The R&D team has a long track record and extensive experience in custom assay development with assay types ranging from ELISA to flow cytometry to nucleic acid testing to cellular interaction and potency testing.
One example is the Beacon assays that were internally developed to detect parvovirus B19 and hepatitis A virus via nucleic acid testing with a full FDA Device Master File submitted. This assay was used for years as a gold standard in the source plasma industry for product safety testing. More recently, a T-regulatory assay has been developed to assess the effect of cellular therapy products on the activity of CD4 and CD8 T-cells.