Services

Method Development/ Validation

Biopharma companies, CROs and Central Laboratories rely on Eurofins Viracor BioPharma for accurate, timely results and the ability to optimize, validate and transfer assays based on study-specific needs. In addition to over 3,000 validated tests we also accept a broad range of specimen types available on over 16 different platforms, widening our capabilities and enabling us to customize to your study’s exact needs.

As your clinical trial assay development partners, we provide specialized expertise in complex bioassay design, optimization, validation and transfer, customized to your study’s needs — together with testing performed in our high throughput CAP/CLIA laboratory. Our experts can offer solutions to minimize risks and keep your program on track, and on time.

We have in-depth expertise in assay validation of both customized assays and commercially available kits.  Validated assays can be transitioned to Viracor’s clinical lab environment for high volume testing of trial samples.

Industry Leading Analytical Technologies & Platforms:

• Immunoassays to detect anti-drug antibodies (ADA), and neutralizing antibodies (NAb)
• Biomarker ligand binding assays using ELISA (e.g. IL-2 release for PD-1/PD-L1 and CTLA-4; IL-8 release for OX-40).
• Inhibitor efficacy determined by proliferation and cytokine secretion assays via ELISpot technology
• qPCR and ddPCR for replication-competent lentivirus (RCL) and replication-competent retrovirus (RCR) testing, measuring gene persistence, quantifying viral load, biodistribution and viral shedding analysis
• Cell-based immunogenicity monitoring using Flow Cytometry and ELISpot technologies to measure ADAs and cytokine production by activated cells, and to detect cytokine release syndrome (CRS).
  
  

Biomarker validations

• Custom/Fit for Purpose (e.g. No testing previously performed by client)
  
  • Feasibility, development, optimization, pre-validation and validation
• Partially Validated Transfer (e.g. Some testing previously performed by client)
  
  • Familiarization, development, optimization, pre-validation and validation
• Fully Validated Transfer (e.g. SOP and validation report provided by client)
  • Pre-validation and validation