On-Demand Webinar: Developing Methods for Comparability Studies of Therapeutic Monoclonal Antibodies
Authors: Kalhari Silvia, Bob Dass | Watch time: 1 hour 11 min | Last Updated: July 8, 2022
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
Watch this on-demand webinar and discover:
- Optimization of binding assays and tips to overcome non-specific binding
- Measuring the 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
Kalhari Silva, Ph.D.
Head of Scientific Innovation and Research
Kalhari Silva is Head of Scientific Innovation and Research at Custom Biologics. Kalhari is responsible for technical oversight and research management of the Bioassay and Molecular Diagnostics groups within the Scientific Research and Innovation Division. She has been with Custom Biologics for five years. Prior to this she was a Postdoctoral Fellow at the Institute of Research in Immunology and Cancer (IRIC), and Health Sciences North Research Institute.
Kalhari received her Ph.D. in biomolecular sciences from Laurentian University via a fully funded scholarship in 2015.
Figure 1. The Octet® platform technology overview.