STEMart’s Aggregation Behavior Analysis service is a comprehensive solution designed to investigate and quantify the aggregation behavior of therapeutic proteins, monoclonal antibodies (mAbs), fusion proteins, and other biologics. Aggregation is a critical factor in drug stability, efficacy, and immunogenicity. Our state-of-the-art technologies offer detailed insights into the aggregation process, providing essential data for formulation development, stability testing, and regulatory compliance. With a focus on precision and reproducibility, we ensure that your formulations meet the stringent standards required for biopharmaceutical development.
Aggregation behavior refers to the process by which proteins or other biologic molecules spontaneously form aggregates, which can impact their function, stability, and safety. Aggregation can occur due to a variety of factors such as pH, temperature, or concentration, and its behavior often varies depending on the specific formulation and conditions. Analyzing aggregation behavior is crucial in understanding the molecular interactions driving aggregation, the kinetics of aggregate formation, and the structural integrity of biologics. By monitoring these behaviors, we help optimize therapeutic formulations to minimize aggregation risks and ensure long-term product stability.
CMC is a fundamental parameter that defines the concentration at which surfactant molecules in a solution spontaneously form micelles. This analysis helps us assess the self-assembly behavior of surfactants, amphiphilic compounds, and their impact on the overall formulation.
Aggregation Kinetics Analysis focuses on the time-dependent aggregation behavior of proteins, peptides, and other biologics. By utilizing advanced technologies such as Dynamic Light Scattering (DLS) and Fluorescence Spectroscopy, we are able to monitor the onset and progression of protein aggregation over time.
Tagg is the temperature at which protein aggregation initiates due to thermal stress. Understanding Tagg is essential for predicting the thermal stability of biologics under different conditions, including storage and transportation. Our Tagg analysis provides high-resolution temperature.
Dose-Dependent Aggregation Behavior Evaluation service assesses how protein aggregation varies with different concentrations of biologics. By utilizing multiple analytical techniques such as SEC-HPLC, DLS, and Analytical Ultracentrifugation (AUC), we quantify the aggregation propensity across a range of concentrations.
For more information on our Aggregation Behavior Analysis services or to discuss your specific biopharmaceutical project requirements, please contact us today.