Bioanalytical Readiness for First-in-Human Studies

Service description

This service supports biotechnology and pharmaceutical companies preparing bioanalytical strategies and assays for First-in-Human (FIH) and early clinical development programmes. The service includes bioanalytical support for pharmacokinetics (PK), immunogenicity (ADA/NAb), pharmacodynamics (PD) and biomarker analysis for small molecules and biologics. Activities may include assay qualification, method transfer, analytical strategy discussions and preparation for regulated bioanalytical studies supporting Phase 1 readiness. The objective of the service is to help innovators reduce technical and regulatory risks before entering clinical development while ensuring robust and reliable bioanalytical approaches aligned with programme needs. Services are adapted to each project’s modality, development stage and regulatory context, combining scientific expertise, quality-focused execution and responsive project management. The service is delivered through close interaction with the sponsor team and can support both exploratory and regulated development activities.

Sector

Biotechnology;Health and medical care;Pharmaceuticals

Technology Readiness Level

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 with project-specific pricing depending on the scope of work, regulatory requirements and bioanalytical strategy needed for each programme. Costs may vary according to assay complexity, development status, analytical requirements, validation needs and study timelines. Collaboration models are adapted to the specific needs and maturity stage of each biotech or pharmaceutical company.

Typical pricing ranges:

Large Molecule PK Method Development: approximately €30,000 – €50,000
Large Molecule PK Method Validation: approximately €40,000 – €60,000
PK Sample Analysis: approximately €40 – €70 per sample

Disclaimer related to service

Timelines and project execution plans are established individually according to regulatory requirements, assay readiness, study scope and sponsor timelines. Availability may depend on laboratory scheduling, analytical complexity and availability of required materials and reference standards.

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