Quantifying critical quality attributes accurately and precisely is an important aspect of regulatory compliance. There is greater demand to optimize processes by integrating advanced analytical tools that maximize quality, safety, and efficacy of biotherapeutics.

Kalhari Silva, from Custom Biologics, will provide insight on how her team designs and establishes methods suitable for comparability studies that allow for their future use in qualified or validated GMP lot release and stability testing. Custom Biologics is a leading large and small molecule CRO that provides highly specialized, GLP-compliant, bioanalytical development, validation and testing services in support of pre-clinical and clinical stages of pharmaceutical drug development.

Three case studies involving the binding of therapeutic monoclonal antibodies to their cellular receptors and soluble targets that contribute to the assessment of their critical quality attributes will be discussed. Their approach to generate reproducible and high-quality data will focus on, but will not be limited to, biosensor selection, ligand/analyte orientation, choice of buffer system, ligand immobilization and troubleshooting tips.