Precision Medicine

Assay Development & Validation Services

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.



Assay Development

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.


Assay Validation

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.


Custom Assay Validation

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:

  • ticked-bulletpoint

    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)


Partner Benefits

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:

Clinical & Regulatory Compliance

Ensure your projects meet the highest standards with PeploBio’s clinical testing conducted in an ISO 15189 certified laboratory. Our services support clinical trials and regulatory submissions, including IVDR and FDA 510k, ensuring compliance and reliability.

Advanced Technology

Leverage our expertise in Flow Cytometry, PCR, cell-based assays, Sanger sequencing, ELISA, and lateral flow technologies. With these advanced tools, we deliver precise and accurate results, driving forward your assay development and validation.

Customisation & Flexibility

We are committed to your project needs and goals. From initial  discussions to completion, we collaborate closely with you, offering tailored  solutions and expert guidance. Whether it's assay design, validation  strategies, or troubleshooting.


Our expertise lies in developing and validating assays, including RUO,LDT, IVD, and companion diagnostics. Backed by years of industry experience, we offer trusted solutions for biotech and pharmaceutical clients.

Assay Development Techniques & Capabilities

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.

More about Assay Development and Validation

Frequently Asked Questions

What is Assay Development?

Assay development is the process of designing and optimising investigative procedures to test or measure the activity and effects of a drug compound on a specific biological target or process. It involves creating functional, relevant, reproducible, high-quality and cost-effective assays free from interference.

What is Assay Validation?

Assay validation is a process that determines the performance of an assay, which has been properly developed, optimised and standardised, for an intended purpose. Validation includes estimates of the analytical and diagnostic performance characteristics of a test.

What types of assays can you support with?

- Binding assays (e.g. ELISA, SPR)
- Enzyme activity assays
- Cell-based assays (e.g. cytotoxicity, reporter gene)
- Bioanalytical assays (e.g. PK, immunogenicity)
- Molecular assays (e.g. qPCR, NGS, Sanger Sequencing)
- Flow Cytometry
- Custom assays for specific targets/applications

What are the key stages of Assay Development and Validation?

1) Assay design and feasibility assessment
2) Assay optimisation (format, conditions, reagents)
3) Pre-validation and characterisation
4) Formal validation testing per regulatory guidelines
5) Cross-validation and transfer
6) Ongoing monitoring and maintenance

How is Assay Validation different from qualification?

Validation is a comprehensive process that provides a high degree of assurance the assay will consistently produce accurate data meeting predefined specifications. Qualification is an evaluation to determine if the assay is suitable for its intended purpose under specified conditions, with more limited testing.

What regulatory bodies and requirements can you support for Assay Development and Validation?

We have extensive experience working with major regulatory bodies worldwide and can support clients in meeting all relevant guidelines and requirements for assay development and validation, including:

1) FDA (U.S. Food and Drug Administration)
3) MHRA (UK Medicines and Healthcare products Regulatory Agency)
4) TGA (Therapeutic Goods Administration, Australia)

Contact us to find out more

We are here to answer your questions, discuss potential collaborations, and explore how our  solutions can benefit you.
Contact us