White Papers

Eurofins Viracor Biopharma scientists validate robust sequencing assay that shows utility in both research and clinical applications for NS2 gene mutation monitoring

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 led to an increased need to perform cellular immunity testing in a regulated environment to ensure the safety and efficacy of these treatments. The most common method for the measurement
of cellular immunity has been Enzyme-Linked Immunospot assays. However, there is a lack of regulatory guidance available discussing the recommendations for developing and validating these types of assays. Hence, the Global CRO Council has issued this white paper to provide a consensus on the different validation parameters required to support Enzyme-Linked Immunospot assays and a harmonized and consistent approach to Enzyme-Linked Immunospot validation among contract research organizations.

Immunotherapies have emerged as some of the most promising approaches to treating cancer patients. Download the Info Sheet to see what assay development and testing services Viracor Eurofins offers for supporting clinical development of Cell & Gene therapy candidates.