In the high-stakes realm of biopharmaceutical research and development, understanding antibody stability is very important. Antibody stability is a multi-faceted concern that includes aspects of aggregation, degradation, and conformational integrity. Each of these potential problems can negatively impact antibody stability and the performance and manufacturability of biotherapeutics.Read More
Recent research on stress factors in monoclonal antibody development underscores the critical need for robust control strategies in monoclonal antibody drug substance production, focusing on the risks posed by various stress conditions during manufacturing. These stressors can lead to protein modifications, impacting both patient safety and product quality. ARGEN, by Yokogawa Fluence Analytics, is a...Read More
Characterizing colloidal stability is central to developing safe and efficacious protein-based therapeutics. To be viable, the target biotherapeutic must remain stable during production, storage, and patient delivery. The most insightful and successful techniques for monitoring and characterizing colloidal stability involve in-situ and real time analysis under modelled stress conditions. This permits the investigation of solution...Read More
These experiments demonstrate the utility of ARGEN™ to define oligomeric states and transitions of Human Insulin under thermal stress. Time to dimerization and time to tetramerization measurements permitted the characterization of a stable dimer species, as well as insights into the mechanisms and kinetics of higher order oligomer formation. Whereas, SEC allows the characterization of...Read More
