Aggregate analysis is done to identify potential protein aggregation that can contribute to the overall purity profile of a biotherapeutic. Aggregates may form due to several reasons, including storage conditions, handling conditions, formulation buffer components, etc. High molecular weight species are separated using size exclusion chromatography (SEC) and quantified using UV-Vis detectors.
KCAS can customize the aggregate analysis approach in a manner to best answer your questions.
KCAS can perform this analysis by using SEC coupled with UV detection to identify any aggregates or sub-visible particles in a dose formulation. KCAS also utilizes the same instrumentation and techniques to monitor bioanalytical reagents pre and post conjugation to biotin, sulfo-tag, etc.
Our long history of HPLC methods and deep understanding of biotherapeutics enables KCAS to customize the approach in a manner to best answer your questions. Conducting aggregate analysis of our reagents is one example of our commitment to ensure the highest quality of reagents are utilized in all aspects of bioanalysis.