Biomarker and Immunogenicity Support for Biologics Development

Service description

This service provides specialised bioanalytical support for biologics development programmes requiring pharmacokinetic (PK), biomarker and immunogenicity assessment during preclinical and clinical stages. The service includes support for pharmacokinetic (PK), anti-drug antibody (ADA), neutralising antibody (NAb), pharmacodynamic (PD) and biomarker analysis using ligand-binding assay platforms and cell-based assays adapted to the specific characteristics of each biologic programme. The objective of the service is to support innovators in understanding biological activity, immunogenicity profile and treatment response while generating high-quality data to support development decisions and regulatory interactions. Activities may include assay development, optimisation, qualification and sample analysis strategies adapted to exploratory or regulated environments. The service combines scientific expertise, regulatory awareness and flexible collaboration models particularly suited for innovative and early-stage biotech companies.

Sector

Biotechnology;Health and medical care;Pharmaceuticals

Technology Readiness Level

TRL 4 – Technology validated in lab

TRL 5 – Technology validated in relevant environment

TRL 6 – Technology demonstrated in relevant environment

TRL 7 – System prototype demonstration in operational environment

TRL 8 – System complete and qualified

Financial requirements

Services are offered on a fee-for-service basis. Pricing and project scope are defined individually according to the scientific and technical requirements of each biologics development programme. Costs may vary depending on assay format, analytical complexity, immunogenicity strategy, biomarker requirements, sample volume and development stage. Flexible collaboration approaches can be adapted to exploratory or regulated development environments.

Typical pricing ranges:

Method Transfer / Qualification for non-regulated environments: approximately €10,000 – €15,000
ADA Method Validation: approximately €60,000 – €80,000
NAb Method Validation: approximately €50,000 – €70,000
ADA Screening Sample Analysis: approximately €50 – €80 per sample
ADA Confirmatory Sample Analysis: approximately €100 – €150 per sample
NAb / Titer Sample Analysis: approximately €250 – €350 per sample

In addition, bioanalytical reporting activities typically range between approximately €3,500 – €7,000 depending on project complexity and reporting requirements.

Disclaimer related to service

Project scope, timelines and analytical strategies are defined according to the specific characteristics and complexity of each biologics development programme. Service execution is subject to laboratory capacity, assay requirements and availability of critical reagents and study materials.

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