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At PeploBio, in partnership with Kingston Analytical Services Toxicology (KAST) at Kingston University London, we support pharmaceutical and clinical research programs with advanced analytical solutions for metabolic therapeutics. KAST is a UKAS-accredited ISO/IEC 17025 laboratory specialising in high-resolution accurate mass spectrometry (HRAMS). Together, we have developed a quantitative HRAMS assay for the detection and measurement of GLP-1 receptor agonists in biological matrices, including plasma and whole blood.
Introducing the GLP-1 HRAMS Assay
The GLP-1 assay is a quantitative platform, designed to detect and measure circulating GLP-1 analogues used in metabolic and obesity-related therapies. Developed with clinical research applications in mind, the assay enables: - Reliable identification of GLP-1 receptor agonists - Quantification of circulating drug concentrations - High specificity detection in complex biological matrices
This provides a robust analytical foundation for studies involving GLP-1 and dual incretin therapies (eg., GIO/GLP-1 analogues).
Why this Matters in Clinical Research
As incretin-based therapies become central to the treatment of obesity, diabetes, and cardiometabolic disease, there is increasing demand for direct measurement of drug exposure and pharmacokinetics in clinical studies. Traditional approaches often rely on indirect biomarkers or patient-reported adherence. In contrast, HRAMS-based quantification enables: - Objective confirmation of drug exposure - Accurate pharmacokinetic profiling - Adherence monitoring in clinical trials - Correlation of drug levels with clinical outcomes
Assay Capabilites
Using high-resolution mass spectrometry, the GLP-1 assay offers: - Quantitative measurement of GLP-1 analogues in plasma and whole blood - High specificity and sensitivity for peptide therapeutics - Compatibility with clinical trial sample workflows - Application across both early-phase and late-phase studies
Supporting Clinical Trials in Metabolic Disease
PeploBio supports clinical trials globally across: - Obesity and metabolic disease - Type 2 diabetes - Cardiovascular risk studies - Incretin-based therapeutic development
We provide CRO-aligned services to integrate GLP-1 analysis into: - Pharmacokinetic (PK) and pharmacodynamic (PD) studies - Dose-response and exposure-response modelling - Adherence and compliance monitoring - Biomarker and endpoint correlation
Designed for Clinical Research
We support both prospective and retrospective study models:
Prospective cohorts - Sample collection, testing, and analysis from new or ongoing clinical trials
Retrospective analysis - Use archived plasma from past studies, registries, or biobanks Our scientific team works with you from exploratory assays to protocol design through regulatory support, assay deployment, and clinical data analysis.
Services
Clinical Trials and Biospecimen Sourcing
At PeploBio, we are a leader in clinical trial development and biospecimen sourcing services
Immunoassay
We integrate immunoassay development into our unique suite of services. Immunoassays are critical in clinical diagnostics, allowing you to characterise the quality of your product and fuel clinical decision-making. We offer an array of platforms and capabilities, including BD FACSLyric, Molecular Devices SpectraMax ID5, ELISA, peptide and antibody screening, cellular phenotyping, receptor occupancy, and TBNK.
As part of our immune-monitoring effort, including our ELISA and flow cytometry services, PeploBio provides assays to pharmaceutical companies to support exploratory, phase 1, and phase 2 clinical trials. Additionally, we offer assay validation testing using our regulatory expertise to facilitate the development of companion diagnostics.
Running a clinical trial and bringing your product to market is no easy feat. At PeploBio, we believe in an integrated approach to drug and device development, which is why we offer clinical trial project management services to oversee your program from start to finish.
We provide extensive experience within the cutting-edge realm of genomics. Likewise, PeploBio has several offerings to help you successfully utilize genomic data, including qPCR sequencing, Sanger sequencing, CRISPR, gene silencing, targeted gene expression analysis, and gene sequencing.
High-quality biospecimen procurement is an essential component to progressing your device's program. We have extensive access to biospecimens through a diverse network of collection sites, providing a wide array of biospecimens for your company's individual needs. In addition, PeploBio delivers a host of biospecimen sourcing services in line with quality and bioethical standards.
Secure global market success through PeploBio's regulatory expertise.
Clinical Performance Evaluation
As part of our testing services, we offer performance evaluations including analytical, clinical and usability studies, to align with your specific market objectives.
PeploBio advises on the In Vitro Diagnostic Regulation (IVDR), an essential requirement for any company wishing to market in vitro diagnostic medical devices within the European Union (EU). The IVDR outlines standards for establishing a medical device's quality, safety, and integrity for diagnostics in vitro. IVDR is also accepted in markets like Asia and Africa, broadening your device's potential impact.
Although the United States is a major market, it is one of the most challenging regions to secure approval. We provide consultant services for interacting with the Food and Drug Administration (FDA) and securing FDA approval. PeploBio can provide expertise in developing robust regulatory strategies to achieve success in the US market.
The UKCA marking is critical for those seeking to manufacture certain medical devices in Great Britain. Our services assess your product to ensure conformity with UKCA requirements, allowing you to display the UKCA marking to communicate compliance.
To market COVID-19 test devices in the UK, you must obtain Coronavirus Test Device Approval (CTDA) for your product. PeploBio is an expert in preparing CTDA submissions, maximizing your company's chance of regulatory approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) to market in the UK.
We help you to establish your medical device's Quality Management System (QMS), supporting your accreditation journey. By creating a suite of policies, procedures, and processes within your QMS, you can ensure the safety and efficacy of your product.
Your ultimate partner for comprehensive diagnostic solutions and unmatched expertise
Partner Hub
PeploBio provides diagnostic testing solutions in the fields of oncology, infectious disease, serology, and more. By joining our partnership, you can access various services providing support in digital marketing, kits, account management, and more. Our partner program offers tiered subscription options, ranging from basic to comprehensive packages. By providing a spectrum of services, PeploBio offers customized solutions for everyone suited to your individual needs and goals.
Diagnostic Tests A-Z
Our state-of-the-art diagnostic testing laboratory offers dozens of testing services, securing PeploBio as your one-stop shop for all things diagnostics. In addition to the wide array of tests, our team provides decades of experience in the field of molecular biology, providing the expertise you need for diagnostic testing success.
About PeploBio
Explore Our Competitive Edge
PeploBio is a specialised CRO supporting pharmaceutical and biotechnology companies in clinical trial through advanced testing and immune monitoring services. Operating across two strategically located sites in the UK and US, we combine deep scientific expertise with operation excellence to accelerate drug development.
Our proprietary MicroCLOT assay, designed for the detection and quantification of fibri(nogen) amyloid microclots, is transforming research in Long Covid, ME/CFS, and chronic inflammatory disease. Combined with a full suite of flow cytometry, assay development, validation and companion diagnostic (CDx) services, we help sponsors generate robust biomarker data and meet regulatory expectations.
We are ICO registered, meaning we prioritize data protection and meet the requirements for GDPR compliance.
As a BIVDA member, we have access to cutting-edge regulatory insights, helping to inform robust regulatory strategies and fostering connections across the industry.
Life Sciences Review recognized our lab's excellence and regulatory adherence as the Top Clinical Laboratory Services Company in the UK in 2022.
