Access to Infrastructure & R&D Support service
Biomarker and Immunogenicity Support for Biologics Development
Provided by Anapharm Bioanalytics - Anapharm Europe S.L.U. · Spain
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.
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.