Method Validation of Surrogate Virus Neutralizing Antibody Test Kit & RT-PCR Lab Developed Test (LDT)

EBPS COVID Case Study 18JAN2021-1-1Client:
• Large Pharmaceutical company

Therapeutic Area:
• COVID-19 Vaccine Development

Study Phase:
• Phase 3, High Patient Volume

Services:
• Method Transfer
• Method Validation
• Sample Analysis 

PROJECT AT A GLANCE

Early in the global pandemic, Eurofins BioPharma Services was at the forefront of addressing an unmet need for a Client conducting a Phase 3 clinical trial for COVID-19 Vaccine Development. One of the requirements was the need for reliable RT-PCR Testing to detect the SARS-CoV-2 virus in a clinical trial setting. In addition, Client expressed their need to monitor the SARS-CoV-2 Neutralizing Antibody status of clinical trial patients.

Prior to March 2020, there did not exist any commercial SARS-CoV-2 testing kit globally. As a world leader in laboratory science, Eurofins deployed their scientific expertise to develop analytical solutions meeting their Client needs with best in class performance, whilst reducing cost and timelines.

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