White Papers

In this white paper, we outline the validation experiments and performance attributes of quantitative BRAF^V600E mutation detection assays conducted using ddPCR at Eurofins Viracor BioPharma.

This white paper explores the qualification studies of the NanoString nCounter PanCancer IO 360 Gene Expression Panel, emphasizing its role in immuno-oncology research. The panel examines 770 genes across 16 pathways, providing insights into tumor-immune interactions and identifying potential biomarkers for immunotherapy.

Neutralizing antibodies (NAb) can be a critical component to assessing safety in therapeutic drug trials or efficacy in vaccine trials. This bulletin highlights the utility of using cell-based neutralizing antibody assays and provides insights on some best practices for industry use where high-throughput capacity and reliable reproducibility are required. 

Our scientists validate robust sequencing assay that shows utility in both research and clinical applications for NS2 gene mutation monitoring. Utilizing Sanger Sequencing, the assay offers timely and cost-effective sequencing, crucial for understanding NS2’s role in RSV infection.

Eurofins Viracor BioPharma scientists contribute to Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development.

Gene therapy, cell therapy, and vaccine research have raised the need for regulated cellular immunity testing. Enzyme-Linked Immunospot (ELISPOT) assays are commonly used, but regulatory guidance on their validation is lacking. The Global CRO Council has issued a white paper to outline validation parameters and promote consistent ELISPOT validation across organizations.