Agilex Biolabs: Gateway to Advanced Bioanalytical Testing
pharmatechoutlook

Pharma Tech Outlook: Pharma Tech Magazine

Agilex Biolabs: Gateway to Advanced Bioanalytical Testing

Follow Agilex Biolabs on :

Jason Valentine, CEO, Agilex BiolabsJason Valentine, CEO
As the clinical trials sector heads towards a $60 billion market in the next five years, quality bioanalytical services that deliver progress and results analysis for a drug therapy are in high demand. Sponsors and CROs rely on a handful of world-class labs that offer bespoke analysis for study results. In Australia, the government’s mission to reduce the time and cost for clinical trials along with attractive R&D incentives and tax rebates of up to 43.5 percent has enabled the country to emerge as a clinical powerhouse for global pharmaceutical and biotech research. Australia is now a leading destination for international clinical trials and a regional hub for Asian clinical research support and management.

Agilex Biolabs, a state-of-the-art lab based in Adelaide, South Australia is one such facility that is making a name for itself as a leader in analysis for studies in Asia, Australia, New Zealand, EU and the USA. “As the largest and most experienced bio-analytical facility in Australia, Agilex is currently the go-to for bioanalytical testing for Asia region early phase clinical trials, and is the only lab of its type in Australia that has been inspected by the Food and Drug Administration (FDA),” says Jason Valentine, CEO of Agilex.

Recognized as a front runner in bioanalytics, with a track-record of 300 early phase clinical trials, the company’s facility boasts the latest technology including the Sciex 4000 LC-MS/MS, Sciex QTRAP 5500 LC-MS/MS, SpectraMax Plate Reader, Mesoscale Discovery System (MSD) and GyrolabxPlore that deliver the most accurate data for clinical trials. But clients say it is really about the excellence of Agilex Biolabs scientific team.

With over ten years of experience, our scientists are capable of developing and validating the most complex assays or preclinical and clinical programs


“With over ten years of experience, our scientists are capable of developing and validating a wide range of assays for preclinical and clinical programs,” says Valentine. The Agilex team also has a growing suite of biomarker assays, which enables detailed understanding of the changes taking place in the body in response to the drug being dosed. According to Valentine, Agilex Biolabs can de-risk early phase clinical trials by “delivering the quality assurance compliance required in the industry”.

Agilex uses a collaborative approach with its clients. Their team collects as much information as possible from the client about the compound, stability, and preclinical information. Then the project moves into the assay development phase to develop the bespoke assay required meeting the client’s clinical needs. Once developed, Agilex validates the method as per current FDA and EMA regulatory guidelines. When the validation phase is complete, samples are analyzed, and quality assurance checks take place. Data is then sent to the agreed group as the per data management plan and a fully compliant bio-analytical report is produced and sent to the client.

What distinguishes Agilex from competitors is its nimble and flexible team that is capable of meeting tight deadlines. “Our ability to scale staffing for speed with a 65 person experienced scientific team, coupled with advanced equipment, allows us to consistently deliver,” says Valentine.

Over the years, Agilex has helped many drug developers successfully register their product with the FDA. “More than 60 percent of our client base is from the U.S, while 30 percent is from the Asia region,” says Valentine. Anticipating a strong growth trajectory of 40 percent year on year, the company now aims to have additional assays developed by their strategic R&D team in order to serve the industry more widely.
Share this Article:
Top 10 Bioanalytical Services Companies - 2019

Company
Agilex Biolabs

Headquarters
Thebarton, Australia

Management
Jason Valentine, CEO

Description
Agilex Biolabs conduct bioanalysis of both small molecule and biologics using the established platforms of LC-MS/MS and immunoassay to support several studies from a global client base. AGILEX Biolabs has over 40 dedicated laboratory staff and more than 20 decades of experience in supporting preclinical and clinical programs. Their scientists have expertise in the development of robust, compliant PK and PD assays de novo or by method transfer from a client’s laboratory. Established in 1995, the company is headquartered in Thebarton, South Australia. The company offers Small Molecule, Large Molecule, LC-MS/MS Bioanalysis, Immunoassay Bioanalysis, clinical trials, and clinical research

Agilex Biolabs

Agilex Biolabs News

Agilex Biolabs and Endpoints News Present 'How to Move Trials to Australia' Webinar

Adelaide, AUS - Agilex Biolabs, Australia's largest specialist bioanalytical laboratory for clinical trials, and Endpoints News launched a new webinar "How Easy is it to Move Your Trials to Australia" at BIO Taiwan 2020.

The webinar details step-by-step guidance for moving new or delayed trials to Australia, and Agilex Biolabs' clients discuss how they made the decision and the benefits, and any challenges.

Agilex Biolabs, the only FDA-inspected lab of its type in the region, is located in Adelaide, South Australia in a science and biotech specialist hub.

Australia's relatively moderate COVID-19 impact due to rapid localised lockdowns for case clusters, combined with the world's most attractive 43.5% rebate on clinical trials costs, makes it the ideal destination for re-booting clinical trials, according to Agilex Biolabs.

Agilex Biolabs and all the early phase units have been open throughout the global COVID-19 pandemic.

CEO Jason Valentine said the key to success was engaging with Agilex Biolabs early.

"By contacting Agilex Biolabs first, for any new trial or trial transition process from another region, we can facilitate the scoping exercise for sponsors by assessing compatible service providers to ensure a good streamlined fit.

Our 20 years of experience working with all the service providers means we understand the nuances of the Australian trial landscape and can recommend the right partners to accelerate start up and save on costs. Getting the right fit for size and experience is vital for success.

This includes everything from CROs, Phase 1 units, sites, Ethics Committees, Government authorities, setting up an Australian affiliate and legal support. Considerations also include later phase plans and continuity.

Australia is well known as an early phase trials destination and at Agilex Biolabs we have a powerful network of early phase units, sites and other providers with whom we work regularly.

In addition, our R&D team need at least 1-2 months to properly develop the assays, and conduct feasibility studies if required."

Biotechs are particularly attracted by Agilex Biolabs' FDA-inspected status, and the 43.5% rebate on clinical trial spend that applies in Australia.

Agilex Biolabs' world-class bioanalytical facilities have OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.

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

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

Agilex also offers pharmacodynamics services that include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including:

- Immunophenotyping

- Receptor occupancy

- Cytokine release assays (whole blood or PBMC stimulation assays) and cytokine/biomarker profiling

- PBMC assays and cellular mechanism of action assays (eg: ADCC)

The biolabs has more than 90 staff including 65 dedicated laboratory staff, and annually support more than 80 clinical trials. This year they will analyse more than 60,000 samples for pharma/biotechs from US, Europe and APAC.

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

ADELAIDE, AU - 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.

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.