Protein Aggregation
Paraytec is a UK based scientific instrument company which develops high performance specialist detectors for the analytical and life sciences instrumentation market.
Protein aggregation detection is of significant importance to producers of monoclonal antibody therapeutics for several reasons. First and foremost, protein aggregation can have detrimental effects on the stability, efficacy and safety of these biotherapeutic proteins.
By screening for protein aggregation in a range of buffer solutions and intravenous infusion media early in the development and formulation process, drug producers can identify potential issues and take necessary measures to mitigate them. This allows for the development of high-quality drugs with improved stability, enhanced therapeutic efficacy, and reduced risks of adverse reactions. Furthermore, protein aggregation detection plays a crucial role in quality control during the manufacturing process. It helps ensure that the final drug product meets the required specifications and regulatory guidelines.
By implementing robust detection methods, drug producers can minimise batch-to-batch variability, maintain consistent product quality, and comply with regulatory standards.
This technical note outlines methodology with the sensitivity and dynamic range required to meet the need for rapid analysis of aggregation of a therapeutic antibody, showing results with dramatic differences in levels of aggregation when HerceptinTM is diluted into two buffer solutions, histidine and phosphate buffered saline.