Validation of a Size-Exclusion Chromatography Method for Bevacizumab Quantitation in Pharmaceutical Preparations: Application in a Biosimilar Study

摘要: In May 2019, the Food and Drug Administration (FDA) proposed a quality range (QR) method for comparative analytical assessment in biosimilar studies. this process, several reference product lots are necessary, selected from wide period of manufacturing dates with different shelf lives, to calculate total variability expressed as standard deviation lots. This one depends on between-lots variation analytic uncertainty (i.e., within-lots variation). During time, must be control stable but an appropriate accuracy precision. such situation, various charts were used fix requirements detect small changes process. The results indicate that is indeed stable, does not meet Analytical Target Profile (ATP) approach, independently established range. However, it satisfy traditional approach ±2%. application new QR shows selection has impact estimated product, consequently QR, penalizing good test products. contribution error known in-control through validation requires higher attention by manufacturer. All these aspects analyzed, using simulation real-data bevacizumab