Immunogenicity Assay Development, Validation & Transfer in a Vaccine Candidate Clinical Trial

vaccine-case-study-image (1)

Discover how Eurofins Viracor BioPharma helped accelerate vaccine development by serving as a single partner for assay optimization, validation, transfer, and high-throughput testing.

In this case study, our team partnered with a global pharmaceutical company developing a promising vaccine candidate to deliver multiple immunogenicity and molecular assays, including ELISpot, neutralizing antibody (NAb), and qPCR methods. Through scientific expertise, assay optimization, and collaborative project execution, we enabled robust immune response assessment and efficient clinical trial testing.

Key highlights include:

  • Rapid transfer, optimization, validation, and deployment of ELISpot, NAb, and qPCR assays
  • Development of a sensitive and specific ELISpot assay to evaluate vaccine-induced T-cell responses
  • Validation and implementation of a cell-based neutralizing antibody assay for assessing humoral immunity
  • Multiple qPCR assay validations to support viral detection and vaccine efficacy assessments
  • Demonstrated analytical concordance between testing sites, supporting confidence in assay performance
  • High-throughput testing capabilities and collaborative project management that exceeded sponsor timeline expectations

This case study illustrates how an integrated bioanalytical partner can streamline complex vaccine development programs by combining scientific expertise, scalable testing, and collaborative execution.

Complete the form below to access this case study.

Immunogenicity Assay Development, Validation & Transfer in a Vaccine Candidate Clinical Trial

To learn more about how Eurofins processes and protects your personal data and your rights, please read our Privacy Notice.