Triangle Laboratory, a leading bioanalytical testing laboratory specializing in ligand binding and cell-based assays, announced today the introduction of statistical service to immunogenicity studies.
Dr. Liu, Head of Bioanalysis at Triangle Laboratory said: “unlike PK and biomarker, there is no calibration curve in immunogenicity assays. The cut point calculated from a group of individual matrices is used for determining the samples as immunogenicity negative or positive status. Thus, the cut point calculation is very critical to ADA and Nab assays.”
“The calculation of cut point estimation requires solid immunogenicity experience and statistical background. Following the immunogenicity guidance and white papers, we are excited to share this great news to our customers. In addition to the cut point, our immunogenicity team supports the calculation of immunogenicity sensitivity and LPC concentration to align with latest FDA expectation.”
About Triangle Laboratory www.trianglelaboratory.com
Triangle Laboratory Inc., a contract research organization (CRO), is a leading bioanalytical laboratory for large molecule bioanalysis. Triangle Laboratory provides TK/PK, ADA, NAb, Biomarker and functional assay services for supporting the development of biologics. Headquartered in Delaware Industrial Park, Triangle Laboratory supports method development, method qualification/validation, and sample analysis under both non-GLP and GLP.