webinar on Rapid Vaccine Development in Australia

Agilex Biolabs, the Australian specialist bioanalytical and toxicology laboratory facilities for clinical trials is partnering with Endpoints News to share the latest on “Non-clinical and clinical pathways for rapid vaccine development in Australia”, in a webinar hosted by Endpoints News Editor Arsalan Arif.

Agilex Biolabs’ Director, Immunoassay, Kurt J. Sales (B.Sc; B.Sc (MED) Hons; M.Sc, Ph.D, PGCM) said:
“The COVID-19 pandemic has seen the rapid development of a series of novel vaccines targeting SARS-CoV-2. Development of multiple COVID-19 vaccine candidates has been facilitated within Australia by the availability of high-quality contract research organizations such as Agilex Biolabs, and a favorable regulatory environment. This webinar will cover the pathways that biotech companies can take for rapid vaccine development, and why Australia is the ideal location. I am joined by my toxicology expert colleagues Dr Peter Tapley and Dr Drew Brockman for this detailed vaccine development webinar.”

In this webinar Dr Sales and specialists from Agilex Biolabs’ toxicology firm, TetraQ Toxicology will provide an overview of strategies to conduct vaccine development within Australia.

It will cover Australian research, and regulatory and clinical infrastructure, which provides a favorable environment for rapid vaccine development. It will also include discussion of a case study for rapid vaccine development based on non-clinical research conducted with a novel COVID-19 protein subunit vaccine.

This case study will review key aspects of non-clinical design required to facilitate approval for first-in-human studies.

Register Here: https://webinars.endpts.com/non-clinical-and-clinical-pathways-for-rapid-vaccine-development-in-australia/
September 7, 2:00 pm – 3:00 pm EDT
Speakers:
Dr Kurt Sales: Director, Immunoassay, Agilex Biolabs
Dr Peter Tapley: Director, TetraQ, an Agilex Biolabs company
Dr Drew Brockman: Head of Toxicology, TetraQ, an Agilex Biolabs company.

https://webinars.endpts.com/non-clinical-and-clinical-pathways-for-rapid-vaccine-development-in-australia/

Agilex Biolabs’ 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.

Latest News – new Immunobiology Lab – watch launch video. https://www.agilexbiolabs.com/launch-of-immunobiology-laboratory/

Agilex Biolabs CEO Jason Valentine said the new laboratory focusses on new and emerging areas of therapeutic interest, including RNA vaccines, siRNA/miRNA clinical targets and gene therapy studies.

“This new facility adds digital droplet quantitative RT-PCR analysis for RNA, siRNA and miRNA clinical trials, including vaccines and gene therapy trials,” he said.

“We are also installing an EliSPOT/FluoroSPOT multi-spot reader for vaccine studies to enable extrapolation of recall immune responses, which coupled with our state-of-the-art BD FACSymphony 5 laser, 20 colour flow cytometer, offers unparalleled sensitivity for immunology and vaccine trials.”

The company offers services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms of LC-MS/MS and Immunoassay.

Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity.

Agilex Biolabs has more than 130 staff which includes 85 dedicated laboratory staff, and supports client pharma and biotech companies from US, Europe and APAC.

Book a confidential briefing with our scientists before you start your next clinical trial. https://calendly.com/agilexbiolabs/30min

About Agilex Biolabs https://www.agilexbiolabs.com/
Agilex Biolabs, the Australian specialist bioanalytical and toxicology laboratory facilities for clinical trials, has more than 24 years’ experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. It has successfully supported hundreds of preclinical and clinical trials from 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.

Agilex Biolabs also offers toxicology services through its company TetraQ, an established GLP toxicology facility in Australia.

Agilex Biolabs has the leading certifications including OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.

The company has recently expanded its main labs by more than 30% to accommodate biotech demand from APAC and the USA. In addition it has launched a new Immunobiology lab – watch the video here. https://www.agilexbiolabs.com/launch-of-immunobiology-laboratory/

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).

Agilex 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

Agilex Biolabs Media Contact:
Kate Newton
Media@AgilexBiolabs.com

Agilex Biolabs’ Toxicology Tapped for SARS-CoV-2 Vaccine Research

Agilex Biolabs, Australia’s largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, said biotechs with first-in-human studies can leverage significant quality, speed and cost advantages working with their company TetraQ toxicology for pre-clinical research in Australia.

TetraQ is a NATA-accredited, GLP-recognised rodent toxicology facility.

The TetraQ toxicology team, whose recent COVID-19 vaccine work is featured in PubMed, is one of the most experienced in the region with more than 15 years of success with biotechs and university researchers. In addition, research costs can be offset by 43.5% with the attractive Australian Government clinical research incentive rebate for USA, Asia and European companies.

Agilex Biolabs works closely with Australia’s leading biotech R&D tax rebate specialist, Bentleys R&D Services, to ensure clients are aware of the R&D benefits.

Bentleys’ Managing Director Mike Burfield said the attractive 43.5% R&D rebate on clinical research spend can be applicable for the entire toxicology program.

“The rebate covers rodent toxicology services at TetraQ, while second species toxicology research conducted overseas can also be potentially eligible depending on the company, saving considerable costs in the pre-clinical stage.

Each year we have hundreds of biotech companies from around the world benefiting from this significant refund system operated by The Australian Government to attract clinical research.

However, it is vital that biotechs take advice prior to starting research, and that company documentation is prepared correctly from the start to take full advantage of these savings during the toxicology program, through to phase I and beyond.”

TetraQ toxicology, which was acquired by Agilex Biolabs earlier this year, started in 2005 based out of the University of Queensland and has since earned a strong global reputation for excellence in GLP rodent pre-clinical safety studies.

Agilex Biolabs CEO, Jason Valentine said:“Biotech clients are discovering the considerable speed and cost advantages of using an Australian-based toxicology facility like TetraQ.”The 43.5% rebate on toxicology costs is a major benefit, but clients are also keen to then leverage the easy and rapid transition to first-in-human trials available in Australia. Australia is known as the ideal early-phase destination because of the many regulatory and cost advantages – and most importantly that clinical data is accepted by the FDA and other major authorities.

TetraQ’s NATA-accredited, GLP-recognised rodent toxicology facility is highly regarded for its personalized service, rapid response, and innovative solutions for biotechs planning their first-in-human studies.”

TetraQ non-GLP toxicology study results can be used to support the design of both key efficacy studies and formal GLP toxicology studies in rodents. Formal GLP toxicity studies can in turn support first-in-human studies. GLP studies employ a test item manufactured under Good Manufacturing Practice (GMP) and a study design informed by non-GLP exploratory toxicity studies as well as the intended clinical use. GLP studies are subject to Quality Assurance (QA) audit, as their results are intended to facilitate the safe design of clinical studies.

The study management and data collection processes are supported by an FDA 21 CFR Part 11-compliant Provantis software system. Furthermore interim and final report preparation is also facilitated by this centralized data collection system to allow rapid delivery of written reports to clients.

Agilex Biolabs has more than 120 staff which includes 85 dedicated laboratory staff and supports client pharma and biotech companies from the US, Europe and APAC.

Agilex Biolabs’ 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.

The company offers services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilizing the two platforms of LC-MS/MS and Immunoassay.

Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity.

Book a confidential briefing with our scientists before you start your next clinical trial. 

About Agilex Biolabs

Agilex Biolabs, Australia’s leading bioanalytical and toxicology laboratory, has more than 24 years of experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. It has successfully supported hundreds of preclinical and clinical trials from 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.

Agilex Biolabs has the leading certifications including OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition. The company has recently acquired TetraQ biolabs and toxicology, and also expanded its main labs by more than 30% to accommodate biotech demand from APAC and the USA. Watch the new lab video walkthrough here.

Agilex Biolabs specializes in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilizing LC-MS/MS, immunoassay (Mesoscale, Gyrolab, Luminex) and flows cytometry (BD FACSymphony A3, 20 color cell analyzer).

Agilex 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

Agilex Biolabs Media Contact:
Kate Newton
Media@AgilexBiolabs.com

Agilex Biolabs Congratulates Bionomics Limited on BNC210 PK Results

Agilex Biolabs, Australia’s largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, today congratulated client Bionomics Limited (Bionomics) on its positive pharmacokinetic (PK) results from a 7-day dosing study in healthy volunteers using the newly developed solid dose oral tablet formulation of BNC210.

Liz Doolin, Bionomics’ Vice President Clinical Development commented that “We greatly value our long-standing partnership with Agilex Biolabs who continue to be a partner of choice for Bionomics and have supported the development of BNC210 from the beginning. We look forward to continuing this partnership into the future.”

Bionomics (ASX: BNO, OTCQB: BNOEF, Germany: AU000000BNO5), is a global, clinical-stage biopharmaceutical company. Bionomics said in their announcement:

“BNC210 is a novel, negative allosteric modulator of the alpha 7 nicotinic acetylcholine receptor in development for the treatment of anxiety and stressor-related disorders, and in November 2019 was granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of Post-Traumatic Stress Disorder (PTSD).

The 7-day dosing PK study in ten healthy volunteers (females and males) demonstrated that at a dose of 900 mg given twice daily, the tablet formulation of BNC210 had steady-state 12-hourly exposure levels ranging from 33-57 mg.h/L which exceed the 12-hourly blood exposure of ~25 mg.h/L predicted as necessary to meet the primary endpoints for effectiveness for treating PTSD patients in future clinical trials.

Dr. Errol De Souza, Executive Chairman of Bionomics said, “We are extremely pleased with the results of the 7-day PK study which demonstrate that we reach steady-state levels on the second day following the start of twice-daily dosing and that we not only meet but exceed the blood exposure predicted from the pharmacometrics analysis as necessary for future trials.

“With the dose now selected, we can initiate manufacturing of the tablets, clinical site selection and regulatory filings in preparation for a Phase 2b trial with BNC210 in PTSD patients projected for mid-2021.”

Dr Kurt J. Sales Agilex Biolabs’ Director Immunoassay said: “Anxiety and stress-related disorders have a major impact on the health and wellbeing of hundreds of thousands of Australians with more than 1 in 4 people reported to be impacted by these disorders. The effects of stress and anxiety not only impact a person’s psychological well-being but also their physical well-being and productivity which in turn has a tremendous impact on the economy.

“Novel treatments such as BNC210 are essential weapons in the fight against anxiety and stress-related disorders. Agilex Biolabs has been working closely with Bionomics for several years, supporting the PK regulated Bioanalysis of BNC210 and is privileged to be a part of this potential new treatment for anxiety and stressor-related disorders.”

Agilex Biolabs’ 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. The company offers services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilizing the two platforms of LC-MS/MS and Immunoassay.

Clients can also access a rebate of up to 43.5% on clinical trial bioanalytical services spend as part of the Australian Government clinical trial attraction program. Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity. Agilex Biolabs has more than 100 staff which includes 75 dedicated laboratory staff and supports client pharma and biotech companies from US, Europe and APAC.

Book a confidential briefing with our scientists before you start your next clinical trial.

About Agilex Biolabs

Agilex Biolabs, Australia’s leading bioanalytical laboratory, has more than 24 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.

Agilex Biolabs has the leading certifications including OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition. 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

Agilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilizing LC-MS/MS, immunoassay (Mesoscale, Gyrolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).

Agilex 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)

Agilex Biolabs media contact:
Kate Newton
Media@AgilexBiolabs.com

Agilex Biolabs and B2S Life Sciences on Immunoassay Bioanalysis for Clinical Trials

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.

Watch the webinar here (no registration required): https://bit.ly/3sZp8IA / https://youtu.be/x0H9a8oCb98

“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.

Book a briefing with Agilex Biolabs before starting your next clinical trial: https://calendly.com/agilexbiolabs/15min

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 media contact:
Kate Newton
Media@AgilexBiolabs.com

Agilex Biolabs Showcases Advanced Immunoassay and Immunobiology Services at Bio-Europe Spring 2021

Agilex Biolabs, Australia’s largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, today announced it will showcase its world-class immunoassay and immunobiology services for regulated bioanalysis at Bio-Europe 2021.

Dr Kurt J. Sales Agilex Biolabs’ Director Immunoassay said:

“Our experienced team can develop or transfer a method for any biologic to support pre-clinical GLP or clinical studies. 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. Our scientists have expertise and experience to solve 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 also features a rebate of up to 43.5% on clinical trial bioanalytical services spend as part of the Australian Government clinical trial attraction program.

Learn more: Take a briefing with our Scientists at Bio-Europe via PartneringOne. Login Here https://informaconnect.com/bio-europe-virtual/

Or Book a Briefing with us before you start your next clinical trial. https://calendly.com/agilexbiolabs/15min

Agilex Biolabs also has the 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 and Agilex Biolabs is a designated essential service so clients can be assured of study continuity.

Australia has led the world in keeping COVID-19 numbers down to almost zero across the country by acting swiftly to minor outbreaks.

The company has recently expanded its labs by more than 30% to accommodate biotech demand from APAC, EU and the USA. Watch the New Labs Walkthrough Video Here https://www.agilexbiolabs.com/new-labs-video

Agilex Biolabs has more than 100 staff which includes 75 dedicated laboratory staff.

About Agilex Biolabs https://www.agilexbiolabs.com/

Agilex Biolabs, Australia’s leading bioanalytical laboratory, has more than 24 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 Media Contact:
Kate Newton
Media@AgilexBiolabs.com

Agilex Biolabs Client Shasqi Announces Click Chemistry Breakthrough with First-Ever Human Application in Launch of Clinical Program

Agilex Biolabs, Australia’s most advanced FDA-inspected specialist bioanalytical laboratory for clinical trials, congratulates client company Shasqi on the announcement of the first-ever application of click chemistry in humans, with the launch of the Company’s lead clinical candidate, SQ3370. Shasqi is the first Y Combinator-backed biotech company to reach clinical development.

San Francisco-based Shasqi said in the announcement:

First Patients Dosed in Phase 1 Clinical Study of SQ3370 for Advanced Solid Tumor Malignancies

Shasqi is First Y-Combinator Biotech Company to Reach First-in-Human Clinical Studies

Shasqi, a clinical-stage biotechnology company developing precision activated oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPACtm) Platform, announced today the first-ever application of click chemistry in humans, with the launch of the Company’s lead clinical candidate, SQ3370. Shasqi is the first Y Combinator-backed biotech company to reach clinical development.

The first two patients have been dosed in Shasqi’s Phase 1 clinical study of SQ3370 for the treatment of advanced solid tumors. SQ3370 is a novel investigational product that activates a non-toxic protodrug into a powerful chemotherapy agent, doxorubicin, precisely at a pre-injected tumor. SQ3370 is designed to allow substantially higher drug doses to be given to the patient, increasing tumor destruction while minimizing toxicity in the rest of the body.

“Shasqi is founded on the belief that one day we will be able to beat cancer without poisoning our bodies. We are excited to reach this milestone with our CAPAC Platform and the launch of Shasqi’s first clinical program,” said Jose M. Mejia Oneto, M.D., Ph.D., Founder and CEO of Shasqi.

The CAPAC Platform is a new therapeutic modality based on click chemistry, which leverages biocompatible chemical reactions, to activate protodrugs at a selected tumor that has been pre-injected with a biopolymer. The CAPAC platform is agnostic to tumor characteristics that can vary from patient to patient, such as biomarker expression and enzymatic activity, rendering it applicable to a broad array of tumor types. Additionally, the CAPAC Platform is highly modular and can be applied to a wide variety of cancer therapeutics in addition to doxorubicin.

“Doxorubicin has been proven effective for dozens of cancers, but severe side effects limit its use. Guiding it directly to the tumor while avoiding damage to the rest of the body may allow us to use doxorubicin and potentially many other drugs in a completely new and effective way for patients,” commented Wayne Saville, M.D., Chief Medical Officer of Shasqi. “Shasqi has taken a novel concept through a rigorous preclinical regulatory path all the way to treating patients in near-record time.”

“Shasqi was Y Combinator’s first therapeutic biotechnology investment and now the first of our life sciences companies to reach clinical development,” said Jared Friedman, Partner, Y Combinator. “We are extremely impressed by the team’s rapid advancement and capital-efficient execution. SQ3370 and CAPAC are not just a standard new small molecule, but rather a broad and powerful new platform leveraging state of the art science and materials to transform the treatment of cancer.”

SQ3370-001 (NCT04106492) is a multicenter, first-in-human, dose-escalation, Phase 1 clinical trial evaluating the safety and tolerability, pharmacokinetics, immune effects, and preliminary anti-tumor efficacy of SQ3370 in patients with locally advanced or metastatic solid tumor malignancies ineligible for standard-of-care therapy. The study is being conducted in the United States and Australia at multiple cancer centers, including MD Anderson Cancer Center and Stanford University. The study is expected to be completed in 2021. More information about the trial is available at: https://clinicaltrials.gov/ct2/show/NCT04106492.

See the announcement here. https://tinyurl.com/y2splohj

Agilex Biolabs is known internationally for its continued investment in the latest technology, and for attracting some of the leading scientists from Australia and around the world.

Agilex Biolabs, the only FDA-inspected lab of its type in the region, also features a rebate of up to 43.5% on clinical trial bioanalytical services spend as part of the Australian Government clinical trial attraction program.

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 recently 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)

Agilex 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 companies from US, Europe and APAC.

Please Book a Briefing with us before you start your next clinical trial. https://calendly.com/agilexbiolabs/15min

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 Media Contact:
Media@AgilexBiolabs.com
Kate Newton

Shasqi media contact:
David Rosen, Argot Partners
media@shasqi.com
+1 (212) 600-1902

Endpoints News Presents “Why Australia and Agilex Biolabs for your Next Clinical Trial” for Bio Europe 2020

Agilex Biolabs, Australia’s most advanced FDA-inspected specialist bioanalytical laboratory for clinical trials, has partnered with Endpoints News to produce an exceptional step-by-step webinar on how to run your trial in Australia, and why Agilex Biolabs is the leading biolabs partner. Watch here (no charge) https://tinyurl.com/yyzf6o44

Agilex Biolabs is known internationally for its continued investment in the latest technology, and for attracting some of the leading scientists from Australia and around the world.

The webinar was launched as part of Agilex Biolabs’ presence at Bio Europe. Click here to meet Agilex Biolabs at Bio Europe via the partneringone tool. https://informaconnect.com/bio-europe-virtual/

Dr Kurt J. Sales, Agilex Biolabs Director, Immunoassay B.Sc (Med)(Hons), M.Sc, PhD, PGCM led with a presentation detailing the rapid trials process in Australia.

He stressed the importance of talking to Agilex Biolabs early, even before selecting a CRO and other partners, due to the depth of advice the scientific team can offer Sponsors, and the time it can take to develop some assays.

The webinar also featured leading clinical research specialist Jane Kelly who has 27 years in the industry. She is CEO of CMAX Clinical Research, a major Phase 1 Unit located near Agilex Biolabs.

Kelly pointed to the significant advantages of having the biolabs close to the Phase 1 Unit in terms of sample transfer and data turnaround, and offering a seamless clinical experience for Sponsors.

Agilex Biolabs, the only FDA-inspected lab of its type in the region, also features a rebate of up to 43.5% on clinical trial bioanalytical services spend as part of the Australian Government clinical trial attraction program.

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 recently 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)

Agilex 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 companies 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.

Agilex Biolabs has 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.

The company offers 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.

Media Contact:
Media@AgilexBiolabs.com
Kate Newton

Agilex Biolabs Develops World’s Most Accurate Cannabinoid Assay

Award-winning Agilex Biolabs, the Asia-Pacific region’s leading bioanalytical laboratory for clinical trials, based in Australia, has developed the world’s most accurate cannabinoid assay.

The announcement was made at BioPharm America (September 21-24, 2020).

The assay is already being used by 4 sponsors in drug development.

Agilex Biolabs CEO Jason Valentine said the company was now very much at the forefront of assay development for cannabis clinical trials, with more assays in the pipeline.

“We have developed a high sensitivity, quantitative assay for the detection of CBN, CBD and THC and metabolites in human plasma.

The Agilex Biolabs cannabinoids assay achieves >98% of ISR (Incurred Sample Reanalysis) samples within the acceptance criteria, which demonstrates that it is robust and reproducible.

The FDA and EMA criteria is 67% of samples within 20%.

This is the best-in-class because we have resolved interferences that over-state THC concentrations that can potentially skew reported data. The improved accuracy and sensitivity means we now have a precise low level assay for our clients.

This competes with anything in the world for accuracy, and cuts the risk of flawed results.

Due to high client demand a CBD and metabolites assay is in development and will be ready before end of the year.”

Agilex is also now offering additional 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)

Agilex Biolabs, the only FDA-inspected lab of its type in the Asia-Pacific, offers bioanalysis for small molecules and biologics for PK, immunogenicity and biomarkers utilising the two platforms of LC-MS/MS and Immunoassay (MesoScale, Gyrolab).

The FDA-inspected facilities have more than 90 dedicated laboratory staff, and annually support more than 80 clinical trials. This year Agilex Biolabs will analyse more than 60,000 samples for pharma/biotechs from US, Europe and APAC.

By combining specialised expertise, technological innovation and a 20-year track record, Agilex Biolabs have supported hundreds of preclinical and clinical trials around the world.

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.

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