RT info:eu-repo/semantics/article
T1 Validation of a size-exclusion chromatography method for bevacizumab quantitation in pharmaceutical preparations: application in a biosimilar study
A1 Oliva Martín, Alexis Manuel
A1 Llabrés Martínez, Matías Antonio
A2 Ingeniería Química y Tecnología Farmacéutica
A2 Desarrollo Galénico de Medicamentos
K1 biosimilar
K1 bevacizumab
K1 control charts
K1 validation
K1 analytical similarity
AB InMay 2019, the Food andDrugAdministration (FDA) proposed a quality range (QR)method for the comparative analytical assessment in biosimilar studies. In this process, several reference product lots are necessary, selected from a wide period of manufacturing dates with different shelf lives, to calculate the total variability expressed as the standard deviation of reference product lots. This one depends on the between-lots variation and analytic method uncertainty (i.e., within-lots variation). During this time, the analytical method must be in control and stable but with an appropriate accuracy and precision. In such a situation, various control charts were used to fix the method requirements and detect small changes in the process. The results indicate that the method is indeed in control and stable, but does not meet the requirements of the Analytical Target Profile (ATP) approach, independently of the established uncertainty range. However, it does satisfy the traditional approach for an uncertainty range of ±2%. The application of this new QR approach shows that the selection of reference lots has an impact on the estimated standard deviation of the reference product, and consequently on the QR, penalizing good test products. The contribution of the analytic method error is known and in-control through the validation process. However, the between-lots variation requires a higher attention and control by the manufacturer. All these aspects were analyzed, using simulation and real-data from various bevacizumab lots.
SN 2297-8739
YR 2019
FD 2019
LK http://riull.ull.es/xmlui/handle/915/39733
UL http://riull.ull.es/xmlui/handle/915/39733
LA en
DS Repositorio institucional de la Universidad de La Laguna
RD 22-dic-2024