Accelerate your drug discovery and clinical research with PeploBio’s end-to-end assay development and validation services. As an ISO 15189 accredited CRO, we specialise in RUO, LDT, IVD, and CDx assays, utilising technologies such as Flow Cytometry, PCR, cell-based assays, Sanger sequencing, ELISA, and lateral flow. With extensive experience in novel targets, biomarkers, genomic and immunoassay technologies, we provide reliable, compliant solutions for every stage of your project. Our collaborative approach includes weekly progress updates and scientific support to ensure your success.
We specialise in developing custom assays tailored to your needs. Our focus is on creating assays that accurately target specific cell populations/biomarkers and offer valuable insights for precision medicine approaches. Utilising our extensive clinical trial site/biobank network and advanced laboratory technologies, including integrated multi-omic workflows, we analyse biomarker expression across various diseases. From high-throughput screening to advanced analyses, we employ cutting-edge tools to improve efficiency and accuracy in assay development.
We provide comprehensive assay validation services for a diverse range of biomarkers, reagents, and devices. Backed by our highly experienced scientific team, proficient in molecular biology, immunology, infectious diseases, biochemistry, metabolism, and oncology, we deliver bespoke assay development services for novel biomarkers.
Once the assay performance reaches optimal levels, we seamlessly transition to supporting our sponsors through rigorous assay validation and subsequent Phase 1-3 clinical trial testing.
Our expertise extends to working with diagnostic products, collaborating with reagent and device manufacturers seeking CDx, UKCA, IVDR, or FDA regulatory approval. With our state-of-the-art QMS and a dedicated team of PhD and HCPC registered scientists, we ensure that our sponsors have access to the necessary personnel and cutting-edge technologies to support their studies.
We are dedicated to ensuring the robustness and reliability of your assays through meticulous validation processes tailored to your specific needs. Our expertise spans a range of validation types, including:
Research Use Only (RUO) validations
Laboratory Developed Test (LDT) validations
Validation for In Vitro Diagnostics (IVD)
Validation for Clinical Trials
Companion Diagnostic (CDx) validations
Submissions to regulatory authorities (IVDR, FDA, TGA & MHRA)
We are dedicated to ensuring the robustness and reliability of your assays through meticulous validation processes tailored to your specific needs. Our expertise spans a range of validation types, including:
Our experienced team and diverse range of platforms can support a wide range of disciplines in bioanalytical testing for assay development and validation, including:
Sanger Sequencing: Accurate and reliable DNA sequencing. Services include sequence verification, mutation detection, targeted gene sequencing, and phylogenetic analysis.
ELISA (Enzyme-Linked Immunosorbent Assay): Sensitive and specific protein/antibody detection. Develop and validate sandwich, competitive, and high-throughput screening ELISAs.
qPCR (Quantitative Polymerase Chain Reaction): Precise quantification of nucleic acids for gene expression, CNV, pathogen detection. Design optimised SYBR Green, TaqMan, and other probe-based qPCR assays.
Immunoassays: Robust assays for detecting and quantifying protein biomarkers, antibodies, and immunogenicity. Develop and validate per regulatory guidelines.
Cell-based Assays: Functional assays evaluating cellular responses, interactions, cytotoxicity, and reporter gene readouts. Tailored for your targets/applications.
Pharmacokinetic (PK) Assays: Measurement of drug concentrations in biological matrices like plasma and tissues. Validated PK assays for all phases.
Ligand-Binding Assays: High-affinity binding studies characterising drug-target interactions and kinetics using techniques like SPR.
Virology Tools: Viral particle detection and quantification via qPCR, ELISA, plaque assays. Viral load monitoring and vaccine potency testing.
Protein Binding Assays: Evaluation of drug-protein binding interactions using techniques like SPR, microscale thermophoresis, and ultrafiltration.
