مقالات پذیرفته شده در هشتمین کنگره بین المللی زیست پزشکی
Effects of Mechanical Stress on Aggregation of Zytux® (Rituximab Biosimilar): A Size Exclusion Chromatography Approach
Effects of Mechanical Stress on Aggregation of Zytux® (Rituximab Biosimilar): A Size Exclusion Chromatography Approach
Afsaneh Farjami,1,*
1. Pharmacy Faculty, Tabriz University of Medical Sciences
Introduction: One popular technique for assessing the stability of therapeutic protein compositions, such as monoclonal antibodies, is mechanical stress. Many stresses are applied to proteins in this approach, including the liquid-air interface, contact with container surfaces, agitation-induced creation of vacuum bubbles, and localized temperature rise. This study aims to investigate, the phenomena of aggregation caused by mechanical stress (shaking and stirring) at different doses of Zytux monoclonal antibody (rituximab biosimilar) using size exclusion chromatography.
The production of aggregate products and antibody aggregation, which can lessen therapeutic effects and enhance immunogenicity, are caused by mechanical stress increasing protein molecules' interaction with hydrophobic surfaces, air/water surfaces, and other surfaces.
Methods: Zytux monoclonal antibody samples were prepared at different concentrations and subjected to mechanical stress by being stirred and shaken at constant speeds of 200 rpm. Throughout the experiment, samples were taken and examined regularly.
Results: The experimental findings indicated that a higher amount of aggregation occurred when mechanical stress was applied by shaking. The greater levels of mechanical stress produced during shaking instead of stirring might cause this rise. Furthermore, a positive trend associated with higher concentration levels has been seen in the aggregation level, mostly explained by Zytux's natural tendency to aggregate in high-concentration circumstances.
Conclusion: The results of this study emphasize how important it is to understand how mechanical stress affects Zytux stability and aggregation tendency. Since mechanical stress may be imposed throughout various processes, including manufacture, shipping, and product handling, this knowledge is especially important when it comes to formulation and storage conditions.