Immunoassays

Nuvisan provides bioanalytical services to support the development of biologics and other large-molecule therapeutics. Our capabilities include PK/TK bioanalysis for biologics, supporting quantification of therapeutic proteins and antibodies throughout development. We also offer immunogenicity testing, including anti-drug antibody (ADA) screening, confirmatory assays and neutralising antibody (NAb) assessments using ligand-binding and cell-based methods. 

Our team develops and performs functional cell-based assays to support characterisation of biologic mechanisms of action and antibody neutralising activity. We also support biomarker and pharmacodynamic (PD) bioanalysis across a broad range of soluble and cell-based endpoints. 

To support reliable data generation, we provide assay development for novel biologics and biosimilars, as well as method transfer and optimisation for sponsor-provided methods, followed by validation in line with regulatory guidelines. Our capabilities also include a range of sample preparation techniques, including PBMC isolation, platelet processing from on-site clinic samples and tissue lysate preparation using the Precellys platform. 

Nuvisan supports bioanalytical work from early discovery through preclinical testing and into clinical development. Our scientists tailor bioanalytical approaches to the needs of each phase, whether this involves high-throughput screening in discovery, regulated TK/PK analysis in GLP preclinical studies, or immunogenicity and biomarker assessments in clinical trials. 

This supports continuity, efficiency and scientific consistency across the development process.

Nuvisan supports a range of large-molecule modalities, including therapeutic proteins, monoclonal antibodies, fusion proteins and other engineered constructs. Our immunogenicity platforms support quantification of anti-drug antibodies (ADAs) and detection of neutralising antibodies (NAbs) using suitable orthogonal approaches. 

In addition to drug-specific measurements, we provide biomarker and pharmacodynamic protein analysis, as well as cell-based functional endpoints relevant to mechanism-of-action studies and immune response assessment.

Nuvisan’s laboratories use a broad range of analytical platforms to support different scientific and regulatory requirements. These include:  

• MSD (Meso Scale Discovery), with multiplexing capability for sensitive ligand-binding assays across a broad dynamic range 
• Gyrolab, for semi-automated, low-volume analysis where sample availability is limited 
• ELISA and Tecan systems for standard and high-throughput ligand-binding assays 
• Flow cytometry for functional cell-based assays and immunophenotyping 
• qPCR to support cell and gene therapy programs 
• Cell-based functional systems, including NAb assays and mechanism-of-action assays. 

This range of platforms helps match the technology to the scientific question, regulatory expectations and available sample volume. Systems are validated as required to support data integrity and reliability.

Our laboratory handles a wide range of human and animal sample matrices. These include standard blood-derived matrices such as serum and plasma, whole blood fractions such as PBMCs and platelets, and more complex or viscous matrices such as sputum. 

We are equipped to manage potentially infectious or S2-classified samples in line with biosafety requirements. We also process tissue lysates using the Precellys homogenisation system and have experience with aqueous fluids including cerebrospinal fluid (CSF), amniotic fluid, and aqueous and vitreous humour. This supports a broad range of study designs. 

We recommend a risk-based approach to immunogenicity assessment in line with current regulatory expectations. This approach considers factors such as molecule type, mechanism of action, patient population, route of administration and clinical context when determining the appropriate testing strategy. 

A risk-based approach supports a scientifically sound and efficient testing plan and helps provide the level of insight needed into a therapy’s immunogenicity profile.