Clinical Bioanalysis of Large Molecules Services

Standardized global bioanalytical technology platforms for Ligand-Binding Immunoassays (LBA) are conducted globally by Pharmaron. Capabilities include serological and cell-based assays for large molecule analyses in PK, PD, ADA, NAb, biomarkers and cell-based assay development, validation and sample analysis. These serological and cell-based platforms are supported in-house by full-method development programs and full-spectrum assay transfer capabilities, including feasibility assessments targeting the specifics of clinical bioanalysis projects for PK/PD/ADA assays, etc. Upon completion of assay development, fully compliant method validation is performed per FDA/EMA/NMPA guidance. Clinical sample analysis is then executed in support of the clinical studies. In addition to LBA assays, other tech-based assay platforms have also been established to support various bioanalytical needs in clinical studies.

• Assay development, transferred and kit-based assay optimization to support bioanalysis of therapeutic biologics in the clinical development phase
• Assay development, transferred and kit-based assay optimization for the analysis of ADA, ADCC, CDC and ADCP, TDAR and NAb, etc.
• Assay development, assay transferred and kit-based assay optimization for analysis of biomarkers of interest