12 5 月, 2022

Elevating Australia’s Scientific Acumen: Large Molecule Facility Doubles Size of Australia’s Top Bioanalytical Laboratory

Thebarton, Australia, May 12, 2022 – (NovationWire) – Agilex Biolabs Pty Ltd has unveiled its new building with a ribbon cutting ceremony by The Honourable Stephen Patterson MP Minister for Trade and Investment at 12:30pm on Thursday 17 February 2022 at 31 Dalgleish street Thebarton South Australia 5031. Agilex Biolabs launched its new laboratory for the analysis of large molecule therapeutics, more than doubling the geographic area of its Adelaide campus. The addition of this 2,520 m2 facility expands the service capabilities of Australia’s most technologically advanced bioanalytical partner and brings a new point of pride to South Australia. State-of-the-art instrument platforms and increased capacity empower drug sponsors from all over the world to succeed as they expand into the novel, promising world of large molecule therapeutics. Areas of medicine such as oncology are seeing new ways of approaching treatment due to innovative modalities like antibody-drug conjugates (ADCs) and allogeneic cell therapies. Gene therapies and vaccines created using genetic platforms such as RNA, miRNA, and siRNA need specialised tools and technology to measure critical safety and efficacy endpoints in human clinical trials. The new Agilex large molecule facility features cutting-edge bioanalytical techniques and equipment specifically designed for these fast-growing therapeutic areas, such as digital droplet quantitative RT-PCR analysis and an EliSPOT/FluoroSPOT multi-spot reader for high-sensitivity molecule detection. Before the new Agilex large molecule facility was built, many drug sponsors conducting clinical trials in Australia would have to ship their clinical samples to labs in other countries to get important patient safety data. The expansion into this kind of support represents South Australia’s ability and willingness to accommodate the huge influx of biopharmaceutical companies from all over the world bringing their toxicology studies and clinical programs to Australia. Adelaide’s scientific community can blossom as Agilex Biolab continues to grow. Already staffed with over 150 scientists and support personnel, the comprehensive bioanalytical service headquarters will soon reach 200 welcoming experts from all over the world to its ranks. “The world’s most talented, driven scientists are drawn to research facilities that foster scientific advancement and cutting-edge technology—many of those people will now be coming to Adelaide,” said Agilex Biolabs CEO, Jason Valentine. “Committed investment and our local community’s support for this new center of scientific excellence will elevate South Australia’s reputation for spurring innovation and harboring success.” The community offered their enthusiastic applause at the new facility’s official opening on Thursday afternoon. The ribbon cutting ceremony was conducted by the Minister for Trade and Investment, The Honourable Stephen Patterson MP. Minister for Trade and Investment Stephen Patterson said the State Government had an ambitious plan to grow SA’s Health and Medical Industries sector’s contribution to the state’s economy. “As a government, we’re working collaboratively with industry to more than double the HMI economic contribution to SA from $2.3 billion to $5 billion by 2030. “South Australia is open for business and at the forefront of world-leading capabilities, bio-tech precincts and an academic research ecosystem that makes it the ideal place to invest and do business.” The traditional ‘welcome to country’ and cleansing ceremony was led by local indigenous leader Jack Buckskin. About Agilex Biolabs Agilex Biolabs is Australia’s leading provider of bioanalytical services and toxicology studies supporting preclinical and clinical drug development. With over 25 years of specialized experience and a rapidly growing suite of full-service offerings, Agilex equips biopharma companies from United States, Asia-Pacific, and European regions with reliable, defendable data as they advance novel therapeutics through the development pipeline. By combining specialized expertise, technological innovation, and a 25-year track record, the Agilex team has successfully supported hundreds of preclinical and clinical trials from around the world. Agilex Biolabs is headquartered in Adelaide, South Australia, with additional laboratory sites in Queensland. For more information, visit https://www.agilexbiolabs.com/ Social Links Twitter: https://twitter.com/AgilexBiolabs LinkedIn: https://linkedin.com/agilex-biolabs YouTube: https://www.youtube.com/channel/UCK8yK3JxXni6QhiorMUIyLA Media Contact Brand: Agilex Biolabs Contact: Janki Patel, Marketing Associate E-Mail: janki.patel@agilexbiolabs.com Website: https://www.agilexbiolabs.com/ SOURCE: Agilex Biolabs The article is provided by a third-party content provider. SEAPRWire ( www.seaprwire.com ) makes no warranties or representations in connection therewith. Any questions, please contact cs/at/SEAPRWire.com Sectors: Top Story, Daily News SEA PRWire: PR distribution in Southeast Asia (Indonesia, Thailand, Vietnam, Singapore, Malaysia, Philippines & Hong Kong )

19 10 月, 2021

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

ADELAIDE, AUS, Oct 19, 2021 - (ACN Newswire via SEAPRWire.com) - 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 studiesThe 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/3aPlWsxDate: 4 NovemberTime: 2PM London/3PM CETSpeaker: Dr Kurt Sales: Director, Immunoassay, Agilex BiolabsAgilex 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/30minAbout 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 NewtonMedia@AgilexBiolabs.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

24 9 月, 2021

Agilex Biolabs 被宣布为 COVID-19 疫苗毒理学临床前研究的 Citeline 奖决赛选手

ADELAIDE, AUS, Sep 24, 2021 - (亚太商讯 via SEAPRWire.com) - Agilex Biolabs 是澳大利亚最有经验和技术最先进的生物分析实验室，也是该地区唯一拥有专门毒理学部门的生物实验室，已被选为 2021 年 Citeline 奖中最成功的早期研究（临床前和 I 期）类别的决赛入围者。Citeline 奖旨在表彰整个生物制药行业的成就，为该行业提供一个表彰其最高成就者的机会。庆祝关键研发活动范围内的成就，从早期和后期研究的成功，到技术工具的进步，再到试验设计和执行的创新。Agilex Biolabs 为生物技术公司提供先进的生物分析服务，并提供毒理学服务以支持其 TetraQ 部门的临床前和早期研究。TetraQ 毒理学主任 Peter Tapley 博士说，提交给 Citeline 奖的研究侧重于对 SARS-CoV-2 Sclamp 蛋白亚基 COVID-19 疫苗在大鼠中的安全性和耐受性的临床前评估。“需要 TetraQ 进行的临床前毒性研究才能使新型 SARS-CoV-2 Sclamp 亚单位疫苗快速获得批准并安全地进入健康志愿者的临床试验，”他说。“这项研究突出了生物技术公司可以采取的快速疫苗开发途径，以及澳大利亚的研究、监管和临床基础设施如何提供支持性环境。”为支持疫苗开发而进行的 TetraQ 安全性研究在 Watterson 等人的“针对严重急性呼吸综合征冠状病毒 2 的分子钳稳定亚单位疫苗的临床前开发”Clin Transl 免疫学中有所引用。 2021 年 4 月 5 日；10(4)：e1269。 doi：10.1002/cti2.1269。 eCollection 2021。TetraQ 对该计划的重要贡献得到了博士的认可。 Brockman、Tran 和 Tapley 作为合著者。Chappell 等在“用于 SARS-CoV-2 的 MF59 佐剂刺突糖蛋白钳疫苗的安全性和免疫原性：随机、双盲、安慰剂对照”中报告了临床前毒性研究计划促进的临床研究的描述，第一阶段试验'柳叶刀感染感染传播。 2021 年 4 月 19 日； S1473-3099(21)00200-0。 doi：10.1016/S1473-3099(21)00200-0。该出版物还引用了 Agilex Biolabs 为支持临床计划而进行的疫苗血清抗体滴度分析。这一贡献得到了 Tran 博士和 Tapley 博士作为合著者的认可。尽管此版本的 SARS-CoV-2 Sclamp 疫苗的开发最终停止，但临床研究证明了 Sclamp 疫苗技术的潜力。COVID-19 大流行见证了一系列针对 SARS-CoV-2 的新型疫苗的快速发展。由于 Agilex Biolabs 等高质量合同研究组织的可用性以及有利的监管环境，澳大利亚境内多种 COVID-19 候选疫苗的开发得到了促进。Agilex Biolabs 的 TetraQ 部门提供一系列毒理学服务，以支持早期到后期的开发计划。这些服务包括探索性毒理学和药代动力学研究以及 GLP 毒理学服务。需要非啮齿类动物（包括狗和非人类灵长类动物）的研究是通过我们的合作实验室进行的。 Agilex Biolabs 世界一流的生物分析和免疫测定服务也支持研究。我们使用LC-MS/MS和免疫测定这两个平台，为小分子和生物制剂提供PK，免疫原性（PD）和生物标志物生物分析服务。Agilex Biolabs 的世界级实验室配备了最先进的设备，包括 Gyrolab Xplore、MSD Quickplex 120、Luminex Magpix、BD FACSymphony A3 流式细胞仪以及即将发布的数字液滴定量实时 RT-PCR。澳大利亚临床试验仍在营业，Agilex Biolabs被指定为必不可少的服务，因此可以确保客户研究的连续性。这家生物实验室拥有140多名员工，其中85名专职实验室人员，支持临床试验来自美国、欧洲和亚太地区的生物技术客户。2021 年 Citeline 奖将于 2021 年 10 月 14 日在美国马萨诸塞州波士顿举行。在您开始下一个临床试验之前，请与我们预约会面。https://calendly.com/agilexbiolabs/30min关于 Agilex Biolabs - www.agilexbiolabs.comAgilex Biolabs 是澳大利亚用于临床试验的专业生物分析和毒理学实验室机构，在执行监管生物分析方面拥有超过 24 年的经验，包括质量方法开发、方法验证和样品分析服务。我们已成功支持了全球数百项临床前和临床试验，客户选择澳大利亚进行简化的监管程序，并获得了在澳大利亚进行的全球最有吸引力的43.5％以上的研发试验回扣。Agilex Biolabs还通过其公司TetraQ提供毒理学服务，TetraQ是在澳大利亚建立的GLP囓齿动物毒理学设施。Agilex Biolabs的世界一流生物分析设施获得了NATA（澳大利亚政府OECD GLP合规性监测机构）的OECD GLP认可和ISO 17025的全球认可。Agilex Biolabs宣布，其实验室设施已扩充了30％以上，以满足主要来自美国和亚太地区和欧盟生物技术公司的需求。此外，还启动了一个新的免疫生物学实验室——在此处观看视频。 https://www.agilexbiolabs.com/launch-of-immunobiology-laboratory/Agilex Biolabs利用液相色谱串联质谱（LC-MS/MS）、免疫分析法（Mesoscale，Gurolab，Luminex）以及流式细胞仪（BD FAC Symphony A3分选仪，20色细胞分析仪）专门从事小分子和生物制剂的生物分析和PK生物制剂、免疫原性和生物指标和免疫药效学评估。Agilex还提供药效学服务，包括使用最先进的技术支持免疫学、细胞生物学和作用方式分析的免疫生物学服务，包括 :- 免疫表型- 受体占用- 细胞因子释放试验（全血或外周单个核细胞（PBMC）刺激试验）和细胞因子/生物标志物分析- PBMC测定和细胞作用机制分析Agilex Biolabs媒体联络:Kate NewtonMedia@AgilexBiolabs.com Copyright 2021 亚太商讯. All rights reserved. (via SEAPRWire)

24 9 月, 2021

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

ADELAIDE, AUS, Sep 24, 2021 - (ACN Newswire via SEAPRWire.com) - 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/30minAbout 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 NewtonMedia@AgilexBiolabs.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

31 8 月, 2021

Agilex Biolabs 与 Endpoints News 合作举办澳大利亚第一次关于快速疫苗开发的网络研讨会

ADELAIDE, AUS, Aug 31, 2021 - (亚太商讯 via SEAPRWire.com) - Agilex Biolabs 是澳大利亚临床试验专业生物分析和毒理学实验室机构，正在与 Endpoints News 合作，在 Endpoints News 编辑 Arsalan Arif 主持的网络研讨会上分享“澳大利亚快速开发疫苗的非临床和临床途径”的最新信息。Agilex Biolabs 免疫分析总监 Kurt J. Sales（理学士；理学学士（医学）荣誉学士；理学硕士、博士、PGCM）说：“COVID-19 大流行见证了一系列针对 SARS-CoV-2 的新型疫苗的快速发展。由于 Agilex Biolabs 等高质量合同研究组织的可用性以及有利的监管环境，澳大利亚境内多种 COVID-19 候选疫苗的开发得到了促进。本次网络研讨会将涵盖生物技术公司可以采取的快速疫苗开发途径，以及为什么澳大利亚是理想的地点。我和我的毒理学专家同事 Peter Tapley 博士和 Drew Brockman 博士一起参加了这场详细的疫苗开发网络研讨会。”在本次网络研讨会中，Agilex Biolabs 毒理学公司 TetraQ Toxicology 的 Sales 博士和专家将概述在澳大利亚进行疫苗开发的策略。它将涵盖澳大利亚的研究、监管和临床基础设施，为快速开发疫苗提供有利环境。它还将包括基于使用新型 COVID-19 蛋白亚单位疫苗进行的非临床研究的快速疫苗开发案例研究的讨论。本案例研究将审查促进首次人体研究批准所需的非临床设计的关键方面。注册点击这里 https://tinyurl.com/2kkjnr4x9 月 7 日，下午 2:00 - 下午 3:00（美国东部时间）演讲者：Kurt Sales 博士：Agilex Biolabs 免疫分析总监Peter Tapley 博士：Agilex Biolabs 公司 TetraQ 的主管Drew Brockman 博士：Agilex Biolabs 公司 TetraQ 毒理学负责人。https://tinyurl.com/2kkjnr4xAgilex Biolabs 的世界级实验室配备了最先进的设备，包括 Gyrolab Xplore、MSD Quickplex 120、Luminex Magpix、BD FACSymphony A3 流式细胞仪以及即将发布的数字液滴定量实时 RT-PCR。最新消息 – 新免疫生物学实验室 – 观看发布视频。https://www.agilexbiolabs.com/launch-of-immunobiology-laboratory/Agilex Biolabs 首席执行官 Jason Valentine 表示，新实验室专注于新兴的治疗领域，包括 RNA 疫苗、siRNA/miRNA 临床目标和基因治疗研究。“这个新设施为 RNA、siRNA 和 miRNA 临床试验增加了数字液滴定量 RT-PCR 分析，包括疫苗和基因治疗试验，”他说。“我们还安装了用于疫苗研究的 EliSPOT/FluoroSPOT 多点阅读器，以便推断召回免疫反应，结合我们最先进的 BD FACSymphony 5 激光、20 色流式细胞仪，为免疫学提供无与伦比的灵敏度和疫苗试验。”我们使用LC-MS/MS和免疫测定这两个平台，为小分子和生物制剂提供PK，免疫原性（PD）和生物标志物生物分析服务。澳大利亚临床试验仍在营业，Agilex Biolabs被指定为必不可少的服务，因此可以确保客户研究的连续性。这家生物实验室拥有130多名员工，其中85名专职实验室人员，支持临床试验来自美国、欧洲和亚太地区的生物技术客户。在您开始下一个临床试验之前，请与我们预约会面。https://calendly.com/agilexbiolabs/30min关于 Agilex Biolabs - www.agilexbiolabs.comAgilex Biolabs 是澳大利亚用于临床试验的专业生物分析和毒理学实验室机构，在执行监管生物分析方面拥有超过 24 年的经验，包括质量方法开发、方法验证和样品分析服务。我们已成功支持了全球数百项临床前和临床试验，客户选择澳大利亚进行简化的监管程序，并获得了在澳大利亚进行的全球最有吸引力的40％以上的研发试验回扣。Agilex Biolabs还通过其公司TetraQ提供毒理学服务，TetraQ是在澳大利亚建立的GLP囓齿动物毒理学设施。Agilex Biolabs的世界一流生物分析设施获得了NATA（澳大利亚政府OECD GLP合规性监测机构）的OECD GLP认可和ISO 17025的全球认可。Agilex Biolabs宣布，其实验室设施已扩充了30％以上，以满足主要来自美国和亚太地区和欧盟生物技术公司的需求。此外，还启动了一个新的免疫生物学实验室——在此处观看视频。 https://www.agilexbiolabs.com/launch-of-immunobiology-laboratory/Agilex Biolabs利用液相色谱串联质谱（LC-MS/MS）、免疫分析法（Mesoscale，Gurolab，Luminex）以及流式细胞仪（BD FAC Symphony A3分选仪，20色细胞分析仪）专门从事小分子和生物制剂的生物分析和PK生物制剂、免疫原性和生物指标和免疫药效学评估。Agilex还提供药效学服务，包括使用最先进的技术支持免疫学、细胞生物学和作用方式分析的免疫生物学服务，包括 :- 免疫表型- 受体占用- 细胞因子释放试验（全血或外周单个核细胞（PBMC）刺激试验）和细胞因子/生物标志物分析- PBMC测定和细胞作用机制分析Agilex Biolabs媒体联络:Kate NewtonMedia@AgilexBiolabs.com Copyright 2021 亚太商讯. All rights reserved. (via SEAPRWire)

26 8 月, 2021

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

ADELAIDE, AUS, Aug 26, 2021 - (ACN Newswire via SEAPRWire.com) - 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 EDTSpeakers:Dr Kurt Sales: Director, Immunoassay, Agilex BiolabsDr Peter Tapley: Director, TetraQ, an Agilex Biolabs companyDr 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/30minAbout 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 NewtonMedia@AgilexBiolabs.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

16 7 月, 2021

Premier of South Australia Launches $1.5m Vaccine and Immunobiology State-of-the art Laboratory for APAC Clinical Trials

ADELAIDE, AUS, July 14, 2021 - (ACN Newswire) - Agilex Biolabs, Australia's largest and most technologically advanced regulated bioanalytical laboratory for clinical trials today announced that the Premier of South Australia the Hon Steven Marshall MP has launched its new $1.5m vaccine and immuno-biology laboratory. The facility, the most sophisticated in APAC, will attract biotechs and pharma from around the world for advanced clinical research. Premier of South Australia the Hon Steven Marshall MP has launched Agilex Biolabs' new $1.5m vaccine and immunobiology laboratory. Over the past 2 years, Agilex Biolabs has invested more than $3.5m in technology and systems at the APAC headquarters in Adelaide.Premier of South Australia, Steven Marshall launched the new facility today, thanking Agilex Biolabs for investing in the State and creating jobs in this important sector."South Australia is the most liveable city in the country, and the third in the world and investment such as this continues to build on this," Premier Marshall said."This new facility certainly puts South Australia firmly on the global map for high-tech clinical research.""We have seen significant advances in vaccines and immunobiology in response to the COVID-19 pandemic and now the Agilex Biolabs' state-of-the-art facility offers the very latest in technology to support the further development of these new and emerging therapies targeting infections, cancer and genetic conditions."Minister for Trade and Investment Stephen Patterson who attended the launch with the Premier said the State Government had an ambitious plan to grow SA's Health and Medical Industries sector's contribution to the state's economy."As a government, we're working collaboratively with industry to more than double the HMI economic contribution to SA from $2.3 billion to $5 billion by 2030."South Australia is open for business and at the forefront of world-leading capabilities, bio-tech precincts and an academic research ecosystem that makes it the ideal place to invest and do business."Agilex Biolabs CEO Jason Valentine said the new laboratory focuses 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."This Agilex Biolabs facility adds to the recent expansion of the small molecule/novel chemical entity laboratory and implementation of the latest 6500+ Sciex LC/MS/MS platforms to enable the development and validation of the highest sensitivity assays in the region for regulated bioanalysis.The laboratory will be completed in the next few months with international clients already booked to access the advanced technology and scientific excellence.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.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.South Australian clinical research has 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. https://calendly.com/agilexbiolabs/15minAbout Agilex Biolabs https://www.agilexbiolabs.com/Agilex Biolabs, Australia's leading bioanalytical and toxicology laboratory, 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 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 at https://youtu.be/WNdPGkdr9FA.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 assaysAgilex Biolabs Media Contact:Kate NewtonMedia@AgilexBiolabs.com

15 7 月, 2021

南澳大利亚州州长为亚太地区临床试验设立了价值 150 万美元的疫苗和免疫生物学一流实验室

ADELAIDE, AUS, Jul 15, 2021 - (亚太商讯 via SEAPRWire.com) - 澳大利亚最大、技术最先进的临床试验监管生物分析实验室 Agilex Biolabs 今天宣布，南澳大利亚州州长史蒂文·马歇尔(Steven Marshall)议员阁下已启动其耗资 150 万美元的新疫苗和免疫生物学实验室。该设施是亚太地区最先进的设施，将吸引来自世界各地的生物技术和制药公司进行高级临床研究。南澳大利亚州州长为亚太地区临床试验设立了价值 150 万美元的疫苗和免疫生物学一流实验室在过去的两年里，Agilex Biolabs 在 Adelaide的亚太总部投资了超过 350 万美元的技术和系统。南澳大利亚州州长史蒂文·马歇尔 (Steven Marshall) 今天启动了新设施，感谢 Agilex Biolabs 在该州投资并在这一重要领域创造就业机会。“南澳大利亚是澳大利亚最宜居的城市，在世界排名第三，这样的投资将继续以此为基础，”马歇尔州长说。“这个新设施无疑使南澳大利亚在高科技临床研究的全球版图上站稳了脚跟。”“我们已经看到疫苗和免疫生物学在应对 COVID-19 大流行方面取得了重大进展，现在 Agilex Biolabs 最先进的设施提供了最新的技术，以支持这些新的和新兴的靶向疗法的进一步开发感染、癌症和遗传病。”与州长一起参加发布会的贸易和投资部长斯蒂芬帕特森(Stephen Patterson )表示，州政府制定了一项雄心勃勃的计划，以增加南澳卫生和医疗行业对州经济的贡献。 “作为政府，我们正在与行业合作，到 2030 年将 HMI 对南非的经济贡献从 23 亿美元增加到 50 亿美元。“南澳大利亚州对商业开放，处于世界领先的能力、生物技术区和学术研究生态系统的最前沿，使其成为投资和开展业务的理想场所。”Agilex Biolabs 首席执行官 Jason Valentine 表示，新实验室专注于新兴的治疗领域，包括 RNA 疫苗、siRNA/miRNA 临床目标和基因治疗研究。“这个新设施为 RNA、siRNA 和 miRNA 临床试验增加了数字液滴定量 RT-PCR 分析，包括疫苗和基因治疗试验，”他说。“我们还安装了用于疫苗研究的 EliSPOT/FluoroSPOT 多点阅读器，以便推断召回免疫反应，结合我们最先进的 BD FACSymphony 5 激光、20 色流式细胞仪，为免疫学提供无与伦比的灵敏度和疫苗试验。”这个Agilex Biolabs 设施增加了最近扩展的小分子/新型化学实体实验室和最新 6500+ Sciex LC/MS/MS 平台的实施，以实现该地区最高灵敏度测定的开发和验证，以进行监管生物分析。实验室将在未来几个月内竣工，国际客户已经预订，以获得先进的技术和卓越的科学成果。这家生物实验室拥有130多名员工，其中85名专职实验室人员，支持临床试验来自美国、欧洲和亚太地区的生物技术客户。我们使用LC-MS / MS和免疫测定这两个平台，为小分子和生物制剂提供PK，免疫原性（PD）和生物标志物生物分析服务。澳大利亚临床试验仍在营业，Agilex Biolabs被指定为必不可少的服务，因此可以确保客户研究的连续性。在您开始下一个临床试验之前，请与我们预约会面。https://calendly.com/agilexbiolabs/15min关于 Agilex Biolabs https://www.agilexbiolabs.com/澳大利亚领先的生物分析实验室Agilex Biolabs在进行规范的生物分析方面拥有24多年的经验，包括品质方法开发，方法验证和样品分析服务。我们已成功支持了全球数百项临床前和临床试验，客户选择澳大利亚进行简化的监管程序，并获得了在澳大利亚进行的全球最有吸引力的40％以上的研发试验回扣。Agilex Biolabs还通过其公司TetraQ提供毒理学服务，TetraQ是在澳大利亚建立的GLP囓齿动物毒理学设施。Agilex Biolabs的世界一流生物分析设施获得了NATA（澳大利亚政府OECD GLP合规性监测机构）的OECD GLP认可和ISO 17025的全球认可。Agilex Biolabs宣布，其实验室设施已扩充了30％以上，以满足主要来自美国和亚太地区和欧盟生物技术公司的需求。在此观看新实验室的演示视频 https://youtu.be/WNdPGkdr9FAAgilex Biolabs利用液相色谱串联质谱（LC-MS/MS）、免疫分析法（Mesoscale，Gurolab，Luminex）以及流式细胞仪（BD FAC Symphony A3分选仪，20色细胞分析仪）专门从事小分子和生物制剂的生物分析和PK生物制剂、免疫原性和生物指标和免疫药效学评估。Agilex还提供药效学服务，包括使用最先进的技术支持免疫学、细胞生物学和作用方式分析的免疫生物学服务，包括 :- 免疫表型- 受体占用- 细胞因子释放试验（全血或外周单个核细胞（PBMC）刺激试验）和细胞因子/生物标志物分析- PBMC测定和细胞作用机制分析（例如：抗体依赖的细胞介导的细胞毒性作用（ADCC））Agilex Biolabs媒体联络:Kate NewtonMedia@AgilexBiolabs.com Copyright 2021 亚太商讯. All rights reserved. (via SEAPRWire)

31 5 月, 2021

Agilex Biolabs and Gyros Protein Technologies Partner for BioAnalysis Zone Webinar on Singlicate Analysis

ADELAIDE, AUS, May 31, 2021 - (ACN Newswire via SEAPRWire.com) - Agilex Biolabs, Australia's largest and most technologically advanced specialist bioanalytical laboratory for clinical trials is partnering with Gyros Protein Technologies and BioAnalysis Zone to share the latest on singlicate analysis on the Gyrolab platform.Register Here https://tinyurl.com/puwwj9zpSinglicate analysis on the Gyrolab platformWednesday 2 June 202118:00 [EDT] 23:00 [BST] | Thursday 3 June 06:00 [CST] 08:00 [AEST]Agilex Biolabs' Principal Method Development Scientist, Morgan Evans will present with Gyros Protein Technologies' Application & Service Director EMEA and Asia Pacific, John Chappell for a comprehensive webinar titled Singlicate analysis on the Gyrolab platform.The webinar topic was inspired by the Agilex Biolabs poster presentation Development and Validation of a PK Method for Tocilizumab in Both Singlicate and Duplicate on the Gyrolab Platform presented at the 13th EBF open symposium. Over the last several years singlet analysis has become a hot topic within the world of LBA non-regulated and regulated bioanalysis. A number of studies have demonstrated positive outcomes on both replicate precision assessment and PK/TK parameters. Due to the highly automated and robust nature of the instrument, Gyrolab has become a front runner in LBA technologies for singlicate analysis. This webinar will look at the overall landscape of singlet analysis and through Agilex Biolabs case studies discuss the use of the Gyrolab technology. It will also look at how lessons learned can inform prospects of singlicate analysis on other technological platforms keeping in mind 'speed to patient' to ensure efficiency in bioanalytical laboratories.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 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 120 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/15minAbout 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. 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 rodent 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. Watch the new lab video walkthrough at https://www.agilexbiolabs.com/new-labs-videoAgilex 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 NewtonMedia@AgilexBiolabs.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

21 5 月, 2021

Agilex Biolabs与Endpoints新闻合作开展消卷积炎症和免疫学临床试验

ADELAIDE, AUS, May 21, 2021 - (亚太商讯 via SEAPRWire.com) - 澳大利亚最大，技术最先进的临床试验专业生物分析实验室Agilex Biolabs与Endpoints News合作，在Endpoints News编辑Arsalan Arif主持的网络研讨会上分享了有关去卷积炎症和免疫学的最新临床试验信息。Agilex Biolabs免疫分析主任Kurt J. Sales（理科学士;理科学士（医学）荣誉;理科硕士，PGCM）：“炎症是一个复杂的生物过程，涉及大量驻留和聚集的免疫细胞，这些细胞动员起来以入侵病原体，从而渗透到组织中。这些免疫细胞在分泌出炎性介质时，其数量增加且活化增强，它们共同发挥作用以协调和调节免疫反应。为您的免疫学临床试验选择正确的生物分析平台对于数据收集至关重要。但是，导航复杂的炎症过程可能很困难。”在这次网络研讨会中，Sales博士将研究这些平台的使用情况，以及如何选择合适的平台。它还将确定在临床试验中用于测量生物液中炎性介质水平的最常见的生物分析平台。使用SARS-COV-2样品，网络研讨会将覆盖一个定制的10种分析物炎症小组，并确定在Covid患者中这些介体所观察到的水平与未感染患者基质之间的比较。还将讨论这些平台如何通过流式细胞术在临床试验受试者中测量特定的免疫学标记。在这里注册美国东部时间5月25日2:00 pm-3:00 pmhttps://webinars.endpts.com/deconvoluting-inflammation-and-immunology-for-clinical-trials/Agilex Biolabs的世界一流实验室配备了先进的设备，包括Gyrolab Xplore，MSD Quickplex 120，Luminex Magpix，BD FACSymphony A3流式细胞仪，以及即将发布的数字液滴定量实时RT-PCR。我们使用LC-MS / MS和免疫测定这两个平台，为小分子和生物制剂提供PK，免疫原性（PD）和生物标志物生物分析服务。澳大利亚临床试验仍在营业，Agilex Biolabs被指定为必不可少的服务，因此可以确保客户研究的连续性。这家生物实验室拥有120多名员工，其中85名专职实验室人员，支持临床试验来自美国、欧洲和亚太地区的生物技术客户。在您开始下一个临床试验之前，请与我们预约会面。https://calendly.com/agilexbiolabs/15min关于 Agilex Biolabs https://www.agilexbiolabs.com/澳大利亚领先的生物分析实验室Agilex Biolabs在进行规范的生物分析方面拥有24多年的经验，包括品质方法开发，方法验证和样品分析服务。我们已成功支持了全球数百项临床前和临床试验，客户选择澳大利亚进行简化的监管程序，并获得了在澳大利亚进行的全球最有吸引力的40％以上的研发试验回扣。Agilex Biolabs还通过其公司TetraQ提供毒理学服务，TetraQ是在澳大利亚建立的GLP囓齿动物毒理学设施。Agilex Biolabs的世界一流生物分析设施获得了NATA（澳大利亚政府OECD GLP合规性监测机构）的OECD GLP认可和ISO 17025的全球认可。Agilex Biolabs宣布，其实验室设施已扩充了30％以上，以满足主要来自美国和亚太地区和欧盟生物技术公司的需求。在此观看新实验室的演示视频 https://youtu.be/WNdPGkdr9FAAgilex Biolabs利用液相色谱串联质谱（LC-MS/MS）、免疫分析法（Mesoscale，Gurolab，Luminex）以及流式细胞仪（BD FAC Symphony A3分选仪，20色细胞分析仪）专门从事小分子和生物制剂的生物分析和PK生物制剂、免疫原性和生物指标和免疫药效学评估。Agilex还提供药效学服务，包括使用最先进的技术支持免疫学、细胞生物学和作用方式分析的免疫生物学服务，包括 :- 免疫表型- 受体占用- 细胞因子释放试验（全血或外周单个核细胞（PBMC）刺激试验）和细胞因子/生物标志物分析- PBMC测定和细胞作用机制分析（例如：抗体依赖的细胞介导的细胞毒性作用（ADCC））Agilex Biolabs媒体联络:Kate NewtonMedia@AgilexBiolabs.com Copyright 2021 亚太商讯. All rights reserved. (via SEAPRWire)

21 5 月, 2021

Agilex Biolabs Partners with Endpoints News on Deconvoluting Inflammation and Immunology for Clinical Trials

ADELAIDE, AUS, May 21, 2021 - (ACN Newswire via SEAPRWire.com) - Agilex Biolabs, Australia's largest and most technologically advanced specialist bioanalytical laboratory for clinical trials is partnering with Endpoints News to share the latest on deconvoluting inflammation and immunology for clinical trials, 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:"Inflammation is a complex biological process involving a host of resident and recruited immune cells which are mobilized to infiltrate tissues in response to invading pathogens. These immune cells boast elevated numbers and heightened activation as they churn out inflammatory mediators, which act in unison to coordinate and modulate the immune response. Choosing the right bioanalytical platform for your immunology clinical trial is critical to data collection. But navigating the intricate inflammation process can be difficult."In this webinar Dr Sales will examine what these platforms look like in use, and how should you go about selecting the right one. It will also identify the most common bioanalytical platforms used during clinical trials to measure levels of inflammatory mediators in biological fluids.Using SARS-COV-2 samples, the webinar will cover a custom 10 analyte inflammatory panel and identify how the levels observed for these mediators in Covid patients compare with an uninfected patient's matrix.It will also discuss how these platforms measure specific immunological markers in clinical trial subjects by flow cytometry.Register Here May 25, 2:00 pm - 3:00 pm EDThttps://webinars.endpts.com/deconvoluting-inflammation-and-immunology-for-clinical-trials/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 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 120 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/15minAbout 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. 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 rodent 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. Watch the new lab video walkthrough at https://www.agilexbiolabs.com/new-labs-videoAgilex 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 NewtonMedia@AgilexBiolabs.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

17 5 月, 2021

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

ADELAIDE, AUS, May 17, 2021 - (ACN Newswire via SEAPRWire.com) - 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 personalised 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 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 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.Book a confidential briefing with our scientists before you start your next clinical trial. https://calendly.com/agilexbiolabs/15minAbout Agilex Biolabs -- https://www.agilexbiolabs.com/Agilex Biolabs, Australia's leading bioanalytical and toxicology laboratory, 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 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: https://www.agilexbiolabs.com/new-labs-videoAgilex 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 NewtonMedia@AgilexBiolabs.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

30 4 月, 2021

Agilex Biolabs祝贺Bionomics Limited BNC210 PK上的结果

ADELAIDE, AUS, Apr 30, 2021 - (亚太商讯 via SEAPRWire.com) - 澳大利亚最大，技术最先进的临床试验专业生物分析实验室Agilex Biolabs今天祝贺客户Bionomics Limited（Bionomics）使用新开发的固体剂型口服片剂在健康志愿者中进行了为期7天的剂量研究，结果为健康志愿者产生了积极的药代动力学（PK）结果 BNC210的配方。Bionomics（ASX：BNO，OTCQB：BNOEF，德国：AU000000BNO5）是一家全球性的临床阶段生物制药公司。Bionomics临床开发副总裁Liz Doolin表示：“我们非常重视与Agilex Biolabs的长期合作关系，后者一直是Bionomics的首选合作伙伴，并从一开始就支持BNC210的开发。我们期待着在未来继续这种伙伴关系。” Bionomics 在公告中表示：“ BNC210是正在开发的新型7烟碱型乙酰胆碱受体阴性负变构调节剂，用于治疗焦虑症和与应激源相关的疾病，并于2019年11月被美国食品药品管理局（FDA）授予“快速通道”称号。创伤后应激障碍（PTSD）的治疗。在十名健康志愿者（男性和女性）中进行的为期7天的剂量PK研究表明，每天两次给予900 mg剂量的BNC210片剂，其稳态12小时暴露水平为33-57mg.h。 / L超过预期的12小时血液暴露量〜25 mg.h / L，以满足将来在临床试验中治疗PTSD患者的主要终点指标。Bionomics执行主席Errol De Souza博士说：“我们对7天PK研究的结果感到非常满意，该研究表明我们在每天两次给药后的第二天达到稳态水平，并且我们不仅满足而且超过药理分析预测的血液暴露，这对以后的试验是必不可少的。现在选择剂量，我们就可以开始生产片剂，进行临床部位选择和监管备案，为BNC210在2021年中旬进行的BSD210患者的2b期临床试验做准备。Agilex Biolabs的免疫检测销售总监Kurt J.博士说：“焦虑和与压力有关的疾病对成千上万的澳大利亚人的健康和福祉具有重大影响，据报道，四分之一的人受到这些疾病的影响。压力和焦虑的影响不仅会影响一个人的心理健康，而且还会影响其身体健康和生产力，进而对经济产生巨大影响。诸如BNC210之类的新型疗法是对抗焦虑症和与压力有关的疾病的必不可少的武器。 Agilex Biolabs与Bionomics紧密合作已有数年，支持PK调节的BNC210生物分析，并荣幸地成为这种针对焦虑症和与应激源相关疾病的潜在新疗法的一部分。”Agilex Biolabs的世界一流实验室配备了先进的设备，包括Gyrolab Xplore，MSD Quickplex 120，Luminex Magpix，BD FACSymphony A3流式细胞仪，以及即将发布的数字液滴定量实时RT-PCR。我们使用LC-MS / MS和免疫测定这两个平台，为小分子和生物制剂提供PK，免疫原性（PD）和生物标志物生物分析服务。Agilex Biolabs是该地区唯一经过FDA审查的同类实验室，作为澳大利亚政府临床试验吸引力计划的一部分，其临床试验生物分析服务支出还可享受高达43.5％的返还。澳大利亚临床试验仍在营业，Agilex Biolabs被指定为必不可少的服务，因此可以确保客户研究的连续性。这家生物实验室拥有100多名员工，其中75名专职实验室人员，支持临床试验来自美国、欧洲和亚太地区的生物技术客户。在您开始下一个临床试验之前，请与我们预约会面。https://calendly.com/agilexbiolabs/15min关于 Agilex Biolabs https://www.agilexbiolabs.com/澳大利亚领先的生物分析实验室Agilex Biolabs在进行规范的生物分析方面拥有24多年的经验，包括品质方法开发，方法验证和样品分析服务。我们已成功支持了全球数百项临床前和临床试验，客户选择澳大利亚进行简化的监管程序，并获得了在澳大利亚进行的全球最有吸引力的40％以上的研发试验回扣。Agilex Biolabs的世界一流生物分析设施获得了NATA（澳大利亚政府OECD GLP合规性监测机构）的OECD GLP认可和ISO 17025的全球认可。Agilex Biolabs宣布，其实验室设施已扩充了30％以上，以满足主要来自美国和亚太地区和欧盟生物技术公司的需求。在此观看新实验室的演示视频 https://youtu.be/WNdPGkdr9FAAgilex Biolabs利用液相色谱串联质谱（LC-MS/MS）、免疫分析法（Mesoscale，Gurolab，Luminex）以及流式细胞仪（BD FAC Symphony A3分选仪，20色细胞分析仪）专门从事小分子和生物制剂的生物分析和PK生物制剂、免疫原性和生物指标和免疫药效学评估。Agilex还提供药效学服务，包括使用最先进的技术支持免疫学、细胞生物学和作用方式分析的免疫生物学服务，包括 :- 免疫表型- 受体占用- 细胞因子释放试验（全血或外周单个核细胞（PBMC）刺激试验）和细胞因子/生物标志物分析- PBMC测定和细胞作用机制分析（例如：抗体依赖的细胞介导的细胞毒性作用（ADCC））Agilex Biolabs媒体联络:Kate NewtonMedia@AgilexBiolabs.com Copyright 2021 亚太商讯. All rights reserved. (via SEAPRWire)

30 4 月, 2021

Agilex Biolabs Congratulates Bionomics Limited on BNC210 PK Results

ADELAIDE, AUS, Apr 30, 2021 - (ACN Newswire via SEAPRWire.com) - 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 pharmacometric 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 utilising 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: https://calendly.com/agilexbiolabs/15minAbout 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.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/WNdPGkdr9FAAgilex 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 (eg: ADCC)Agilex Biolabs media contact:Kate NewtonMedia@AgilexBiolabs.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

29 4 月, 2021

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

ADELAIDE, AUS, Apr 29, 2021 - (ACN Newswire via SEAPRWire.com) - 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/15minAbout Agilex Biolabs -- https://www.agilexbiolabs.comAgilex 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 NewtonMedia@AgilexBiolabs.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

7 4 月, 2021

Agilex Biolabs Buys Leading Biolab TetraQ as Part of APAC Expansion Plans

Adelaide/Brisbane, Australia, Apr 7, 2021 - (ACN Newswire via SEAPRWire.com) - Agilex Biolabs, Australia's largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, today announced the purchase of leading biolab TetraQ, based out of the University of Queensland.Agilex Biolabs CEO Jason Valentine said the Board and senior management at Agilex Biolabs were extremely pleased with the purchase of such a high-calibre bioanalytics company."TetraQ complements the Agilex Biolabs work in Australia and APAC with its expert staff and years of experience in regulated bioanalytical services," he said."The TetraQ purchase is part of our regional expansion plans.""Agilex Biolabs is already the largest and most technologically advanced biolabs in Australia, and the TetraQ addition to the business will further expand support for biotech clients running trials in Australia.""We are also looking forward to introducing our clients to the well-established TetraQ toxicology capabilities for their discovery and pre-clinical work in Australia, which can also attract the 43.5% tax rebate.""The clinical trials bioanalytics sector is one of the fastest-growing services globally with Australia and APAC a preferred location for conducting trials - especially since the COVID-19 pandemic."TetraQ Director Dr Peter Tapley said he was very pleased that TetraQ was now an Agilex Biolabs company."They are the leader in the sector with 24 years of experience, and offer our clients a significantly expanded range of services and technologies," he said."Agilex Biolabs is known globally for its comprehensive services, specialist scientists, and the very latest technology. So this is the ideal next step for TetraQ and its staff and clients.""I am pleased to be working alongside Agilex Biolabs' CEO Jason Valentine as we expand our offering and leverage the synergies that make our two companies leaders in the sector."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 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 100 staff which includes 75 dedicated laboratory staff and supports clinical research for biotech clients from US, Europe and APAC.The company has recently launched the GALEXI(TM) client portal, and has taken delivery of two more Sciex API 6500+(TM) LC-MS/MS systems. Key certifications include OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.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.About TetraQ www.tetraq.com.auTetraQ is a Brisbane-based provider of bioanalytical and rodent toxicology and pharmacokinetics services for new drug and vaccine products. Our facility has NATA recognition for compliance with the OECD Principles of Good Laboratory Practice (GLP).Our bioanalytical facility is located at the Royal Brisbane and Women's Hospital, and our in-life studies are run in a custom unit at the St Lucia campus of The University of Queensland. These two arms of TetraQ offer co-ordinated support for clients bringing pharmaceutical products to market.TetraQ's bioanalytical facility determines small molecule and protein concentrations in matrices including plasma, serum, urine and tissue homogenates. We can develop and validate methods to support pharmacokinetic (PK) sample analysis for both pre-clinical and clinical studies.We also offer pharmacodynamic (PD) analysis of biomarkers based on commercial ELISA kits or Meso Scale Discovery multiplex technology.Agilex Biolabs Media Contact:Kate NewtonMedia@AgilexBiolabs.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

7 4 月, 2021

Agilex Biolabs收购领先的Biolab TetraQ作为APAC扩展计划的一部分

Adelaide / Brisbane, West Australia, Apr 7, 2021 - (亚太商讯 via SEAPRWire.com) - 澳大利亚最大，技术最先进的临床试验专业生物分析实验室Agilex Biolabs今天宣布收购昆士兰大学以外的领先生物实验室TetraQ。的首席执行官Jason Valentine说，Agilex Biolabs 董事会和高级管理层对购买这样一家高质量的生物分析公司感到非常高兴。他说：“ TetraQ凭借其专业的员工和多年的受监管生物分析服务经验，补充了Agilex Biolabs在澳大利亚和亚太地区的工作。购买TetraQ是我们区域扩张计划的一部分。Agilex Biolabs已经是澳大利亚最大，技术最先进的生物实验室，TetraQ的新增业务将进一步扩大对在澳大利亚进行试验的生物技术客户的支持。”“我们也期待为我们的客户介绍完善的TetraQ毒理学功能，以帮助他们在澳大利亚进行发现和临床前工作，这也可以吸引43.5％的退税。临床试验生物分析领域是全球增长最快的服务之一，澳大利亚和亚太地区是进行试验的首选地点，尤其是自COVID-19大流行以来。”TetraQ董事Peter Tapley博士说，他对TetraQ现在是Agilex Biolabs公司感到非常高兴。 “他们是拥有24年经验的行业领导者，并为我们的客户提供了范围广泛的服务和技术。Agilex Biolabs以其全面的服务，专业的科学家和最新技术而闻名全球。因此，对于TetraQ及其员工和客户而言，这是理想的下一步。我很高兴与Agilex Biolabs的首席执行官Jason Valentine合作，扩大我们的产品范围，并利用使两家公司在该领域处于领先地位的协同作用。”Agilex Biolabs利用液相色谱串联质谱（LC-MS/MS）、免疫分析法（Mesoscale，Gurolab，Luminex）以及流式细胞仪（BD FAC Symphony A3分选仪，20色细胞分析仪）专门从事小分子和生物制剂的生物分析和PK生物制剂、免疫原性和生物指标和免疫药效学评估。Agilex还提供药效学服务，包括使用最先进的技术支持免疫学、细胞生物学和作用方式分析的免疫生物学服务，包括 :- 免疫表型- 受体占用- 细胞因子释放试验（全血或外周单个核细胞（PBMC）刺激试验）和细胞因子/生物标志物分析 - PBMC测定和细胞作用机制分析（例如：抗体依赖的细胞介导的细胞毒性作用（ADCC））这家生物实验室拥有100多名员工，其中75名专职实验室人员，支持临床试验来自美国、欧洲和亚太地区的生物技术客户。Agilex Biolabs最近启动了GALEXI 客户门户，并已交付了另外两个Sciex API 6500 + LC-MS / MS系统。Agilex Biolabs的世界一流生物分析设施获得了NATA（澳大利亚政府OECD GLP合规性监测机构）的OECD GLP认可和ISO 17025的全球认可。关于 Agilex Biolabs -- www.agilexbiolabs.com  澳大利亚领先的生物分析实验室Agilex Biolabs在进行规范的生物分析方面拥有20多年的经验，包括品质方法开发，方法验证和样品分析服务。我们已成功支持了全球数百项临床前和临床试验，客户选择澳大利亚进行简化的监管程序，并获得了在澳大利亚进行的全球最有吸引力的40％以上的研发试验回扣。我们使用LC-MS / MS和免疫测定这两个平台，为小分子和生物制剂提供PK，免疫原性（PD）和生物标志物生物分析服务。关于 TetraQ -- www.tetraq.com.auTetraQ是布里斯班的一家提供新药和疫苗产品生物分析和啮齿动物毒理学以及药代动力学服务的提供商。我们的设施获得了NATA认可，符合OECD良好实验室规范（GLP）。我们的生物分析设施位于皇家布里斯班和妇女医院，我们的生命研究在昆士兰大学St Lucia校区的定制单元中进行。TetraQ的这两个部门为将药品推向市场的客户提供协调支。TetraQ的生物分析设备可测定包括血浆，血清，尿液和组织匀浆的基质中的小分子和蛋白质浓度。我们可以开发和验证支持临床前和临床研究的药代动力学（PK）样品分析的方法。我们还提供基于商业ELISA试剂盒或Meso Scale Discovery多重技术的生物标志物药效学（PD）分析。Agilex Biolabs媒体联络:Kate NewtonMedia@AgilexBiolabs.com Copyright 2021 亚太商讯. All rights reserved. (via SEAPRWire)

18 3 月, 2021

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

ADELAIDE, AU, Mar 17, 2021 - (ACN Newswire) - 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/15minAgilex 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-videoAgilex 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 NewtonMedia@AgilexBiolabs.com

18 3 月, 2021

Agilex Biolabs在2021年春季欧洲生物技术展上展示先进的免疫分析和免疫生物学服务

ADELAIDE, AU, Mar 18, 2021 - (亚太商讯 via SEAPRWire.com) - 澳大利亚最大，技术最先进的临床试验专业生物分析实验室Agilex Biolabs今天宣布，它将在《 Bio-Europe 2021》上展示其世界一流的免疫分析和免疫生物学服务，用于受监管的生物分析。销售Agilex Biolabs的免疫分析主任Kurt J.博士说：“我们经验丰富的团队可以为任何生物制剂开发或转让一种方法，以支持临床前GLP或临床研究。我们世界一流的实验室配备了先进的设备，包括Gyrolab Xplore，MSD Quickplex 120，Luminex Magpix，BD FACSymphony A3流式细胞仪，以及即将发布的数字液滴定量实时RT-PCR。我们的科学家具有解决最复杂的免疫原性和药物耐受性问题的专业知识和经验，这是早期和晚期阶段免疫肿瘤学研究中经常遇到的问题。”Agilex Biolabs是该地区唯一经过FDA审查的同类实验室，作为澳大利亚政府临床试验吸引力计划的一部分，其临床试验生物分析服务支出还可享受高达43.5％的返还。了解更多信息：通过PartneringOne了解我们在生物欧洲的科学家进行简介, 在此登录。https://informaconnect.com/bio-europe-virtual/在您开始下一个临床试验之前，请与我们预约会面。 https://calendly.com/agilexbiolabs/15minAgilex Biolabs的世界一流生物分析设施获得了NATA（澳大利亚政府OECD GLP合规性监测机构）的OECD GLP认可和ISO 17025的全球认可。澳大利亚临床试验仍在营业，Agilex Biolabs被指定为必不可少的服务，因此可以确保客户研究的连续性。澳大利亚通过迅速应对小规模疫情，将COVID-19的数量降低到几乎零，在世界上处于领先地位。Agilex Biolabs宣布，其实验室设施已扩充了30％以上，以满足主要来自美国和亚太地区和欧盟生物技术公司的需求。在此观看新实验室的演示视频 https://www.agilexbiolabs.com/new-labs-video 这家生物实验室拥有100多名员工，其中75名专职实验室人员。关于 Agilex Biolabs https://www.agilexbiolabs.com/澳大利亚领先的生物分析实验室Agilex Biolabs在进行规范的生物分析方面拥有24多年的经验，包括品质方法开发，方法验证和样品分析服务。我们已成功支持了全球数百项临床前和临床试验，客户选择澳大利亚进行简化的监管程序，并获得了在澳大利亚进行的全球最有吸引力的40％以上的研发试验回扣。我们使用LC-MS / MS和免疫测定这两个平台，为小分子和生物制剂提供PK，免疫原性（PD）和生物标志物生物分析服务。Agilex Biolabs媒体联络:Kate NewtonMedia@AgilexBiolabs.com Copyright 2021 亚太商讯. All rights reserved. (via SEAPRWire)

27 10 月, 2020

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

ADELAIDE, AU, Oct 27, 2020 - (ACN Newswire) - 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/yyzf6o44Agilex 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-videoAgilex 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/15minAustralia: +61 8 8302 8777 | China: +86 21 8036 9483 | South Korea: +82 80 812 1255 | USA: +1 800 247 1909About 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.comKate Newton Copyright 2020 ACN Newswire. All rights reserved. www.acnnewswire.com