Developing Methods for Comparability Studies of Therapeutic Monoclonal Antibodies: Minimize Time, Maintain Quality

This webcast features: Kalhari Silva, PhD, Head of Scientific Research, Custom Biologics, and Bob Dass, PhD, Senior Scientist, Octet Applications, Sartorius.

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 preclinical 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.

Learning Objectives:

  • Optimization of binding assays and tips to overcome nonspecific binding.
  • Measurement of functional properties of therapeutic monoclonal antibodies.
  • Tips for generating reproducible and high quality data.
  • Use of the Octet® platform to establish assay conditions in a fraction of the time.

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