Case Study

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Area(s) of Expertise: Biomarkers & Bioanalytics

Service(s): Pharmacodynamics (PD) 

Platform(s): ELISA - Fluorescence Based 

Client's Need: Transfer and validate an assay measuring specific activity of cytoplasmic protein. The specific activity in information to measure the PD of the follow-on biologic. Prior attempts to transfer this assay to four clinical reference laboratories failed feasibility studies. At that point, the assay was deemed non-transferable. After running the assay in-house for many years, the burden on resources required the client to revisit outsourcing.

Viracor Eurofins Laboratories Solution:

  • Viracor Eurofins scientists met with client to assess failure points in prior attempts
  • Managed protocol complexity and provided guidance on minor process modifications
  • Maintained rigid protocol standards during feasibility testing

Viracor Eurofins Results:

  • Viracor Eurofins passed feasibility and accepted transfer of the assay
  • Transfer validation completed in 8 weeks
  • Modifications optimized sample output by 20% to provide faster turnaround time and increase cost savings
  • Client expanded contract to include validation of the oncology follow-on biologic PD assay for preclinical samples, clinical samples, and clinical samples of the current oncology drug
  • Client regained vital resources to refocus efforts on new product development