Immunoassays

Expert immunoassay solutions for PK/TK and immunogenicity in drug development

Nuvisan’s immunoassay services specialize in bioanalysis for large molecules, offering comprehensive services including PK/TK analysis, immunogenicity assessments, and cell-based assays. We provide method development, validation and routine analysis on platforms such as MSD, Gyrolab, Tecan and flow cytometry. Our team has deep expertise in functional testing, immune monitoring and complex sample preparation for preclinical and clinical phases. We enable high-quality, reliable results tailored to your specific needs, with a focus on regulatory compliance and scientific excellence across all stages of drug development.

Antibodies, immunoglobulin Ig proteins 3D medical

Flexibility due to diversity: our immunoassay platforms and labs

Ligand binding assays at Nuvisan are performed using ELISA, mesoscale technology (including multiplex assays) or Gyrolab, for highest sensitivity in the low double-digit fg/ml range. Assays can be transferred to our laboratories or built from scratch, as our scientists are highly experienced. While we have scientists specialized and responsible for each individual platform, our team is well trained to also support cross-functional assays and can integrate innovative platforms.
Furthermore, we are not only experts in analysing samples, but also in processing them before analysis. In our fully equipped cell culture laboratory, we can, for example, prepare PBMCs or platelets from whole blood directly derived from our own on-site clinics. Furthermore, we have experience with various tissues and can prepare lysates using our tissue homogenizer, Precellys.

PK support

At Nuvisan, we are dedicated to supporting your drug development journey with expert pharmacokinetic bioanalysis services. Our commitment to quality, regulatory compliance, and customer satisfaction helps ensure that you receive the precise and reliable data you need to advance your therapeutic candidates with confidence. During both assay development and transfer, we have an early focus on the parameters that will be assessed during validation according to current regulations to avoid surprises and/or laboratory investigation reports.

ADA/NAb and cell-based

Measuring anti-drug antibodies (ADA) is essential for ensuring the safety and efficacy of biotherapeutic drugs. It provides critical insights into the immunogenicity of the treatment, impacts on drug efficacy, and pharmacokinetic profiles. The classical 3-tiered approach encompasses a screening assay, confirmatory assay and neutralizing antibody (NAb) assay, coupled with titration of confirmed positive samples. This comprehensive strategy is designed to meet the highest standards of regulatory compliance and scientific rigor, helping ensure that your drug development program progresses smoothly and efficiently. Therefore, at Nuvisan we propose a risk-based analysis of ADAs as stated by the EMA immunogenicity guideline (2017): “The purpose of investigating immunogenicity of therapeutic proteins is to understand the clinical consequences; i.e. consequences for PK, PD, efficacy and safety”. This means that we suggest performing ADA analysis based on the risk and drug development phase. However, we are always capable of storing your samples until possible analysis and can also provide sample banking until submission.

ADCs

Antibody-drug-conjugates (ADCs) are very complex and combine the specificity of antibodies with the potency of cytotoxic drugs. Therefore, the analysis of ADCs is multi-disciplinary, as both the antibody part and the drug part need to be assessed. Conjugated and total antibody measurements are usually performed using an immunoassay and can be supported by Nuvisan. We can also support antibody-conjugated drug and free drug using LC-MS. Supporting you with all necessary assays is not only advantageous in terms of time during assay development – as our team can efficiently gather and communicate information across disciplines – but it also means only one shipment of samples is required, reducing logistical complexities and costs.

Biosimilar assays (clinical)

In contrast to the validation of an assay to support PK or Immunogenicity of an NBE, a special validation program is needed for biosimilars. We adapted the proposal for PK analysis from AAPS (Marini et al.,2014; Thway et al.,2019) and implemented a validation package for biosimilars compared to their originator(s). The final goal is the use of the one-assay strategy whenever possible. Our well-trained team and subject matter experts have extensive experience with bioanalysis and regulatory requirements for biosimilars and are happy to help and support you with your specific candidate.

Immunoassays (biomarkers)

Discover how our immunoassay solutions can support your biomarker project.

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Scientist prepares samples in laboratory

Chromatography & MS

Explore our comprehensive LC-MS/MS services.